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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.

U.S. Centers for Disease Control and Prevention. BCG vaccine fact sheet .

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 Laura Dorwart is a health journalist with particular interests in mental health, pregnancy-related conditions, and disability rights. She has published work in VICE, SELF, The New York Times, The Guardian, The Week, HuffPost, BuzzFeed Reader, Catapult, Pacific Standard, Health.com, Insider, Forbes.com, TalkPoverty, and many other outlets.

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Where to Go

You can get most recommended vaccines at your doctor’s office, and many recommended vaccines are also available at local pharmacies, health centers, health departments, and travel clinics. Below you’ll find information and tools to help you find out where to get vaccinated near you—and some tips for making an appointment.

Find vaccines near you!

How do I get a COVID-19 vaccine?

COVID-19 vaccines are safe, effective, and free for everyone age 12 and older living in the United States, regardless of insurance or immigration status. To find a COVID-19 vaccination location near you:

• Text your zip code to 438829
• Call 1-800-232-0233
• Visit Vaccines.gov

Your doctor’s office

If you have a doctor who you see regularly, you can schedule an appointment to talk about vaccines you and your family may need — and to get vaccinated.

Many local pharmacies offer most recommended vaccines for adults, as well as some travel vaccines. If you plan on getting vaccinated at a pharmacy, consider calling ahead to:

• Find out if the pharmacy has the vaccine you need . This is an especially good idea if you need a travel-related vaccine.
• Ask what you will need to pay . Many vaccines are covered by health insurance. But if you don’t have insurance, try calling a few pharmacies and ask what they charge for vaccines — prices can vary.

Health centers

Federally funded health centers provide a variety of health care services, including vaccination. You can go to a health center even if you don’t have health insurance — and some may offer sliding fees based on your income.

Use the Health Center Finder to find a list of health centers near you.

State and local health departments

State and local health departments are a great resource for finding out where to get vaccinated. They may also have information about state vaccine requirements and free and low-cost vaccines, including vaccines for travel.

Click on your state to explore your state health department’s vaccine information.

• Alabama (AL)
• Alaska (AK)
• Arizona (AZ)
• Arkansas (AR)
• California (CA)
• Colorado (CO)
• Connecticut (CT)
• Delaware (DE)
• District of Columbia (DC)
• Florida (FL)
• Georgia (GA)
• Hawaii (HI)
• Illinois (IL)
• Indiana (IN)
• Louisiana (LA)
• Kansas (KS)
• Kentucky (KY)
• Maryland (MD)
• Massachusetts (MA)
• Michigan (MI)
• Minnesota (MN)
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• Nebraska (NE)
• Nevada (NV)
• New Hampshire (NH)
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• New Mexico (NM)
• New York (NY)
• North Carolina (NC)
• North Dakota (ND)
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• Rhode Island (RI)
• South Carolina (SC)
• South Dakota (SD)
• Tennessee (TN)
• Vermont (VT)
• Virginia (VA)
• Washington (WA)
• West Virginia (WV)
• Wisconsin (WI)
• Wyoming (WY)
• American Samoa (AS)
• Federated States of Micronesia (FM)
• Marshall Islands (MH)
• Northern Mariana Islands (MP)
• Puerto Rico (PR)
• Virgin Islands (VI)

Travel clinics

Planning a trip outside the United States? Travel clinics are a great resource for getting pre-travel health advice and vaccines for travelers. Travel clinics have doctors and nurses who specialize in travel health and vaccines. They may also stock vaccines that doctor’s offices and pharmacies don’t have.

Always call a travel clinic before you go — you’ll need an appointment at most of them, and you may need to see a doctor before you get vaccinated. Use the resources below to find a travel clinic.

To find a travel clinic near you, visit:

• International Society of Travel Medicine (ISTM) — travel medicine specialists
• American Society of Tropical Medicine and Hygiene (ASTMH) — infectious disease specialists who may practice travel medicine

Yellow fever clinics

Only certain travel clinics stock the yellow fever vaccine, which is required to travel in some countries. If you need the yellow fever vaccine, find a clinic that offers the yellow fever vaccine .

Learn more about vaccines for travelers .

Get vaccinated

Getting vaccinated is easy. Vaccines are available at the doctor’s office and many pharmacies — and most are covered by insurance.

Find out how to get vaccinated .

Want to learn about the journey of your child’s vaccine?

See how vaccines are developed, approved, and monitored .

Available vaccines - Travel vaccinations

The following vaccinations are available for people travelling abroad.

Cholera vaccination

Vaccination against  cholera isn't routinely needed for most travellers.

But in some cases it may be recommended for aid workers and people likely to have limited access to medical services – for example, people working in refugee camps or after natural disasters.

Most cases of cholera are confined to regions of the world with poor sanitation and water hygiene, such as parts of:

• South America

The vaccine is usually given as a drink in 2 separate doses, taken 1 to 6 weeks apart.

Children aged 2 to 6 years old should have a third dose taken 1 to 6 weeks after the second dose.

You should make sure you have the final dose of this vaccine at least a week before you travel.

A single booster dose or full revaccination is usually recommended if you have previously been vaccinated against cholera and you're planning to travel to an area where the infection is common.

Diphtheria vaccination

A combined vaccination that protects against diphtheria , polio and tetanus is routinely given to all children in the UK.

You should make sure you and your children are up-to-date with your routine vaccinations before travelling.

Further booster doses are usually only recommended if you're going to visit parts of the world where diphtheria is widespread and your last vaccination dose was more than 10 years ago.

Diphtheria is more common in parts of the world where fewer people are vaccinated, such as:

• Central and Southeast Asia
• Eastern Europe

Additional doses of the vaccination are given in a single 3-in-1 Td/IPV (tetanus, diphtheria and polio) injection.

Hepatitis A vaccination

Vaccination against  hepatitis A is recommended if you're travelling to countries where there are poor levels of sanitation and hygiene, and hepatitis A is common.

Ask your GP, pharmacy or travel clinic if you should have the hepatitis A vaccine if you're travelling to:

• Sub-Saharan and North Africa
• the Middle East
• South and Central America

The vaccination against hepatitis A is usually given as a single initial injection, with a second dose 6 to 12 months later. Two doses should protect you for at least 25 years.

You should preferably have the initial dose at least 2 weeks before you leave, although it can be given up to the day of your departure if needed.

Jabs that offer combined protection against hepatitis A and hepatitis B or typhoid are also available if you're likely to also be at risk of these conditions.

Hepatitis B vaccination

Vaccination against  hepatitis B is recommended if you're travelling in parts of the world where hepatitis B is common, especially if you'll be doing activities that increase your risk of developing the infection.

Hepatitis B is spread through blood and body fluids. Things like having sex, injecting drugs or playing contact sports on your travels can increase your risk.

Anyone travelling for long periods or who's likely to need medical care while abroad is also at increased risk.

Hepatitis B is found worldwide, but it's more common in parts of:

• Sub-Saharan Africa
• Southern and Eastern Europe
• parts of South America

The hepatitis B vaccination generally involves a course of 3 injections. Depending on how quickly you need protection, these may be spread over a period as long as 6 months or as short as 3 weeks.

A combined hepatitis A and hepatitis B jab is also available if you're likely to be at risk of both these conditions while travelling.

Japanese encephalitis vaccination

Vaccination against  Japanese encephalitis  is usually recommended if you're planning a long stay (usually at least a month) in a country where you could get the condition.

It's particularly important if:

• you're visiting during the rainy season or there's a year-round risk because of a tropical climate
• you're going to visit rural areas, such as rice fields or marshlands
• you'll be taking part in any activities that may increase your risk of becoming infected, such as cycling or camping

Japanese encephalitis is found throughout Asia and beyond. The area it's found in stretches from the western Pacific islands in the east, across to the borders of Pakistan in the west.

It's found as far north as Northeastern China and as far south as the islands of the Torres Strait and Cape York in Northeastern Australia.

Despite its name, Japanese encephalitis is now relatively rare in Japan because of mass immunisation programmes.

Find out more about risk areas on the Travel Health Pro website

Vaccination against Japanese encephalitis usually consists of 2 injections, with the second dose given 28 days after the first.

Ideally, you need to have the second dose a week before you leave.

Read more about preventing Japanese encephalitis .

Meningococcal meningitis vaccination

Vaccination against some types of meningococcal meningitis  is usually recommended if you're travelling to areas at risk and your planned activities put you at higher risk – for example, if you're a long-term traveller who has close contact with the local population.

High-risk areas for meningococcal meningitis include:

• parts of Africa
• Saudi Arabia during the mass gatherings of Hajj or Umrah

All travellers to Saudi Arabia for the Hajj or Umrah pilgrimages are required to show proof of vaccination.

If travelling to a high-risk area, you should be vaccinated against meningococcal meningitis with a MenACWY vaccine, also known as the quadrivalent meningococcal meningitis vaccine.

This is a single injection that should be given 2 to 3 weeks before you travel. Babies under a year old need 2 injections.

You should have the MenACWY vaccine before travelling to high-risk areas, even if you had the  meningitis C vaccine as a child.

Read more about the  meningococcal meningitis vaccine .

Measles, mumps and rubella (MMR) vaccination

The MMR vaccine that protects against measles ,  mumps and  rubella is routinely given to all children in the UK. 

You should make sure you and your children are up-to-date with routine vaccinations, including MMR, before travelling.

If you haven't been fully vaccinated against these conditions or you're not already immune, you should ask about MMR vaccination before you travel.

The MMR vaccine is given as 2 injections. These are usually given when a child is 3 years and 4 months old.

But if vaccination has been missed previously, adults can have the doses 1 month apart, and children can have them 3 months apart if necessary.

Read more about the MMR vaccine .

Polio vaccination

A combined vaccination that protects against diphtheria,  polio and tetanus is routinely given to all children in the UK.

Further booster doses are usually only recommended if you're going to visit parts of the world where polio is, or has recently been, present and your last vaccination dose was more than 10 years ago.

Currently the condition is most common in Pakistan and Afghanistan, but it's also a risk in other regions of the world.

Read more about the  3-in-1 Td/IPV vaccine .

Rabies vaccination

Vaccination against rabies is advised if you're travelling to an area where you could get rabies, particularly if:

• you're staying for a month or more
• there's unlikely to be quick access to appropriate medical care
• you plan to do activities that could put you at increased risk of exposure to rabies, such as cycling or running

Rabies can be found in many parts of the world. GOV.UK provides a detailed list of countries that have rabies in domestic animals or wildlife .

Vaccination involves a course of 3 injections before you travel, usually given over a period of 28 days.

