Fair Question for the Pfizer COVID-19Vaccine…

Dear Editor:

Fair Question For the Pfizer COVID-19 vaccine:  What  substantiated the drastic reductions from the sub-zero storage requirement — minus 70 degrees Celsius which equals minus 94 degrees Fahrenheit?  Initially temperature maintenance was emphasized as so important, shipping containers had temperature sensors.

Since COVID vaccination sites have significantly increased — including at Rite Aid stores, Walgreens and essentially some “pop-up” spots (such as community centers) — I was curious how they were equipped to satisfy the Antarctica-range temperature. 

In researching online, I found “. . . FDA allows more flexible storage, transportation conditions  for Pfizer BioNTech COVID-19 Vaccine.” (fda.gov February 25, 2021)

“The U.S. Food and Drug Administration is allowing undiluted frozen vials of the Pfizer BioNTech COVID-19 to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.”

“This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer [-70°C] . . . .”

Another temperature storage reduction for the vaccine was reported in “Pfizer Vaccine Can Stay Longer at Warmer Temperatures Before Being Discarded.” (npr.com May 19, 2021) 

The story included: “Food and Drug Administration [FDA] says it’s now OK to store the Pfizer COVID-19 vaccine at NORMAL REFRIGERATOR TEMPERATURES for up to a month. This is much longer than was previously allowed under the FDA’s emergency authorization and will make storage and distribution of the vaccine easier.”

I found nothing reporting the vaccine had been altered in any way. Inquiring minds might question — How can thawed vaccine remain unspoiled, for up to 30 days — with only very minimal refrigeration — but frozen storage was at a mega-minus temperature? ( Also, previously, the maximum refrigerator storage was up to 5 days.)

Pfizer submitted data to the FDA to demonstrate justification for the preceding change. I couldn’t find any details. Seems they accepted the information as the Gospel. 

-Kat Massey