Tuberculosis Vaccine: In the United States and Around the World

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

Medically reviewed by Ronald Lubelchek, MD

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.

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:

• Weakness

• Night sweats

• Fever

• Lack of appetite

• Unwanted weight loss

• Fatigue

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.
  

Which Countries Use It?

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:

• Bangladesh

• China

• Democratic Republic of the Congo

• India

• Indonesia

• Nigeria

• Pakistan

• 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.

Efficacy and Side Effects

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

• Fever

• Headache

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:

• Glycerin

• Citric acid

• Magnesium sulfate

• Iron ammonium citrate

• Potassium phosphate

• Asparagine

• Lactose

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

Summary

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.

Frequently Asked Questions

Where can you get a TB shot in the United States?

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.

Who should get a TB vaccine?

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.

Why does the TB vaccine cause scarring?

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.

Read the original article on Verywell Health.