If you're bitten, licked or scratched by an animal in a country where rabies is a problem, further doses of rabies vaccine (with or without a special anti-rabies injection given around the wound) may be required as emergency treatment.

Find out more about the rabies vaccine

GOV.UK: Rabies risks for travellers

Tetanus vaccination

A combined vaccination that protects against diphtheria, polio and tetanus is routinely given to all children in the UK.

Further booster doses are usually only recommended if:

• you're travelling to areas where access to medical services is likely to be limited and your last vaccination dose was more than 10 years ago
• you've not had two booster doses

Read more about the 3-in-1 Td/IPV vaccine .

Tick-borne encephalitis vaccination

Vaccination against  tick-borne encephalitis (TBE)  is usually recommended for anyone who plans to live or work in a high-risk area, or hike and camp in these areas during late spring or summer.

The ticks that cause TBE are mainly found in forested areas of central, eastern and northern Europe, although at-risk areas also include eastern Russia and some countries in east Asia, including some regions of China and Japan.

The vaccination requires a course of 3 injections for full protection. The second dose is given 1 to 3 months after the first and provides immunity for about a year.

A third dose, given 5 to 12 months after the second, provides immunity for up to 3 years.

The course can sometimes be accelerated if necessary. This involves 2 doses being given 2 weeks apart.

Booster doses of the vaccine are recommended every 3 years, if necessary.

Tuberculosis (TB) vaccination

The BCG vaccine (which stands for Bacillus Calmette-Guérin vaccine) protects against tuberculosis , which is also known as TB.

The BCG vaccine isn't given as part of the routine NHS vaccination schedule. It's given on the NHS only when a child or adult is thought to have an increased risk of coming into contact with TB.

When preparing for travel abroad, the BCG vaccine is recommended for any unvaccinated people under 16 who'll be living or working with friends, family or local people for more than 3 months in a country where TB is common or the risk of multi-drug resistant TB is high.

The BCG vaccine is given as a single injection.

Areas of the world where the risk of TB is high enough to recommend BCG vaccination for previously unvaccinated travellers include:

• parts of South and Southeast Asia

Read more about the BCG vaccine .

Typhoid vaccination

Vaccination against typhoid fever is recommended if you're travelling to parts of the world where the condition is common, particularly if you'll: 

• have frequent or prolonged exposure to conditions where sanitation and food hygiene are likely to be poor
• be staying or working with local people

High-risk areas include:

• parts of South and Central America

Two main vaccines are available for typhoid fever in the UK. One is given as a single injection, and the other is given as 3 capsules to take on alternate days.

It's also possible to have a combined hepatitis A and typhoid jab.

Ideally, the typhoid vaccine should be given at least 1 month before you travel, but it can be given closer to your travel date if necessary.

Booster vaccinations are recommended every 3 years if you continue to be at risk of infection.

Read more about the typhoid vaccine .

Yellow fever vaccination

Vaccination against yellow fever is advised if you're travelling to areas where there's a risk of getting yellow fever.

Some countries require a proof of vaccination certificate before they let you enter the country.

Yellow fever occurs in some areas of tropical Africa and Central and South America. More information about yellow fever and areas where it's found is available on Travel Health Pro .

A single dose of the yellow fever vaccine is thought to provide lifelong protection. For most people, a booster dose is no longer recommended.

You must have a yellow fever vaccination at least 10 days before you travel. You will also need to complete a yellow fever vaccination checklist to make sure you can have the vaccine.

Find out more about the yellow fever vaccination checklist on the Travel Health Pro website

You should be issued with an International Certificate of Vaccination or Prophylaxis when you have the vaccine. This certificate is valid for life.

Some people cannot have the yellow fever vaccine.

Read more about the  yellow fever vaccine and who can have it .

When to get further advice

Speak to your GP before having any vaccinations if:

• you're planning to get pregnant
• you're pregnant
• you're breastfeeding
• you have an immune deficiency
• you have any allergies

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

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Baylor College tests Tuberculosis vaccine's

Researchers at Baylor College of Medicine are seeking adult volunteers to investigate whether the BCG vaccine, commonly used to prevent tuberculosis globally, can reduce TB infection with just a single dose in travelers visiting countries with high incidences of the disease.

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TB vaccine: WHO expert explains why it’s taken 100 years for a scientific breakthrough, and why it’s such a big deal

Regional Adviser, Immunisation, WHO Regional Office for Africa, Stellenbosch University

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Charles Shey Wiysonge previously received funding from the South African Medical Research Council.

Stellenbosch University provides funding as a partner of The Conversation AFRICA.

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The BCG vaccine for TB has been used for 100 years. It is largely effective for children under five, but less so in older people and can’t be used on patients who have certain medical conditions. Today we’re the closest we’ve ever been to discovering a vaccine that might replace or complement it. Charles Shey Wiysonge, the World Health Organization’s Regional Adviser for Immunisation, discusses the latest developments in the fight against one of the world’s deadliest diseases.

Why has it taken so long?

We do not yet have a new vaccine for TB. But, for the first time, there are several vaccine candidates that are at advanced stages of clinical development.

Vaccine development usually takes decades and unfolds step by step. Experimental vaccine candidates are created in the laboratory and tested in animals before moving into progressively larger human clinical trials.

Clinical trials are research studies that test an intervention such as a vaccine in human beings and occur in phases, from phase 1 to phase 3. We say vaccines are in clinical development when they reach the clinical trial stage.

A phase 1 trial is a first-in-human study which recruits a small number of healthy people (usually fewer than 100), to assess whether a candidate vaccine is safe.

Phase 2 trials are typically conducted among several hundred participants, to assess whether the candidate vaccine produces an immune response.

For phase 3 trials, thousands of people are enrolled to assess whether the vaccine is efficacious and safe. Phase 3 TB vaccine trials are currently going on in Gabon, Kenya, Russia, South Africa, Tanzania and Uganda.

Even though we are still, at best, three years away from broad regulatory approval of a new TB vaccine, the scientific community can do a lot now to prepare for its use, and to inform the public so that the vaccine may be accepted when it becomes available.

TB vaccines are very challenging to develop. The bacterium that causes the disease is complex, and is proficient at evading the human immune system. We don’t yet have a full understanding of how to appropriately target the bacterium or what kind of immune responses are needed to induce immunity. But there are some interesting approaches in the pipeline and there have been some encouraging data from clinical trials that are providing clues.

Why do we need a new TB vaccine?

TB is a global health emergency. About 2 billion people are currently infected with Mycobacterium tuberculosis , and of those, 5% to 10% may become ill with TB and will potentially transmit the bacterium.

In 2021 , nearly 10.6 million people developed TB disease and 1.6 million died. We urgently need new tools to fight TB, including new and improved vaccines.

The Bacille Calmette-Guérin (BCG) vaccine has saved tens of millions of lives and is effective in children under the age of five in preventing TB deaths and severe forms of the disease.

The vaccine has variable efficacy for protection against pulmonary TB (TB affecting the lungs) in adolescents and adults – and it is pulmonary TB that’s responsible for the majority of TB transmission. So new and improved vaccines that are effective in preventing pulmonary TB in adolescents and adults are essential to control TB, and to reduce transmission to all, including newborn babies.

TB is the leading cause of death among people living with HIV. People living with HIV have up to 20 times higher risk of developing TB disease compared to those without HIV infection. The current BCG vaccine is not recommended for use in people living with HIV, for safety reasons. Although BCG is a safe vaccine in immunocompetent infants (those whose immune systems are working properly), severe adverse events can occur in HIV-infected infants following vaccination with BCG.

These adverse events include a rare but life threatening condition known as disseminated BCG disease . However, new TB vaccine candidates are being developed and evaluated to offer clinical benefit in people living with HIV.

How effective has the BCG vaccine been?

BCG vaccines are given to more than 100 million children every year worldwide, at birth or soon after. The effectiveness of BCG can vary depending on several factors, including the prevalence of TB in a given area, the strain of the BCG vaccine used, and the age at which BCG was administered.

Several studies have shown that the effect of the BCG wanes as children approach adolescence. People may become infected with TB but not be aware of it.

What will happen to the BCG vaccine?

The BCG vaccine will not be replaced by another TB vaccine until and unless there is compelling data on the safety and efficacy of an alternative. Most of the current vaccines in advanced stages of clinical trials are tested in adolescents and adults. Their safety and efficacy would need to be proven in newborn infants to be able to replace BCG.

In addition, BCG vaccination has nonspecific beneficial effects on overall mortality and leads to more reductions in child mortality than would be expected by just protecting against tuberculosis. There is thus a great possibility that BCG would remain in use.

What will a new vaccine mean for the fight against TB?

This depends on what the clinical trial data for the new vaccine candidates show. Most importantly, any new vaccine will need to be safe, and it will need to offer clear clinical benefit to populations at risk. We hope that the TB vaccine candidates that are in the pipeline will be effective at reducing TB infection, TB disease and TB transmission and can become part of a combination of tools in the fight against TB.

This article is part of a media partnership between The Conversation Africa and the 2023 Conference on Public Health in Africa.

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Ending TB Is Within Reach — So Why Are Millions Still Dying?

Tuberculosis has passed Covid as the top infectious disease killer, despite new medicines and better diagnostic tools.

Gifty Gyan, who was diagnosed with tuberculosis in June, was weighed at the Kaneshie Polyclinic in Accra, Ghana. Credit...

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By Stephanie Nolen

Photographs by Natalija Gormalova

Stephanie Nolen reported this story from Ghana. She has covered tuberculosis around the world for more than 20 years.

• Published Nov. 6, 2023 Updated Nov. 7, 2023

At Kaneshie Polyclinic, a health center in a hardscrabble neighborhood of Accra, the capital of Ghana, there is a rule. Every patient who walks through the door — a woman in labor, a construction worker with an injury, a child with malaria — is screened for tuberculosis.

This policy, a national one, is meant to address a tragic problem; two-thirds of the people in this country with tuberculosis don’t know they have it.

Tuberculosis, which is preventable and curable, has reclaimed the title of the world’s leading infectious disease killer, after being supplanted from its long reign by Covid-19. But worldwide, 40 percent of people who are living with TB are untreated and undiagnosed, according to the World Health Organization. The disease killed 1.36 million people in 2022, according to a new W.H.O. report released on Tuesday .

The numbers are all the more troubling because this is a moment of great hope in the fight against TB: Significant innovations in diagnosing and treating it have started to reach developing countries, and clinical trial results show promise for a new vaccine. Infectious disease experts who have battled TB for decades express a new conviction that, with enough money and a commitment to bring those tools to neglected communities, TB could be nearly vanquished.

