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Tuberculosis Vaccine: In the United States and Around the World

There are several reasons it’s not available in the United States

• History and Modern Use

Which Countries Use It?

• In the U.S.

Efficacy and Side Effects

• Vaccine Ingredients

Frequently Asked Questions

The tuberculosis vaccine, also known as the bacille Calmette-Guérin (BCG) vaccine, is used to protect against tuberculosis (TB) and related complications. 

The BCG vaccine is no longer routinely given in the United States and isn’t recommended for the general population by the Centers for Disease Control and Prevention (CDC). However, it’s still given to babies and young children in many countries worldwide. The tuberculosis vaccine may also be considered in the United States for certain people with significant risk factors for prolonged exposure to TB.

In this article, we’ll go over the history and use of the tuberculosis vaccine, including which countries use it, age recommendations, effectiveness, side effects, and more.

Teka77 / Getty Images

History and Modern Use of Tuberculosis Vaccine

Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis . Usually, M. tuberculosis bacteria attack the lungs, which causes pulmonary TB. Symptoms of pulmonary tuberculosis include a severe, persistent cough, chest pain, and coughing up blood. Other symptoms of TB may include:

• Night sweats
• Lack of appetite
• Unwanted weight loss

In some cases, M. tuberculosis bacteria can attack other body parts, such as the spine, brain, or kidneys. Many people who are infected with TB don’t have any symptoms. This is known as latent TB infection (LTBI). People with LBTI can’t spread TB to others.

However, about 5 to 10% of people with LTBI develop active TB. People with TB disease have symptoms and can spread M. tuberculosis through actions like coughing, speaking, and singing. Screening for LTBI is recommended for anyone at greater risk of exposure to TB.  

If left untreated, TB can be serious and even fatal. Tuberculosis is especially dangerous for immunocompromised people, including people with human immunodeficiency virus (HIV).

In the early 1900s, the BCG vaccine was developed by researchers Albert Calmette and Camille Guérin to protect against tuberculosis and related complications. It was in wide use by the 1920s but fell out of favor after the Lübeck disaster in 1930 in which 73 infants tragically died in the first year after receiving a contaminated version of the vaccine. More than a decade later, the BCG vaccine came back in response to rising global tuberculosis rates after World War II.  

However, the tuberculosis vaccine is no longer routinely administered in the United States. Studies have shown mixed results in terms of the vaccine’s effectiveness. Some people who have received the vaccine may also get a false positive result on a tuberculin skin test (TST), which can complicate treatment plans and lead to confusion.

While BCG vaccination may cause a false-positive skin test result (when the test indicates that the disease is present when it is not), getting the BCG vaccine will not cause a false-positive TB blood test.

Additionally, the risk of TB in the United States is so low that the benefits of getting vaccinated may not outweigh the potential downsides.

Mandatory BCG vaccination is now somewhat controversial, but many countries with a high incidence of TB cases continue to vaccinate newborns just after birth. Globally, around 2 million–3 million people die from TB disease and related complications yearly. Deaths from tuberculosis are particularly common in developing countries and countries with high rates of HIV, as well as in environments like nursing homes, prisons, homeless shelters, and hospitals.  

In the United States, the CDC recommends that the BCG vaccine be considered only for the following groups:

• Children: Some children with a high risk of developing TB may benefit from BCG vaccination. This includes children who cannot be treated for tuberculosis and who live with adults who have untreated, ineffectively treated, or drug-resistant TB.
• Healthcare workers: Healthcare workers who are employed in settings where a large number of patients have drug-resistant TB and/or where tuberculosis treatments have failed may consider BCG vaccination, if recommended by their healthcare provider.

The BCG vaccine is given to infants on a regular basis in over 180 countries. According to the World Health Organization (WHO), many countries in Southeast Asia, sub-Saharan Africa, and the former Soviet Union have high rates of TB disease. There are also high TB rates in other parts of Europe, Africa, and Asia, as well as parts of the Americas.

Examples of countries where there is a high incidence of tuberculosis include:

• Democratic Republic of the Congo
• Philippines

Tuberculosis Vaccine Travel Restrictions and Requirements

The risk of developing drug-resistant TB disease is extremely rare while traveling internationally. However, your healthcare provider may recommend that your child receive the BCG vaccine if you are planning to travel to a country with high rates of TB if your child is under 5 years old.  If you plan to travel to a country with high rates of tuberculosis, especially drug-resistant tuberculosis, the CDC recommends a tuberculin skin test or blood test first. If you test negative, you should get another test eight to 10 weeks after returning to the United States. Make sure to take any recommended precautions against infection if you spend time in a high-risk environment, such as a healthcare setting.

Age Recommendations

The BCG vaccine is most effective in babies and children under 5. Older children and adults may not benefit as much from receiving it. However, people of all ages may still be considered for the vaccine if they have certain risk factors.

In areas where the BCG vaccine is routinely administered, it’s usually given to newborns. For example, the BCG vaccine is recommended for all newborns as part of the Hong Kong Childhood Immunisation Programme.

How Effective Is the Tuberculosis Vaccine in Children Ages 5 and Up?

Recent research suggests that the tuberculosis vaccine is only significantly effective in preventing severe disease in children under age 5. Among kids age 5 and up who haven’t had a positive TB test, some studies indicate that BCG vaccination doesn’t offer reliable protection against TB disease and related complications.

Tuberculosis Cases in the United States

In the United States, tuberculosis cases are relatively rare. In total, 8,300 TB cases were reported to the CDC’s National Tuberculosis Surveillance System in 2022. Rates of TB disease in the United States decreased consistently from 1993–2019.

They briefly declined sharply (by 19.9%) during the beginning of the COVID-19 pandemic in early 2020 and rose by 9.4% in 2021. Still, the overall number of U.S. TB cases in 2022 was lower than in 2019.

Evidence of the effectiveness of the tuberculosis vaccine is somewhat mixed. According to a 2022 systematic review and meta-analysis, the BCG vaccine was found to be 18% effective overall in protecting against tuberculosis disease and related complications.

It is primarily effective in infants and young children. It is, however, very effective in preventing young children from getting severe forms of tuberculosis like tuberculosis meningitis and miliary tuberculosis.

The most common side effects of the BCG vaccine are:

• Swollen glands in the armpit near the injection site
• A sore at the site of injection, which often releases discharge, scabs over, and leaves behind a scar
• Other skin reactions

Very rarely, BCG vaccination can lead to serious complications, such as abscesses or bone inflammation.

You shouldn’t get the tuberculosis vaccine if you:

• Are pregnant
• Are living with HIV
• Are immunocompromised
• Are allergic to any of the vaccine ingredients

BCG Vaccine Ingredients

The BCG vaccine is a live vaccine . It uses a weakened strain of Mycobacterium bovis (M. bovis), a bacterium closely related to the one that causes TB. Other ingredients include:

• Citric acid
• Magnesium sulfate
• Iron ammonium citrate
• Potassium phosphate

As with other vaccines, the tuberculosis vaccine has been thoroughly tested and vetted for safety.

The bacille Calmette-Guérin (BCG) vaccine, or tuberculosis vaccine, is used in certain countries worldwide to prevent tuberculosis (TB) infection and complications. Typically, the vaccine is given as a shot in the upper arm to infants just after birth. The tuberculosis vaccine is safe, but evidence of its effectiveness in protecting against TB is relatively mixed.

The BCG vaccine is no longer widely used in the United States. However, according to the CDC, the BCG vaccine may be considered for children and adults with a high risk of tuberculosis exposure. Examples include healthcare workers and children who are regularly cared for by adults with drug-resistant tuberculosis or untreated TB.

The TB shot is not given routinely in the United States. However, you can ask your healthcare provider about getting the vaccine if you have a significant risk factor for TB disease.

They may be able to give you the vaccine themselves in their office, or they may recommend that you visit a different clinic or local health agency to be vaccinated. A nearby TB control program may also offer vaccination.

In the United States, the TB vaccine is sometimes considered for people who test negative for TB and are continuously exposed to it regularly. Some examples of high-risk groups include certain healthcare workers and children who live with adults with drug-resistant TB. People who live or work in communal, crowded settings, such as prisons, homeless shelters, and certain hospitals, may also be at risk.

Up to 97% of people who receive the TB vaccine will develop a small scar at the injection site (typically the upper arm). Around two to four weeks after getting the vaccine, you may notice a raised “bubble” on the skin, which usually scabs over and heals within a few months. This is because of the skin’s reaction to the weakened form of Mycobacterium bovis , a bacterium closely related to the one that causes TB disease.

Correction - September 1, 2023: This article was updated to correct the BCG vaccine ingredients.

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U.S. Centers for Disease Control and Prevention. Basic TB facts .

U.S. Centers for Disease Control and Prevention. Signs & symptoms: TB .

U.S. Centers for Disease Control and Prevention. How TB spreads .

US Preventive Services Task Force, Mangione CM, Barry MJ, et al. Screening for Latent Tuberculosis Infection in Adults: US Preventive Services Task Force Recommendation Statement .  JAMA . 2023;329(17):1487-1494. doi:10.1001/jama.2023.4899

World Health Organization. BCG vaccine .

Luca S, Mihaescu T. History of BCG vaccine . Maedica (Bucur) . 2013;8(1):53-8. PMID: 24023600; PMCID: PMC3749764.

Food and Drug Administration. BCG vaccine package insert .

World Health Organization. 2.1 TB incidence .

NSW Health. Overseas travel with children .

U.S. Centers for Disease Control and Prevention. TB information for international travelers fact sheet .

Martinez L, Cords O, Liu Q, et al. Infant BCG vaccination and risk of pulmonary and extrapulmonary tuberculosis throughout the life course: a systematic review and individual participant data meta-analysis .  Lancet Glob Health . 2022;10(9):e1307-e1316. doi:10.1016/S2214-109X(22)00283-2

Family Health Service. Bacille Calmette-Guerin (BCG) Vaccine .

Schildknecht KR, Pratt RH, Feng PI, Price SF, Self JL. Tuberculosis — United States, 2022 . MMWR Morb Mortal Wkly Rep 2023;72:297–303. doi:10.15585/mmwr.mm7212a1

Trunz BB, Fine P, Dye C. Effect of BCG vaccination on childhood tuberculous meningitis and miliary tuberculosis worldwide: a meta-analysis and assessment of cost-effectiveness .  The Lancet . 2006;367(9517):1173-1180. doi:10.1016/S0140-6736(06)68507-3

National Health Service. BCG (TB) vaccine side effects .

Mohamed L, Madsen AMR, Schaltz-Buchholzer F, Ostenfeld A, Netea MG, Benn CS, Kofoed PE. Reactivation of BCG vaccination scars after vaccination with mRNA-Covid-vaccines: Two case reports . BMC Infect Dis . 2021;21(1):1264. doi:10.1186/s12879-021-06949-0

By Laura Dorwart Dr. Dorwart has a Ph.D. from UC San Diego and is a health journalist interested in mental health, pregnancy, and disability rights.

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A Look at Each Vaccine: Tuberculosis Vaccine

Vaccine education center.

The tuberculosis (TB) vaccine is rarely used in the United States. It is only recommended for children living with someone who is actively infected with TB who either (1) cannot take antibiotics to treat the infection or (2) is infected with a strain of TB that is highly resistant to all antibiotics. Decisions regarding this vaccine are typically made in consultation with a local TB control program. The TB vaccine is given as a single shot.

In most other countries, the vaccine for tuberculosis, known as the BCG vaccine, is used more commonly because of the frequency of tuberculosis.

The disease

The impact of tuberculosis.

Tuberculosis kills more people in the world than any other infection. Each year about 10 million people are infected with TB and about 1.8 million die. Cases of TB occur in the United States each year, but most are diagnosed in people not born in the U.S. In 2018, less than 10,000 cases of TB and fewer than 500 deaths were caused by TB.

What is tuberculosis?

Tuberculosis (TB) is caused by a bacterium,  Mycobacterium tuberculosis . The infection primarily attacks the lungs. The bacterium is so destructive that it is common to cough up both mucus and blood. Those less than 5 years old are susceptible to a severe, often fatal, form of TB (called "miliary" TB) that spreads to many parts of the body, including the lining of the brain (meninges).

Extremely contagious, TB is spread through the simple act of sneezing, talking and coughing. Many people who are infected don't get sick right away; rather, the bacteria remain dormant, reactivating years, even decades, later. That's when lung disease and the characteristic cough begin.

A tuberculin skin test (TST; also sometimes called a PPD test, which stands for “purified protein derivative”) and chest X-ray are the best ways to tell if someone is infected with TB. A blood test can be used in older children and adults.

Is the incidence of TB in the United States increasing?

The incidence of tuberculosis had been steadily increasing in the United States since the 1980s coincident with the HIV epidemic. However since 1993, a slow decline in the number of cases has occurred likely due to better control of HIV with the use of anti-retroviral drugs. Unfortunately, the rate of decline is so slow that predictions suggest tuberculosis will not be eliminated from the United States during this century.

The vaccine

How is the tuberculosis vaccine made.

Known as BCG, the TB vaccine has been around since the early 1920s. It is made by weakening a strain of bacteria similar to tuberculosis that was first isolated in cows. This strain of bacteria, called  Mycobacterium bovis , is similar enough to the human strain ( Mycobacterium tuberculosis ) that vaccination with the bovine strain protects against disease caused by the human strain.

Does the tuberculosis vaccine have side effects?

Soreness at the site of the injection is common. About 3 of every 10,000 people immunized with the tuberculosis vaccine develop painful swelling under the arm.

Who should get the tuberculosis vaccine?

