(Adds comment from FDA)
FRANKFURT, Feb 19 (Reuters) - Pfizer Inc andBioNTech SE have asked the U.S. health regulator torelax requirements for their COVID-19 vaccine to be stored atultra-low temperatures, potentially allowing it to be kept inpharmacy freezers.
Approval by the Food and Drug Administration (FDA) couldsend a strong signal to other regulators around the world thatmay ease distribution of the shot in lower-income countries.
The companies have submitted new temperature data to the FDAto support an update to the current label that would allow vialsto be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for atotal of two weeks.
The current label requires the vaccine to be stored attemperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaningit has to be shipped in specially designed containers.
The shot's cold-storage requirements set off a scrambleamong U.S. states at the beginning of the rollout for dry ice,in which it can be stored temporarily when there are nospecialized freezers available, for instance in rural areas.
Amesh Adalja, senior scholar at the Johns Hopkins Center forHealth Security, said the higher temepratures should "greatlyexpand the ability to use this vaccine in many parts of theworld (or even the U.S.) that do not have the capacity for deepfreeze storage".
Pfizer/BioNTech's vaccine, along with Moderna Inc'stwo-dose shot, has already won U.S. emergency-use authorizationand is being widely distributed as part of the country's massvaccination efforts.
The FDA confirmed that it had received Pfizer's request andsaid changes to the vaccine's authorization must be requested bya company and include data supporting the change. It saidauthorization would come either through a granting letter or areissued letter of authorization, either of which would beposted on the regulator's web site.
The update from the drugmakers comes as two studies fromIsrael found that the vaccine greatly reduced virustransmission, and the shot was backed by two of the SouthAfrican government's top advisers.
The new data also will be submitted to global regulatoryagencies within the next few weeks, the two companies said.
A BioNTech spokeswoman declined to provide more details onthe timing and which agencies would be contacted.
"The data submitted may facilitate the handling of ourvaccine in pharmacies and provide vaccination centres an evengreater flexibility," BioNTech Chief Executive Ugur Sahin said.
Deutsche Post, which has shipped COVID-19vaccines to several European countries, Israel, Bahrain, Mexicoand Singapore, among other states, said -25 degrees wouldprovide some relief but transportation would still not be easy.
A spokeswoman said air freight would likely no longerrequire dry ice on board, increasing storage capacity per plane.
BioNTech has said it imposed long-term storage andtransportation requirements of -70 degrees out of cautionbecause it had started stability and durability tests on itsvaccine relatively late.
Even though it launched its COVID-19 vaccine developmentprogramme as early as January 2020, working on four compounds inparallel, it did not decide until July which of the four toproceed with, and only then started stability tests.
If approved, the less onerous storage requirements wouldprovide significant logistical relief.
The World Health Organization's COVAX global vaccine-sharingprogramme has so far limited distribution of Pfizer-BioNTechvaccines to just a few countries, partly out of concern over alack of infrastructure in developing nations.
The WHO said it was hopeful that eased requirements couldbroaden its reach.
"We are aware of reports of this and look forward to seeingthe data. If proven correct, this could make rollout of thevaccine easier in all countries, and particularly in low-incomeones," it said.
Moderna's product, which like Pfizer's is based on so-calledmessenger RNA molecules, is already cleared https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html#:~:text=How%20to%20Store%20the%20Moderna%20COVID-19%20Vaccine&text=Vaccine%20may%20be%20stored%20in,for%20this%20vaccine%20is%20tighterfor storage at -25 to -15 degrees Celsius.
(Reporting by Manojna Maddipatla and Ankur Banerjee inBengaluru, Ludwig Burger in Frankfurt, John Miller in Zurich,Matthias Inverardi in Duesseldorf, Michael Erman in Maplewood,N.J. and Lisa Baertlein in Los Angeles; Editing by ShounakDasgupta, Anil D'Silva, Jan Harvey and Nick Macfie)