“This is the best news we’ve seen in tuberculosis in decades,” said Puneet Dewan, an epidemiologist with the TB program at the Bill & Melinda Gates Foundation. “But there’s a gap between having an exciting pipeline and actually reaching people with those tools.”

A recent visit to the Kaneshie clinic revealed both the progress and the remaining barriers. Despite the clinic’s policy of screening everyone for TB, which most often attacks the lungs, by asking a few questions about coughs and other symptoms, patients streamed into the single-story, cement-block building and were sent for care without any such queries. A member of the TB team, it turned out, was on holiday, another was on maternity leave and a third was out sick. That left just two, who were busy processing tests and doling out drugs.

So no one was screened, not that day or any other day in the previous week.

“It is a good policy, it works well when we can do it, but personnel is a problem,” said Haphsheitu Yahaya, the tuberculosis coordinator at the clinic.

When the screening policy is working, new medications — the first to come to market since the 1970s — can be taken as just a couple of pills each day, rather than as handfuls of tablets and painful injections, the way TB treatments have been delivered in the past.

Those diagnosed with drug-resistant TB receive medication to take for six months — a far shorter time than previously required. For decades, the standard treatment for drug-resistant TB was to take drugs daily for a year and a half, sometimes two years. Inevitably, many patients stopped taking the medicines before they were cured and ended up with more severe disease. The new drugs have far fewer onerous side effects than older medications, which could cause permanent deafness and psychiatric disorders. Such improvements help more people to continue taking the drugs, which is good for patients, and eases the strain on a fragile health system.

In Ghana and most other countries with a high prevalence of TB, the drugs are paid for by the Global Fund to Fight AIDS, Tuberculosis and Malaria, an international partnership that raises money to help countries fight the diseases. The sustainability of those programs depends on donor largess. Currently, the treatment for adults recommended by the W.H.O. costs at least $150 per patient in low- and middle-income countries.

“If our patients had to pay, we would not have one single person taking treatment,” Ms. Yahaya said.

Still, there has been progress in recent months in making the medicines more affordable, and prices may soon drop further. Johnson & Johnson has lowered the price of a key TB drug in some developing countries. The company had faced pressure from patient advocacy groups, the United Nations and even the novelist John Green, who devoted his widely followed TikTok account to TB test and treatment price s. The company also agreed in September not to enforce a patent, which means generic drug companies in India and elsewhere will be able to make a significantly cheaper version of the medication.

And for the first time in more than a hundred years, there is real hope for an effective vaccine: A promising candidate called M72, developed by the pharmaceutical company GSK with financial backing from the Gates Foundation and other philanthropies, is now in the last stage of clinical trials.

(However, as ProPublica recently reported , it’s not clear who will have the rights to sell the vaccine, where it will be available and how much it will cost. Taxpayer and philanthropic money has paid for much of the vaccine’s development, but GSK retains control of critical components.)

M72 is one of 17 vaccine candidates that are currently being tested in trials, providing a wellspring of possibilities. The only TB vaccine in use today was first given to people in 1921; it is helpful primarily for babies and does little to protect adolescents and adults, who account for more than 90 percent of TB transmission globally.

Better technology to diagnose TB is slowly reaching clinics in developing countries. Clinics across South Asia and sub-Saharan Africa, including the one in Ghana, now have machinery to use rapid molecular diagnostic tests — equipment that was donated as part of the Covid response. That means that many health centers have finally stopped using an unreliable diagnostic method, developed in the 1800s, of viewing sputum smears under microscopes.

Still, last year, less than half of people diagnosed with TB were first given a molecular test, according to the new TB report. The rest were diagnosed with a microscope, or, in many cases, by their clinical symptoms.

The molecular diagnosis can also spot drug-resistant TB right away. (The old method involved starting a person on a course of the most common drugs and waiting to see whether the treatment worked; if patients had the drug-resistant form of the disease, they just got sicker.)

Joshua Dodoo, a driver, came to Kaneshie clinic in March with a lingering cough. He had been shedding pounds and couldn’t sleep. When he saw a doctor for what he thought was malaria, he was sent for a TB test. The one PCR machine in the clinic’s lab was in heavy use, so it was a few days before he learned from a nurse that he had TB.

“I was so frightened,” Mr. Dodoo said, adding that he had not realized people still caught the disease.

His wife, Sadia Ribiro, was calmer and able to hear the nurse, Richard Boadi, explain that there is a cure, and that Mr. Dodoo would be given the treatment for free.

Ms. Ribiro was tested; people living in close contact with a person who has TB account for a significant percentage of the 10.6 million new infections each year. She was negative, and was put on a course of preventive drugs for three months. These medications are new, too: Until recently, preventive therapy could take a year or more, and few patients finished it.

But then, the system broke down. The couple’s two children, who are 3 and 11, were not screened. Mr. Dodoo said they were in school so it was difficult to bring them to the clinic, and they had seemed healthy. Then, even as he started regaining weight and feeling better, the children started coughing and complaining of fatigue.

But they didn’t get a test until months later, when Mr. Boadi tracked them down at home. Only 30 percent of TB infections in children are diagnosed.

Ms. Yahaya, the clinic director, said that, while preventive therapy worked remarkably well, the experience of Mr. Dodoo’s family was typical. People who are newly diagnosed don’t want anyone to know that they have the disease, which is associated with poverty and suffering, so they don’t volunteer information about other people who may have been infected. And the understaffed health system struggles to track them.

Only 169 health centers across Ghana have the capacity to use the new testing method. Usually, samples must be sent away — up to a three-hour drive in some rural areas. By the time results come in, it can be hard to track down those who were tested.

“The equation is simple: If we were putting more resources into testing for TB, we would be finding more TB,” said Dr. Yaw Adusi-Poku, who heads Ghana’s national TB control program.

That will require more molecular testing sites, more staff members trained to spot the disease, more people to ask questions at the clinic door, more nurses like the intrepid Mr. Boadi, who turns up at his patients’ doors to encourage them to have their families tested (and who frequently digs into his own pocket to help patients pay for bus fare to pick up their drugs).

Molecular diagnosis is considerably more expensive than the old method. Cepheid, the company that makes cartridges for the testing machines, recently agreed to cut the price of each one to $8 from $10, which the company says is at cost. An analysis commissioned by Doctors Without Borders found that the cartridges could be made for under $5; the company says this is inaccurate. Cepheid continues to charge $15 per test for the diagnosis of extremely drug-resistant TB, the most lethal form of the disease.

Funding for TB services in low- and middle-income countries fell to $5.8 billion in 2022 from $6.4 billion in 2018, which is just half of what the W.H.O. says is needed. About $1 billion is available each year for TB research, half the amount that the United Nations says is required.

At a special meeting on TB at the United Nations in September, governments committed to spending at least $22 billion a year on TB by 2027. But at a similar meeting in 2018, the same donors promised to spend $13 billion by 2022, less than half of which materialized.

“I’m happy that we have these innovations, but the fact that they exist, that the W.H.O. recommends them, doesn’t mean people have access to them,” said Dr. Madhukar Pai, the associate director of the McGill International TB Centre at McGill University in Montreal. “The costs are still too high, and you need someone to deliver them.”

Stephanie Nolen covers global health. She has reported on public health, economic development and humanitarian crises from more than 80 countries around the world. More about Stephanie Nolen

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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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Tuberculosis prevention: current strategies and future directions

Affiliations.

• 1 Baylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX, USA. Electronic address: [email protected].
• 2 Department of Epidemiology, School of Public Health, Boston University, Boston, Massachusetts.
• 3 Institute of Health Informatics, University College London, London, United Kingdom.
• 4 Institute for Global Health, University College London, London, United Kingdom.
• 5 Baylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX, USA.
• 6 University of Montpellier, TransVIHMI, IRD, INSERM, Montpellier, France.
• 7 Department of Transplant and Infection Immunology, Saarland University, Homburg, Germany.
• 8 Max Planck Institute for Infection Biology, Berlin, Germany; Max Planck Institute for Multidisciplinary Sciences, Göttingen, Germany; Hagler Institute for Advanced Study, Texas A&M University, College Station, USA.
• 9 Baylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX, USA; Division of Clinical Infectious Diseases, Research Center Borstel, Borstel, Germany; German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Borstel-Riems, Borstel, Germany; Respiratory Medicine and International Health, University of Lübeck, Lübeck, Germany.
• 10 Baylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX, USA; Division of Clinical Infectious Diseases, Research Center Borstel, Borstel, Germany; German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Borstel-Riems, Borstel, Germany.
• PMID: 37918510
• DOI: 10.1016/j.cmi.2023.10.023

Background: An estimated one fourth of the world's population is infected with Mycobacterium tuberculosis, and 5-10% of those infected develop tuberculosis in their lifetime. Preventing tuberculosis is one of the most underutilized but essential components of curtailing the tuberculosis epidemic. Moreover, current evidence illustrates that tuberculosis manifestations occur along a dynamic spectrum from infection to disease rather than a binary state as historically conceptualized. Elucidating determinants of transition between these states is crucial to decreasing the tuberculosis burden and reaching the END-TB Strategy goals as defined by the World Health Organization (WHO). Vaccination, detection of infection, and provision of preventive treatment are key elements of tuberculosis prevention.

Objective: This review provides a comprehensive summary of recent evidence and state-of-the-art updates on advancements to prevent tuberculosis in various settings and high-risk populations.

Sources: We identified relevant studies in the literature and synthesized the findings to provide an overview of the current state of tuberculosis prevention strategies and latest research developments.

Content: We present the current knowledge and recommendations regarding tuberculosis prevention, with a focus on M. bovis Bacille-Calmette-Guérin (BCG) vaccination and novel vaccine candidates, tests for latent infection with M. tuberculosis, regimens available for tuberculosis preventive treatment (TPT) and recommendations in low- and high-burden settings.

Implications: Effective tuberculosis prevention worldwide requires a multipronged approach that addresses social determinants, improves access to tuberculosis detection and to new short TPT regimens. Robust collaboration and innovative research are needed to reduce the global burden of tuberculosis and develop new detection tools, vaccines, and preventive treatments that serve all populations and ages.

Copyright © 2023. Published by Elsevier Ltd.

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Guidance for Screening for Tuberculosis Infection and Disease during the Domestic Medical Examination for Newly Arrived Refugees

Overview of overseas tuberculosis screening for refugees, documentation of overseas tb evaluation, domestic refugee screening for tuberculosis, overview of treatment.