The tuberculosis vaccine is recommended only for those children living with someone with TB who either cannot take the antibiotics required to treat the infection or who is infected with a strain that is highly resistant to all antibiotics. Ultimately, only a small number of people in the United States fall into these categories.

Other questions you might have

Since tb is increasing in the united states, why isn't the vaccine recommended for everyone at risk of catching the disease.

The TB vaccine is good at protecting against the severe form of disease found in young children (called "miliary" TB), but it is not as good at protecting against the lung infection commonly found in adolescents and adults. Because miliary TB is very uncommon in the United States, we do not routinely use the TB vaccine. The United States is one of only two countries that have never routinely used the TB vaccine (The Netherlands is the other).

If we are not routinely using the tuberculosis vaccine, what are we doing to stop the spread of tuberculosis in the United States?

The United States does two things to stop the spread of TB. First, people who are actively or silently infected with TB are identified by performing regular skin tests (referred to as either TST or PPD). Second, once identified, people with TB are treated with one or more antibiotics that are effective against the bacteria: specifically, isoniazid (or INH), rifampin, ethambutal or pyrazinamide.

Relative risks and benefits

Do the benefits of the tuberculosis vaccine outweigh its risks.

The tuberculosis vaccine is not highly effective at preventing lung infections caused by the tuberculosis bacteria. For this reason, the vaccine is only recommended for a small subset of those in contact with someone infected with tuberculosis ─ specifically someone in constant contact with a person infected with TB who either refuses to take antibiotics or is infected with a strain that is resistant to all antibiotics. On the other hand, the tuberculosis vaccine has no serious side effects. Therefore, in the small subset of people who should use the vaccine, the benefits clearly outweigh the risks.

Disease risks

• Coughing up blood and mucus 
• Antibiotics don’t always work
• Can lead to miliary TB, particularly in children, spreading to other parts of the body including the meninges
• Disease can be fatal

Vaccine risks

• Pain at the injection site
• Painful, swelling under the arm (3 in 10,000 people) 
• May not protect against more common type of tuberculosis

Plotkin SA, Orenstein W, Offit PA and Edwards KM. Tuberculosis vaccines in Vaccines, 7th Edition, 2018, 1095-1113.

Centers for Disease Control and Prevention. Data and Statistics . September 6, 2019.

Schmit KM, Wansaula Z, Pratt R, Price SF, Langer AJ. Tuberculosis-United States, 2016. MMWR Morb Mortal Wkly Rep 2017; 66:289-296.

Materials in this section are updated as new information and vaccines become available. The Vaccine Education Center staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family's personal health. You should not use it to replace any relationship with a physician or other qualified healthcare professional. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult your physician or, in serious cases, seek immediate assistance from emergency personnel.

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Vaccines for Travelers

Vaccines protect travelers from serious diseases. Depending on where you travel, you may come into contact with diseases that are rare in the United States, like yellow fever. Some vaccines may also be required for you to travel to certain places.

Getting vaccinated will help keep you safe and healthy while you’re traveling. It will also help make sure that you don’t bring any serious diseases home to your family, friends, and community.

On this page, you'll find answers to common questions about vaccines for travelers.

Which vaccines do I need before traveling?

The vaccines you need to get before traveling will depend on few things, including:

• Where you plan to travel . Some countries require proof of vaccination for certain diseases, like yellow fever or polio. And traveling in developing countries and rural areas may bring you into contact with more diseases, which means you might need more vaccines before you visit.
• Your health . If you’re pregnant or have an ongoing illness or weakened immune system, you may need additional vaccines.
• The vaccinations you’ve already had . It’s important to be up to date on your routine vaccinations. While diseases like measles are rare in the United States, they are more common in other countries. Learn more about routine vaccines for specific age groups .

How far in advance should I get vaccinated before traveling?

It’s important to get vaccinated at least 4 to 6 weeks before you travel. This will give the vaccines time to start working, so you’re protected while you’re traveling. It will also usually make sure there’s enough time for you to get vaccines that require more than 1 dose.

Where can I go to get travel vaccines?

Start by finding a:

• Travel clinic
• Health department
• Yellow fever vaccination clinic

Learn more about where you can get vaccines .

What resources can I use to prepare for my trip?

Here are some resources that may come in handy as you’re planning your trip:

• Visit CDC’s travel website to find out which vaccines you may need based on where you plan to travel, what you’ll be doing, and any health conditions you have.
• Download CDC's TravWell app to get recommended vaccines, a checklist to help prepare for travel, and a personalized packing list. You can also use it to store travel documents and keep a record of your medicines and vaccinations.
• Read the current travel notices to learn about any new disease outbreaks in or vaccine recommendations for the areas where you plan to travel.
• Visit the State Department’s website to learn about vaccinations, insurance, and medical emergencies while traveling.

Traveling with a child? Make sure they get the measles vaccine.

Measles is still common in some countries. Getting your child vaccinated will protect them from getting measles — and from bringing it back to the United States where it can spread to others. Learn more about the measles vaccine.

Find out which vaccines you need

CDC’s Adult Vaccine Quiz helps you create a list of vaccines you may need based on your age, health conditions, and more.

Take the quiz now !

Get Immunized

Getting immunized is easy. Vaccines and preventive antibodies are available at the doctor’s office or pharmacies — and are usually covered by insurance.

Find out how to get protected .

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Bacille Calmette-Guérin (BCG) Vaccination for Tuberculosis (TB)

Bacille Calmette-Guérin (BCG) vaccine is a live vaccine that gives variable protection against tuberculosis (TB).

In NSW, BCG vaccination is recommended for specific groups most at risk of TB.

​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​About the BCG vaccine

The tuberculosis (TB) vaccine is called the bacille Calmette-Gu é rin (BCG) vaccine. TB is a disease caused by TB bacteria that is spread through the air from person to person. TB of the lungs is the most common type although TB can occur anywhere in the body and can cause severe illness. TB can be cured with special antibiotics. More information is available from the TB factsheet . 

BCG vaccination is more effective in babies and children than adults. BCG vaccination provides more than 70% protection against severe types of TB in young children (such as TB of the brain). The BCG vaccine is given by injection just under the skin on the upper arm. 

The BCG vaccine can take 3 months to provide protection against TB. The BCG vaccine should ideally be given 3 months before travel to a country where TB is common . BCG vaccination loses its effectiveness over time, usually within 5 to 15 years.

Live vaccine

BCG is a live vaccine. People who need more than one live vaccine injection should either: 

• have all their live vaccines injected on the same day, or 
• allow at least 4 weeks between the BCG and other live injected vaccines.

Watch for TB symptoms 

Who should have a bcg vaccination.

In NSW, BCG vaccination is recommended for: 

• children younger than 5 years of age who are traveling for 4 weeks or more to a country or countries where TB is common
• children younger than 5 years of age considered by TB services to be at ongoing risk of TB exposure in Australia 
• children younger than 5 years of age who live with someone with Hansen’s disease (leprosy)
• healthcare workers travelling overseas to work in a country where BCG vaccination is required or strongly recommended.

Pre-vaccination assessment

A tuberculin skin test (Mantoux test or TST) is needed prior to BCG vaccination if you: 

• were born in a country where TB is common  
• have lived or travelled to a country or region where TB is common 
• have been in close contact with a person with lung TB. 

BCG vaccination is not recommended if you have a positive tuberculin skin test, low immunity, or a current illness with fever.

BCG vaccination sore

After vaccination it is normal for a sore to form where the needle went in. Normally, the sore should take a few weeks to form a red bump, then an open sore, and a few months to heal to a small, flat scar. If the sore forms within 1 week it is considered a fast or accelerated reaction, and it is important to call the clinic where the vaccination was given.

If you or your child do not get a BCG sore within 6 weeks of vaccination, call the clinic where the BCG vaccination was given. Some people may respond more slowly to the vaccination. In rare cases, a person may not have a response to the vaccine, not get a BCG sore and not be protected against TB. If you do not have a response to the vaccine, re-vaccination is not recommended.

How to look after your BCG vaccination sore

• keep the area clean and dry 
• carefully pat the area dry after baths or showers 
• keep the area uncovered where possible 
• do not cover with plastic dressings or sticking plasters such as ‘Band-Aids’ 
• do not use creams or ointments. 

If the sore starts to ooze you can cover it with a piece of loose, sterile cloth (e.g. gauze) that is taped down at the edges but still allows air to get in. 

You can continue to do all your normal activities such as baths, showers, swimming, and sports.

More information is available at  how to care for your BCG vaccination sore.

Are there any side effects ​with BCG vaccination?

BCG vaccination is very safe, and side-effects are generally mild. Occasional side effects include: 

• fast or accelerated BCG vaccination sore development 
• painful, red and swollen BCG vaccination sore 
• swelling of the glands in the armpit or neck 
• very notifiable scarring of the skin at the injection site, known as keloid scarring. 

Very rare side effects include  wid espread BCG infection which can be treated with antibiotics. 

If you have any concerns or experience any side effects, please contact the clinic where you or your child were vaccinated or your after-hours healthcare provider. 

More information

• For more information on TB or contact details of your local TB clinic, visit  Tuberculosis .
• You can request a BCG vaccination​ .

Translations

Translations of this fact sheet are available in:

• Bengali / বাংলা
• Traditional Chinese / 繁體中文
• Simplified Chinese / 简体中文
• Filipino / Tagalog
• French / Français
• Hindi / हिंदी
• Indonesian / Bahasa Indonesia
• Nepali / नेपाली
• Portuguese / Português
• Telugu తెలుగు
• Vietnamese / Tiếng Việt Nam

• Future Perfect

Every year, tuberculosis kills over a million people. Can a new vaccine turn the tide?

For the last 100 years, we’ve only had one TB vaccine — and it leaves a lot to be desired.

by Jess Craig

It’s 2024, and people are still dying from ... consumption.

This ancient disease, known today as tuberculosis or TB, has plagued humanity for thousands of years , and as recently as a few hundred years ago, was thought to be responsible for some 25 percent of all deaths in Europe and North America.

Inside this story

• Why tuberculosis is so deadly — and so neglected • How the current vaccine works and where it falls short • The latest progress in new TB vaccine development

Today, TB is both preventable and treatable — there’s a century-old vaccine, effective antibiotics, and known behavioral and sanitation safeguards that disrupt transmission. Yet in 2022, more than 10 million people globally still fell ill from TB and 1.3 million died, making it the second deadliest infectious disease that year. (More people die from TB generally, but Covid-19 temporarily outpaced it.) More than 80 percent of those TB cases and deaths occur in low- and middle-income countries.

That’s largely because people in those countries are more likely to suffer from contributing risk factors to TB, such as malnourishment and HIV.

But beyond those factors, when it comes to preventing illness and death in these regions, physicians, researchers, and public health officials say that the available vaccine and treatments don’t do enough: The vaccine is given to infants and only offers protection in the first few years of life, leaving large swaths of people at risk, while antibiotic treatments take months to cure the disease.

“TB is a disease of poverty,” explained Helen McShane , professor of vaccinology at the University of Oxford, where she and her team are developing a new TB vaccine among other TB research. “There have been decades of neglect where there was no funding for new drugs or new vaccines for TB.”

But for the first time, promising new vaccines are now in the pipeline and may help prevent TB in adolescents and adults who currently have no such protection. These vaccines might also be more effective than what we have right now. Several are undergoing phase 3 trials — the last step before vaccine makers can apply to international and national agencies for approval.

“It is excellent news,” said Matteo Zignol, unit head of the WHO’s Global Tuberculosis Programme. The success of the first wave of vaccines has helped usher in more support and funding to the field, but many researchers say we will need more than just a few effective vaccines. “We all wish [the M72/AS01E vaccine trial] is going to be a successful trial, but in any case, this is going to be like a first generation sort of new vaccine, and we really need more candidates to be able to help the epidemic.”

It’ll likely still take years for the vaccines to be rolled out, but if approved, the new vaccines have the potential to save hundreds of thousands of lives, making an enormous dent in a disease that has killed humans for millennia.

Why do we need another TB vaccine?

One of the strange things about tuberculosis is that having the bacterium that causes TB doesn’t mean you have the disease. In a 2016 paper published in PLOS Medicine , researchers estimated that nearly 25 percent of the world’s population has a latent TB infection. For most people, though, the bacteria remain dormant and never go on to cause disease.

Basic preventative measures — such as improving sanitation, ensuring proper ventilation in hospitals and laboratories, and proactively identifying and treating high-risk patients — helped greatly reduce TB cases in developed countries like the US, where there were around 8,000 TB cases reported in 2022. Many lower-income countries, unfortunately, still have underdeveloped public health systems and lack the resources to implement the multipronged approach necessary to stamp out TB. That is where vaccination can be a critical tool.

The world’s first and only available TB vaccine, the Bacille Calmette-Guérin (BCG) vaccine, was created in 1921. Given the low burden of TB in the US, BCG is not routinely given to infants, but it is commonly used in many other countries. In Africa and Southeast Asia — the regions with the highest TB burden — 80 and 91 percent of 1-year-olds received the BCG vaccine in 2022, respectively, according to estimates by the WHO.

The BCG vaccine is considered safe with rare side effects, but it’s not very effective. One meta-analysis of 26 studies reported that when the BCG vaccine was given during infancy, it was 37 percent effective against all forms of TB during the first five years of life, but did not offer protection among adolescents and adults.

The way TB infects someone also plays a role in how contagious the disease can be and limits the vaccine’s ability to prevent disease. Usually, TB infects the lungs — that’s pulmonary TB. But Mycobacterium tuberculosis can infect the liver, bones, spinal cord, brain, urinary tract, bladder, kidneys, and even the intestines. When TB infects organs other than the lungs, it’s called extrapulmonary TB. Individuals with extrapulmonary disease don’t usually infect others, while those with TB in their lungs can more easily spread the bacterium to others by breathing, coughing, or sneezing.

