What is the special precaution of BCG vaccine?
Bacillus Calmette-Guerin (BCG) Vaccine
BCG vaccine provides immunity or protection against tuberculosis (TB). The vaccine may be given to persons at high risk of developing TB. It is also used to treat bladder tumors or bladder cancer.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
HOW should this medicine be used?
Your doctor or a health care provider will administer this medicine. When used to protect against TB, it is injected into the skin. Keep the vaccination area dry for 24 hours after receiving the vaccine, and keep the area clean until you cannot tell the vaccination area from the skin around it.
When used for bladder cancer, the medicine flows into your bladder through a tube or catheter. Avoid drinking fluids for 4 hours before your treatment. You should empty your bladder before treatment. During the first hour after the medication is infused, you will lie on your stomach, back, and sides for 15 minutes each. Then you will stand, but you should keep the medication in your bladder for another hour. If you cannot keep the medication in your bladder for the entire 2 hours, tell your health care provider. At the end of 2 hours you will empty your bladder in a seated manner for safety reasons. Your urine should be disinfected for 6 hours after the medication is administered. Pour a similar amount of undiluted bleach in the toilet after you urinate. Let it stand for 15 minutes before flushing.
Various dosing schedules may be used. Your doctor will schedule your treatment. Ask your doctor to explain any directions you do not understand.
When the vaccine is given to protect against TB, it usually is given only one time but may be repeated if there is not a good response in 2-3 months. Response is measured by a TB skin test.
What SPECIAL PRECAUTIONS should I follow?
Before receiving BCG vaccine,
- tell your doctor and pharmacist if you are allergic to BCG vaccine or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antibiotics, cancer chemotherapy agents, steroids, tuberculosis medications, and vitamins.
- tell your doctor if you have had a recent smallpox vaccination or if you have had a positive TB test.
- tell your doctor if you have an immune disorder, cancer, fever, an infection, or an area of severe burns on your body.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking BCG vaccine, call your doctor immediately.
What SIDE EFFECTS can this medicine cause?
BCG vaccine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- swollen lymph nodes
- small red areas at the site of injection. (These usually appear 10-14 days after injection and slowly decrease in size. They should disappear after about 6 months.)
- fever
- blood in the urine
- frequent or painful urination
- upset stomach
- vomiting
If you experience any of the following symptoms, call your doctor immediately:
- severe skin rash
- difficulty breathing or swallowing
- wheezing
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory.
BCG vaccination for babies
The Bacillus Calmette-Guérin (BCG) vaccination is given to new born babies at risk of getting tuberculosis (TB). TB is a very serious infectious disease that can cause TB meningitis in babies.
How the BCG vaccine works
BCG vaccine has a weakened form of the bacteria that cause tuberculosis (TB).
The vaccine doesn’t cause TB, but helps your baby develop protection (immunity) against the disease.
The BCG vaccination is particularly effective in protecting babies and young children against the more rare severe forms of TB such as TB meningitis (swelling of the lining of the brain).
Tuberculosis
TB is a serious, but curable, infectious disease that can lead to TB meningitis in babies.
Most people in Northern Ireland recover fully after treatment, however, TB meningitis can be fatal or cause severe disability.
How TB is spread
You can only catch TB from someone coughing whose lungs or throat are already infected with TB.
When they cough, tiny droplets are produced that contain the bacteria. If you breathe in the droplets you too can catch the infection.
You usually need to spend a long time in close contact with an infected person (with TB in their lungs or throat) before you catch TB.
Symptoms of TB
TB can affect any part of the body. You should contact the doctor if you or your baby:
- have a cough that lasts longer than three weeks
- have a fever
- sweat especially at night
- unexplained weight loss
- a general and unusual sense of tiredness and being unwell
- cough up blood
When the BCG vaccine is given
The vaccine is given to a baby if they are likely to come into contact with someone who has TB.
This includes babies who:
- live in an area with high rates of TB
- have parents or grandparents that are from a country with high rates of TB
The vaccine is offered when your baby is newborn in hospital or after you bring your baby home.
How the vaccine is given
Your baby will get the BCG vaccination in the upper part of the left arm.
Possible side effects
Immediately after the injection, a raised blister will appear. This shows that the injection has been given properly.
Within two to six weeks of the injection a small spot will appear. This may be quite sore for a few days, but it should gradually heal if you don’t cover it. It may leave a small scar.
Occasionally, your baby may develop a shallow sore where they had the injection. If this is oozing fluid and needs to be covered, use a dry dressing – never a plaster – until a scab forms. This sore may take as long as several months to heal.
If you are worried or you think the sore has become infected, see your doctor.
Asking for BCG vaccination
The vaccine is only offered to people at increased risk of tuberculosis infection. You or your child will be assessed to check you’re eligible for vaccination.
