FDA receives new stability data on Pfizer’s COVID-19 vaccine

New stability data could allow Pfizer and BioNTech’s COMIRNATY® COVID-19 vaccine to be stored at normal refrigerated temperatures for up to two weeks.

Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/].

[Credit: Dimitris Barletis/].

Pfizer and BioNTech have submitted new data to the US Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C, temperatures more commonly found in pharmaceutical freezers and refrigerators.

This data is 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.

The companies stated the submission includes stability data generated on batches of the COMIRNATY® COVID-19 vaccine manufactured over the past nine months, 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.

“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the US and around the world,” remarked Dr Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centres greater flexibility in how they manage their vaccine supply.”

Ugur Sahin, Chief Executive Officer and Co-founder of BioNTech added: “Our top priority was to quickly develop a safe and effective vaccine and make it available to the most vulnerable people in the world in order to save lives. At the same time, we have continuously collected data that could enable storage at around -20°C. The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility. We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”

Currently, the 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. It can remain stored at these temperatures for up to 6 months. The vaccines are shipped in a specially-designed thermal container that can be used as temporary storage for a total of up to 30 days by refilling with dry ice every five days. Before mixing with a saline diluent, the vaccine may also be refrigerated for up to five days at standard refrigerator temperature, between 2⁰C and 8⁰C. If approved, the option to store at -25°C to -15°C (-13°F to 5°F) for two weeks would be in addition to this five-day option to store at standard refrigerator temperature.

As additional stability data are obtained, the companies said they anticipate the shelf life and/or expiration date could be extended and that alternate short-term temperature storage may be considered.

The vaccine has Marketing Authorization in the EU and Emergency Use Authorization or equivalent in the US, UK and Canada, among other countries for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

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