Pulmonary infections account for the majority of TB morbidity and mortality. Exact percentages vary by country, but globally around 63 percent of all TB cases were pulmonary in 2021, according to the WHO. BCG vaccine efficacy against pulmonary TB infections still remains a bit of a mystery as studies have reported efficacy rates ranging from 0 to 80 percent and efficacy tends to be lowest in high-burden countries close to the equator.

Researchers are not quite sure why this is. One theory is that those who live closer to the equator are more likely to be exposed to non-tuberculous mycobacteria, which are similar to the pathogen that causes TB. This exposure confers preexisting immunity which may actually hinder the BCG vaccine from doing its job, McShane said.

All in all, researchers estimate that the BCG vaccine prevents only 5 percent of all vaccine-preventable deaths due to TB. For comparison, vaccines for measles, smallpox, and polio are 93 , 95 , and 90 percent effective in preventing disease, respectively.

So why now? What can a new TB vaccine actually accomplish?

Despite the limitations of the BCG vaccine, no new vaccine candidates have emerged in the past 100 years. M. tuberculosis is notoriously difficult to make a vaccine for because the bacterium has an adept ability to evade the human immune system. As Vox’s Dylan Matthews reported last year, “TB is a hard disease to vaccinate against. While most vaccines target viruses, TB is a bacterium, and one with a strange lifecycle.”

Economic and political factors play a role as well. After many high-income countries made huge strides in reducing TB in the late 1990s and early 2000s, they allocated few resources to further research and development of new vaccines and treatments, focusing instead on other health threats such as cancer and cardiovascular disease. TB fell into the category of neglected diseases.

McShane recalled when her team conducted the first trials of a new generation TB vaccine in 2002. “At the time, there were about 50 candidate vaccines being tested for malaria and about 50 for HIV,” she said. “Of course, for both of those pathogens, there is a Western market. There is no Western market for a TB vaccine.”

Since then, however, there have been renewed efforts to eradicate TB. The emergence of drug-resistant TB has threatened to reverse what global gains against TB have been made and may even cause a TB resurgence in the US and other low-burden countries, spurring more attention and funding to the disease. The Global Fund and the Stop TB Partnership have also launched major advocacy campaigns to bring more attention to the epidemic.

Additionally, in 2016 , the World Health Organization set a goal to end the TB epidemic by 2030 . The US government has also ramped up investments in global TB eradication efforts. In the 2023 fiscal year, the US contributed more than $400 million to the cause, nearly double its total investments for global TB in fiscal year 2013.

As of last year, there are 16 new TB vaccine candidates in development, four of which are in phase 3 clinical trials — which, if successful, would likely be the last phase of trials before FDA or WHO approval. Some vaccines aim to replace the BCG vaccine altogether while other candidates will serve as boosters to the BCG vaccine among adolescents and adults, McShane explained.

One vaccine, M72/AS01E, seems to be the most promising candidate, buoyed by support and funding from the Bill and Melinda Gates Foundation. In a phase 2B clinical trial conducted in South Africa, Kenya, and Zambia, more than 3,500 adults with latent TB were randomly assigned to receive either two doses of the M72/AS01E vaccine or a placebo. Initial vaccine efficacy was 54 percent. Three years later, a follow-up analysis revealed that the vaccine had prevented active TB cases in 49.7 percent of people who received the vaccine.

Most other TB vaccine candidates have demonstrated similar efficacy rates. “It’s unlikely that we’re going to get a vaccine against tuberculosis that is 100 percent effective anytime soon,” McShane said.

But even a TB vaccine with low efficacy can have profound global implications. If the M72/AS01E vaccine demonstrates safety and efficacy in the ongoing phase 3 trial, then for the first time, the world could prevent at least a good portion of infections among adolescents and adults.

“One of the big issues is that even if we’ll have a vaccine, it’ll be a game changer, but the effectiveness is around 50 percent. So it’s not one of the best, but it is something,” said Eliud Wandwalo, head of TB at the Global Fund to Fight AIDS, Tuberculosis and Malaria .

Given the relatively low efficacy rates, these new TB vaccines are not a silver bullet for eradicating TB globally. For most of the world, improvements in sanitation, infrastructure, and medication are also urgently needed. Currently, it takes six months of ongoing therapy to cure TB, and as drug-resistant strains of TB become more common, existing antibiotics will become less and less useful. The vaccine will be just one of the tools in the toolbox, Wandwalo said.

“If you look at the trajectory and projections, if we continue the same pace with the same tools, we’ll be ending TB in the next 180 years,” he said. “It’s a dire projection. But I think with a vaccine, we are likely to be able to end TB in our lifetime.”

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• About the Handbook

Vaccination for international travellers

Ensure that travellers are up to date with routine vaccines. Also consider other vaccines based on travel itinerary, activities and risk of disease exposure.

Recently added

This page was added on  09 June 2018 .

Updates made

This page was updated on 23 October 2023 .  View history of updates

Millions of Australians travel overseas every year. More than half of these trips are to destinations other than New Zealand, North America and Europe. 1

This page helps with making decisions about travel vaccines. Also check the disease-specific chapters in this Handbook for details about specific vaccines.

See also Infographic. Vaccination for international travellers .

Health risks of overseas travel

Health risks associated with international travel include exposure to:

• infective agents
• altitude and temperature extremes
• other physical, psychological and environmental hazards
• poor-quality or limited access to clean water, shelter, hygiene and sanitation facilities, and health and medical care

The level of health risks depends on factors such as:

• the traveller’s underlying physical and mental health and physiological state
• the itinerary and activities undertaken
• the duration of exposure to various hazards during travel

Travellers at increased risk of serious travel-associated infections include:

• young children and infants
• pregnant women
• people with underlying medical conditions, especially immunocompromising conditions due to disease or medical treatment
• people spending extended periods in multiple regions with poor resources or in remote areas
• people participating in events where large numbers of people will gather, such as major sporting, cultural, social or religious events
• migrant families travelling back to their region of origin to visit friends and relatives

Those travelling to visit friends and relatives are more likely to: 2

• have closer contact with local populations
• stay in remote or rural areas
• consume higher-risk food and beverages

Those travelling to visit friends and relatives are less likely to: 2,3

• recognise the health risks associated with travelling
• seek pre-travel health advice
• obtain the recommended vaccines or prophylaxis

Common infections acquired by travellers

Exposure to infectious diseases is one of the many health hazards of international travel. Some of these diseases are vaccine preventable. Although some of these diseases are present in Australia, the risk of acquiring them overseas may be higher because of:

• higher disease incidence in other countries
• increased risk of exposure from participating in certain activities while travelling

Foodborne and waterborne infections

It is common for travellers to ingest contaminated food or beverages, resulting in an illness. 4-6  Practicing safe eating and drinking habits is essential to minimise the risk of contracting food and waterborne diseases while travelling. These include treating water or only drinking bottled water, avoiding undercooked meat, and avoiding raw fruit and vegetables (unless they can be peeled or washed in safe water prior to eating). Most infections are diarrhoeal diseases due to enteric pathogens, but some are due to extra-intestinal microorganisms, such as hepatitis A virus and Salmonella enterica serotype Typhi (causing typhoid).

Vaccines are available against hepatitis A, typhoid and cholera.

Vector-borne infections

Insect-borne — especially mosquito-borne — infections, such as malaria and dengue, are important causes of fever in Australian travellers returning from endemic areas, particularly Southeast Asia and Oceania. 4,6

A dengue vaccine (Dengvaxia) is available for the prevention of secondary dengue infections (not primary prevention of initial dengue infection ) in select individuals. See Clinical advice: ATAGI statement on use of Dengvaxia® for Australians .

Japanese encephalitis occurs throughout much of Asia and the Western Pacific region, including eastern Indonesia and Papua New Guinea. 7 Yellow fever occurs only in parts of Africa and South America, 8 and tick-borne encephalitis occurs in parts of Europe and Asia. 9

Vaccines are available against Japanese encephalitis , yellow fever and tick-borne encephalitis .

Some other vector-borne diseases and parasitic (including protozoal and helminthic) diseases are also important for international travellers. Some are preventable through appropriate barrier precautions and chemoprophylaxis (for example, malaria). 9

Aerosol-borne infections

Vaccine-preventable infections transmitted by aerosols and/or droplets include: 9

• influenza (the most common vaccine-preventable infection among travellers) 10
• meningococcal disease
• varicella (chickenpox)

The incidence of measles and mumps is higher in many overseas countries, including some developed countries, than in Australia.

Tuberculosis is a rare infection in travellers. 11 Expatriates who live in endemic areas for a long time are more likely to acquire tuberculosis than short-term visitors. 12

Vaccines are available against all of these diseases.

Bloodborne and sexually transmitted infections

Some Australian travellers may be at risk from bloodborne and sexually transmissible infections, such as chlamydia, gonorrhoea, hepatitis B, hepatitis C and HIV. In some areas, healthcare workers using non-sterile medical equipment or other poor infection control practices may transmit these viruses and other bloodborne agents.

Vaccines are available against hepatitis B.

Exotic infectious agents

Travellers may be exposed to a variety of other exotic infections, such as:

• rabies from bites or scratches from rabid dogs, bats and other mammals in many countries
• schistosomiasis from exposure to water infested with the parasites, especially in Africa
• leptospirosis through activities such as rafting or wading in contaminated streams

Of these diseases, vaccines are available only against rabies.

Recommending travel vaccines

Although recommending appropriate vaccines is important, it is not the only part of a pre-travel medical consultation. Travel vaccines — those relevant for travelling — include all relevant vaccines, not just the ones that prevent diseases that most commonly occur overseas.

Do not recommend a vaccine based only on the destination country, because there is no single ‘correct’ list of vaccines for travel to any particular country.

There are 3 categories of travel vaccines:

• routinely recommended vaccines (not specific to travelling overseas)
• selected vaccines based on travel itinerary, activities and likely risk of disease exposure
• vaccines required by the International Health Regulations 2005 (IHR) or for entry into specific countries

Questions for a pre-travel medical consultation

During a pre-travel medical consultation, ask questions about the traveller’s:

• personal information, including age and whether they are pregnant or planning pregnancy
• underlying medical conditions, particularly immunocompromising conditions, and current medicines
• vaccination history (including adverse events following immunisation) and allergy history
• purpose of travel and intended activities, especially those associated with various environmental risks and hazards
• plans for travel insurance

Also ask about their itinerary in detail, including:

• date of departure and time available for vaccinations
• specific localities and routes
• rural versus urban stay
• duration of stay
• likely access to health care and other services
• likelihood of changing the planned itinerary

This information helps to tailor recommendations about preventive vaccination or chemoprophylaxis for exposure risks during the proposed trip. It also allows the clinician to advise about other appropriate preventive health measures (for example, food and water precautions, avoiding bites from mosquitoes or other arthropods) and about managing possible health conditions during travel.

Organisational requirements for vaccination

Some overseas organisations, such as schools, colleges and universities, require evidence of vaccination or immunity against some vaccine-preventable diseases, such as measles and meningococcal disease. Consider these requirements when planning and scheduling vaccines before departure.

Routinely recommended vaccines (not specific to travelling overseas)

Vaccinate all prospective travellers according to the recommended vaccination schedule appropriate for their age, underlying health conditions, occupation and lifestyle. Vaccines might include, for example, pneumococcal polysaccharide vaccine for an older person, or hepatitis B vaccine for a first aid officer. 

Also ensure that all children are vaccinated according to the National Immunisation Program schedule. In exceptional circumstances, give the National Immunisation Program vaccines at the minimum age rather than the recommended age (see Table. Minimum acceptable age for the 1st dose of scheduled vaccines in infants in special circumstances ). Children vaccinated using the minimum age rather than the recommended age may need extra vaccine doses to ensure adequate protection. Observe the minimum interval requirements between doses (see Table. Minimum acceptable dose intervals for children <10 years of age ). The chances of being exposed to some diseases, such as measles and mumps, may be greater during overseas travel, even to other developed countries.

For some itineraries, it may be appropriate for the traveller to receive some booster doses earlier than the routine recommended time. An example may be diphtheria-tetanus booster.

Diphtheria, tetanus and pertussis

Vaccinate adult travellers against tetanus before departure, particularly if:

• their risk of sustaining a tetanus-prone wound is high
• there could be delays in accessing health services where they can receive tetanus toxoid boosters safely, if required

Offer dTpa vaccine during a pre-travel consultation if the traveller has never received a dose of dTpa . This provides protection against pertussis (see Pertussis ). 

For high-risk travel, consider giving a booster dose of either dTpa or dT vaccine if more than 5 years have passed (see Tetanus ).

Hepatitis B

Most Australian children born since 2000 have been vaccinated against hepatitis B under the National Immunisation Program or state and territory school-based vaccination programs.

Hepatitis B vaccine is recommended for long-term or frequent travellers to regions of intermediate or high endemicity of hepatitis B, including:

• Central and South America

This is because travellers may be exposed to hepatitis B virus through bloodborne routes (including during emergency medical or dental procedures) or sexual routes. According to 1 survey, about half of Australian travellers who spent at least 3 nights in Southeast or East Asia participated in at least 1 activity that had a risk of hepatitis B transmission. 13

See also Hepatitis B .

Influenza and pneumococcal disease

Older travellers and those with any relevant underlying medical or behavioural risk factors should receive pneumococcal vaccine. See Pneumococcal disease for more details.

Consider influenza vaccine for all travellers, especially if they are travelling to a region during its influenza season. Influenza vaccine is particularly relevant if:

• there is an influenza epidemic at the traveller’s destination
• the person is travelling in a large tourist group, especially one that includes older people
• the person is travelling on cruises, where people are relatively confined for days to weeks

See also Influenza. 