For more information about the vaccine and tuberculosis, go to the PHA website:
- BCG and your baby: protecting your baby against TB
- TB (Tuberculosis): the disease, its treatment and prevention
More useful links
- Immunisation for children
- Illnesses and conditions
BACILLE CALMETTE GUERIN (BCG) VACCINE
Identification features of BCG vaccine (Fig. 4.1)
• The vaccine is available in dark bottles to protect from sunlight.
• Some bottles have a long neck as the vaccine is packed in vacuum.
Type of vaccine
• Live
• Freeze dried powder
Dose
For institutional deliveries: 0.05 mL at the time of birth or up to age of 4 weeks
• In case of home delivery, if given at 6 weeks: 0.1 mL (along with Pentavalent – 1 and other routine vaccines)
Route of administration
Strictly intradermal injection
Site of injection
Just above the insertion of deltoid on the left arm to maintain uniformity and for helping surveyors in verifying the receipt of the vaccine.
If the injection is too high, too anterior or posterior, the adjacent lymph nodes may get involved, inflamed, and tender.
Schedule of immunization
Single dose at birth.
If not given at birth, give at 6 weeks along with routine vaccination at 6 weeks of age.
Precaution while injecting BCG
• Injection should remain intradermal.
• Do not use antiseptic before injection.
• If spirit has been applied, wait for it to completely dry off before injecting the vaccine.
• For 6 months, no injection should be given in the same arm in which BCG was given.
What is the reason for giving BCG through strictly intradermal route? What if the dose goes deeper, e.g., subcutaneous?
If BCG vaccine penetrates into the deeper tissue, it can cause local abscess and enlarged and painful axillary lymph nodes. There is a small chance of this infection getting disseminated too, if the cellular immunity of the recipient is low.
Why do we give 0.05 mL dose of BCG to newborns (below 1 month of age)?
This is because the skin of newborns is thin and an intradermal injection of 0.1 mL may break the skin and penetrate into the deeper tissue and this may cause local abscess and enlarged axillary lymph nodes.
Which strain is used?
Danish 1331 is the WHO recommended strain of bacteria for the production of vaccine.
Reconstitution
Normal saline is the recommended diluent.
The reconstituted vaccine may be used up to 3 hours and left over should be discarded.
Why cannot we use distilled water as diluent when normal saline is not available?
Distilled water is an irritant to the skin. As BCG is to be given intradermally, distilled water can cause irritation of the skin which may cause ulceration at the site of injection and in severe cases even sloughing of the skin.
Complications
• Prolonged ulceration at the vaccination site
• Severe ulceration
• Suppurative lymphadenitis
• Tubercular osteomyelitis
• Disseminated BCG infection (BCG-osis) and even death
Storage of vaccine
• Long-term storage, e.g., at PHC15°C to20°C, in the deep freezer
• The vaccine may be stored between 2°C to 8°C for a few weeks at the place of use such as the subcenter
• Protect from light
Protective efficacy
Approximately 15–20 years and the protection is partial protection. It is believed that BCG may offer only partial protection from TB but it seems to prevent severe form of childhood tuberculosis such as miliary tuberculosis and tubercular meningitis.
Normal reaction after BCG vaccination
• Immediately after a satisfactory injection— wheal of 5 mm in diameter which later subsides.
• After 2–3 weeks—a papule develops which gradually grows in size till 4-8 mm.
• After 5 weeks—the papule subsides or breaks down into a shallow ulcer, usually covered with a crust.
• Within 6–12 weeks—healing occurs, leaving a permanent scar, 4–8 mm in diameter.
• Mantoux positivity develops usually after8weeksof injection.
If no scar appears after administering BCG, should one re-vaccinate the child?
There is no need to re-vaccinate the child even if there is no scar.
Contraindications to BCG vaccination
• Generalized eczema
• Infective dermatosis
• Pregnancy
• States of reduced immunity (immunocompromised) such as
— Hypogammaglobulinemia
— HIV positive with symptoms
— Congenital immunodeficiency
— Leukemia
— Lymphoma
— Generalized malignancy under chemo-therapy
Which type of immunity is mainly induced by giving BCG vaccine?
BCG vaccine predominantly induces cell mediated (delayed-type hypersensitivity) type of immunity
References:
1. GOI. Immunization Handbook for Medical Officers. New Delhi: Department of Health and Family Welfare; 2016.
2. Park K. Principles of epidemiology and epidemiologic methods. In: Park’s Textbook of Preventive and Social Medicine, 24th ed. Jabalpur, India: M/S Banarasidas Bhanot Publishers; 2009.
3. Park K. Epidemiology of communicable diseases. In: Park’s Textbook of Preventive and Social Medicine, 24th ed. Jabalpur, India: M/S BanarasidasBhanot Publishers; 2009.
4. Fine PEM, Sterne JAC, Pönnighaus JM, Rees RJW. Delayed-type hypersensitivity, mycobacterial vaccines and protective immunity. Lancet 1994;344:1245–9
