FRANKFURT, Feb 19 – Pfizer Inc and BioNTech SE have asked the U.S. health regulator to ease ultra-low temperature storage requirements for their COVID-19 vaccine, which could allow it to be kept in freezers. from pharmacies, the companies said Friday.
Approval by the Food and Drug Administration (FDA) could send a strong signal to other regulatory bodies around the world and facilitate the distribution of the vaccine in low-income countries.
The companies have submitted new temperature data to the FDA to support a labeling update, which would allow the vaccine vials to be stored between -25 and -15 degrees Celsius for two weeks.
The current label requires that the vaccine be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC, which means that it must be shipped in specially designed containers.
Cold storage requirements for the vaccine triggered a fight for dry ice between states in the United States early in the deployment.
The Pfizer / BioNTech vaccine, along with Moderna Inc’s two-dose injection, has already been cleared for emergency use in the United States and is being widely distributed as part of mass vaccination efforts.
The update from drug manufacturers comes as two studies conducted in Israel have shown that the vaccine greatly reduces transmission of the virus, and the injection has been endorsed by one of the top advisers to the South African government.
The new data will also be presented to global regulatory agencies in the coming weeks, the two companies said.
“The data presented may facilitate the handling of our vaccine in pharmacies and provide vaccination centers with even greater flexibility,” said BioNTech CEO Ugur Sahin.
BioNTech has said it imposed long-term storage and transportation requirements at minus 70 degrees as a precaution, as it had started stability and durability testing of its vaccine relatively late.