Measles, mumps and rubella

Inadequately vaccinated young adult travellers are responsible for most current measles outbreaks in Australia. This occurs when they acquire the infection overseas and bring it back to Australia. Some countries, regions or communities — including developed countries — have a higher incidence of measles and mumps than Australia. 9

Australians born during or since 1966 who have not received the recommended 2 doses of MMR (measles-mumps-rubella)–containing vaccines are recommended to receive MMR vaccine before travelling. This also applies to infants 6–12 months old travelling to areas with measles outbreaks or where measles is endemic . The exception is for pregnant women, because MMR is a live vaccine and is contraindicated in pregnancy. 

People born before 1966 do not need to receive measles-containing vaccine (unless serological evidence indicates that they are not immune). This is because circulating measles virus and disease were prevalent before 1966, so most people would have acquired immunity from natural infection .

However, confirmed cases of measles have occurred in people born before 1966. 14 If in doubt about a person’s immunity, it may be faster and easier to vaccinate the person than conduct serological testing . See Serological testing for immunity to measles . 

See also Measles . 

Unvaccinated travellers are recommended to receive varicella vaccine if they either:

• have not had clinical disease, or
• have an uncertain history of clinical disease and serology shows a lack of immunity 

The exception is for pregnant women, because varicella vaccine is a live vaccine and is contraindicated in pregnancy.

See also Varicella .

Meningococcal disease

Vaccination against meningococcal serogroups A, C, W-135, Y and B is recommended for certain age and population groups who are at increased risk of meningococcal disease.

In addition, MenACWY (quadrivalent meningococcal) vaccine is recommended for people who are:

• planning travel to, or living in, parts of the world where epidemics of serogroup A, C, W-135 or Y meningococcal disease occur, particularly the ‘meningitis belt’ of sub-Saharan Africa 15
• planning travel to mass gatherings, such as pilgrims travelling to the Hajj in Saudi Arabia

Seek up-to-date epidemiological information to determine whether a traveller needs meningococcal vaccination. See Accessing up-to-date travel information.

The Saudi Arabian authorities require that all pilgrims travelling to Mecca (for the Hajj or Umra) have evidence of recent vaccination with the quadrivalent meningococcal vaccine. 16  See Requirements for travellers to Mecca and Accessing up-to-date travel information .

See also Meningococcal disease .

Poliomyelitis

Ensure that all travellers are age-appropriately vaccinated against polio (see Poliomyelitis ).

If the person is travelling to a country where wild poliovirus is still circulating, they should receive inactivated poliovirus ( IPV ) vaccine if they have not completed a 3-dose primary course of any polio vaccine. Travellers who have completed the primary course should receive a single booster dose.

The World Health Organization (WHO) Global Polio Eradication Initiative website website has an up-to-date list of polio-affected countries.

Documented evidence of polio vaccination is not routinely required for travellers under the International Health Regulations. However, documented evidence of vaccination may be temporarily required according to WHO recommendations in response to new evidence of the spread of wild poliovirus (see Vaccines required by the International Health Regulations or for entry into specific countries and Documentation and certificates ).

International polio epidemiology and associated travel requirements can change. Check the Australian Government Department of Health website for current recommendations for Australian travellers .

Ensure that all travellers are age-appropriately vaccinated against COVID-19. Foreign governments may require evidence of COVID-19 vaccination before a traveller is allowed to enter. The Australian-issued International COVID-19 Vaccination Certificate is a secure way to prove COVID-19 vaccination history that has been developed to meet agreed international travel standards. Parents and carers of children <14 years of age, adolescents ≥14 years of age and adults can get a copy of their COVID-19 vaccination certificate at any time:

• using their Medicare online account through myGov
• through the Medicare Express Plus mobile app
• by calling 1800 653 809 (free call)

See also COVID-19 .

Vaccines based on travel itinerary, activities and likely risk of disease exposure

Use a risk assessment approach when recommending travel vaccines. Weigh the potential risks of disease exposure and protective benefits from vaccination against potential adverse effects, and the non-financial and financial costs of vaccination.

Prioritise vaccines for diseases that are:

• common and of significant impact, such as influenza and hepatitis A
• less common, but have severe potential adverse outcomes, such as Japanese encephalitis and rabies

Consider booster doses, where appropriate (see disease-specific chapters in this Handbook for recommendations). If the person is departing for travel soon, consider an accelerated schedule, if appropriate, such as for hepatitis B vaccine or the combination hepatitis A-hepatitis B vaccine (see Hepatitis A and Hepatitis B ). Although immunity may be established sooner with the accelerated schedule, people who receive an accelerated schedule need another dose about a year later to complete the course and ensure long-term protection.

Most travellers do not need cholera vaccine. 16,17  The risk of a traveller acquiring cholera is very low if they avoid contaminated food and water.

No country requires travellers to have certification of cholera vaccination. No country has official entry requirements for cholera vaccination

See also Cholera .

Hepatitis A

Hepatitis A vaccine is recommended for all travellers ≥1 year of age travelling to moderately or highly endemic countries (including all developing countries). The exceptions are people who have evidence of natural immunity after previous infection .

Normal human immunoglobulin is no longer used to protect travellers against hepatitis A.

See also Hepatitis A .

Japanese encephalitis

While now considered an emerging disease in Australia, Japanese Encephalitis is more likely in travellers to endemic regions overseas. 18 Japanese encephalitis ( JE ) vaccine is recommended for travellers spending a month or more in endemic areas in Asia, Papua New Guinea or the outer islands of Torres Strait during the JE virus transmission season.

Consider JE vaccination for shorter-term travellers, particularly if:

• travel is during the wet season 
• travel may be repeated
• the person will spend a lot of time outdoors 
• the person’s accommodation has no air-conditioning, screens or bed nets

Check a reputable source before travel for information about JE virus activity — for example, Health Information for International Travel (the ‘Yellow Book’) . 19

A traveller’s overall risk of acquiring JE in these JE - endemic countries is likely to be low (<1 case per 1 million travellers). Determine the specific risk according to the: 17

• season of travel
• regions visited 
• duration of travel
• extent of outdoor activity
• extent to which the person avoids mosquito bites 

See also Japanese encephalitis .

Before travel to rabies- endemic regions, advise people about:

• the risk of rabies infection
• avoiding close contact with wild, stray and domestic animals — especially dogs, cats, monkeys and bats 
• the importance of appropriate immediate wound care of all animal bites and scratches 

See also Rabies and other lyssaviruses, including Australian bat lyssavirus .

Recommendations for rabies vaccination as pre-exposure prophylaxis

When deciding whether to give a pre-travel prophylactic rabies vaccination, assess the:

• likelihood of exposure to potentially rabid animals
• access to appropriate health care and availability of post-exposure prophylaxis , including rabies immunoglobulin , should there be an at-risk exposure
• timeliness of access to health care after exposure

Use a lower threshold for recommending rabies pre-exposure prophylaxis for children travelling to endemic areas.

Benefits of vaccination as pre-exposure prophylaxis

Pre-travel rabies vaccination:

• ensures that the traveller has received a safe and efficacious vaccine
• simplifies the management of a subsequent exposure because the person will need fewer doses of vaccine
• means that rabies immunoglobulin — which is often extremely expensive, and difficult or even impossible to obtain in many developing countries — is not needed
• reduces the urgency of post-exposure prophylaxis

Tick-borne encephalitis

Tick-borne encephalitis (TBE) is caused by a tick-borne RNA flavivirus. The disease may involve the central nervous system. TBE is prevalent in parts of central and northern European temperate regions, and across northern Asia. Travellers are at risk when hiking or camping in forested areas in endemic regions during the summer months.

Safe and effective vaccines are available. Vaccination is recommended only for people with a high risk of exposure.

TBE vaccine is not registered in Australia, but a small stock of vaccine may be available for use under the Special Access Scheme .

Tuberculosis

Vaccination with BCG (bacille Calmette–Guérin) vaccine is generally recommended for tuberculin-negative children <5 years of age who will be staying in high-risk countries for an extended period (3 months or longer).

Vaccinating older children and adults appears to be less beneficial. However, consider vaccinating tuberculin-negative children aged ≥5 years but <16 years who may be living or travelling for long periods in high-risk countries.

A high-risk country is one that has a tuberculosis incidence of >40 per 100,000 population.

For travellers who need BCG vaccine, consider the following precautions when scheduling their vaccination visits:

• If possible, give BCG vaccine at least 3 months before the person will arrive in an endemic area.
• Give other live viral vaccines (for example, MMR , varicella, yellow fever) at the same time or with a minimum 4-week interval after BCG vaccination.
• A tuberculin skin test (TST; Mantoux), performed by trained and accredited healthcare practitioners, is recommended before receiving BCG vaccine for all individuals (except infants aged <6 months).
• People may suppress reactions to tuberculin for 4–6 weeks after viral infections or live viral vaccines, particularly measles infection and measles-containing vaccines.

State and territory tuberculosis services can provide tuberculin skin tests and BCG vaccine.

See also Tuberculosis .

Typhoid vaccine may be recommended for travellers ≥2 years of age travelling to endemic regions, including: 

• the Indian subcontinent
• most Southeast Asian countries 
• several South Pacific nations, including Papua New Guinea 

This advice is also relevant for those travelling to endemic regions to visit friends and relatives.

Inactivated parenteral and live oral typhoid vaccine formulations are available.

See also Typhoid fever .

Yellow fever

Yellow fever vaccine is recommended for all people ≥9 months of age travelling to, or living in, an area with a risk of yellow fever virus transmission. 20

To minimise the risk of introducing yellow fever, some countries require documented evidence of yellow fever vaccination for entry, in line with the International Health Regulations (see Vaccines required by the International Health Regulations or for entry into specific countries ).

When assessing the need for yellow fever vaccination, consider:

• the risk of the person being infected with yellow fever virus
• country entry requirements
• individual factors such as age, pregnancy and underlying medical conditions 

Vaccination is generally not recommended for travel to areas with a low probability of yellow fever virus exposure — that is: 

• where human yellow fever cases have never been reported 
• where evidence suggests only low levels of yellow fever virus transmission in the past 

However, consider vaccination for a small subset of travellers to lower-risk areas who are at increased risk of exposure to mosquitoes or who are unable to avoid mosquito bites. 20

People aged ≥60 years are at increased risk of severe adverse events after primary yellow fever vaccination. Weigh the adverse effects of vaccinating people in this age group against the potential for yellow fever virus exposure and, in turn, the benefits of vaccination. 17

See also Yellow fever .

Booster doses

Most people do not need a booster dose of yellow fever vaccine. A single dose induces protective antibody levels that last for many decades. However, certain people are recommended to receive a booster if their last dose was more than 10 years ago and they are at ongoing risk of yellow fever virus infection . See Yellow fever .

Vaccines required by the International Health Regulations or for entry into specific countries

Yellow fever requirements.

The International Health Regulations require yellow fever vaccination for travelling in certain circumstances. This is to:

• protect travellers who are likely to be exposed to yellow fever 
• stop importation of the virus into countries that have the relevant vectors (see Yellow fever ).

Some countries may require documented evidence of yellow fever vaccination as a condition of entry or exit (see Planning and documenting vaccines ). This includes countries that do not currently have yellow fever circulating.

Australia’s yellow fever travel requirements are detailed in the Australian Government Department of Health’s yellow fever fact sheet .

Contact the relevant embassies or consulates in Australia to confirm the entry requirements for yellow fever vaccination for the countries a traveller intends to enter or transit through. 

Requirements for travellers to Mecca

Each year, Saudi Arabia’s Ministry of Health publishes the requirements and recommendations for entry visas for travellers on pilgrimage to Mecca (Hajj and Umra). 16

For pilgrims travelling directly from Australia, only evidence of MenACWY vaccination is currently mandatory. However, check the current requirements when advising prospective Hajj and Umra pilgrims (see Meningococcal disease and Accessing up-to-date travel information ).

Temporary requirements

The International Health Regulations may temporarily introduce requirements for other vaccine-preventable diseases in response to changes in disease epidemiology that are of international health concern. An example is for polio vaccination.

Because country vaccination requirements are subject to change at any time, confirm all current vaccination requirements for the countries a traveller intends to enter or transit through before travel. See Poliomyelitis and Accessing up-to-date travel information .

Planning and documenting vaccines

Ideally, start vaccination courses early enough before departure to allow:

• monitoring of any possible adverse events 
• time for adequate immunity to develop

Requirements for multiple vaccines

A traveller may need multiple vaccines before they depart. Apply the standard recommendations and precautions when giving multiple vaccines (see Administration of vaccines ).

A traveller may need more than 1 clinic visit if they need multiple vaccines or doses (for example, rabies pre-exposure prophylaxis or hepatitis B vaccine). Pay special attention to scheduling of these visits, and consider:

• dose interval precautions (for example, for multiple live vaccines)
• requirements for pre-vaccination tests (for example, tuberculin skin test)
• potential interference by some antimalarials, if relevant (for example, rabies vaccine)

Documentation and certificates

It is important to document travel vaccines: 

• in the clinic’s record
• in the traveller’s record that they can carry with them 
• on the Australian Immunisation Register

The record should also include all the other routinely recommended vaccines that the traveller has ever received. 

For yellow fever vaccination, a traveller needs to have an International Certificate of Vaccination or Prophylaxis (ICVP), which only Yellow Fever Vaccination Centres can provide under the International Health Regulations (see Yellow fever ). 

Travellers may also need an ICVP for other vaccine-preventable diseases, such as polio, based on temporary recommendations.

See also Accessing up-to-date travel information .

