BRIEF—New data filed with FDA showing simpler storage for BioNTech/Pfizer vaccine

Germany’s BioNTech and partner Pfizer said on Friday they had submitted new data to the US Food and Drug Administration demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators.

Trade-named Comirnaty in Europe, and also know as BNT162b2 in the USA, the vaccine was one of the first to be approved.

However, it has the drawback of onerous storage requirements, needing an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to ‑76ºF).

The data have been submitted to the FDA to support a proposed update to the US Emergency Use Authorization (EUA) Prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer.

Getting approved will allow distribution to dramatically expand to doctors’ surgeries, pharmacies and more remote regions.

The FDA submission includes stability data generated on batches manufactured over the past nine months of COVID-19 vaccine development, from the batches that supplied the earliest clinical trials through the commercial scale batches currently in production.

These data also will be submitted to global regulatory agencies within the next few weeks, the companies said.