According to the latest reports, Pfizer Inc and BioNTech SE have asked the U.S. health regulator to relax the requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in the pharmacy freezers.
The approval given by the Food and Drug Administration could thereby send a strong signal to the other regulators around the world that may further ease the distribution of the shot in lower-income countries.
The companies have submitted new temperature data to the FDA to support an update to the current label that would allow vials to be stored at -25 to -15 degrees Celsius for a total of two weeks.
The current label requires the vaccine to be stored at temperatures between -80 degrees Celsius and -60 degrees Celsius that means it has to be shipped in specially designed containers.
The shot’s cold-storage requirements set off a scramble among the U.S. states at the beginning of the rollout for dry ice, in which it can be stored temporarily where there shall be no specialized freezers available, for instance in the rural areas.
A senior scholar at the Johns Hopkins Center for Health Security, Amesh Adalja said that the higher temperatures should greatly expand the ability to use this vaccine in several parts of the world, that do not have the capacity for deep-freeze storage.
The Pfizer/ BioNTech’s vaccine along with Moderna Inc’s two-dose shot has already won the U.S. emergency use authorization and is being widely distributed as a part of the country’s mass vaccination efforts.
The FDA has confirmed that it had received Pfizer’s request and said that the changes to the vaccine’s authorization must be requested by a company and should include data that supports the change. It said that the authorization would come either through a granting letter or a reissued letter of authorization, either of which would be posted on the regulator’s website.
The update from the drug makers comes in as the two studies from Israel found that the vaccine greatly reduced the virus transmission, and the shot was backed by two of the4 South African government’s top advisers.
The two companies have stated that the new data will also be submitted to the global regulatory agencies.
A BioNTech spokeswoman has reportedly declined to provide details on the timing and which agencies would be contacted.
BioNTech Chief Executive Ugur Sahin has said that the data submitted may facilitate the handling of their vaccine in pharmacies and provide vaccination centers even greater flexibility.
The WHO has stated that it was hopeful that the eased requirements could broaden the reach. It further stated that they are all aware of the reports of this and are looking forward to making the rollout of the vaccine easier in all countries, especially the low-income ones.
Moderna’s product which very much like Pfizer’s is based on the so-called messenger RNA molecules is already cleared for storage at -25 to -15 degrees Celsius.