Vaccinating travellers with special risk factors

See Vaccination for women who are planning pregnancy, pregnant or breastfeeding , Vaccination for people who are immunocompromised and the disease-specific chapters in this Handbook for recommendations for travellers who are pregnant or immunocompromised.

Accessing up-to-date travel information

International travellers’ health risks constantly change. Up-to-date information, and knowledge of the changing epidemiology and current outbreaks of infectious and emerging diseases are essential. Reliable online information sources include:

• World Health Organization (WHO) for disease outbreak news, and its Travel and health section for specific advice on travel and health, including travel vaccination recommendations
• Travelers’ health , United States Centers for Disease Control and Prevention (CDC)
• Travel health information , Australian Government Department of Health
• Smartraveller , the Australian Government’s travel advisory and consular information service, which provides up-to-date advice about health, safety and other risks of specific destinations for Australian travellers

The following resources have comprehensive technical advice on international travel and health, including vaccination:

• the latest edition of WHO’s International travel and health
• the CDC’s Health Information for International Travel (the ‘Yellow Book’)
• Australian Bureau of Statistics. 3401.0 – Overseas arrivals and departures, Australia, Mar 2018 (accessed May 2018). 
• Paudel P, Raina C, Zwar N, et al. Risk activities and pre-travel health seeking practices of notified cases of imported infectious diseases in Australia. Journal of Travel Medicine 2017;24(5):tax044.
• Heywood AE, Watkins RE, Iamsirithaworn S, Nilvarangkul K, MacIntyre CR. A cross-sectional study of pre-travel health-seeking practices among travelers departing Sydney and Bangkok airports. BMC Public Health 2012;12:321.
• Chen LH, Leder K, Barbre KA, et al. Business travel-associated illness: a GeoSentinel analysis. Journal of Travel Medicine 2018;25.
• Angelo KM, Kozarsky PE, Ryan ET, Chen LH, Sotir MJ. What proportion of international travellers acquire a travel-related illness? A review of the literature. Journal of Travel Medicine 2017;24.
• Freedman DO, Weld LH, Kozarsky PE, et al. Spectrum of disease and relation to place of exposure among ill returned travelers. New England Journal of Medicine 2006;354:119-30.
• Halstead SB, Hills SL, Dubischar K. Japanese encephalitis vaccines. In: Plotkin SA, Orenstein WA, Offit PA, Edwards KM, eds. Plotkin's vaccines. 7th ed. Philadelphia, PA: Elsevier; 2018.
• Staples JE , Monath TP, Gershman MD, Barrett AD. Yellow fever vaccines. In: Plotkin SA, Orenstein WA, Offit PA, Edwards KM, eds. Plotkin's vaccines. 7th ed. Philadelphia, PA: Elsevier; 2018.
• World Health Organization (WHO). Chapter 6: Vaccine-preventable diseases and vaccines . In: International travel and health. Geneva: WHO; 2017. 
• Steffen R. Travel vaccine preventable diseases-updated logarithmic scale with monthly incidence rates. Journal of Travel Medicine 2018;25.
• Denholm JT, Thevarajan I. Tuberculosis and the traveller: evaluating and reducing risk through travel consultation. Journal of Travel Medicine 2016;23.
• Lachish T, Tenenboim S, Schwartz E. 35 - Humanitarian Aid Workers. In: Keystone JS, Kozarsky PE, Connor BA, et al., eds. Travel Medicine (Fourth Edition). London: Elsevier; 2019. (Accessed 6 July 2023). https://www.sciencedirect.com/science/article/pii/B9780323546966000355
• Leggat PA, Zwar NA, Hudson BJ. Hepatitis B risks and immunisation coverage amongst Australians travelling to Southeast Asia and East Asia. Travel Medicine and Infectious Disease 2009;7:344-9.
• Winkler NE, Dey A, Quinn HE, et al. Australian vaccine preventable disease epidemiological review series: measles, 2012-2019. Commun Dis Intell (2018) 2022;46.
• World Health Organization (WHO). Epidemic meningitis control in countries of the African meningitis belt, 2017. Weekly Epidemiological Record 2018;93:173-84.
• World Health Organization (WHO). International travel and health: health conditions for travellers to Saudi Arabia for the pilgrimage to Mecca (Hajj) . 2017 (accessed May 2018). 
• Freedman DO, Chen LH. Vaccines for International Travel. Mayo Clinic Proceedings 2019;94:2314-39.
• Furuya-Kanamori L, Gyawali N, Mills DJ, et al. The Emergence of Japanese Encephalitis in Australia and the Implications for a Vaccination Strategy. Trop Med Infect Dis 2022;7.
• Hills SL, Rabe IB, Fischer M. Infectious diseases related to travel: Japanese encephalitis . In: CDC yellow book 2018: health information for international travel. New York: Oxford University Press; 2017. 
• World Health Organization (WHO). International travel and health (accessed Apr 2018). 

Page history

Minor updates to clinical guidance around routinely recommended vaccines (not specific to travelling overseas), including the addition of advice regarding COVID-19.

Editorial update to reflect changes to pneumococcal vaccine recommendations for older adults and people with medical risk factors.

Guidance on vaccination of travellers against measles, mumps and rubella updated to reflect advice in the Measles chapter.

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• Frequently Asked Questions About TB

For the General Public:

What is TB?

What are the symptoms of tb, how is tb spread, is there a difference between tb infection, and tb disease, what should i do if i have spent time with someone with a tb infection, what should i do if i have been exposed to someone with tb disease, how do i get tested for tb, who can administer a tuberculin skin test (tst), how often can tsts be repeated, where can i get tested for tb, what does a positive tb test mean, can i get vaccinated for tb, what if someone has received the bcg vaccine (which is given in many countries), why is tb infection treated, how is tb disease treated, how many people in texas have tb, for health care professionals.

• What are the recommendations for screening health care personnel (HCP) for tuberculosis upon hire?
• How often should HCPs be screened for TB after hire? Is annual testing recommended?
• If annual testing with a TST or blood test is no longer routinely recommended, should HCP be checked for symptoms of TB periodically?

How should I screen my employees for TB upon hire if they say they already have a positive TB skin or blood test?

Can a new hire’s documented negative tuberculin skin test (tst) result be used in performing a baseline two-step tst.

• What do I need to know if my HCW has received a BCG vaccine?

Are routine or annual CXRs still recommended?

Can my employee with a positive tb skin or blood test return to work.

• What further actions do I need to take when HCPs are diagnosed with TB infection or TB disease?
• Should HCP be treated for TB infection?

Have the updated 2019 guidelines for screening HCPs for TB changed the need for a facility risk assessment?

Does dshs have a sample form that healthcare facilities may use to document tb screening, testing, and education.

• Are there TB screening forms for health care professionals?

Where can I find more information regarding screening healthcare personnel for TB?

Tb and covid-19.

• Do COVID-19 and TB share similar symptoms?

Are there recommendations to delay TB screening in persons recently vaccinated against COVID-19?

General reporting requirements, how do i report tuberculosis screening results, recommendations for tb screening of adults and children in various settings, are there general recommendations about which adults should and should not be screened for tb in texas, and how to screen them, are there general recommendations about which children should and should not be screened for tb in texas, and how to screen them, what are the screening requirements for tb testing in facilities that provide care to children, what are the screening requirements for tb testing in adult care centers such as assisted living facilities, for schools, do all employees in texas schools still need a tuberculin skin test, do all new students in texas schools still need a tuberculin skin test, for correctional settings, are correctional facilities in texas required to screen inmates and employees for tb, other resources, what are other recommended sites where i can find information about tuberculosis, for the general public.

Tuberculosis (TB) is a disease caused by germs that spread from person to person through the air. TB usually affects the lungs, but it can also affect other parts of the body, such as the brain, the kidneys, or the spine. A person with TB can die if they do not get treatment.  

The general symptoms of TB disease include:

• Feelings of sickness or weakness
• Weight loss
• Night sweats.

The symptoms of TB disease of the lungs also include:

• Coughing up blood

Symptoms of TB disease in other parts of the body depend on the area affected.  

TB germs go into the air when a person with TB disease of the lungs or throat coughs, sneezes, speaks, or sings. These germs can stay in the air for several hours, depending on the environment.  People who breathe in air containing these TB germs can become infected.  This is called TB infection or latent TB infection (LTBI). If untreated, TB infection can become TB disease.   

People with TB infection have TB germs in their bodies, but they are not sick because the germs are not active. These people do not have symptoms of TB disease and they cannot spread the germs to others. However, they may develop TB disease in the future. They are often prescribed treatment to prevent them from developing TB disease.

People with  TB disease  are sick from TB germs that are active, meaning that they are multiplying and destroying tissue in their bodies.  They usually have symptoms of TB disease.  People with TB disease of the lungs or throat are capable of spreading germs to others. They are prescribed drugs that can treat TB disease.  

A person with TB infection cannot spread germs to other people. You do not need to be tested if you have spent time with someone with a TB infection. However, if you have spent time with someone with TB disease or someone with symptoms of TB, you should contact your doctor or  local or regional health department  for TB screening recommendations.  

Not everyone who is exposed to TB becomes infected with the TB germs. If you believe you have been exposed to TB, you should contact your doctor or the local health department for more information about screening and testing.  

Two tests can be used to help detect TB infection: a skin test or a TB blood test.

The Mantoux  tuberculin skin test (TST)  is performed by injecting a small amount of fluid (called tuberculin) into the skin in the lower part of the arm. A person given the TST must return within 48 to 72 hours to have a trained healthcare worker look for a reaction on the arm; this must be done in person.

The  TB blood test , known as the Interferon Gamma Release Assay (IGRA), measures how the patient’s immune system reacts to the germs that cause TB when present. There are currently two Federal Drug Administration (FDA) approved blood tests on the market: the QuantiFERON®–TB Gold In-Tube test (QFT-GIT) and the T-SPOT®.TB test (T-Spot).

Although the tuberculin skin test has been the most common screening method in Texas, many health departments now use the IGRA test as the standard tool. When choosing a skin test or blood test, consideration can be made based on age, health status (see  policy TB 1004 ), BCG status, and other factors of the person needing the test. 

A positive TST or IGRA only tells you if you have TB germs in your body. Other tests may be needed to tell if you have TB disease, such as a chest x-ray (CXR) and other laboratory testing of sputum.  

A tuberculin skin test (TST) is considered a medical act and should only be performed by an individual working under the order of a licensed physician. There is no requirement for the individual to be a licensed healthcare worker. DSHS recommends those who administer a TST meet knowledge and clinical skills requirements, have received training, and demonstrate competency before administering a TST.

The Texas DSHS TB Program recommends that anyone who administers a TST has reviewed, is familiar with, and can readily access the recommendations within the following documents:

• CDC Fact Sheet  “Tuberculin Skin Testing”
• CDC fact sheet  “Targeted Tuberculin Testing and Interpreting Tuberculin skin Test Results”
• CDC  Mantoux Tuberculin Skin Testing Facilitator Guide
• Tubersol package insert
• Aplisol package insert

In-person training on how to administer a TST is available through the Heartland National TB Center.  For a listing of TB training opportunities, visit the  Heartland National TB Center website .  

In general, there is no risk associated with repeated tuberculin skin test placements. If a person does not return within 48-72 hours for a tuberculin skin test reading, a second test can be placed as soon as possible. There is no contraindication to repeating the TST unless a previous TST was associated with a severe reaction.  

In general, the Texas Department of State Health Services does not recommend that low-risk individuals be tested for tuberculosis. If a test is needed or recommended, the general public may ask their primary care provider, local clinics, or pharmacies, among other sites. You may also contact your  local or regional health department  for recommendations regarding individual testing needs.  

A person with a positive TST or blood test has a TB germ in their body. It does not tell whether or not the person has TB infection or TB disease. Other tests, such as a chest x-ray, symptom screening, and testing of sputum (phlegm), are needed to determine whether the person has TB infection or TB disease.  

There is a vaccine for TB, but it is not generally recommended for use in the United States.  Bacille Calmette-Guérin, or BCG , is a vaccine used in many countries with high rates of TB. BCG vaccination does not completely prevent people from getting TB, but it is used to protect infants and young children from serious, life-threatening diseases, specifically miliary TB and TB meningitis.  

In many parts of the world where TB is common,  Bacille Calmette-Guérin, (BCG) vaccine  is used to protect infants and young children from serious, life-threatening diseases, specifically miliary TB and TB meningitis. However, it does not completely prevent people from getting TB.

The  effect of the BCG vaccine  wanes over time and may have little to no effect on positive TST results among adults who received the vaccine as a child.  

A person with a history of BCG vaccination can be tested and treated for TB infection if they react to the TST.   TST reactions  should be interpreted based on risk stratification regardless of BCG vaccination history. IGRAs use M. tuberculosis-specific antigens that do not cross-react with BCG, and therefore, do not cause false positive reactions in BCG recipients— this means a blood test, or IGRA, is preferred for BCG-vaccinated individuals.  

If you have TB infection but not TB disease, your doctor may want you to take a drug to kill the TB germs and prevent you from developing TB disease. The decision about taking treatment for TB infection will be based on your chances of developing TB disease. Some people are more likely than others to develop TB disease once they have a TB infection. This includes people with HIV infection, people who were recently exposed to someone with TB disease, and people with certain medical conditions.  

TB disease can be treated by taking multiple drugs for several months, generally 6 to 12 months. People who have TB disease must finish the medicine and take the drugs exactly as prescribed. If they stop taking the drugs too soon, they can become sick again; if they do not take the drugs correctly, the germs that are still alive may become resistant to those drugs. TB that is resistant to drugs is harder and more expensive to treat. In some situations, local health department staff meets regularly with patients who have TB to watch them take their medications. This is called directly observed therapy (DOT). DOT helps the patient complete treatment in the least amount of time.

