Pfizer and FDA held a meeting about the mRNA COVID-19 19 vaccine. Distribution of the
vaccine was an important issue that was discussed in the meeting session. As it was pointed out,
there is a great need to ensure proper storage of the vaccine which contains proteins, so that the
chemicals in it may not be interfered with leading to improper functioning of the vaccine. Anita
Patel, who is the deputy task force for vaccine for Pfizer, outlined the following QA/QC that
companies involved in the production and distribution of the vaccine must observe.
Requirements for the distribution of the Vaccine;
o Vaccine must be kept at ~ -75º throughout supply chain
o Minimum order/ship quantity = 195 vials = 975 doses
o Reverse logistics to return reusable shippers
Requirements for the storage sites of the vaccine;
o The vaccine product must be stored in ultra-low temperature freezer or temporarily in
Thermal shipper
o The trained staff handling Thermal shipper must ensure it is re-charged with 23kg dry ice
within 24 hours once opened.
o When the shipper is opened 2x/day (3min/opening) and used for longer-term storage, it
must be refilled with dry ice every 5 days – max life of 30 days.
o Vaccine can be stored at 2-8 degree Celsius for 5 days; cannot refreeze
important requirements for the administration of the vaccine are;
o At site, it is mix with diluent (0.9% saline USP),
o Thawed product must be used or disposed within 6 hours.
o Atypical, 0.3mL dose volume
As highlighted in the slides, administration of the COVID-19 19 vaccine requires highly trained
clinical personnel who can ensure that low ultra-low temperatures are maintained using thermal
shipper, periodically replenishing of the dry ice and that the product is administered before its
expiry.
References
https://www.fda.gov/media/144325/download