• As part of the domestic screening, all overseas medical records should be reviewed, a thorough medical history obtained, and a physical examination completed.
• All refugee applicants (aged ≥2 years) must undergo evaluation overseas for tuberculosis (TB) and are assigned one or more TB classifications prior to departure. Overseas TB screening results, treatment, and classifications are documented on the US Department of State (DS) forms.
• If Interferon Gamma Release Assay (IGRA) was negative overseas (within the last 6 months), and there are no signs or symptoms of TB disease upon physical examination, no further domestic evaluation is needed.
• If the overseas IGRA was negative but performed ≥6 months prior to the domestic examination, repeat IGRA.
• Treatment for latent tuberculosis infection (LTBI) should be considered after TB disease is ruled out for those with positive IGRA results, unless TB disease or LTBI treatment was completed prior to arrival.
• For children aged <2 years, a tuberculin skin test (TST) is recommended (if not previously treated for LTBI or TB disease).
• If IGRA was not done overseas or a negative IGRA was documented > 6 months prior, an IGRA is recommended at the domestic examination.
• If overseas or domestic IGRA is positive, LTBI treatment should be considered after TB disease is ruled out (if not previously treated for LTBI or TB disease).
• Any refugee, regardless of country of origin, with signs or symptoms of TB disease should undergo clinical evaluation for TB disease
• Differentiating between LTBI and TB Disease (Pulmonary)

Source: CDC Division of Tuberculosis Elimination

This guidance briefly describes the overseas TB medical screening process for refugees resettling to the United States and outlines the evaluation of newly arrived refugees for TB during the domestic medical screening examination. This document supplements guidelines for the general US patient population, and highlights specific needs among refugees to be used in conjunction with current guidelines from national authorities (American Thoracic Society [ATS]/Centers for Disease Control and Prevention [CDC]/ Infectious Diseases Society of America [IDSA]) and state TB control programs.

From 2018 to 2019, the number of TB disease cases in the United States decreased by 1.2% [ 1 ]. Additionally, in 2019, the TB rate was 2.7 per 100,000 people, the lowest rate on record [ 1 ]. While TB is decreasing overall in the United States, country of birth continues to be a major risk factor for TB in the United States, with the majority of reported TB cases occurring among non-US born persons (71.4%) [ 1 ]. The prevalence of drug-resistant TB or extrapulmonary TB cases, which are more challenging to diagnosis and manage, is also higher among foreign-born persons [ 2 ]. Studies have indicated that reactivation of LTBI, rather than recent transmission, is the primary driver of TB disease in the United States, accounting for >80% of all TB cases [ 2 ].

Additionally, 13.5% of cases among non-US born persons occurred within one year of arrival in the United States [ 1 ]. It is important to identify and treat new arrivals with LTBI soon after arrival [ 3 ]. The risk of TB disease appears to remain high for many years after resettlement, making it essential that clinicians find and treat LTBI before TB disease develops [ 4 ]. Healthcare providers who serve refugees should maintain a high index of suspicion for TB disease even long after arrival [ 5 ]. CDC and the US Preventive Services Task Force (USPSTF) recommend LTBI screening and, if positive, treatment for LTBI for persons who were born in, or have lived in, countries with high TB prevalence [ 6 , 7 ].

Before departure for the United States, all refugees must undergo an overseas medical examination that focuses on inadmissible conditions, including TB disease. By law, refugees diagnosed with an inadmissible condition are not permitted to depart for the United States until the condition has been treated. CDC stipulates the content of this examination through Technical Instructions (TIs)  issued to panel physicians and organizations that perform the medical screening examinations. Figure 1 outlines the required TB screening components for refugees being resettled to the United States from countries with a high burden of TB. CDC defines high burden for the purposes of screening as any country with a WHO-estimated TB disease incidence rate of ≥20 cases per 100,000 population.

Figure 1. Tuberculosis screening for applicants in high tuberculosis burden countries

View large image and text description

Source: CDC Division of Global Migration Health, Tuberculosis Technical Instructions for Panel Physicians

Note: All applicants <2 years of age living in high burden countries must have a physical examination and history provided by a parent or guardian. Applicants who have signs or symptoms suggestive of TB disease or have known HIV must have an IGRA or TST and a chest x-ray (CXR). Applicants with signs or symptoms suggestive of TB disease must provide three sputum specimens to undergo microscopy for acid-fast bacillus (AFB), as well as culture for mycobacteria, and drug susceptibility testing for positive cultures.

Classifications and Travel Clearance All refugee applicants must be assigned one or more TB classifications. TB classification is determined by screening results, and treatment, if required. Table 2 describes the TB classifications and travel clearance for all refugee applicants.

Table 2. TB Classifications and Travel Clearance

*Directly observed therapy (DOT) is the required form of treatment for applicants diagnosed with tuberculosis disease during medical screening. Treatment of tuberculosis disease must be administered following Division of Global Migration Health (DGMH)-defined DOT  policies and practices during the entire course of therapy.

Note: Applicants can be both Class B1 and Class B3, or Class B2 and Class B3. However, other combinations of TB classifications are not permitted.

Panel physicians must document TB screening and treatment results on the DS 2054 ( Medical Examination ), DS 3030 ( TB Worksheet ), and DS 3026 ( Medical History and Physical Examination Worksheet ). All medical documentation must be included with the required DS forms. Refugees receive copies of these documents and should provide them to the evaluating provider in the United States. In addition, the information is available through CDC’s Electronic Disease Notification (EDN) system to state or local health departments. Evaluating providers in the United States who are not receiving this information should contact the State Refugee Coordinator or state refugee health program for guidance. Overseas medical documents include information pertinent to the TB evaluation, such as—

• Medical history and physical examination
• The IGRA laboratory report (if the test was indicated) or TST documentation (including name of product, expiration date, amount administered) if IGRA is not licensed in the country where screening is conducted
• Digital CXR file for all applicants aged ≥15 years and, when indicated, for younger applicants
• Sputum smear and culture results for TB, if required
• DOT regimen received, including doses of all medications, start and completion dates, and periods of interruption
• Radiology reports of CXR findings before, during, and after treatment
• Clinical course, such as clinical improvement or lack of improvement during and after treatment
• Sputum smear AFB microscopy results obtained before, during, and after treatment
• Reports of cultures for mycobacteria obtained before, during, and after treatment, including reports of contamination
• Drug susceptibility test results for an tuberculosis isolate
• IGRA laboratory report, including all numeric values

All refugees, including those classified with a TB condition overseas, should receive a comprehensive domestic medical screening within 90 days of arrival. The goal of the domestic screening for TB is to find persons with LTBI, in order to facilitate prompt treatment and control, and to find persons who may have developed TB disease since the overseas medical examination.

Medical History and Physical Examination of Refugees for Tuberculosis during the Domestic Medical Screening Evaluation

TB disease should be encountered infrequently during the domestic medical screening examination because all new arrivals have been screened for TB disease prior to departure. Clinicians should be aware that the overseas medical exam is aimed at diagnosing pulmonary TB disease and may fail to detect extrapulmonary disease. Therefore, it is important for clinicians to perform a thorough history and physical examination aimed at identifying any refugee who may have pulmonary or extrapulmonary TB disease. Some persons with TB disease have minimal symptoms, and a high index of suspicion should be maintained for those with any concerning history, such as household exposure to TB, or signs of active disease.

Symptoms of pulmonary TB are often indolent and nonspecific, and include malaise, weight loss, night sweats, cough, chest pain, fever, and hemoptysis. Symptoms of extrapulmonary TB disease generally reflect the organ involved (e.g., abdominal pain with gastrointestinal TB). Although extrapulmonary TB can be found in nearly any organ of the body, lymph nodes, including those in the thorax, are the most common extrapulmonary sites.

All predeparture medical records for the refugee should be closely reviewed. A thorough post-arrival medical history should be obtained. In addition to current signs or symptoms of TB disease (e.g., weight loss, night sweats, fever, cough), specific information may be helpful in recognizing persons who might have TB disease or LTBI:

• Previous history of TB
• Prior treatment suggestive of TB treatment
• Prior diagnostic evaluation suggestive of TB
• Family or household contact with a person who has or had TB disease, treatment, or diagnostic evaluation suggestive of TB

In addition, in children, a history of recurrent pneumonias, paroxysmal wheezing, failure to thrive, or recurrent or persistent fevers should increase the index of suspicion.

For general guidance on the physical examination, see History and Physical Examination Screening Guidance . The examination for TB should focus on inspection and palpation of all major palpable lymph node beds and a careful skin examination, as it may reveal cutaneous disease, scars from scrofula or bacille Calmette-Guérin (BCG) vaccination, or hints of prior chest surgery.

Testing Newly Arrived Refugees for TB Infection and Disease

The overseas medical exam is universal for all refugees. Results of overseas TB testing and treatment should be available to domestic clinicians for review for all refugee arrivals from TB endemic countries.

For children 2 to 14 years of age coming from endemic countries (TB incidence rate of ≥ 20 cases per 100,000 population), an IGRA result should be available. If the IGRA was negative and performed <6 months before departure, and if the child has no signs or symptoms of TB disease upon physical examination, no further evaluation is needed. Additionally, if the IGRA was positive and the child completed TB disease or LTBI treatment prior to the domestic examination and has no signs or symptoms of TB disease upon physical examination, no further evaluation is needed. If the IGRA was negative but performed ≥6 months prior to the domestic examination, a repeat IGRA should be performed. For children aged <2 years from endemic countries, LTBI testing is recommended, if not previously treated for TB disease or LTBI. Currently, TST is the preferred test for children age <2 years. Skin testing and interpretation should be done in accordance with the ATS/CDC/IDSA Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children .

Refugees > 15 years of age are universally screened with a CXR prior to arrival in the US. Refugees > 15 years of age who have clinical signs or symptoms of TB disease, or have a positive CXR, or who are HIV positive, will have had three sputum smears and three sputum cultures performed prior to arrival. If they are diagnosed with TB disease, they receive full DOT prior to arrival. If a refugee ≥15 years has LTBI diagnosed prior to arrival but has not received LTBI treatment, they should be offered treatment if they have no current no signs or symptoms suggestive of TB disease and no contraindications to treatment. A refugee aged > 15 years who had a normal CXR prior to departure should be offered an IGRA if—

• overseas IGRA was not performed
• overseas IGRA results are unavailable or
• overseas IGRA screening was performed > 6 months prior and results were negative.

Any new arrival, regardless of country of origin, with signs or symptoms of TB should undergo clinical evaluation for TB disease.

Figures 2 and 3 outline the domestic screening algorithms for most refugee children aged 2–14 years and refugees aged > 15 years, respectively. Further information regarding domestic screening is detailed below.

Figure 2. Domestic screening protocol for refugees who had an IGRA test prior to departure (most children aged 2–14 years)

*In rare circumstances, refugees may receive LTBI treatment prior to departure. In this case, if no signs or symptoms of TB disease, further evaluation is not needed.

