Bacillus Of Calmette and Guerin Vaccine, Live (Intradermal)

The Bacillus Calmette-Guérin (BCG) live vaccine, or BCG vaccine, for short, helps prevent tuberculosis in high-risk patients.

Overview

Tuberculosis, commonly shortened as TB, is considered to be a very serious disease. It is potentially fatal if medical intervention is not completed.

The most common signs of TB include coughing, fever, and night sweats. To effectively wipe out the disease, patients who are diagnosed with this condition must undergo a series of treatments for a prolonged period of time.

When a patient is asymptomatic, he or she can still spread the disease to others in the same household, for example. This applies to cases of active TB vs. latent TB where the disease lies dormant in the body and cannot be spread in such an inactive state.

TB can be spread when microscopic droplets carrying the TB bacteria come into contact with someone else. The most common route of transmission is when an infected party sneezes or coughs.

Once isolated to developing countries, tuberculosis became a major health concern in the 1980s when HIV emerged and there were increasing reports of TB patients exhibiting resistance to the available drug treatments at the time.

The healthcare industry took extensive measures to curtail resurgence of the disease by cultivating the Bacillus Calmette-Guérin live vaccine for high-risk patients. Though popular in other places worldwide, the Bacillus Calmette-Guérin live vaccine does not fall under the list of recommended vaccines in the United States. It is generally suggested for high-risk groups only including:

  • People who live in shelters, group, or transitional homes
  • Individuals who are incarcerated or homeless
  • Foreign-born individuals

Condition(s) Treated?

  • Tuberculosis prevention

Type Of Medicine?

  • Antituberculosis drug

Side Effects

Some of the most commonly reported side effects of the BCG vaccine include:

  • Flu-like symptoms
  • Fever
  • Blurred vision
  • Hypersensitivy
  • Skin lesions
  • Keloids (permanent)

Most of these side effects subside after a few days. If these symptoms persist for longer than three (3) days, this could be a sign of an active and acquired tuberculosis infection. Seek medical help right away if you do not feel better. You should also get emergency medical help if your symptoms are accompanied by:

  • A fever of 103°F or higher (24-48 hours)
  • Acute inflammation

Rare Side Effects of the BCG Vaccine

Serious complications resulting from the BCG vaccine are rare. Some examples include:

  • Abscesses at the site of injection - These could last for up to three months
  • Lesions - Could possibly persist for up to five months at the injection site
  • BCG osteitis - Could develop within 2 months to 2 years following a BCG vaccination

The most serious side effect of the BCG vaccine is a disseminated BCG infection, which could be fatal. Fatalities have been predominantly reported in individuals with a compromised immune system.

Dosage

Using one 50 MG vial of lyophilized (freeze-dried) powder, the following doses are standard for the BCG vaccine:

  • Adults: 1 mL of sterile water for percutaneous injection only - Added to one vial of BCG vaccine
  • Infants under 4 weeks: Reduced dosage

Though widely used in other parts of the world, the Bacillus Calmette-Guérin live vaccine is not generally recommended for American citizens, except in a few cases, such as:

  1.  When Infants and Children Face Prolonged Exposure

In cases where minors are unable to live apart from someone diagnosed with active or latent TB, the Bacillus Calmette-Guérin live vaccine may be recommended. Patients must pass a negative skin test in order to be eligible for the vaccine.

  1. Health Workers in High-Risk Settings

Medical workers who regularly come into contact with patients diagnosed with TB should be vaccinated to reduce the risk of transmission. Though this is not mandatory and other control mechanisms are usually in place, the health group, along with individual medical workers, will generally come to a decision on the best action to take.

Proper Use

After injecting to a localized area percutaneously, no dressing is needed. Medical workers should cover the injection site loosely and inform patients to keep it dry for up to a day. Patients should also avoid contact with others as live organisms are present in the BCG vaccine. The risk of infection is therefore probable.

Interactions

The Bacillus Calmette-Guérin live vaccine should not be used in conjunction with Deflazacort unless a medical provider determines this to be completely necessary. In such cases, doses may be adjusted. Patients who are also taking the following prescriptions should not take the Bacillus Calmette-Guérin live vaccine, as negative drug interactions have been proven:

  • Abatacept
  • Adalimumab
  • Azathioprine
  • Bortezomib
  • Bosutinib
  • Cabazitaxel
  • Capecitabine
  • Cisplatin
  • Cladribine
  • Clofarabine
  • Cyclophosphamide
  • Cytarabine
  • Dasatinib
  • Daunorubicin
  • Doxorubicin
  • Epirubicin
  • Everolimus
  • Fingolimod
  • Gemcitabine
  • Immune Globulin
  • Mitoxantrone
  • Oxaliplatin
  • Paclitaxel
  • Rilonacept
  • Secukinumab
  • Tositumomab
  • Vinblastine

This is not an extensive list. Medical providers generally refer to drug interaction checkers to determine possible risks of negative interactions.