DSHS provides TB medications to public health clinics across Texas. These clinics treat patients with TB disease. Also, people who are presumed to have TB may be given treatment while their clinicians perform further testing to confirm or rule out TB disease.

Each year, DSHS provides information on the number of TB cases per county. The most current information is found on the  TB statistics page .

What are the recommendations for screening health care personnel (HCP) for tuberculosis upon hire? 

The Department of State Health Services (DSHS) in partnership with the National Tuberculosis Controllers Association (NTCA) and Centers for Disease Control and Prevention (CDC), recommends that both paid and unpaid healthcare personnel (HCP) receive the following upon hire:

• A single blood test known as an interferon-gamma release assay (IGRA) or a two-step tuberculin skin test (TST) ;
• An individual risk assessment to determine baseline risk for TB and interpret the IGRA or TST results; and
• A signs and symptoms screening assessment.

DSHS developed a sample  Baseline Tuberculosis Assessment for Health Care Personnel form  that may be used by healthcare facilities. DSHS also recommends completing the  Tuberculosis Screening Results and Work Clearance for Health Care Personnel  after performing a baseline TB assessment.

These recommendations may be used by healthcare facilities and other entities to guide the development of their internal TB screening policies. These recommendations should not be interpreted as DSHS policies.  

After hire, how often should HCPs be screened for TB? Is annual testing recommended?

Annual TB testing using an IGRA or TST is not  routinely  recommended. Healthcare facilities should perform TB testing and complete a signs and symptoms assessment after known or ongoing exposure to TB or complete a signs and symptoms assessment annually for HCPs with untreated TB infection.  HCPs should also be educated about TB treatment options for TB infection.

We developed a sample  After Hire Tuberculosis Assessment for Health Care Personnel form  that may be used for HCPs with untreated TB infection or anytime an HCP is tested for TB after hire.

*Annual TB testing using an IGRA or TST and symptom screening may be considered for HCP with significant occupational risks, such as pulmonologists or respiratory therapists in high-risk settings, or in settings where TB exposures have occurred in the past (i.e. emergency departments). This decision should be developed by the healthcare staff responsible for infection control and may be made in collaboration with your local health department.  

If annual testing with a TST or blood test is no longer  routinely  recommended, should HCP be checked for symptoms of TB periodically?

We recommend that facilities consider the local epidemiology of  TB in their county , including  risk factors for TB  in their staff, and any past TB exposures in the facility when deciding to implement periodic TB screening after baseline testing. The purpose of screening for TB using a signs and symptoms assessment questionnaire is to ensure active TB is identified early. Anyone with symptoms of TB should be referred for medical evaluation.   

HCPs with documentation of a previous positive TST or IGRA result, or documentation confirming completion of treatment for TB infection or disease, should be screened for TB in the following way:

• Complete a TB signs and symptoms assessment.
• Have a baseline chest x-ray (CXR) performed (unless a recent copy is available).

HCP with documentation of a previous positive TST or IGRA result should not be re-tested with a TST or IGRA.

After the baseline screening, serial or routine CXRs are not recommended; however, persons exhibiting symptoms of TB disease require a CXR regardless of history.

HCP  without documentation  of the previous test result should undergo baseline screening with a two-step TST or an IGRA. An  individual risk assessment  and signs and symptoms screening assessment should also be completed (refer to  Baseline Tuberculosis Assessment for Health Care Personnel ). Copies of the TB screening results and responses to the symptom screen and individual risk assessment should be kept by the employee as documentation in case of future screenings.

Yes, a new hire’s documentation of a negative TST result can be recorded as step one of the two-step TST  when administered at any time during the previous 12 months, if the result was documented in millimeters (mm).  The TST administered at hire will be recorded as step two of the two-step TST.

For more details, refer to the  Guidelines for Preventing the Transmission of M. TB in Health-Care Setting, 2005  TB Infection-Control Surveillance.  

What do I need to know if my employee has received a BCG vaccine?

The IGRA and TST are not contraindicated for persons who have been vaccinated with Bacillus Calmette–Guérin (BCG). The effectiveness of BCG wanes over time but it may cause a false-positive reaction to the TST, which may complicate decisions about diagnosing TB infection and prescribing treatment. IGRAs use M. tuberculosis-specific antigens that do not cross-react with BCG, and therefore, do not cause false positive reactions in BCG recipients.  This means an IGRA test is preferred for BCG-vaccinated individuals.  More information can be found on the  CDC website .  

No, chest X-rays should not be performed routinely or annually for persons with a positive IGRA or TST. Healthcare personnel, patients, or institutional residents with a baseline positive or newly positive IGRA or TST result who are likely to be infected with TB should receive one chest radiograph to exclude a diagnosis of TB disease. Repeat chest x-rays are not needed unless signs or symptoms of TB develop, or a clinician recommends a repeat chest radiograph, or after a new exposure to TB.

Healthcare personnel who have a previously positive IGRA or TST result and who change jobs should carry documentation of the results of their IGRA or TST, chest radiograph, and documentation of treatment history for TB infection, if applicable, to their new employer.  

HCPs who are  likely   * infected with TB  based on a positive TST or IGRA result and individual risk should be referred for a CXR and medical evaluation to rule out active TB before returning to work. If a diagnosis of  TB infection  is made, the HCP may return to work, as TB infection is not contagious. They should be educated on treatment options for TB infection to reduce their chance of developing TB disease.

HCPs who are asymptomatic, unlikely* to be infected with TB, and who are at low risk for progression to TB disease based on individual risk, should have a second test (either an IGRA or a TST) if their first test is positive. Only when the second test is positive in low-risk individuals is TB infection considered an  accurate diagnosis .

HCPs with TB infection should be offered treatment by  CDC guidelines , after discussion with a licensed healthcare provider.  *determining if an individual is likely or unlikely to be infected with TB is based on the results of an  individual risk assessment . Refer to the following for more details on diagnosing TB infection:  academic.oup.com/cid/article/64/2/e1/2629583 .  

What further actions do I need to take when HCPs are diagnosed with TB infection or TB disease? 

TB infection, TB disease, and suspicion of TB disease are all reportable to your  local health department . See  How do I report TB?  for reporting requirements.   

Should HCPs be treated for TB infection? 

Treatment for TB infection should be considered in all persons to prevent the progression of TB disease. This  decision  should be made between the HCP and their healthcare provider.

When facilities screen for TB, DSHS recommends that an annual education component be included in the screening plan. Education can include information on the signs and symptoms of TB, the difference between TB infection and disease, TB risk factors, and the risks of developing TB disease if not treated.  

No, facility risk assessments are still recommended. The results of the assessment are no longer used to determine the frequency of TB screening but are useful in documenting infection control in facilities. Refer to the  CDC website  for more details on the use of the risk assessment and updates to the 2019 guidelines.  

Yes. DSHS has developed the following forms that facilities may use or modify to fit their need.

• Baseline Tuberculosis Assessment for Health Care Personnel . It is intended for use in healthcare facilities when assessing employees for TB upon hire.
• After Hire Tuberculosis Assessment for Health Care Personnel . It is intended for use in healthcare facilities when assessing employees for TB any time after baseline screening.
• Tuberculosis Screening Results and Work Clearance for Health Care Personnel . It allows facilities to document the results of baseline and after-hire screening including the recommended annual education.

These forms are not required by DSHS but may be used to guide and document facility screening practices, as they align with DSHS and CDC recommendations.  

Are there TB screening forms for healthcare professionals?

Yes. You can find a list of forms on the TB Forms and Resources page .  

Refer to the  Centers for Disease Control and Prevention (CDC) website  for more information.  

Do COVID-19 and TB share similar symptoms? 

Yes, TB and COVID-19 have some similar symptoms such as a cough or a fever. Only a licensed healthcare provider can determine the cause of symptoms and further testing may be needed. For healthcare providers, it is important to “Think TB” when symptoms and risk factors for TB are present. See  Tuberculosis and COVID-19 Know the Difference  for details.  

No, TB screening should not be delayed for people with risk factors for TB who have been vaccinated against COVID-19. The Centers for Disease Control and Prevention (CDC) has  information about TB screening practices and the COVID-19 vaccine .

It is recommended that those in charge of TB screening visit the CDC website periodically for any updates regarding TB screening practices.  When considering the impact of TB in your area, please consult with your  regional or local health department  (R/LHD). Report suspected and confirmed TB infections to your R/LHD.  

Both TB infection and TB disease are  Notifiable Conditions  reportable to the  local or regional health department  TB Programs. Reporting details can be found on the DSHS website, which includes  reporting forms . 

Tuberculosis Infection-  Reportable within one (1) week to the local or regional health department.  A diagnosis of a latent TB infection is NOT complete until the following criteria have been met:

• Positive skin test with results written in millimeters and date read, or positive IGRA blood test results; and
• Documentation that the patient has no current  signs or symptoms  of active tuberculosis disease; and
• CXR results that are read as normal, or not consistent with TB; and
• There is no suspicion of Active TB disease

TB Disease or Suspicion of TB Disease-  Reportable within one (1) working day.  

Yes, the DSHS TB Unit has recommendations for TB screening of adults in Texas, depending on identified TB risk factors. Please refer to the information in  Tuberculosis Screening Recommendations for Adults in Various Settings (TB-1002) .  

Yes, the DSHS TB Unit has recommendations for TB screening of children in Texas, depending on identified TB risk factors. Please refer to the information in  Tuberculosis Screening Recommendations for Children in Various Settings (TB-1003) .  

Facilities with a permit or license from Texas Health and Human Services (HHS) to provide care to children will abide by the chapters that apply to each type of facility in the  Texas Administrative Code (TAC) Title 26, Part 1 .

The  Minimum Standards page  on the HHS website contains links to the standards related to daycare facilities, 24-hour residential care, and child-placing agencies. These links are located at the bottom of the page.

Any facilities that provide care to children and are not listed above should first review the Texas Administrative Code for any statutory requirements or check with their licensing or credentialing agency. Collaboration with a  local or regional TB program  may assist in developing screening, testing, and treatment plans.  

Screening requirements for adults working in these facilities are outlined in the  Long-Term Care Regulatory Provider Letter :

• Assisted Living Facility
• Day Activity and Health Services Facility
• Intermediate Care Facility for Individuals with an Intellectual Disability or Related Conditions
• Home and Community Support Services Agency
• Nursing Facility, and
• Prescribed Pediatric Extended Care Center 

Facilities licensed by HHS for adult care in  Type A and Type B Assisted Living Facilities  will abide by  Texas Administrative Code (TAC) Title 26 Part 1 Chapter 553 Subchapter E Rule §553.261B . TB requirements are summarized below; however, each facility should review the TAC for specific details:

• Facilities must develop written policies for the control of communicable diseases in employees and clients, including TB screening and the provision of a safe and sanitary environment for clients and their families.
• Screen employees for TB within two weeks of employment.
• After hire, facilities must follow  CDC guidance in Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019 . See  FAQs for Health Care Professionals .
• Facilities must screen residents for TB upon admission and after exposure to TB. Any facilities that provide care to adults and are not listed above review the Texas Administrative Code for any statutory requirements or check with their licensing or credentialing agency. Collaboration with a  local or regional TB program  may assist in developing screening, testing, and treatment plans.  

There is no statewide requirement for teachers or other school employees to have a tuberculin skin test or TB blood test. The Centers for Disease Control and Prevention (CDC) and DSHS discourage the use of tuberculin skin testing or IGRA blood tests for persons who have no risk factors for TB exposure.

However, anyone with  signs or symptoms  of TB should be considered for medical evaluation.

Specifications for employee or volunteer TB screening may be required by a licensing, credentialing, or insurance policy, or by the school district’s regulations and requirements. Each school should defer to its policy.  

No. A tuberculosis questionnaire has been developed by the Texas Department of State Health Services to identify children at high risk for TB infection. Refer to the  list of counties with a high incidence of TB  where the use of the questionnaire is recommended before entering school. As resources allow, school districts in other counties may use the TB questionnaire to identify children who should receive a TB skin test before school entry.

Children who have a positive reaction to the TB skin test but have no symptoms of TB disease should  NOT  be kept out of school while they are being evaluated for treatment of TB infection.

The American Academy of Pediatrics (AAP) recommends that physicians routinely assess a child's risk of TB exposure with a questionnaire and offer tuberculin skin testing only to at-risk children. The AAP does not recommend routine tuberculin skin testing of children with no TB risk factors for school entry, daycare attendance, WIC eligibility, or camp attendance.

A tuberculin skin test may be applied on the same day as routine immunizations. The skin test will need to be read 48-72 hours later. If a skin test is not placed on or before the day of a live virus immunization such as measles-mumps-rubella (MMR), then the skin test should be postponed for at least six weeks.

For more information about TB screening for children in school settings visit the following links:

• Recommendations for TB Screening of School Aged Children
• Tuberculosis Questionnaire in English
• Tuberculosis Questionnaire (en Español)  

The law (Chapter 89 of the Texas Health & Safety Code) in Texas requires county correctional facilities that meet any one of three criteria to screen all inmates for TB by the seventh day of incarceration and annually thereafter, and to screen all employees and volunteers both pre-employment and annually thereafter. 

The three criteria are as follows:

• a capacity of 100 or more beds, 
• housing inmates transferred from a county that has a jail with a capacity of 100 or more beds, or 
• housing inmates from another state. 

The law also requires all correctional facilities in the state, including youth detention facilities, regardless of whether they meet the criteria stated above, to report to the Texas Department of State Health Services, Infectious Disease Intervention and Control Branch, the release of inmates being treated for TB so that the Department can arrange for continuity of care.  