**Refugees that received tuberculosis therapy as DOT, carefully supervised by a US panel physician, will be classified as B0. Those treated outside the panel physician system will be classified as B1 TB, Pulmonary. State and local TB officials will be notified via the EDN of arrivals with Class B status.

Note: Either IGRA or TST are acceptable tests. However, IGRA is preferred for children ≥5 years of age.

Figure 3. Domestic screening protocol for refugees who did not have overseas IGRA testing but had a CXR (most refugees aged > 15 years)

* Refugees that received tuberculosis therapy as DOT, carefully supervised by a US panel physician, will be designated with a B0 classification. Those treated outside the panel physician system will be classified as B1 TB, Pulmonary. State and local TB officials will be notified via the EDN of arrivals with Class B status.

**In rare circumstances, refugees may receive LTBI treatment prior to departure. In this case, if no signs or symptoms of TB disease, further evaluation is not needed.

Note: Either IGRA or TST are acceptable tests. However, IGRA is preferred for persons ≥5 years of age.

When domestic LTBI screening is offered, either IGRA or TST are acceptable tests (IGRA is preferred for those aged ≥5 years). A summary of recommended uses, benefits, and limitations for IGRA and TST can be found in the ATS/CDC/IDSA Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children  It should be noted that a negative IGRA or TST result does not eliminate TB disease from the differential diagnosis in a patient with signs or symptoms of TB disease. Additionally, a positive test result, from either IGRA or TST, should be accompanied by an evaluation for TB disease with a thorough history and examination for signs and symptoms, and a CXR.

TB Blood Tests (Interferon Gamma Release Assay [IGRA])

An IGRA is a blood test used to determine if a person is infected with M. tuberculosis . IGRAs measure the immune response to TB proteins in whole blood. Currently, QuantiFERON®-TB Gold Plus (as of March 2020 manufactured by Qiagen) and T-SPOT®. TB (Oxford Immunotec) are the two IGRAs currently approved in the United States. It is important to note that TB blood tests should not be performed on a person who has written documentation of either a previous positive TB test result (TB blood test or TST) or treatment for TB disease.

For additional information on TB blood tests, refer to the Latent Tuberculosis Infection, A Guide for Primary Health Care Providers [PDF – 60 pages] .

Mantoux Tuberculin Skin Test (TST)

In otherwise healthy refugees from areas of the world where TB is common, ≥10 mm of induration is considered a positive result. A cutoff of ≥5 mm of induration is considered a positive result in persons with HIV infection, those with recent close contact with a known case of infectious TB, persons with fibrotic changes on CXR consistent with prior TB, persons with organ transplants, and other immunosuppressed persons. Many refugees from TB-endemic areas have been vaccinated against TB with BCG vaccine. IGRA is preferred for testing persons who have been vaccinated with BCG. Although previous BCG vaccination may influence TST results, especially in infants, a history of vaccination with BCG should not influence interpretation of TST results in adults. Many refugees will believe their test is positive due to past BCG vaccination. Clinicians should be prepared to thoroughly explain to the patient the reasons for not considering BCG vaccination in the interpretation of TST or IGRA results.

TST testing can be performed in all persons, including children and pregnant women. However, the test is contraindicated for persons who have had a local reaction with blistering or a systemic allergic response. False negative results may be more frequent in young children and in persons with a compromised immune system. False negatives also may occur more commonly in populations with highly prevalent M. tuberculosis infection (a high pretest probability). A TST should be administered and read by a specifically trained healthcare provider. For additional information about performing a TST, visit the CDC TB website .

Diagnostic Evaluation

Chest radiography.

Any patient with signs or symptoms of TB disease should have a CXR. If recent CXRs from the overseas medical exam are available and there has been no change in clinical status (no new signs or symptoms of pulmonary or extrapulmonary TB disease), there is no need to repeat the CXR. However, clinical judgment should be used in each case. If documentation is not available at the initial screening visit, providers should contact their State Refugee Coordinator, or the CDC ( [email protected] ) to obtain overseas testing results. If overseas CXR results cannot be obtained, or the test was done > 6 months prior and the result was negative, repeat CXR should be performed.

A posterior-anterior (PA) radiograph should be the primary image obtained in adults and older children. In children too young to cooperate with PA positioning, an anteroposterior (AP) view should be obtained. Additionally, a lateral chest radiograph is recommended in children <10 years old, because hilar adenopathy, a common pediatric TB finding, can be difficult to visualize on a PA or AP view. Any new CXR should be compared to previous films. Pregnant women with a positive TST or IGRA or other CXR indication should be protected with wraparound abdominal and pelvic lead shielding during chest radiography.

When the CXR has suspicious findings, or other signs or symptoms of TB are present, sputum specimens must be collected for smear and culture testing. Further information on testing can be found in the ATS/CDC/IDSA Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children .

Confirmed LTBI

Some states require LTBI reporting. Refugees with positive IGRA or TST results and normal findings on CXR should be offered LTBI treatment in accordance with CDC guidelines [8]. Information on how to choose the most effective treatment regimen for each patient, adverse drug effects, monitoring, and assessing adherence is available on the CDC TB website .

Suspected or Confirmed TB Disease

Screening results indicating TB disease may include a combination of a positive results from IGRA or TST, abnormal findings on CXR, pathology findings consistent with TB disease (e.g., caseating granuloma), signs or symptoms consistent with TB disease, sputum or tissue smear positive for AFB, a positive nucleic acid amplification test performed on the initial respiratory specimen, or a culture positive for M. tuberculosis. Prompt treatment should be initiated in consultation with a specialist for presumptive or confirmed clinical TB disease. All presumptive or confirmed cases (pulmonary or extrapulmonary) should be reported to the local health authorities within 24 hours of determination so that appropriate public health measures can be implemented, and management with an infectious disease or TB expert is recommended. Culture confirmation is not needed before starting therapy for cases with a high index of suspicion. When pulmonary or laryngeal TB is suspected, the patient should be isolated in an appropriate setting to prevent spread of infection until the patient is no longer considered infectious.

A complete discussion of treatment for TB disease and LTBI is beyond this scope of this guidance document. CDC treatment guidelines call for clinicians to not only prescribe an appropriate regimen (length of course of treatment and treatment regimen), but also ensure adherence to the regimen until treatment is completed. TB disease should be diagnosed and treated in consultation with the public health department and TB medical experts.

Treatment Guidelines

• Guidelines for the Treatment of Latent Tuberculosis Infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020
• Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis

Sources of Additional Information

Additional information regarding tuberculosis can be found on the CDC TB website .

• Centers for Disease Control and Prevention (CDC), Reported Tuberculosis in the United States, 2019 . 2020, US Department of Health and Human Services, CDC: Atlanta, GA.
• Oeltmann, J.E., et al., Multidrug-resistant tuberculosis outbreak among US-bound Hmong refugees, Thailand, 2005. Emerg Infect Dis, 2008. 14 (11): p. 1715-21.
• Guo, H. and J. Wu, Persistent high incidence of tuberculosis among immigrants in a low-incidence country: impact of immigrants with early or late latency. Math Biosci Eng, 2011. 8 (3): p. 695-709.
• Tsang, C.A., et al., Tuberculosis Among Foreign-Born Persons Diagnosed >/=10 Years After Arrival in the United States, 2010-2015. MMWR Morb Mortal Wkly Rep, 2017. 66 (11): p. 295-298.
• Lillebaek, T., et al., Persistent high incidence of tuberculosis in immigrants in a low-incidence country. Emerg Infect Dis, 2002. 8 (7): p. 679-84.
• Bibbins-Domingo, K., et al., Screening for Latent Tuberculosis Infection in Adults: US Preventive Services Task Force Recommendation Statement. Jama, 2016. 316 (9): p. 962-9.
• Centers for Disease Control and Prevention. Deciding When to Treat Latent TB Infection . 2018 [cited 2020 October 21]; Available from: https://www.cdc.gov/tb/topic/treatment/decideltbi.htm .
• Sterling, T.R., et al., Guidelines for the Treatment of Latent Tuberculosis Infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020. MMWR Recomm Rep, 2020. 69 (1): p. 1-11.

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• About the Handbook

Tuberculosis

Information about tuberculosis (TB) disease, vaccines and recommendations for vaccination from the Australian Immunisation Handbook.

Recently added

This page was added on  05 June 2018 .

Updates made

This page was updated on 05 August 2022 .  View history of updates

Vaccination for certain groups of people is funded by states and territories .

Tuberculosis is caused by the bacterium Mycobacterium tuberculosis . Most people who become infected with M. tuberculosis have latent tuberculosis infection , which means they are not ill and not infectious. People with tuberculosis disease, in contrast, are ill and usually infectious.

BCG (bacille Calmette–Guérin) vaccine is recommended for:

• Aboriginal and Torres Strait Islander children aged <5 years in some parts of Australia
• Healthcare workers with a high risk of exposure to tuberculosis
• Young children who will be travelling to settings with high tuberculosis incidence
• Some children born to parents from countries with high tuberculosis incidence
• Young children who are a household contact of a person with leprosy

BCG vaccine is given as a single dose by intradermal injection .

A tuberculin skin test pre-vaccination is recommended for some people prior to BCG vaccination, based on a risk assessment of the likely exposure to tuberculosis in the past.

The World Health Organization considers tuberculosis a global emergency. BCG vaccine is recommended for those at highest risk of severe outcomes of tuberculosis.

Recommendations

Aboriginal and torres strait islander people.

Aboriginal and Torres Strait Islander people in some states and territories experience a significant burden of tuberculosis (see Tuberculosis in Australia ). BCG vaccine is recommended for young children living in these regions. 1 Consult state and territory guidelines for more details on BCG vaccination programs for Aboriginal and Torres Strait Islander children.

Tuberculin skin test screening before vaccination is only required in some circumstances. See Tuberculin skin testing before vaccination for details.

See also Vaccination for Aboriginal and Torres Strait Islander people .

Occupational groups

The efficacy of BCG vaccination in adults is more limited compared with in children. See Vaccine Information.

In the workplace, tuberculosis prevention and control should focus on:

• infection control measures
• employment-based screening
• therapy for latent tuberculosis infection

Healthcare workers working overseas in high tuberculosis incidence settings, particularly those with limited infection prevention and control measures, have an increased risk of acquiring tuberculosis. Assess the need for BCG vaccination in these workers.

Consider BCG vaccination for TST negative health care workers in any setting who are at high risk of exposure to drug resistant tuberculosis. This is because drug resistant infections are difficult to treat.

