Covid vaccine, Aifa instructions for use: from thawing to single doses



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Italy and Europe do vaccinate against Covid-19: the doses of Pfizer-BioNTech are ready to reach the different centers of classification And be inoculate to priority groups identified by the government. And on the eve of Vaccine day, on the day the campaign begins, the Italian Medicines Agency (Aifa) publishes the guidelines for the correct storage, handling and administration of Cominarty, the mRNA vaccine against Covid-19. Aifa reminds that the vaccine must be prepared by a health worker adopting aseptic techniques, to ensure the sterility of the prepared dispersion. It is administered in two doses, the second after at least three weeks from the first.

Conservation
As is known, before use, the vaccine should be stored in freezer at a temperature between between -90 ° C and -60 ° C. Exposure to Direct sunlight and ultraviolet light. Only after thawing can the vials be handled under conditions of ambient light. Once extracted from the freezer, vial trays with open lid or vial trays containing less than 195 vials can remain at room temperature for a maximum of 3 minutes to allow removal or transfer. After returning to the freezer after being exposed to room temperature, the vial trays should remain in the freezer for at least 2 hours before you can remove them again. One time extract from the freezer, explains Aifa, the closed vaccine can be stored before use up to 5 days at a temperature between 2 and 8 ° C and up to 2 hours at a temperature not exceeding 30 ° C. Once thawed, the vaccine must not be refrozen. When the drug is diluted, it can remain for 6 hours at a temperature between 2 and 30 ° C.

Antifreeze
The bottle multidose, Aifa continues, it is stored in the freezer and must be thawed before dilution. Frozen vials should be transferred to a room at an inclusive temperature. between 2 and 8 ° C defrost. May be necessary 3 mineral thaw a pack of 195 vials. Alternatively, the frozen vials can be thawed for 30 minutes at a temperature not higher than 30 ° C for immediate use. The operator must wait, explains the guide, for the thawed vial to reach room temperature, then turn it gently by 10 times before dilution.

Dilution
Thawed vaccine must be diluted inside the original vial with 1.8 ml sodium chloride solution for injection 9 mg / mL (0.9%), using a 21 gauge needle (or thinner). Aifa explains that it is necessary stabilize the Pressure in the vial before remove the needle from the vial cap, aspirating 1.8 mL of aria into the empty solvent syringe. Then it is necessary to re-invert the diluted dispersion gently 10 times, without stirring. the diluted vaccine should appear, Aifa explains, as a dispersion of whitish color, free particles visible. In the presence of particles or in case of discoloration, it is recommended throw the diluted vaccine.

The preparation of single doses.
After dilution, continue with the guide, the vial contains 2.25 mL, corresponding to 5 doses 0.3 ml. Then the operator has to suck the required dose 0.3 mL of diluted vaccine using a makes sterile. Any unused vaccine must be discarded. within 6 hours by dilution. Cominarty, Aifa recalls, is administered for intramuscular route after dilution as a cycle of 2 doses (0.3 ml each) at a distance of at least 21 days one from another. The preferred location is the deltoid region of the arm, the one in which vaccines are commonly injected.



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