Up to now, undiluted vials had to be stored at ultra-low freezer temperatures of between -80ºC to -60ºC (-112ºF to -76ºF).
While the main transport and storage conditions remain at the ultra-low temperatures, the US Food and Drug Administration (FDA) will now allow the vials to be stored at standard pharmaceutical freezer temperatures of -25°C to -15°C (-13°F to 5°F) for up to 2 weeks. Vials can also be transported at this temperature, although this counts towards the 2 week total.
Last month Pfizer and BioNTech submitted new stability data to the FDA to request the amended conditions, which means the vaccine can now be kept in standard fridge or freezer conditions for a total of nearly three weeks: instead of just five days at standard fridge temperatures before administration as originally outlined in the Emergency Use Authorization (EUA). This submission included data on batches manufactured over the past nine months from the earliest clinical trials through to commercial scale batches currently in production.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said: “This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites.”
Pfizer/BioNTech’s data on storage conditions also will be submitted to global regulatory agencies within the next few weeks.
Labels for the Pfizer-BioNTech COVID-19 vaccine state that the vaccine must be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to ‑76ºF) for up to 6 months.
The option to store at -25°C to -15°C (-13°F to 5°F) for two weeks has now been authorized by the FDA.
The vaccine can then be refrigerated for up to five days at standard refrigerator temperature, between 2⁰C and 8⁰C (36⁰F and 46⁰F), before mixing with a saline diluent.