Image of a vial of the Pfizer – BioNTech Comirnaty vaccineIntroduction to the Vaccine
The Pfizer – BioNTech Comirnaty vaccine is an mRNA vaccine. mRNA vaccines help the body's cells produce a harmless piece of a protein. This harmless protein then triggers the body's immune response to produce antibodies against the SARS-CoV-2 virus. mRNA vaccines:
The Pfizer – BioNTech Comirnaty vaccine was granted Emergency Use Listing (EUL) by the World Health Organization on 31 December 2020. This vaccine has been licensed and authorised for use in many countries worldwide.
In Vietnam, the Pfizer – BioNTech Comirnaty vaccine was approved for conditional use for urgent needs in COVID-19 prevention and control under Decision No. 2908/QĐ-BYT dated 12 June 2021.
Manufacturer:
+ Pfizer Manufacturing Belgium NV - Belgium.
+ BioNTech Manufacturing GmbH - Germany.
Vaccine Presentation
+ A multidose vial containing 0.45 ml of frozen concentrated suspension for injection, equivalent to 6 doses after dilution with the diluent. Each dose (0.3 ml) contains 30 mcg of COVID-19 mRNA vaccine (encapsulated in lipid nanoparticles).
+ Packed in trays of 195 vials (1,170 doses). Each tray dimensions: 23 cm x 23 cm x 4 cm.
+ The diluent is 0.9% normal saline (0.9% Sodium Chloride) without preservatives. Use a 5 ml (or 3 ml) syringe to withdraw 1.8 ml to dilute one vial of vaccine.
Clinical trial results show that the efficacy of the Pfizer – BioNTech Comirnaty vaccine in protecting against COVID-19 ranges from 95% to 100% approximately 7 days after the second dose.
Vaccine Storage
Ultra-low temperature storage (-90°C to -60°C)
Store in an ultra-low temperature freezer between -90°C and -60°C. At this temperature range, the vaccine can be stored until the expiry date printed on the vial label (6 months from the date of manufacture).
If an ultra-low temperature freezer is not available, Pfizer thermal shipping containers may be used to extend storage time. The vaccine can be stored in the thermal shipping container for up to 30 days if dry ice is replenished regularly every 5 days. Do not open the thermal shipping container for more than 3 minutes at a time.
Keep vaccine vials upright in the tray and protect from light. Do not open the vial tray or remove the vaccine vials until ready for thawing/use.
Storage in a cold room / ultra-low temperature freezer (-25°C to -15°C)
The vaccine can be stored in a cold room or ultra-low temperature freezer between -25°C and -15°C for up to 2 weeks.
Record the date when storage at "-25°C to -15°C" begins.
Upon expiry of the 2-week period in the cold room or ultra-low temperature freezer, the vaccine can be transferred to a refrigerator (+2°C to +8°C) for an additional maximum period of 1 month (31 days). Record the date and time when storage at +2°C to +8°C begins.
Storage in a cold room / refrigerator (+2°C to +8°C)
The vaccine can be stored in a cold room or refrigerator at +2°C to +8°C for up to 1 month (31 days). Whenever the vaccine is transported at +2°C to +8°C, the transportation time is included in the 1-month (31-day) limit, and the total transportation time at +2°C to +8°C must not exceed 12 hours.
Record the date storage begins at +2°C to +8°C to monitor the duration the vaccine has been kept at this temperature. DO NOT re-freeze the vaccine.
Note: When transferring trays/vials between storage environments:
+ Do not touch the vaccine vials until needed for removal from the tray for use or transfer to another storage environment.
+ Wear protective gloves when handling frozen vaccine vials.
+ When removing a vial from the tray, do not remove the entire tray from the freezing environment. If a tray is removed from the -25°C to -15°C freezer, ensure it is returned to the freezer in less than 1 minute.
+ Once individual vials are removed from the tray at room temperature, they must not be returned to the frozen state and should be thawed for use.
+ Do not re-freeze thawed vials.
Storage after dilution:
Store the diluted vaccine vial at +2°C to +8°C on a foam pad inside a vaccine carrier. The diluted vaccine must be used within 6 hours.
Source: Guidelines for COVID-19 Vaccine Administration Practice