Warnings

Patients and medical workers should note all precautions outlined regarding the BCG vaccine.

Immunity Is Not Guaranteed

According to medical studies, the Bacillus Calmette-Guérin (BCG) live is considered to be roughly 50% effective in preventing the transmission of tuberculosis.

As a result, the BCG vaccine does not offer guaranteed protection against tuberculosis. It merely reduces the risk of transmission. As a result, patients who receive the Bacillus Calmette-Guérin live vaccine should exercise caution and try to avoid contact with individuals diagnosed with either active or latent TB.

Pre-Existing Conditions

Tell your doctor if you smoke or drink as these lifestyle habits could affect how well you respond to the Bacillus Calmette-Guérin (BCG) live vaccine and how it works. You should also inform your medical provider about the presence of:

  • Infections or Fevers - The presence of a fever is a sign of a pre-existing infection, which could potentially amplify some of the common side effects of taking the Bacillus Calmette-Guérin (BCG) live vaccine.
  • Skin Conditions - Inform your doctor about any skin infections or irritations you may be experiencing on any area of the body.

Impaired Immune System

Patients who have a weakened immune system should not be given the Bacillus Calmette-Guérin (BCG) live vaccine due to the increased risk of side effects. In particular, tell your doctor if you have been diagnosed with any of the following conditions:

Additionally, patients whose immune systems are impaired due to certain treatments should not take the Bacillus Calmette-Guérin (BCG) live vaccine. These include but aren't limited to:

  • Alkylating Agents
  • Antimetabolites
  • Radiation
  • Steroids

Allergies

Tell your doctor if you have ever had an allergic reaction to BCG or any other foods or substances. Past incidences could increase the risk of an anaphylactic reaction to the Bacillus Calmette-Guérin (BCG) live vaccine. Patients' full immunization history must be assessed to determine any past or severe allergic reactions to vaccinations prior to use.

Nursing Mothers

Expecting or breastfeeding mothers should weigh the risks and benefits with a medical provider prior to taking the Bacillus Calmette-Guérin live vaccine.

Precautions for Medical Workers

Nurses are typically charged with administering the Bacillus Calmette-Guérin live vaccine to patients. As this medication encloses live, attenuated mycobacteria, according to the FDA, medical professionals must heed all warnings to handle with care.

Medical workers should avoid making direct contact with broken skin on patients. To avoid inhaling the live microorganisms and risk transmission, protective gear should be worn at all times during preparation, including gloves and masks.

To prevent cross-contamination, other medical instruments should not be handled in places where the BCG vaccine was used. Use a new puncture device for every patient or bag of BCG vaccine dispensed. Disposals should be made in select biohazard waste containers to prevent exposure to other workers and patients.

Active Tuberculosis

Patients who have been diagnosed with active tuberculosis should not be given Bacillus Calmette-Guérin live vaccine. A skin or lab test should be completed to complete an accurate diagnosis.

Other Vaccinations

Healthcare experts suggest scheduling vaccinations, including the BCG vaccine, at least 30 days apart from each other to reduce the risk of side effects.

Storage

Pay attention to the expiration date on each box of BCG vaccine. Always store away from direct sunlight and in refrigerated temperatures of 36-46°F (2-8°C).

A reconstituted vial can be refrigerated for up to two hours and kept away from sunlight. Do not refreeze.

Summary

The Bacillus Calmette-Guérin (BCG) live vaccine helps prevent the spread of pulmonary tuberculosis or TB in high-risk groups, including medical workers and patients who are institutionalized.

The vaccine is not intended or should never be given to patients with an active case of tuberculosis or in patients with a demonstrated family history of immune deficiency syndromes.

The vaccine does not 100% protect against pulmonary tuberculosis transmission. As a result, contact should be avoided with other individuals who are known to carry the disease.

The BCG vaccine is administered percutaneously in what's labeled as a "deltoid region"and only by a qualified worker who is trained on how to responsibly handle and inject the vaccine.

Resources
Last Reviewed:
December 26, 2017
Last Updated:
April 05, 2018