Centers for Disease Control and Prevention:

• Basic TB Facts  
• Tuberculosis Fact Sheet  
• Frequently asked questions about HIPAA Privacy Rule

Medical Consultation:

• TB Medical Consultation Process

Tuberculosis (TB)

• How to Report Tuberculosis
• TB News and Announcements
• TB Epidemiology Reports and Fact Sheets
• Epi Profile Section 1 - An Overview of Tuberculosis in Texas
• Epi Profile Section 2 - Geographic Distribution of TB in Texas
• Epi Profile Section 3 - Affected Populations
• Epi Profile Section 4 - Case Diagnosis
• Epi Profile Section 5 - Recent Transmission
• Epi Profile Section 6 - Mortality
• Epi Profile Section 7 - At-Risk Populations
• Epi Profile Section 8 - Drug Resistant Tuberculosis
• Epi Profile Section 9 - Public Health Follow-Up Outcomes
• Epi Profile Section 10 - Reporting Requirements
• Epi Profile Section 11 - References
• Epi Profile - Data Tables
• Annual Tuberculosis Screening Report for Jail Administrators
• Binational TB Program - Data
• Binational TB Program - Education and Training Materials
• Binational TB Program - Frequently Asked Questions Espanol
• Binational TB Program - Manual and Forms
• Binational TB Program - Referral Criteria
• Binational TB Program - TB Binational Contacts
• TB Surveillance Resources and Reporting Instructions
• TB Forms Resources
• DSHS-Recognized Tuberculosis Medical Consultants
• National Electronic Disease Surveillance System (NEDSS) for Tuberculosis Programs

DSHS TB Program

Travel vaccination advice

If you're planning to travel outside the UK, you may need to be vaccinated against some of the serious diseases found in other parts of the world.

Vaccinations are available to protect you against infections such as yellow fever , typhoid and hepatitis A .

In the UK, the  NHS routine immunisation (vaccination) schedule protects you against a number of diseases, but does not cover all of the infectious diseases found overseas.

When should I start thinking about the vaccines I need?

If possible, see the GP or a private travel clinic at least 6 to 8 weeks before you're due to travel.

Some vaccines need to be given well in advance to allow your body to develop immunity.

And some vaccines involve a number of doses spread over several weeks or months.

You may be more at risk of some diseases, for example, if you're:

• travelling in rural areas
• backpacking
• staying in hostels or camping
• on a long trip rather than a package holiday

If you have a pre-existing health problem, this may make you more at risk of infection or complications from a travel-related illness.

Which travel vaccines do I need?

You can find out which vaccinations are necessary or recommended for the areas you'll be visiting on these websites:

• Travel Health Pro
• NHS Fit for Travel

Some countries require proof of vaccination (for example, for polio or yellow fever vaccination), which must be documented on an International Certificate of Vaccination or Prophylaxis (ICVP) before you enter or when you leave a country.

Saudi Arabia requires proof of vaccination against certain types of meningitis for visitors arriving for the Hajj and Umrah pilgrimages.

Even if an ICVP is not required, it's still a good idea to take a record of the vaccinations you have had with you.

Find out more about the vaccines available for travellers abroad

Where do I get my travel vaccines?

First, phone or visit the GP practice or practice nurse to find out whether your existing UK vaccinations are up-to-date.

If you have any records of your vaccinations, let the GP know what you have had previously.

The GP or practice nurse may be able to give you general advice about travel vaccinations and travel health, such as protecting yourself from malaria.

They can give you any missing doses of your UK vaccines if you need them.

Not all travel vaccinations are available free on the NHS, even if they're recommended for travel to a certain area.

If the GP practice can give you the travel vaccines you need but they are not available on the NHS, ask for:

• written information on what vaccines are needed
• the cost of each dose or course
• any other charges you may have to pay, such as for some certificates of vaccination

You can also get travel vaccines from:

• private travel vaccination clinics
• pharmacies offering travel healthcare services

Which travel vaccines are free?

The following travel vaccines are available free on the NHS from your GP surgery:

• polio (given as a combined diphtheria/tetanus/polio jab )
• hepatitis A

These vaccines are free because they protect against diseases thought to represent the greatest risk to public health if they were brought into the country.

Which travel vaccines will I have to pay for?

You'll have to pay for travel vaccinations against:

• hepatitis B
• Japanese encephalitis
• tick-borne encephalitis
• tuberculosis (TB)
• yellow fever

Yellow fever vaccines are only available from designated centres .

The cost of travel vaccines that are not available on the NHS will vary, depending on the vaccine and number of doses you need.

It's worth considering this when budgeting for your trip.

Other things to consider

There are other things to consider when planning your travel vaccinations, including:

• your age and health – you may be more vulnerable to infection than others; some vaccines cannot be given to people with certain medical conditions
• working as an aid worker – you may come into contact with more diseases in a refugee camp or helping after a natural disaster
• working in a medical setting – a doctor, nurse or another healthcare worker may require additional vaccinations
• contact with animals – you may be more at risk of getting diseases spread by animals, such as rabies

If you're only travelling to countries in northern and central Europe, North America or Australia, you're unlikely to need any vaccinations.

But it's important to check that you're up-to-date with routine vaccinations available on the NHS.

Pregnancy and breastfeeding

Speak to a GP before having any vaccinations if:

• you're pregnant
• you think you might be pregnant
• you're breastfeeding

In many cases, it's unlikely a vaccine given while you're pregnant or breastfeeding will cause problems for the baby.

But the GP will be able to give you further advice about this.

People with immune deficiencies

For some people travelling overseas, vaccination against certain diseases may not be advised.

This may be the case if:

• you have a condition that affects your body's immune system, such as HIV or AIDS
• you're receiving treatment that affects your immune system, such as chemotherapy
• you have recently had a bone marrow or organ transplant

A GP can give you further advice about this.

Non-travel vaccines

As well as getting any travel vaccinations you need, it's also a good opportunity to make sure your other vaccinations are up-to-date and have booster vaccines if necessary.

Although many routine NHS vaccinations are given during childhood, you can have some of them (such as the MMR vaccine ) as an adult if you missed getting vaccinated as a child.

There are also some extra NHS vaccinations for people at higher risk of certain illnesses, such as the flu vaccine , the hepatitis B vaccine and the BCG vaccine for tuberculosis (TB) .

Your GP can advise you about any NHS vaccinations you might need.

Find out about NHS vaccinations and when to have them

Page last reviewed: 16 March 2023 Next review due: 16 March 2026

Implications of subclinical tuberculosis for vaccine trial design and global effect

Affiliations.

• 1 Aurum Institute NPC, Houghton, Parktown, South Africa; Department of Medicine, Vanderbilt University, Nashville, TN, USA; School of Public Health, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. Electronic address: [email protected].
• 2 Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK; TB Modelling Group, TB Centre, London School of Hygiene & Tropical Medicine, London, UK.
• 3 Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
• 4 University of Washington, Seattle, WA, USA.
• 5 MRC Clinical Trials Unit, University College London, London, United Kingdon; WHO Collaborating Centre for TB Research and Innovation, Institute for Global Health, University College London, London, UK.
• 6 TB Centre, London School of Hygiene & Tropical Medicine, London, UK; Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK; Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa.
• 7 MRC Clinical Trials Unit, University College London, London, United Kingdon; CIDRI-AFRICA, School of Public Health, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
• 8 McGill International TB Centre, McGill University, Montreal, QC, Canada.
• 9 ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFECT), Barcelona, Spain.
• 10 Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa; Division of Infectious Diseases, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
• 11 South African Tuberculosis Vaccine Initiative, Department of Pathology and Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
• 12 Byramjee-Jeejeebhoy Government Medical College, Johns Hopkins University Clinical Research Site, Pune, India.
• 13 Gates Medical Research Institute, Cambridge, MA, USA.
• 14 Division of Infection and Immunity, University College London, London, United Kingdon; Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa.
• 15 Department of Global Health and Amsterdam Institute for Global Health and Development, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, Netherlands.
• PMID: 38964359
• DOI: 10.1016/S2666-5247(24)00127-7

Tuberculosis is a leading cause of death from an infectious agent globally. Infectious subclinical tuberculosis accounts for almost half of all tuberculosis cases in national tuberculosis prevalence surveys, and possibly contributes to transmission and might be associated with morbidity. Modelling studies suggest that new tuberculosis vaccines could have substantial health and economic effects, partly based on the assumptions made regarding subclinical tuberculosis. Evaluating the efficacy of prevention of disease tuberculosis vaccines intended for preventing both clinical and subclinical tuberculosis is a priority. Incorporation of subclinical tuberculosis as a composite endpoint in tuberculosis vaccine trials can help to reduce the sample size and duration of follow-up and to evaluate the efficacy of tuberculosis vaccines in preventing clinical and subclinical tuberculosis. Several design options with various benefits, limitations, and ethical considerations are possible in this regard, which would allow for the generation of the evidence needed to estimate the positive global effects of tuberculosis vaccine trials, in addition to informing policy and vaccination strategies.

Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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The first vaccine for malaria received major regulatory approval in 2015.

It didn’t become part of vaccination programs in africa until 2024., what if it had come faster, what if the shots had arrived 9 years ago, that’s how many children’s deaths could have been averted..

By Stephanie Nolen

Stephanie Nolen interviewed more than 30 scientists, health officials and other key players in the development of the malaria vaccines to report this article.

Nurses in countries from Sierra Leone to Cameroon are packing a new vaccine into the coolers they tote to villages for immunization clinics: a shot to protect against malaria, one of the deadliest diseases for children. Babies and toddlers in eight countries in the region recently started to get the vaccine as part of their routine childhood shots. Seven other African countries are eagerly awaiting its arrival.

This is a milestone in global health.

But it’s also a cautionary tale about a system that is ill equipped to deliver critical tools to the people who need them most. It took decades and at least a billion dollars to reach this point. Even now, only a fraction of the children whose lives are at risk will get the vaccine this year, or next year, or the year after. It’s been clear for some time what went wrong, but almost none of those issues have been fixed. That means that the next desperately needed vaccine stands every chance of running into those same problems. Take, for example, a new vaccine for tuberculosis that started clinical trials a few months ago. If it works as well as hoped, it could save at least a million lives a year. We’ll know by 2028 if it stops tuberculosis infections. But if it follows the same trajectory, it will be at least 2038 before it’s shipped to clinics.

“Children are receiving the vaccine, and for that, I am the happiest man in the world. But on the other hand, I cannot avoid being dismayed at this inexcusably long delay.”

— Dr. Joe Cohen, co-inventor of the first malaria vaccine

The U.S. Army started work on a malaria vaccine back in the 1980s, hoping to protect soldiers deployed to the tropics. It teamed up with the drug company GlaxoSmithKline, and together they produced promising prototypes. But the military lost interest after a few years, and that left GSK with a problem. The people who desperately needed a malaria vaccine were in villages in sub-Saharan Africa. They would not be able to pay for a product that would cost millions of dollars to develop. GSK needed an altruistically minded partner. It found one in the nonprofit global health agency PATH, and by the late 1990s they had a vaccine to test. The Bill & Melinda Gates Foundation put up more than $200 million to test it. The clinical trials were complex, because this was a whole new type of vaccine — the first ever against a parasite — delivered to children in places with limited health systems. The process took more than a decade. Finally, in 2014, results showed this vaccine cut severe malaria cases by about a third. This was a successful result, but not as much protection as scientists had hoped to see. Still, GSK and PATH planned a production facility to make millions of doses. Gavi, the organization that procures vaccines for low- and middle-income countries, with funds from donors, would buy them.

Then the Gates Foundation pulled its support.

There was a shake-up in the malaria division, and the leadership reoriented toward a new goal: eliminating the disease. The new malaria team said the vaccine didn’t work well enough to justify pouring millions more dollars into it. It would be better, they said, to wait for a more effective shot in the future, and in the meantime to fund other strategies, such as genetically modifying mosquitoes.

“If you go from very enthusiastic to very unenthusiastic and you’re the Gates Foundation, people pay attention.”

— Dr. Robert Newman, former director, Global Malaria Program, W.H.O.

The decision was driven by researchers who were looking at data. They didn’t factor in that the idea of a vaccine, even one with limited efficacy, would be so important to African parents — and African governments, which would come to see this as a classic example of a paternalistic donor ignoring their priorities. More than 300,000 children died of malaria that year. The foundation’s announcement shoved the vaccine into limbo — in ways the foundation today says it did not anticipate.

“In hindsight, we could have communicated more often and more clearly about our decisions and listened more clearly to what the impact of those might have been on other institutions and their decisions.”

— Dr. Chris Elias, president of global development at the Bill & Melinda Gates Foundation

GSK and PATH tried to push the vaccine forward. The company submitted a 250,000-page dossier to the European Medicines Agency, which can approve products not relevant in Europe but of humanitarian benefit. In 2015, the agency said the vaccine was safe (with some issues it wanted GSK to continue to study), and PATH began hunting for new financial partners to replace Gates.

Then came a second shock.

The World Health Organization evaluates new vaccines to decide what’s safe and well made, so that countries and Gavi know what to order. The malaria vaccine needed this sign-off, and since the European agency, a stringent regulator, had approved it, GSK and PATH assumed the W.H.O. would do so swiftly, too. Two groups met to consider the vaccine for the W.H.O.: an external advisory committee that evaluates vaccines, and a panel of malaria experts. The malaria specialists, who had seen African hospital wards full of children dying of the disease, said, “Yes, let’s go.”

But the vaccine experts said: No.

