BCG Vaccine

BCG Vaccine is a prescription medication belonging to the vaccine class

BCG vaccine is approved for the prevention of tuberculosis (TB).

The BCG vaccine (Bacillus Calmette-Guérin vaccine) is part of India's routine National Immunization Schedule (NIS).

The BCG vaccine is absorbed into the bloodstream upon administration and is primarily distributed to vital immune cells. Its effectiveness is not significantly influenced by metabolic processes or conventional excretion, as its action relies on the immune response.

The common side effects associated with the BCG vaccine include fever, chills, nausea, swelling of glands in the arm where the injection was administered, headache, etc.

BCG Vaccine is available in the form of percutaneous powder for injection.

The Bacillus of Calmette and Guerin (BCG) vaccine belonging to the vaccine class acts as an immunostimulant. BCG acts by stimulating the body's cellular immunological response. It is made from a weakened strain of Mycobacterium bovis, a bacterium that causes tuberculosis in humans. The vaccine stimulates the body's cellular immunological response, carried out by T cells. This increase in reaction aids the body in identifying and eliminating the TB-causing Mycobacterium tuberculosis. The principal way that the BCG vaccination interacts is with cells, particularly T cells, rather than receptors. Its main impact is to improve the body's resistance to TB infection.

The BCG vaccine requires some time to establish a reaction regarding how it functions, typically several weeks. Long-lasting defense against TB is provided by its protective properties, which can continue for years once triggered.

BCG vaccine can be used to prevent tuberculosis and its symptoms, such as TB meningitis and miliary TB.

It may provide some protection against leprosy, another illness caused by mycobacteria.

The BCG vaccine can help to build a defence against TB infection, reducing the chances of consequences like TB meningitis and miliary TB. This vaccine provides health benefits by activating the body's response, particularly involving T lymphocytes, to better protect against tuberculosis (TB).

BCG vaccine is approved for use in the following clinical indications

1. Infants and children who have been exposed to TB:

It is advised for individuals who have negative results from a tuberculin skin test but run a higher risk of being exposed to TB patients or those who have drug-resistant TB for an extended period and cannot be segregated from them.

It is advised for those with negative tuberculin skin test results but cannot be separated from or are at increased risk of extended exposure to TB patients or those with drug-resistant TB.

2. Medical Personnel Exposed to TB in High-Risk Environments:

If intensive infection control measures have failed and HCWs are expected to encounter drug-resistant TB patients, they should consider getting vaccinated with BCG. Medical personnel should be aware of the risks and advantages, but it shouldn't be mandated.

3. Healthcare Personnel Exposed to Tuberculosis in Low-Risk Environments:

The BCG vaccination is not advised for HCWs working in settings with a low risk of M. tuberculosis transmission.

Intradermally: The BCG vaccine is administered as a liquid directly onto the skin of your upper arm. The vaccine is then delivered into the shallow layers of skin using a multi-pronged needle device, pricking the skin through the liquid. The BCG vaccine contains live tuberculosis germs that can "shed" from the injection site. This implies that for a brief period after receiving the vaccine, your vaccination sore will be contagious and could spread bacteria to anyone who comes into contact with it. Cover your vaccine sore lightly for at least 24 hours with clothing or a light gauze dressing.

The BCG vaccine comes in vials of 20 infant doses.

 Each vial of the freeze-dried BCG preparation contains between 1 and 8 × 108 CFU, or roughly 50 mg wet weight, of BCG.

BCG Vaccine is available in the form of percutaneous powder for injection. Before administration, it must be diluted with water. After mixing, it becomes a solution that may be injected into the skin using a multiple-puncture tool.

Dosage adjustments for adult patients

Drop 0.2 to 0.3 mL of vaccine from the syringe onto the cleansed deltoid and spread throughout a 1 to 2-inch region using the edge of the multiple puncture instrument.

Dosage adjustment for pediatric use

• For children older than one month: Drop 0.2 to 0.3 mL of vaccine from the syringe onto the cleansed deltoid and spread throughout a 1 to 2-inch region using the edge of the multiple puncture instrument.
• For infants: When reconstituting, cut the dose in half by using 2 mL of sterile water for injection.

BCG Vaccine should be used in the prevention of tuberculosis along with appropriate dietary restrictions.

People with conditions such as high blood pressure, diabetes, chronic kidney disease (CKD), gout, heart failure, obesity, polycystic ovarian syndrome (PCOS), hypothyroidism, respiratory allergies/asthma, or other health issues may be required to follow dietary restrictions recommended by their healthcare providers to effectively manage their conditions.

BCG Vaccine may be contraindicated in the following conditions

• The BCG vaccine is not recommended for people with weakened systems, such as those with HIV or individuals who may undergo organ transplantation and risk immunosuppression.
• Pregnant women should also avoid it, although ongoing research is examining its safety during pregnancy.
• Before administering the vaccine, it is crucial to evaluate the possibility of allergies or reactions to a previous dose of the BCG vaccine or any of its components.
• Additionally, individuals of all ages including infants, children, and adults, with immune deficiency diseases should not receive the BCG vaccine to prevent negative outcomes associated with vaccination.

