Vaccine Specific Information

6. Pfizer-BionTech
It is an mRNA-based vaccine, with the efficacy of 95-97%, the recommended age is 16 year and above.

• Characteristics:
• Frozen, sterile, and preservative-free.
• Multi-dose concentrates for dilution before administration.
• One vial (0.45 mL) contains 6 doses of vaccine after dilution.
• An interval of 21–28 days between the doses is recommended.
• Before dilution, invert vaccine vial gently 10 times, do not shake.
• Draw into the mixing syringe 1.8 ml of diluent, add 1.8 mL of diluent into the vaccine vial.
• Equalize the pressure in the vial before removing the needle by withdrawing 1.8 ml of air into the empty diluent syringe.
• Gently invert the vial with diluted vaccine 10 times to mix, use all vaccine within 6 hours after dilution.
• Inspect to make sure that the vaccine is an off-white uniform suspension; do not use if discolored or if containing particles.
• Given intramuscularly,0.3ml, the preferred site is deltoid muscle.
• Use diluent: - 0.9% sodium chloride solution for injection, unpreserved, in a 10 mL vial for single use 1.8 mL diluent required per 6 dose vaccine vials.
• Before dilution, vials must reach room temperature and be diluted within 2 hours.
• Thaw vaccine up to 3 hours at 2 to 8 °C in refrigerator or for 30 minutes at 25 °C before dilution.
• Discard any unused vaccine 6 hours after dilution, or at the end of the immunization session, whichever comes first.
• Vaccine Handling:

• At -80 to -60 °C in freezer, or
• At -90 to -60 °C in thermal shipper as temporary storage for up to 30 days from delivery

• Diluent storage temperature is room temperature (up to 30 °C).
• Undiluted vaccine storage temperature -90 to -60 °C: 6 months after the time of manufacturing.
• Undiluted thawed vaccine at 2 to 8 °C: up to 120 hours (5 days) prior to dilution.
• Undiluted thawed vaccine at temperatures up to +30 °C.
• Do not refreeze thawed vials.
• Do not freeze diluted vaccine.
• It is light sensitive and has no VVM.

• Adverse events following immunization:  
• Currently there have been increased reports of cases of inflammation of the heart called myocarditis and pericarditis
• Very common AEFIs: Headache, nausea, vomiting, myalgia, arthralgia
• Contraindications:
• A history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine
• BNT162b2 should not be administered to individuals with a known history of severe allergic reaction to polyethylene glycol (PEG), or
• Related molecules as PEG is a component of the vaccine