Some other occupational groups have a risk of tuberculosis exposure but are not recommended to receive BCG vaccine because the evidence of benefit of BCG vaccination is limited and infection prevention can be undertaken. This includes healthcare workers at tuberculosis clinics or refugee health clinics, embalmers and people involved in autopsies.

Children aged <5 years travelling to countries with high tuberculosis incidence (>40 cases per 100,000 population per year) are at increased risk of acquiring tuberculosis and developing severe disease. 2 BCG vaccine is most effective at preventing severe tuberculosis (miliary tuberculosis and tuberculous meningitis) in children. See Epidemiology and Vaccine information .

Children should ideally receive the vaccine at least 3 months before departure to a high risk destination. Consider discussing future travel plans with parents and carers of young infants at the earliest possible age.

The risk assessment should take account of the following:

• the child’s age
• how long they are in the high-risk area — the longer the exposure the higher the risk of infection
• the proximity of contact to others — staying with friends or family members in the community increases the risk of infection, particularly if they have a history of recent tuberculosis
• the tuberculosis incidence at the destination

See the World Health Organization’s country-specific incidence data . 3

If additional information is needed to support the risk assessment, seek expert input. Discuss with state or territory tuberculosis services, a paediatric infectious diseases specialist or travel vaccine centres.

BCG vaccine is not as effective in older children and adults. It is not recommended for people in these age groups who are travelling to a country with high tuberculosis incidence, except in some healthcare workers.

Other groups

Children aged <5 years born to parents from countries with high tuberculosis incidence who are now living in Australia are not recommended to receive BCG vaccine, because of the low incidence of tuberculosis in Australia and the uncertainty of the benefit of vaccination compared with the risk of vaccine adverse events.

Tuberculosis is uncommon in children born in Australia. However, children born in Australia to parents from countries with a high tuberculosis incidence (>40 cases per 100,000 population per year) may have a higher risk of tuberculosis exposure from parents and travelling family, in their early life. 4 BCG vaccination may be recommended in some cases, based on an individual risk assessment.

Children born outside of Australia may also be at high risk of disease, but have often previously received a BCG vaccine shortly after birth in their country of birth. See Epidemiology .

Tuberculin skin test (TST) screening before vaccination is only required in some circumstances. See Tuberculin skin testing before vaccination for details.

BCG vaccine provides some protection against infection with Mycobacterium leprae , the organism that causes leprosy. 5 Children aged <5 years with family or household contacts who have leprosy may be recommended to receive BCG vaccine, based on an individual risk assessment.

Tuberculin skin testing before vaccination

The need for TST should be determined by an individual risk assessment that considers whether the person:

• was born in a tuberculosis-endemic country (>40 cases per 100,000 population per year)
• has lived or travelled to a tuberculosis-endemic country or region (>40 cases per 100,000 population per year)
• had exposure to a close contact with tuberculosis or who is under investigation for tuberculosis

If an immunocompetent person who was required to have a TST is confirmed to be negative (induration of <5mm), they can receive BCG vaccine. A person with a TST of 5mm or greater or who has an accelerated BCG reaction (see below), should be considered for further investigation of latent or active tuberculosis.

The TST uses tuberculin, a purified protein derivative. This causes a hypersensitivity reaction in people who have previously been infected with Mycobacterium tuberculosis . ‘False positive’ hypersensitivity reactions can also occur in:

• people infected with other (non-tuberculous) mycobacteria

• people who have previously received BCG vaccine. Vaccination interferes with the interpretation of tuberculin skin test (TST) results

Interferon-gamma release assays (IGRAs) are a type of blood test that can detect M. tuberculosis infection (similar to the TST), but the TST is still the preferred method of screening for past tuberculosis exposure before BCG vaccination. Although TST and IGRA essentially provide the same information, there is uncertainty about whether hypersensitivity detected by IGRA is also associated with an accelerated local BCG reaction (as is the case with a positive TST). 6

Both measles virus and measles-containing live attenuated vaccines  7,8 inhibit the response to tuberculin. TST-positive people may become TST-negative for 4–6 weeks after measles infection or vaccination. This should be taken into account when considering the timing of a TST in people who have had a measles-containing vaccine.

You can give a tuberculin skin test on the same day or visit with a COVID-19 vaccine. There is no specific time interval restriction between a tuberculin skin test and receiving a COVID-19 vaccine. Inhibition of response to a tuberculin skin test is not expected following administration of COVID-19 vaccines.

People with cellular immune compromise may also have a false negative TST, and BCG vaccination is generally contraindicated in this group since it is an attenuated live vaccine. See Contraindications and precautions .

Health professionals must correctly administer and interpret the TST. Consult state or territory tuberculosis guidelines for advice.

Vaccines, dosage and administration

Tuberculosis vaccines available in australia.

The Therapeutic Goods Administration website provides product information for each vaccine .

See also Vaccine information  for more details.

Note: The only BCG vaccine registered for use in Australia ( BCG vaccine (Sanofi-Aventis Australia)) has not been available for some time.

Other BCG vaccines are available in Australia under a special prescribing arrangement (e.g. BCG Vaccine SSI [Statens Serum Institut, Denmark]). These vaccines can be used in the same manner as the registered unavailable vaccine. Contact state and territory public health authorities for more information on obtaining BCG vaccines. See also Public health management .

Please note that different vaccines may use different strains of M. tuberculosis which may differ slightly in antigenic properties. See Vaccine information .

Dose and route

BCG vaccine is a single dose given by intradermal injection . The standard dose is:

• In newborns and infants <12 months of age, the dose is 0.05 mL.
• In children ≥12 months of age and adults, the dose is 0.1 mL.

If BCG is inadvertently given subcutaneously, there is no need to repeat vaccination as the vaccine will still have a protective effect. The person should be informed that they may be more likely to experience an injection site reaction, or regional lymph node involvement, but overall BCG is a very safe vaccine.

Only healthcare workers who are trained in intradermal vaccination procedures should administer BCG vaccine. See Administration of vaccines .

BCG revaccination is generally not recommended, because of a lack of evidence for increased efficacy . 9

BCG vaccine may be available from state and territory tuberculosis services , and may be available through some travel medicine clinics.

BCG vaccination procedures

BCG vaccination steps are:

1. Wear protective eyewear

The following people should wear protective eyewear:

• the person giving the vaccine
• the person receiving the vaccine
• the parent or carer holding a small child who is receiving the vaccine

Eye splashes can ulcerate. If eyes are splashed, wash the eyes with saline or water immediately. Any irritation to the eye as a result of a should be followed up in the subsequent weeks, with an assessment by a medial practitioner and/or a specialist ophthalmologist.

2. Identify the correct injection site

Inject BCG vaccine into the skin over the region where the deltoid muscle inserts into the humerus. This is just above the midpoint of the upper arm. This site is recommended to minimise the risk of keloid formation.

By convention, use the left upper arm, if possible. This can assist people who may later look for evidence of BCG vaccination.

3. Inject the vaccine intradermally

See Administration of vaccines for information on the intradermal vaccination technique.

Response to BCG vaccination

After BCG vaccination, a small, red papule forms and ulcerates within 2–3 weeks of vaccination. The ulcer heals with minimal scarring over several weeks. Local lymph nodes may be swollen and tender.

More serious injection site reactions are less common. See Adverse events .

People who have latent or previous tuberculosis infection and receive BCG vaccine are likely to have an accelerated response. An accelerated cutaneous reaction to BCG is not more severe than typical BCG reactions and have no long-term detrimental effect - it simply occurs more rapidly. This is characterised by:

• induration within 24–48 hours
• pustule formation within 5–7 days
• healing within 10–15 days

Clinical trials have not shown a consistent relationship between the size of tuberculin reactions after BCG vaccination and the level of protection.

Performing a TST to demonstrate immunity after BCG vaccination is not recommended. 10,11

Co-administration with other vaccines

People can receive BCG vaccine at the same time as, or at any time after, other inactivated vaccines.

People can receive BCG vaccine and another live parenteral vaccine (such as MMR [measles-mumps-rubella], varicella or yellow fever) either on the same day or at least 4 weeks apart.

For three months following a BCG vaccine, do not give any other vaccine in the same arm.

People can receive BCG vaccine at any time in relation to oral live vaccines. These include rotavirus vaccine and oral poliovirus vaccine (in infants who have received it overseas).

Contraindications and precautions

Contraindications.

BCG vaccine is contraindicated in people who have had anaphylaxis after any component of a tuberculosis vaccine.

BCG is an attenuated live vaccine that is contraindicated in the following groups:

• people with known or suspected HIV infection ,12 even if they are asymptomatic or have normal immune function. This is because of the risk of disseminated BCG infection 13,14
• people treated with high doses of corticosteroids or other immunosuppressive therapy . These therapies include monoclonal antibodies against tumour necrosis factor (TNF)-alpha, such as infliximab, etanercept and adalimumab. See Vaccination for people who are immunocompromised
• people with congenital cellular immunodeficiencies, including specific deficiencies of the interferon-gamma pathway
• people with active malignancies involving bone marrow or lymphoid systems, any person with cancer receiving immunosuppressive therapy , or people who completed chemotherapy within the previous 3 months. See People with cancer in Vaccination for people who are immunocompromised
• people with any serious underlying illness, including severe malnutrition
• pregnant women. BCG vaccine has not been shown to harm the fetus, but receiving live vaccines in pregnancy is not recommended
• people who have previously had tuberculosis or a positive (≥5 mm) TST

Precautions

Defer BCG vaccination in the following groups:

• neonates who are medically unstable, until the neonate is in good medical condition and ready for discharge from hospital
• infants born to mothers who are suspected or known to be HIV-positive, until HIV infection of the infant can be confidently excluded
• people with active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination
• people being treated for latent tuberculosis infection , because the therapy is likely to inactivate the BCG vaccine
• people with significant febrile illness, until 1 month after recovery
• infants aged <6 months born to mothers who were treated with bDMARDs (biologic disease-modifying anti-rheumatic drugs) in the 3rd trimester of pregnancy. These medicines include TNF-alpha-blocking monoclonal antibodies. These infants often have detectable TNF-alpha-blocking antibodies for several months.15-17 See also Use of immunosuppressive therapy during pregnancy in Vaccination for women who are planning pregnancy, pregnant or breastfeeding

Vaccination before or after administration of immunoglobulin or blood products

People can receive BCG vaccine at any time before or after receiving immunoglobulin or any antibody-containing blood product. These preparations and BCG vaccines have minimal interaction. 18 See also Vaccination for people who have recently received normal human immunoglobulin and other blood products .