The treating physician must closely monitor the patient and keep pharmacovigilance as follows:

• Please administer the BCG vaccine through a device avoiding intravenous, subcutaneous, intramuscular, or intradermal methods. It is common to experience reactions at the injection site, such as swelling of lymph nodes, induration, and formation of pustules. These reactions typically last up to 3 months. In some cases, severe local reactions may occur, including ulceration draining lymph nodes or pus at the puncture site. Such reactions can persist for weeks. It should be brought to immediate attention if observed.
• While receiving the BCG vaccine can cause flu symptoms, monitoring for fever exceeding 103°F or prolonged inflammation beyond 2 to 3 days may indicate an active infection and require immediate consultation with a healthcare professional.
• Although rare, it is crucial to note that individuals with compromised systems are at risk of developing disseminated BCG infection, which can be a complication.
• When preparing and administering the BCG vaccine, always adhere to techniques. Each patient should have their multiple puncture device used for vaccination. Furthermore, handle all equipment and materials as substances.
• It is not recommended to vaccinate individuals with deficiency or those who are at high risk for HIV infection. Before proceeding with vaccination, review the patient's immunization history. Assess their risk of reactions. Ensure access to epinephrine in case of reactions.
• Vaccination should only be considered for individuals who have tested negative on a skin test using 5 TU (tuberculin units). After receiving the vaccine, advise patients to keep the vaccination site clean and dry for 24 hours and report any reactions promptly.
• After receiving the vaccine, you might experience flu symptoms for a period of time. However, if you develop a fever or experience prolonged reactions, it is important to seek immediate medical evaluation.

There is no sufficient scientific evidence traceable regarding the use and safety of BCG vaccines in concurrent use with alcohol.

There is no sufficient scientific evidence traceable regarding the use and safety of BCG vaccines in breastfeeding.

There is no sufficient scientific evidence traceable regarding the use and safety of BCG vaccines in pregnancy.

There is no sufficient scientific evidence traceable regarding the use and safety of BCG vaccines in concurrent use with any particular food.

The adverse reactions related to BCG Vaccine can be categorized as:

Common: fever, chills, nausea, malaise, dysuria, infection, flu-like symptoms, anaemia, urinary urgency, hematuria

Less Common: rash, abdominal pain, diarrhoea, leukopenia, renal toxicity, hemorrhagic cystitis, nocturia, headache, genital inflammation, urinary incontinence, pulmonary infection, myalgia

Rare: Urea nitrogen in the blood increased, Creatinine increased, Coagulopathy, Disseminated sepsis, Hepatitis, Myoglobinuria, uveitis, nephritis

The clinically relevant drug interactions of the BCG Vaccine are briefly summarized here.

• Immunoglobulins have a reduced therapeutic impact.
• Immunosuppressants, bone marrow depressants, antibiotics, and radiation therapy have a reduced therapeutic impact.
• Because BCG is a live vaccination, the immunological response to the vaccine may be compromised if administered within 30 days of another live vaccine.

The common side of BCG Vaccine inclincludes following:

• discomfort or discharge from the injection site
• a headache
• a high temperature (fever)
• the The where the injection was administered has swollen glands under the armpit.

The use of BCG Vaccine should be prudent in the following group of special populations:

Pregnancy Category C:

Currently, no animal studies have been undertaken to investigate the effect of the BCG vaccine on health. It is unclear whether this vaccine poses any developmental concerns or affects women's fertility. Although there is no known risk to the fetus from the BCG vaccine, it is not recommended for use during pregnancy.

Nursing Mothers

It is unknown if BCG is excreted in human milk. Because many medications are excreted in human milk, there is a risk of major adverse effects from BCG in nursing infants.

Pediatric Use

Infants vaccinated with BCG and exposed to people with active tuberculosis should be treated with caution.

  Dosage adjustment for pediatric use

• For children older than one month: Drop 0.2 to 0.3 mL of vaccine from the syringe onto cleansed deltoid and spread throughout a 1 to 2-inch region using the edge of the multiple puncture instrument.
• For infants: When reconstituting, cut the dose in half by using 2 mL of sterile water for injection

Geriatrics

The physician should be vigilant about the knowledge pertaining to the identification and treatment of overdosage of BCG Vaccine

Overdoses from the BCG vaccine are uncommon, but they have occurred. The degree of problems varies depending on the dosage used. It resulted in the creation of abscesses, tissue damage, and lymph nodes in certain cases. Significant skin lesions and lymph node swelling were found when greater doses were delivered.

The BCG (Bacillus Calmette Guérin) vaccine works in pharmacology by stimulating the system.

Pharmacodynamics:

When injected into the skin, BCG triggers a response in the system at the injection site. This response involves cells such as macrophages and T cells, which engulf the weakened Mycobacterium bovis in the vaccine. As a result, a series of reactions occur, protecting against tuberculosis.

Pharmacokinetics:

In terms of Pharmacokinetics, BCG does not follow the patterns of drugs. It is not significantly absorbed into the bloodstream. Remains localized at and near the injection site and lymph nodes. There is no involvement of circulation, metabolism or excretion in its process. The unique pharmacodynamic properties and limited pharmacokinetic profile distinguish BCG from pharmaceuticals, highlighting its role as an immunostimulant.

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Hart PD. Efficacy and Applicability of Mass B. C.G. Vaccination in Tuberculosis Control. BMJ. 1967;1:587–92

Corbel MJ, Fruth U, Griffiths E, et al. Report on a WHO Consultation on the Characterisation of BCG Strains, Imperial College, London. Vaccine. 2004;22:2675–80

Tuberculosis Research Centre (ICMR), Chennai. Fifteen Year Follow-up of Trial Of BCG Vaccines in South India for Tuberculosis Prevention. Indian J Med Res. 1999;110:56–69

https://www.fda.gov/files/vaccines, blood & biologics/published/Package-Insert---BCG-Vaccine.pdf

https://reference.medscape.com/drug/tice-bcg-vaccine-tice-strain-343147#91

https://www.nhs.uk/conditions/vaccinations/bcg-tuberculosis-tb-vaccine/#:~:text=How the BCG vaccination is,usually leaves a small scar.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927726/#:~:text=BCG vaccine overdose has been,with lymphadenopathy have been reported.