- Pfizer and BioNTech on Friday asked the Food and Drug Administration to authorize storage of their COVID-19 vaccine at temperatures between minus 15 and minus 25 degrees Celsius for up to two weeks. If granted, the change could enable easier distribution than is possible now because of the current requirement that doses must be stored at between minus 60 and minus 80 degrees Celsius.
- Moderna's vaccine, by comparison, can be stored for up to 30 days at refrigerator temperatures of between 2 and 8 degrees Celsius, a difference that gives it an advantage in more rural or community-based vaccination settings. The Pfizer and BioNTech vaccine needs specialized shipping containers and storage facilities that aren't always available at pharmacies and healthcare providers.
- FDA approval of the change would lower one hurdle to expanding immunizations, which have been hampered by manufacturing and supply chain issues. President Joe Biden plans to have available 600 million vaccine doses by the end of July, nearly enough to vaccinate all 330 million U.S. residents and a big jump from the 73 million doses delivered to date.
Messenger RNA, the technology behind both of the U.S.-authorized coronavirus shots, proved a useful tool for quickly developing a vaccine. As mass-distributed products, however, they have limitations — namely, that RNA molecules are unstable and sensitive to temperature changes.
BioNTech said it has now conducted stability studies on vaccine doses manufactured over the past nine months, ranging from those used in early clinical trials to commercial-scale batches. The tests have determined doses can remain stable at the warmer temperatures "commonly found in pharmaceutical freezers and refrigerators," the partners stated Friday.
Under the current FDA authorization, the vaccine must be held in ultra-cold freezers found only in specialized facilities, or for up to 30 days in custom-designed boxes kept cold with dry ice that needs to be refilled every five days. This has placed a heavy burden on providers administering the shot, requiring they properly handle dry ice and closely monitor temperatures.
Advisors to the Centers for Disease Control and Prevention, when reviewing the vaccine's limitations, were concerned that it could only be used at "centralized sites with adequate equipment and high throughput."
BioNTech and Pfizer have now asked the FDA to authorize storage at warmer temperatures "for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer." If the agency agrees, it could give a lift to the mass vaccination programs now ongoing, making distribution and administration logistically easier.
Another step forward could come soon. A vaccine from Johnson & Johnson will be reviewed by an FDA advisory panel on Feb. 26. and, if it receives a positive vote, could gain emergency authorization shortly after.
A large study showed that vaccine to be effective after just one dose, versus the two needed for a full regimen of either Pfizer's or Moderna's vaccines.