Adverse events

The normal reaction to BCG vaccination is described in Vaccines, dosage and administration . With the proper procedure less than 5% of vaccinated people experience adverse events; ~2.5% may develop a local injection site ‘cold abscess’ and ~1% regional lymphadenitis with/without ‘cold abscess’ formation. 19

Other adverse events include: 20

• local suppurative complications. This does not require treatment with anti-tuberculosis medicine unless there is perceived risk of disseminated BCG disease (see below), but BCG is inherently resistant to pyrazinamide and optimal treatment requires careful consideration; 21 it is best to seek specialist advice from state or territory tuberculosis services .
• keloid formation. This risk is minimised if the injection is no higher than the level of insertion of the deltoid muscle into the humerus
• disseminated BCG disease, but the risk is extremely low (1–4 cases per million vaccinated people) and it is only observed in people with immune compromise. Treatment with anti-tuberculosis medicines may be warranted, but BCG is inherently resistant to pyrazinamide and optimal treatment requires careful consideration; 21 it is best to seek specialist advice from state or territory tuberculosis services.

Nature of the disease

Tuberculosis is caused by Mycobacterium tuberculosis and other organisms of the M. tuberculosis complex (M. TB complex) 22 . M. tuberculosis is the cause of almost all tuberculosis in Australia 23

Pathogenesis

Infection usually occurs when a person inhales the tuberculosis bacteria , which reach the lungs. M. bovis can be ingested from unpasteurised milk, consumed in countries where M. bovis remains prevalent (not Australia)

If the person’s immune system can contain the bacteria , the person will be infected but not develop active disease. This is called latent tuberculosis infection .

If the bacteria overcome the immune system, which may occur after many years of immune control, the person develops active disease and may become infectious if pulmonary disease occurs. 24

Transmission

M. tuberculosis is usually transmitted by the airborne route. Factors affecting transmission include: 22

• duration of exposure
• frequency of exposure
• proximity to the infected person (high-density or communal living situations may increase the risk of transmission)

Persons with extrapulmonary TB with no lung or larygneal involvement are not infectious.

Clinical features

Tuberculosis most commonly presents as lung disease, which accounts for 60% of notified tuberculosis cases in Australia. 25 Common symptoms of pulmonary tuberculosis are:

• weight loss
• coughing up blood (mainly in adults with late-stage pulmonary disease)

Extrapulmonary tuberculosis can occur in any part of the body. Tuberculosis lymphadenitis is the most common extrapulmonary manifestation.

Disseminated disease (miliary tuberculosis) and meningeal tuberculosis are more common in very young children. 26 These are among the most serious manifestations of tuberculosis disease. 20

Most people infected with M. tuberculosis remain asymptomatic. There is a 10% lifetime risk of developing clinical illness. Clinical disease can develop many years after the original infection . The risk varies depending on age and immune status.

Groups more prone to rapidly progressive disease include: 22

• young children (infants and children <5 years of age)
• elderly people
• people who are immunocompromised as a result of medical treatment, disease or adverse socioenvironmental circumstances.

Epidemiology

Tuberculosis in australia.

In Australia, tuberculosis is an uncommon disease, with annual incidence remaining below 7 per 100,000 population since 1980s. 27

Most tuberculosis cases in Australia (more than 85%) occur in people who were born overseas, especially in countries with a high incidence of tuberculosis. 3,28 See latest WHO Global Tuberculosis Report for up-to-date information . 29

The rate of multidrug-resistant (MDR) tuberculosis in Australia remains low (approximately 2% of bacteriologically confirmed cases with drug susceptibility testing available). 30

Tuberculosis in animals ( Mycobacterium bovis ) has been eradicated in Australia by screening and culling programs. 31

Tuberculosis in Aboriginal and Torres Strait Islander people

In most states and territories, rates of tuberculosis among Aboriginal and Torres Strait Islander people overall are comparable to rates among Australian-born non-Indigenous people. However, notifications of tuberculosis among Aboriginal and Torres Strait Islander people in some states and territories are disproportionately higher than for Aboriginal and Torres Strait Islander people and non-Indigenous people in other states.

Regions with higher rates of tuberculosis include: 25

• the Northern Territory
• Far North Queensland

See Vaccination for Aboriginal and Torres Strait Islander people .

Screening for tuberculosis

Screening programs in Australia focus on:

• contacts of notified cases
• people at increased risk of tuberculosis infection , including refugees and healthcare workers

Tuberculosis in other countries

The World Health Organization declared tuberculosis a global emergency in 1993, and recent reports have reaffirmed the threat to human health. 32 In 2019, there were about 7.1 million incident cases of tuberculosis globally. 29

Vaccine information

When reconstituted, BCG vaccine is a suspension of a live attenuated strain of M. bovis . Worldwide, many BCG vaccines are available, but they are all derived from the original strain selected by Calmette and Guerin, which was first tested in humans in 1921. 33

Sanofi-Aventis Australia markets the only BCG vaccine registered for use in Australia, although this vaccine is currently unavailable. See Vaccines, dosage and administration . Contact your state or territory health authority to access a BCG vaccine.

Efficacy of BCG vaccine

In children.

BCG vaccination in young children provides: 34

• ~25% protection against tuberculosis infection
• ~70% protection against active tuberculosis
• >70% protection against severe forms of tuberculosis disease in young children, including miliary tuberculosis and tuberculosis meningitis. 35-39

The efficacy of BCG vaccine against pulmonary disease in adults is less consistent, and has ranged from no protection to 80% in controlled trials. 35   The reason for the wide variation is not clear, but it has been attributed to differences in:

• study quality
• BCG strains
• host factors, such as age at vaccination and nutritional status
• the prevalence of infection with environmental mycobacteria

Duration of protection

The duration of protection after BCG vaccination has been difficult to measure because the time between infection and disease can be decades. Benefit from infant vaccination has been found in studies with follow-up of up to 40 years, but protection is thought to decline over 10–20 years. 20 Immune memory responses may remain for 10–50 years. 41-43

Other uses of BCG vaccine

BCG vaccination offers some protection against Mycobacterium leprae , which causes leprosy. 5

BCG is also used as treatment for bladder cancer, but this is a different preparation that is instilled directly into the bladder.

Transporting, storing and handling vaccines

The currently available vaccine, BCG Vaccine SSI, is presented in a multidose vial. For more information on use of multidose vials, see Administration of vaccines .

Transport according to National Vaccine Storage Guidelines: Strive for 5. 44 Store at +2°C to +8°C. Do not freeze. Protect from light.

BCG vaccine must be reconstituted . Add the entire contents of the diluent container to the vial and shake until the powder completely dissolves. Reconstituted vaccine is very unstable. Use within 4–6 hours.

Public health management

Tuberculosis is a notifiable disease in all states and territories in Australia. The Communicable Diseases Network Australia national guidelines for the public health management of tuberculosis 40 have details on the management of tuberculosis cases and their contacts.

State and territory public health authorities can provide further advice about:

