BCG vaccine is a live attenuated vaccine prepared from mycobacterium Bovis. It is used to induce active immunity against mycobacterium tuberculosis. For those who have never been infected but are at risk of contracting TB, the BCG vaccination is administered to immunise them actively against Mycobacterium tuberculosis.

The following patient population is one in whom the BCG vaccine is advised by the ACIP (Advisory Committee on Immunization Practices):

• Children and infants exposed to pulmonary TB patients but with a negative tuberculin skin test (especially with isoniazid and rifampicin-resistant strains).
• Workers in the medical field who come into contact with patients who have TB who have strains that are resistant to isoniazid and rifampicin, where there is a chance of continuous transmission of the resistant strains and where appropriate infection control measures are lacking.
• Those who provide medical treatment and humanitarian aid in regions where multidrug-resistant TB is prevalent.

It is also used for the prevention of leprosy (Off-Label Use)

BCG Vaccine Dose in Adults

Dose in the treatment of Immunization against tuberculosis:

• 0.2 to 0.3 mL percutaneous.
• In 2 to 3 months, a PPD test including 5 tuberculin units should be performed. Repeating the immunisation is advised if the test is negative.

Note: In 10 to 14 days, a little red papule at the injection site manifests; it grows to a maximum diameter of 3 mm in 4 to 6 weeks.

Dose in the prevention of leprosy (off-label use):

• 0.2 - 0.3 mL percutaneous.
• A single dose offers partial protection while multiple doses may provide greater protection. However, the interval between dosages has not been specified.

BCG Vaccine Dose in Children

Dose in the treatment of Immunization against tuberculosis:

• Infants, Children, and Adolescents:
  • single percutaneous dosage of 0.2–0.3 mL.
  • Individuals with a negative test should be revaccinated after one year of age.
  • In two to three months, a PPD test requiring five TU (tuberculin units) should be conducted.

Note: At the injection site, a little red papule form in 10 to 14 days and grows to a maximum diameter of 3 mm in 4 to 6 weeks.

BCG vaccine for the prevention of leprosy in areas with high incidence:

• Infants, Children, and Adolescents:
  • 0.2 to 0.3 mL administered intravenously in one dosage (BCG vaccine - WHO position paper, 2018 recommendations) 

Pregnancy Risk Factor: D

• Limited data is available.
• The BCG vaccination is not advised for use in pregnant women due to the potential harm to the foetus.
• Conception should be avoided for four weeks following the administration of live attenuated vaccinations to pregnant women.

BCG use during breastfeeding:

• It is unknown if the vaccination is excreted in breastfeeding.
• The advantages of vaccination for the mother and the dangers to the foetus should be evaluated due to the possibility of negative consequences for the baby.

BCG Vaccine Dose in Renal Disease:

• Adjustment in the dose has not been provided by the manufacturer in patients with kidney disease.

BCG Vaccine Dose in Liver Disease:

• Adjustment in the dose has not been provided by the manufacturer in patients with liver disease.

Side Effects of BCG Vaccine:

After the vaccine, local responses may happen and last for three months. Up to a few weeks may pass between more severe symptoms. Up to five months following the vaccine, more acute symptoms may appear and last for several weeks.

Frequency not defined.

• Dermatologic:
  • Skin ulceration at the injection site
  • Pustules at the injection site
• Infection:
  • BCG Osteomyelitis may occur from 4 months to 2 Years after the vaccination.
• Hematologic & Oncologic:
  • Cervical Lymphadenopathy
  • Lymphadenitis
  • Auxillary Lymphadenopathy
• Respiratory:
  • Flu-Like Symptoms
• Local:
  • Induration at the Injection Site
  • Tenderness at the Injection Site
  • Injection Site Lesion
  • Itching at the Injection Site

Contraindication to BCG vaccination Include:

• Allergic reactions to the vaccine or any component of the formulation.
• Acquired Immunosuppression as in HIV infection, leukemia, lymphoma, cancer therapy, or the use of corticosteroids
• Congenital immune deficiencies.
• Active tuberculosis.

Warnings & Precautions

• Anaphylactoid & hypersensitivity reactions:
  • After immunisation, severe anaphylactic responses might happen.
  • During vaccination usage, immediate access to epinephrine 1 mg/mL and other life-saving medications should be possible.
• BCG reaction:
  • At the injection site, the vaccination can cause induration, pustule development, and axillary or cervical lymphadenopathy.
  • These local responses might persist for up to three months.
  • Patients with draining sinuses have a higher risk of developing severe ulceration and suppurative lymphadenitis.
  • Within a five-month period, caseous lesions and purulent discharge are possible, and they can last for several weeks.
  • Anorexia, myalgia, neuralgia, and flu-like symptoms are just a few of the hypersensitivity reactions that might linger for one to two days.
• Disseminated infections:
  • Since BCG is a live vaccine, it may cause BCG infection in immunocompromised patients.
  • People who experience local responses or a feverish condition (higher than 103 F) lasting more than 3 days should stop receiving the BCG vaccine permanently and start receiving antimycobacterial therapy with more than 2 agents while a diagnostic assessment is being carried out.
  • Pyrazinamide should not be a part of the antimycobacterial therapy as BCG infection is not sensitive to it.
  • The most frequent disseminated infection that can develop four months to two years after receiving a BCG immunisation is BCG osteomyelitis.
  • It primarily affects the epiphyses of the long bones
• Syncope:
  • BCG vaccination may result in syncope that may lead to serious secondary injury like a skull fracture or intracranial bleeding.
  • It should be administered in a proper place where the risk of fall and secondary injury is minimal and syncopal attack can be managed promptly.
• Acute illness:
  • It is not advisable to immunise patients who are experiencing moderate or severe acute sickness.
  • It can, however, be given to people who are experiencing a minor acute sickness.
• HIV:
  • It is contraindicated in HIV patients (especially those with low CD4 counts).

Monitor:

• Prior to vaccination, a PPD (Purified protein derivative) test should be performed in non-endemic regions where BCG is not a regular component of the WHO EPI programme.
• There may be fever and flu-like symptoms.
• After the injection, local responses might last for two to three days.
• 15 minutes after the vaccination delivery, keep an eye on the patient for anaphylaxis and syncope.
• If syncope occurs, the patient should be made to lie supine or in a Trendelenburg position to reestablish cerebral perfusion.

How to administer BCG?

Only percutaneous administration of the BCG vaccination is advised.

It shouldn't be given SubQ, intramuscularly, topically, or intravenously.

It shouldn't be combined with other shots or vaccinations, and each injection needs to be given with a different syringe and needle.

• The vaccine should be injected into a clean dried site, preferably the deltoid muscles of the right arm.
• The needle should be positioned horizontally while pulling the skin tight.
• Apply pressure over the area for 5 seconds.
• Apply a loose covering and maintain dry skin for a whole day.

Mechanism of action of BCG Vaccine:

• The Bacillus of Calmette and Guérin (BCG) strain of Mycobacterium Bovis was cultured to create the BCG vaccine, a live attenuated bacterial vaccination.
• Mycobacterium tuberculosis is actively defended against by it.

International Brands of BCG Vaccine:

• BCG Vaccine

BCG Vaccine in Pakistan: