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FRANKFURT, February 20 – Pfizer Inc and BioNTech SE have asked the US 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 pharmacy freezers. .
The approval of the Food and Drug Administration (FDA) could send a strong signal to other regulators around the world that could facilitate the distribution of the injection in low-income countries.
The companies have submitted new temperature data to the FDA to support an update to the current label that would allow the vials to be stored at -25 to -15 degrees Celsius (-13 ° F to 5 ° F) for a total of two weeks.
The current label requires that the vaccine be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), which means that it must be shipped in specially designed containers.
The cold storage requirements of the injection sparked a fight between the US states at the beginning of the release of dry ice, where it can be temporarily stored when specialized freezers are not available, for example in rural areas.
Amesh Adalja, principal investigator at the Johns Hopkins Center for Health Safety, said that higher temperatures should “greatly expand the ability to use this vaccine in many parts of the world (or even the US) that they do not have the capacity for deep freezing storage ”.
The Pfizer / BioNTech vaccine, along with the two-dose injection from Moderna Inc, has already obtained US emergency use authorization and is being widely distributed as part of the nation’s mass vaccination efforts.
The FDA confirmed that it had received the request from Pfizer and said changes to the vaccine authorization must be requested by a company and include data to support the change. It said authorization would come through a concession letter or reissued authorization letter, either of which would be posted on the regulator’s website.
The update from drug manufacturers comes as two studies from Israel found that the vaccine greatly reduced transmission of the virus, and the vaccine was endorsed by two of the top advisers to the South African government.
The new data will also be sent to global regulatory agencies in the coming weeks, the two companies said.
A BioNTech spokeswoman declined to provide further details on when and the agencies that would be contacted.
“The data presented can facilitate the handling of our vaccine in pharmacies and provide vaccination centers with even greater flexibility,” said BioNTech CEO Ugur Sahin.
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 not yet be easy.
A spokeswoman said air travel likely no longer requires dry ice on board, increasing storage capacity per plane.
BioNTech has said it imposed long-term storage and transportation requirements of -70 degrees as a precaution because it had started stability and durability testing of its vaccine relatively late.
Although it launched its Covid-19 vaccine development program in January 2020, working on four compounds in parallel, it did not decide until July which of the four to continue with, and only then did it begin stability testing.
If approved, the less burdensome warehousing requirements would provide significant logistical relief.
The World Health Organization’s global COVAX vaccine exchange program has so far limited the distribution of Pfizer-BioNTech vaccines to a few countries, in part due to concerns about the lack of infrastructure in developing countries.
WHO said it was hopeful that easing the requirements could broaden their scope.
“We are aware of the reports of this and we look forward to seeing the data. If proven correct, this could facilitate the deployment of the vaccine in all countries, and particularly in low-income ones, ”he said.
Moderna’s product, which like Pfizer’s is based on so-called messenger RNA molecules, is already authorized for storage between -25 and -15 degrees Celsius. – Reuters