• public health management of tuberculosis
• using alternative vaccine products in special circumstances, such as during shortages of the registered vaccine
• National Tuberculosis Advisory Committee. The BCG vaccine: information and recommendations for use in Australia – National Tuberculosis Advisory Committee update October 2012. Communicable Diseases Intelligence 2013;37:E65-72.
• Toms C, Stapledon R, Coulter C, Douglas P, National Tuberculosis Advisory Committee. Tuberculosis notifications in Australia, 2014. Communicable Diseases Intelligence 2017;41:E247-63.
• World Health Organization. World health statistics - Tuberculosis profile. 2022. (Accessed 25 April 2022). https://worldhealthorg.shinyapps.io/tb_profiles/?_inputs_&entity_type=%22country%22&lan=%22EN%22&iso2=%22AF%22
• Smith BB, Hazelton BJ, Heywood AE, et al. Disseminated tuberculosis and tuberculous meningitis in Australian-born children; case reports and review of current epidemiology and management. Journal of Paediatrics and Child Health 2013;49:E246-50.
• Zodpey SP, Bansod BS, Shrikhande SN, Maldhure BR, Kulkarni SW. Protective effect of Bacillus Calmette Guerin ( BCG ) against leprosy: a population-based case-control study in Nagpur, India. Leprosy Review 1999;70:287-94.
• National Tuberculosis Advisory Committee. Position statement on interferon-γ release assays in the detection of latent tuberculosis infection . Communicable Diseases Intelligence 2012;36:125-31.
• McLean HQ, Fiebelkorn AP, Temte JL, Wallace GS. Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations of the Advisory Committee on Immunization Practices (ACIP). [erratum appears in MMWR Morb Mortal Wkly Rep. 2015 Mar 13;64(9):259]. MMWR. Recommendations and Reports 2013;62(RR-4):1-34.
• Starr S, Berkovich S. Effects of measles, gamma-globulin-modified measles and vaccine measles on the tuberculin test. New England Journal of Medicine 1964;270:386-91.
• World Health Organization. SAGE Evidence to recommendations framework. 2017. (Accessed 28 March 2022). https://www.who.int/immunization/sage/meetings/2017/october/2_EvidencetoRecommendationFramework_BCG.pdf
• Menzies D. What does tuberculin reactivity after bacille Calmette-Guérin vaccination tell us? Clinical Infectious Diseases 2000;31 Suppl 3:S71-4.
• Hart PD, Sutherland I, Thomas J. The immunity conferred by effective BCG and vole bacillus vaccines in relation to individual variations in induced tuberculin sensitivity and to technical variations in the vaccines. Tubercle 1967;48:201-10.
• Hesseling AC, Marais BJ, Gie RP, et al. The risk of disseminated Bacille Calmette-Guerin ( BCG ) disease in HIV-infected children. Vaccine 2007;25:14-8.
• Hesseling AC, Cotton MF, Fordham von Reyn C, et al. Consensus statement on the revised World Health Organization recommendations for BCG vaccination in HIV-infected infants. International Journal of Tuberculosis and Lung Disease 2008;12:1376-9.
• Mansoor N, Scriba TJ, de Kock M, et al. HIV-1 infection in infants severely impairs the immune response induced by Bacille Calmette-Guérin vaccine. Journal of Infectious Diseases 2009;199:982-90.
• Cheent K, Nolan J, Shariq S, et al. Case report: Fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's disease. Journal of Crohn's and Colitis 2010;4:603-5.
• Mahadevan U, Terdiman JP, Church J, et al. Infliximab levels in infants born to women with inflammatory bowel disease. Gastroenterology 2007;132 Suppl 2:A144.
• Mahadevan U, Miller JK, Wolfe DC. Adalimumab levels detected in cord blood and infants exposed in utero. Gastroenterology 2011;140 Suppl 1:S61-2.
• Connelly Smith K, Orme IM , Starke JR. Tuberculosis vaccines. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines. 6th ed. Philadelphia, PA: Elsevier Saunders; 2013.
• Turnbull FM, McIntyre PB, Achat HM, et al. National study of adverse reactions after vaccination with bacille Calmette-Guérin. Clinical Infectious Diseases 2002;34:447-53.
• World Health Organization. BCG vaccines: WHO position paper – February 2018. Weekly Epidemiological Record 2018;93:73-96.
• Hesseling AC, Rabie H, Marais BJ, et al. Bacille Calmette-Guérin vaccine-induced disease in HIV-infected and HIV-uninfected children. Clinical Infectious Diseases 2006;42:548-58.
• Fitzgerald DW, Sterling TR, Haas DW. Mycobacterium tuberculosis. In: Bennett JE , Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's principles and practice of infectious diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015.
• Lumb R, Bastian IB, Jelfs PJ, et al. Tuberculosis in Australia: bacteriologically-confirmed cases and drug resistance, 2011. A report of the Australian Mycobacterium Reference Laboratory Network. Communicable Diseases Intelligence 2014;38:E369-75.
• National Center for HIV/ AIDS , Viral Hepatitis, STD, and TB Prevention, Division of Tuberculosis Elimination. Introduction to the Core Curriculum on Tuberculosis: what the clinician should know. 6th ed. Atlanta, GA: Centers for Disease Control and Prevention; 2013. https://www.cdc.gov/tb/education/corecurr/pdf/corecurr_all.pdf
• Barry C, Konstantinos A, National Tuberculosis Advisory Committee. Tuberculosis notifications in Australia, 2007. Communicable Diseases Intelligence 2009;33:304-15.
• Perez-Velez CM, Marais BJ. Tuberculosis in children. New England Journal of Medicine 2012;367:348-61.
• Bareja C, Waring J, Stapledon R, Toms C, Douglas P. Tuberculosis notifications in Australia, 2011. Communicable diseases intelligence quarterly report 2014;38:E356-68.
• NSW Health. List of countries with a tuberculosis incidence of 40 cases per 100,000 persons or greater. 2021. (Accessed 28 March 2022). https://www.health.nsw.gov.au/Infectious/tuberculosis/Pages/high-incidence-countries.aspx
• World Health Organization. Tuberculosis data: global tuberculosis report. 2021. (Accessed 28 March 2022). https://www.who.int/teams/global-tuberculosis-programme/data
• World Health Organization. BCG vaccines: WHO position paper – February 2018. 2018. (Accessed 28 March 2022). https://apps.who.int/iris/bitstream/handle/10665/260307/WER9308-73-96.pdf?sequence=1&isAllowed=y
• Ingram PR, Bremner P, Inglis TJ, Murray RJ, Cousins DV. Zoonotic tuberculosis: on the decline. Communicable Diseases Intelligence 2010;34:339-41.
• World Health Organization (WHO). The End TB Strategy: global strategy and targets for tuberculosis prevention, care and control after 2015. Geneva: WHO; 2014. http://www.who.int/tb/strategy/End_TB_Strategy.pdf
• Wittes RC. Immunology of bacille Calmette-Guérin and related topics. Clinical Infectious Diseases 2000;31 Suppl 3:S59-63.
• Roy A, Eisenhut M, Harris RJ, et al. Effect of BCG vaccination against Mycobacterium tuberculosis infection in children: systematic review and meta-analysis. BMJ 2014;349:g4643.
• Bourdin Trunz B, Fine PE, 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;367:1173-80.
• Colditz GA, Berkey CS, Mosteller F, et al. The efficacy of bacillus Calmette-Guérin vaccination of newborns and infants in the prevention of tuberculosis: meta-analyses of the published literature. Pediatrics 1995;96:29-35.
• Rodrigues LC, Diwan VK, Wheeler JG. Protective effect of BCG against tuberculous meningitis and miliary tuberculosis: a meta-analysis. International Journal of Epidemiology 1993;22:1154-8.
• Colditz GA, Brewer TF, Berkey CS, et al. Efficacy of BCG vaccine in the prevention of tuberculosis: meta-analysis of the published literature. JAMA 1994;271:698-702.
• Brewer TF. Preventing tuberculosis with bacillus Calmette-Guérin vaccine: a meta-analysis of the literature. Clinical Infectious Diseases 2000;31 Suppl 3:S64-7.
• Barreto ML, Pereira SM, Ferreira AA. BCG vaccine: efficacy and indications for vaccination and revaccination. Jornal de Pediatria 2006;82(3 Suppl):S45-54.
• Aronson NE, Santosham M, Comstock GW, et al. Long-term efficacy of BCG vaccine in American Indians and Alaska Natives: a 60-year follow-up study. JAMA 2004;291:2086-91.
• Sterne JA, Rodrigues LC, Guedes IN. Does the efficacy of BCG decline with time since vaccination? International Journal of Tuberculosis and Lung Disease 1998;2:200-7.
• Weir RE, Gorak-Stolinska P, Floyd S, et al. Persistence of the immune response induced by BCG vaccination. BMC Infectious Diseases 2008;8:9.
• National vaccine storage guidelines: Strive for 5. 2nd ed. Canberra: Australian Government Department of Health and Ageing; 2013. https://beta.health.gov.au/resources/publications/national-vaccine-storage-guidelines-strive-for-5-2nd-edition
• Communicable Diseases Network Australia ( CDNA ). Tuberculosis ( TB ): CDNA national guidelines for the public health management of TB . Canberra: Australian Government Department of Health; 2015. http://www.health.gov.au/cdnasongs

Page history

Recommendations for skin testing before BCG vaccination have changed. A tuberculin skin test before BCG vaccination is now only recommended in limited circumstances, based on a risk assessment.

Updates to all sections of the Tuberculosis chapter have been made including Recommendations, Vaccines, dosage and administration, Contraindications and precautions, Adverse events, Nature of the disease, Clinical features, Epidemiology, Vaccine information, Transporting, storing and handling vaccines, Public health management and Variations from product information.

Changes to 4.20.10 Precautions

4.20.10 Precautions

Addition of text to clarify when BCG vaccination should be deferred in people with skin conditions.

Help us improve the Australian Immunisation Handbook

Printed content may be out of date. For up to date information, always refer to the digital version:

All vaccine preventable diseases

Acknowledgement

The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.

© Commonwealth of Australia | Department of Health and Aged Care

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TB vaccine: WHO expert explains why it's taken 100 years for a scientific breakthrough, and why it's such a big deal

Posted: 8 November 2023 | Last updated: 9 November 2023

The BCG vaccine for TB has been used for 100 years. It is largely effective for children under five, but less so in older people and can't be used on patients who have certain medical conditions. Today we're the closest we've ever been to discovering a vaccine that might replace or complement it.

But, why has it taken so long?

We do not yet have a new vaccine for TB. But, for the first time, there are several vaccine candidates that are at advanced stages of clinical development.

Vaccine development usually takes decades and unfolds step by step. Experimental vaccine candidates are created in the laboratory and tested in animals before moving into progressively larger human clinical trials.

Clinical trials are research studies that test an intervention such as a vaccine in human beings and occur in phases, from phase 1 to phase 3. We say vaccines are in clinical development when they reach the clinical trial stage.

- A phase 1 trial is a first-in-human study which recruits a small number of healthy people (usually fewer than 100), to assess whether a candidate vaccine is safe.

- Phase 2 trials are typically conducted among several hundred participants, to assess whether the candidate vaccine produces an immune response.

Even though we are still, at best, three years away from broad regulatory approval of a new TB vaccine, the scientific community can do a lot now to prepare for its use, and to inform the public so that the vaccine may be accepted when it becomes available.

TB vaccines are very challenging to develop. The bacterium that causes the disease is complex, and is proficient at evading the human immune system. We don’t yet have a full understanding of how to appropriately target the bacterium or what kind of immune responses are needed to induce immunity. But there are some interesting approaches in the pipeline and there have been some encouraging data from clinical trials that are providing clues.

Why do we need a new TB vaccine?

TB is a global health emergency. About 2 billion people are currently infected with Mycobacterium tuberculosis , and of those, 5% to 10% may become ill with TB and will potentially transmit the bacterium. In 2021 , nearly 10.6 million people developed TB disease and 1.6 million died. We urgently need new tools to fight TB, including new and improved vaccines.

The Bacille Calmette-Guérin (BCG) vaccine has saved tens of millions of lives and is effective in children under the age of five in preventing TB deaths and severe forms of the disease.

The vaccine has variable efficacy for protection against pulmonary TB (TB affecting the lungs) in adolescents and adults – and it is pulmonary TB that’s responsible for the majority of TB transmission. So new and improved vaccines that are effective in preventing pulmonary TB in adolescents and adults are essential to control TB, and to reduce transmission to all, including newborn babies.

TB is the leading cause of death among people living with HIV. People living with HIV have up to 20 times higher risk of developing TB disease compared to those without HIV infection. The current BCG vaccine is not recommended for use in people living with HIV, for safety reasons. Although BCG is a safe vaccine in immunocompetent infants (those whose immune systems are working properly), severe adverse events can occur in HIV-infected infants following vaccination with BCG.

These adverse events include a rare but life threatening condition known as disseminated BCG disease . However, new TB vaccine candidates are being developed and evaluated to offer clinical benefit in people living with HIV.

How effective has the BCG vaccine been?

BCG vaccines are given to more than 100 million children every year worldwide, at birth or soon after. The effectiveness of BCG can vary depending on several factors, including the prevalence of TB in a given area, the strain of the BCG vaccine used, and the age at which BCG was administered. Several studies have shown that the effect of the BCG wanes as children approach adolescence. People may become infected with TB but not be aware of it.

What will happen to the BCG vaccine?

The BCG vaccine will not be replaced by another TB vaccine until and unless there is compelling data on the safety and efficacy of an alternative. Most of the current vaccines in advanced stages of clinical trials are tested in adolescents and adults. Their safety and efficacy would need to be proven in newborn infants to be able to replace BCG.

In addition, BCG vaccination has nonspecific beneficial effects on overall mortality and leads to more reductions in child mortality than would be expected by just protecting against tuberculosis. There is thus a great possibility that BCG would remain in use.

What will a new vaccine mean for the fight against TB?

This depends on what the clinical trial data for the new vaccine candidates show. Most importantly, any new vaccine will need to be safe, and it will need to offer clear clinical benefit to populations at risk. We hope that the TB vaccine candidates that are in the pipeline will be effective at reducing TB infection, TB disease and TB transmission and can become part of a combination of tools in the fight against TB.

This article is part of a media partnership between The Conversation Africa and the 2023 Conference on Public Health in Africa.

This article is republished from The Conversation under a Creative Commons license. Read the original article .

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