The Food and Drug Administration on Thursday approved storage and transportation of COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE at standard freezer temperatures for up to two weeks instead of ultra-cold conditions.
Last week, the companies asked the US health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers.
It can now be stored at between -13°F to 5°F for up to two weeks, according to the new FDA guidance.
‘Alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,’ Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.
So far, 66.5 million doses of COVID-19 vaccines have been administered in the US, with 13.6 percent of the population getting one dose or more. Of those, 35 million were made by Pfizer.
Pfizer’s COVID-19 vaccine can now be stored at between -13°F to 5°F for up to two weeks, instead of keeping it in ultra-cold, dry ice-pack containers (pictured), FDA said Thursday
In December, the FDA granted emergency use authorization to the vaccine and current label to be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.
But the cold-chain requirements had pharmacists and shipping companies on edge about keeping the delicate and precious vaccine doses safely stored.
It comes after winter storms that destabilized shipping of all kinds and knocked out power in states like Texas caused a massive delay of six million doses of COVID-19 shots.
Many of them were held back amid uncertainty there would be functional storage cold enough to keep them from spoiling on the other end.
The shot’s cold-storage requirements set off a scramble among US states at the beginning of the rollout for dry ice, in which it can be stored temporarily when there are no specialized freezers available, for instance in rural areas.
Most regular, local pharmacies do not have freezers capable of reaching the deep-freeze temperatures previously required, meaning they had to pack their Pfizer doses with dry ice until they could be used.
And once the shots are defrosted, they have to be used within five days.
Reports emerged of clinic workers showing up in PPE in grocery stores asking who wanted a vaccine before they spoiled (this happened for Moderna vaccines as well).
A malfunctioning refrigerator in California reportedly spoiled thousands of doses of the Pfizer vaccine.
And shipments to at least eight European countries were delayed after a logistical problem threatened to destabilize their temperature during shipping.
Deutsche Post, which has shipped COVID-19 vaccines to several European countries, Israel, Bahrain, Mexico and Singapore, among other states, said -25 degrees would provide some relief but transportation would still not be easy.
A spokeswoman said air freight would likely no longer require dry ice on board, increasing storage capacity per plane.
BioNTech has said it imposed long-term storage and transportation requirements of -70 degrees out of caution because it had started stability and durability tests on its vaccine relatively late.
Even though it launched its COVID-19 vaccine development program as early as January 2020, working on four compounds in parallel, it did not decide until July which of the four to proceed with, and only then started stability tests.
The less onerous storage requirements should provide significant logistical relief for the rollout of the vaccine worldwide, particularly in lower-income countries.