(Reuters) – Pfizer Inc and BioNTech SE have submitted new temperature data to the U.S. health regulator that they said Friday could allow their COVID-19 vaccine to be stored in pharmacy freezers instead of in ultra-cold storage facilities.
If adopted, the less onerous storage requirements would greatly relieve the spread of the vaccine, especially in low-income countries that do not have the necessary infrastructure.
The Pfizer / BioNTech vaccine, along with a two – dose Moderna Inc bullet, has gained U.S. emergency use (EUA) approval and is being widely distributed as part of the country ‘s major vaccination efforts.
The new data was submitted to the U.S. Food and Drug Administration to support a proposed update to the standard EUA label that would allow vaccine filters to be stored at -25 to -15 degrees Celsius (-13 ° F to 5 ° F) for a total of two weeks as an alternative to storage in an ultra-low temperature freezer.
“The data submitted could improve the treatment of our vaccine in developing and giving vaccine establishments even greater flexibility,” said BioNTech CEO Ugur Sahin.
The standard Pfizer / BioNTech label requires the vaccine to be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), requiring it to be placed in specially designed containers .
The new data will be submitted to global regulatory bodies within the next few weeks, the two companies said.
A BioNTech spokesperson declined to provide further details about when and which organizations would receive a warning
Reporting with Manojna Maddipatla in Bengaluru and Ludwig Burger in Frankfurt; Edited by Shounak Dasgupta and Anil D’Silva