Pfizer, BioNTech Submit COVID-19 Vaccine Stability Data to FDA

March 04, 2021 - Pfizer and BioNTech recently announced the submission of new data to FDA demonstrating the stability of their COVID-19 vaccine when stored at higher temperatures. 

Specifically, the company’s COVID-19 vaccine, BNT162b2, can be stored at -25°C to -15°C, or-13°F to 5°F, temperatures more commonly found in pharmaceutical freezers and refrigerators. 

In November, the CDC determined that the Pfizer vaccine must be stored in an ultra-cold freezer between -112°F and -76°F for up to six months. But these temperatures require special freezers usually found in research labs and hospitals. 

And while Pfizer is developing deep freeze “suitcases” that can be sealed and are safe for shipment in non-refrigerated trucks, these suitcases could create challenges for hospitals, pharmacies, and outpatient clinics that have to administer the vaccines to US citizens. 

Therefore, the FDA submission includes stability data gathered on batches of doses manufactured throughout COVID-19 vaccine development. The data will also be submitted to global regulatory agencies over 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 U.S. and around the world,” Albert Bourla, chairman and chief executive officer at Pfizer said in the announcement. 

“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Bourla continued. 

The Pfizer-BioNTech vaccine doses 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, Pfizer said.

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, or36⁰F and 46⁰F.

The new vaccine stability data have been submitted to FDA in hopes that the agency will update its emergency use authorization prescribing information. The update would allow for vaccine trials to be stored at -25°C to -15°C, or-13°F to 5°F,for two weeks as an alternative to storage at an ultra-low temperature, Pfizer explained. 

The option to store at these temperatures for two weeks would be in addition to the five-day option to store at standard refrigerator temperature. 

As more stability data is obtained, Pfizer said it anticipates the shelf life or expiration date of its vaccine could be extended. And alternate short-term temperature storage may be considered.

“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,” said Ugur Sahin, CEO and co-founder of BioNTech.

“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,” Sahin continued. 

Pfizer and BioNTech revealed results from an ongoing clinical trial at the end of December, which showed that the vaccine elicited a 95 percent protection against COVID-19 in individuals 16 years of age or older. 

Since then, HHS and the Department of Defense (DoD) have purchased over 300 million total doses of BNT162b2. Vaccine administration costs for private-sector administration partners are being covered by healthcare payers and an HHS program to cover costs for the uninsured.

The expanded supply allows the government to accelerate vaccination efforts and get shots into the arms of the American people.