They argued that a small increase in cases of meningitis in children who got the shot hadn’t been sufficiently explained. If this small-chance issue turned out to be an actual problem, it could undermine African parents’ confidence in all childhood vaccines, with catastrophic consequences. Second, they feared that countries might struggle to deliver the vaccine. It came in four doses, none delivered on the usual childhood immunization schedules; the last dose came a year after the third, and without it, the vaccine offered little protection. In the end, there was a compromise: The W.H.O. announced what it called a pilot implementation, in Kenya, Malawi and Ghana, that would cost close to $100 million.

“I think that was the right thing. It meant a delay, which was unfortunate. But everyone, including GSK, knew a larger rollout was coming, and they should be ready. Did they act accordingly? I’m afraid not.”

— Dr. Pedro Alonso, former director, Global Malaria Program, W.H.O.

When GSK heard that instead of triumphantly shipping malaria shots to Africa, it would have to put the vaccine through another evaluation, executives ordered that the production facility and the vaccine ingredients be directed to more lucrative products.

“All the manufacturing plans that GSK had put in place were derailed. They stopped manufacturing because they did not want to continue to assume the risk of keeping a facility going for several years at huge expense for a vaccine that they weren’t sure was ever going to see the light of day.”

— Dr. Ashley Birkett, former director of the PATH Malaria Vaccine Initiative

Two years later, the W.H.O. had scraped together funding. GSK restarted a small production line to make enough of the vaccine for the study. At Gavi, however, board members representing Africa were demanding answers.

When was Africa going to get a vaccine for malaria?

Gavi turned to MedAccess, an organization that provides funding to reduce the financial risk for private companies working on medical products for low-income nations. With MedAccess’ support, Gavi offered a deal to protect GSK from financial risk, saying, in essence, we’ll fund you to start producing, and if the vaccine isn’t approved, we’ll cover the loss. GSK agreed and kept the production line open. In the end, the news was good. Data from the pilot showed no safety risk, and the W.H.O. approved the vaccine for Gavi to buy in bulk and ship to Africa. It was December 2021. But then GSK told Gavi that after all the agony of winning approval, it could produce only 12 million doses of its vaccine each year, tens of millions fewer than anxious countries were hoping for. Many people in the vaccine world believe that the issue was the chemical used to boost the strength of the immune response from vaccines, something called an adjuvant. It was made from the bark of a Chilean tree, and it has proved to be one of the more valuable substances the company ever produced.

When GSK said it would be limited in how much of its malaria vaccine it would make, angry collaborators at the W.H.O. and other agencies suggested it was because the company was keeping most of the adjuvant for more lucrative products such as its shingles vaccine, Shingrix, which sells for $350 per dose (compared with $10 for the malaria shot). GSK says that the adjuvant is not the constraint but that the factory that produces the vaccine is 50 years old and simply can’t make any more than those 12 million doses at present. The company says it will expand to an additional three million per year starting in 2026.

“The adjuvant is not the issue.”

— Dr. Thomas Breuer, chief of global health, GSK

The company has licensed the vaccine to Bharat Biotech, a drug maker in India, and is sharing the technology to produce it, but that process is complex; it will be at least five years until Bharat is making the vaccine on its own. In the meantime, GSK will upgrade its facility in Belgium later this year, and then make about 15 million doses a year until Bharat takes over. But until the end of 2025, there will be enough doses for only 4.5 million children, which could mean many more may fall ill and die.

Except: there is a second vaccine.

While this protracted process was playing out, a second malaria vaccine was moving through clinical trials. It was developed by researchers at the University of Oxford, who faced the familiar financial challenge. In 2021, the Serum Institute of India, the world’s biggest vaccine maker, put up the money to move the vaccine through a costly Phase 3 clinical trial. But there was still the question of production: it would cost millions of dollars to start mass-producing the vaccine, and the company had no guarantee of when, or even if, it would be able to sell it. The GSK experience had cast a chill over the whole field. The Oxford team submitted its clinical trial data for approval to the W.H.O. right around the time the GSK shot finally cleared the last hurdle. Because the two vaccines are based on essentially the same science, this one moved much more quickly through the process. And the Serum Institute bet big.

“We decided just to go ahead and make 25 million.”

— Adar Poonawalla, chief executive, Serum Institute of India

Those doses were made in time to be shipped in 2024, and the Serum Institute says it has the capacity to make 100 million doses per year. Even so, more than a decade after it was proved that a vaccine could protect children from malaria, only a fraction of the children at risk will get the shot this year or next. Gavi will ship about 11 million doses this year. The organization says that’s as much as countries rolling it out can handle right now. Policy Cures Research, a nonprofit that studies global health research investment, calculated that if the GSK vaccine had moved through the system as quickly as the Oxford-Serum shot did, the deaths of 590,000 children could already have been prevented . It’s an unsettled debate among experts, whether the W.H.O. pilot study was worth the years it added — was it better to err on the side of caution, because the stakes were so high for children’s health, or to gamble, given the scale of malaria’s devastation? When the W.H.O. decided on this delay, it seemed like the world might be winning the fight against malaria. The sense of urgency in the hunt for new tools was lower than it is today, when malaria deaths are climbing. And, in the Covid-19 era, regulators are more comfortable with emergency approval for vaccines than they were a decade ago.

The malaria vaccines we have now won’t be the last. There are 65 new candidate vaccines in the development pipeline. They will all face this question of how to raise funds for production before we know they work. Some of the lessons from the malaria experience have been applied to the tuberculosis vaccine, but it is made with the same GSK adjuvant and key questions about supply remain unresolved.

If the new tuberculosis vaccine proves effective, will it get to the people who need it any faster?

There is still no system that solves the fundamental problem of how to pay for at-risk production of a tool that is vitally important for the health of millions of people who can’t afford to pay for it. All the work on the tuberculosis vaccine is being bankrolled by philanthropies, which set their own agendas — not by the countries that need the vaccine.

“We will have scientific questions which may hold us up: You have to know that we may need to ride this out for longer than our wishful thinking would like. Who is going to pay for that and for how long?”

— Aurélia Nguyen, chief program officer, Gavi

Produced by Antonio de Luca

Stephanie Nolen is a global health reporter for The Times. More about Stephanie Nolen

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Bharat biotech readying tuberculosis, cholera vaccines, suchitra ella says bbil has stopped production of the covid-19 vaccines as done by other manufacturers worldwide.

Bharat Biotech International (BBIL), which developed India's first indigenous COVID-19 vaccine Covaxin and the world's first nasal vaccine iNCOVACC against the same virus, is close to launching vaccines against Tuberculosis and Cholera. The company is also developing vaccines against diseases like Chikungunya, Malaria and Zika, Suchitra Ella, Managing Director and Co-Founder of BBIL tells Fortune India.

''Our cholera vaccine is ready and is going through the regulatory approval and licensing process. Similarly, we have exclusive technology transfer for a malaria vaccine and we'll be making it again for the first time'', she says.

Bharat Biotech is developing a cholera vaccine, licenced from Hilleman Laboratories, a joint venture between MSD and UK-based Wellcome Trust, in 2019. It completed the Phase 3 trial at various locations in India in early 2023. In collaboration with Spanish biopharmaceutical company Biofabri, it is currently undertaking clinical trials in India of MTBVAC, a tuberculosis vaccine.

Bharat Biotech, which makes about 20 vaccines and 4-5 biotherapeutics, is also preparing to manufacture the world's first malaria vaccine approved by the World Health Organisation (WHO), developed by GlaxoSmithKline (GSK) after 30 years of research and development. In June 2021, GSK, PATH, and Bharat Biotech signed a product transfer agreement for the malaria vaccine.

MTBVAC is being developed as a more effective and potentially longer-lasting vaccine than BCG for newborns and for the prevention of TB disease in adults and adolescents, for whom there is currently no effective vaccine. The only vaccine in use today, BCG (Bacillus Calmette and Guérin), is an attenuated variant (weakened versions of virus or bacteria) of the bovine TB pathogen. It is more than a hundred years old and has a very limited effect on pulmonary tuberculosis, which is responsible for the transmission of the disease. MTBVAC is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human.

Suchitra Ella says BBIL has stopped production of the COVID-19 vaccines as done by other manufacturers worldwide. The production facilities created for the purpose can be refurbished to make other vaccines. The facilities can also quickly make newer versions of Covid-19 vaccines if the pandemic resurfaces with new mutated strains of the virus.

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• Section 5 - Tuberculosis
• Section 5 - Typhoid & Paratyphoid Fever

Perspectives : Testing Travelers for Mycobacterium Tuberculosis Infection

Cdc yellow book 2024.

Author(s): John Jereb

Screening for asymptomatic Mycobacterium tuberculosis infections should only be carried out for travelers at risk of acquiring tuberculosis (TB) at their destinations (see Sec. 5, Part 1, Ch. 22, Tuberculosis ). Screening with a tuberculin skin test (TST) or interferon-γ release assay (IGRA) in very-low-risk travelers might produce false-positive test results, leading to unnecessary additional screening or treatment. IGRAs, which require a single blood draw, are approximately as specific as TST in people who have not been vaccinated with bacillus Calmette-Guérin (BCG) and are more specific in BCG-vaccinated populations. Moreover, TST is prone to boosting sensitivity in serial testing, necessitating a 2-step initial test for establishing a baseline, which is unneeded with IGRAs. Using screening tests in very-low-prevalence populations will probably produce more false positives than true positives.

Travelers at risk for TB infection include those going to live in a TB-endemic country or anyone intending to spend any length of time in routine contact with patients in health care facilities or populations living in congregate settings (e.g., homeless shelters, prisons, refugee camps). People at low risk for exposure to TB, which includes most travelers, do not need to be screened before or after travel.

For travelers who anticipate a long stay or contact with a high-risk population, perform pretravel screening by using an IGRA or, when IGRA is not available, 2-step TST screening. CDC guidelines recommend testing with an IGRA (as opposed to TST) for people aged ≥5 years in low-risk populations. The American Academy of Pediatrics guidelines recommend an IGRA for children ≥2 years old; some pediatric TB experts use IGRAs for all children. If an IGRA is used for pretravel testing and there is concern for a false positive in an otherwise low-risk traveler, a second test can be used, which confirms TB infection only if both tests are positive. If the IGRA result is negative, repeat the traveler’s test 8–10 weeks after they return from their trip; however, data supporting a recommendation for regular serial testing for a long-term traveler are limited.

If TST is used for pretravel testing, use the 2-step TST for any traveler undergoing TST testing for the first time. The 2-step method is not needed for travelers who have already been tested and found to have a negative result within the previous 2 years. For the 2-step method, anyone whose baseline TST yields a negative result should be retested 1–3 weeks after the initial test; if the second test result is negative, the patient can be considered not infected. If the second test result is positive, the patient is classified as having skin test boosting, possibly because of previous M. tuberculosis infection.

The 2-step TST is recommended over single TST in this population because some people infected with M. tuberculosis years earlier (or who were sensitized by BCG or nontuberculous mycobacteria) exhibit waning delayed-type hypersensitivity to tuberculin. When skin tested years after infection, these people might have a negative initial TST result even though they had been sensitized previously. The first TST might stimulate the ability to react to subsequent tests, however, resulting in a “booster” reaction. When the test gets repeated at some future date, a positive result could be misinterpreted as a new M. tuberculosis infection (recent conversion) rather than a boosted reaction. For travelers who do not have enough time to complete a 2-step TST before departure, a single-step TST is an acceptable alternative, but an IGRA is preferred.

If the result of a pretravel test (either IGRA or 2-step TST) for M. tuberculosis infection is negative, a traveler should have a posttravel test with the same type of test used pretravel, 8–10 weeks after returning from their trip. People who have repeat TSTs should be tested with the same tuberculin purified protein derivative solution, because switching products can lead to different test results. The US Food and Drug Administration has approved 2 commercially available tuberculin solutions for skin testing: Aplisol (JHP Pharmaceuticals) and Tubersol (Sanofi Pasteur). During extended (>6 months) stays in, or repeated travel to, high-risk settings, travelers should have repeat testing every 6–12 months while traveling outside the United States and then 8–10 weeks after final return, all with the same type of test used pretravel.

In general, do not mix the types of tests used for a person. The discordance between TST and IGRA results is ≤15%; in most instances of discordance, the TST result is positive and the IGRA is negative. Multiple reasons for the discordance exist, and clinicians cannot be confident about the reason for discordance in any single person. If a clinician does decide to mix tests, going from TST to IGRA is better than the other way around, because the likelihood of a discordant result with the TST negative and the IGRA positive is much lower. Such discordant results might become unavoidable as more medical establishments switch from TSTs to IGRAs.

When testing travelers who were born or took up residence in TB-endemic areas, consider the greater background prevalence of infection in these places. In a study among 53,000 adults in Tennessee, the prevalence of a positive TST results among foreign-born participants was >11× that of US-born participants (34% vs. 3%). Confirming M. tuberculosis test status before travel would prevent the conclusion that a positive result after travel was due to recent infection.

The following authors contributed to the previous version of this chapter: Neela D. Goswami, Philip A. LoBue

Bibliography

Hagmann SH, Han PV, Stauffer WM, Miller AO, Connor BA, Hale DC. Travel-associated disease among US residents visiting US GeoSentinel clinics after return from international travel. Fam Pract. 2014;31(6):678–87.

Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, et al. American Thoracic Society/Infectious Diseases Society/Centers for Disease Control and Prevention clinical practice guidelines: diagnosis of tuberculosis in adults and children. Clin Infect Dis. 2017;64(2):111–5.

US Preventive Services Task Force. Screening for latent TB infection in adults: US Preventive Services Task Force recommendation statement. JAMA. 2016:316(9):962–9.

. . . perspectives chapters supplement the clinical guidance in this book with additional content, context, and expert opinion. The views expressed do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).

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