Pfizer and BioNTech submit request to revise FDA EUA, start pregnancy study

Feb. 22, 2021

Pfizer and BioNTech announced the submission of new data to the U.S. Food and Drug Administration (FDA) 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, according to a news release.

This 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.

Additionally, the first participants have been dosed in a global phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in preventing COVID-19 in healthy pregnant women 18 years of age and older.

Speaking about storage temperatures for the vaccine, Albert Bourla, Chairman and Chief Executive Officer of Pfizer, said, “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”

Currently, the labels for the Pfizer-BioNTech COVID-19 vaccine, including the EUA label in the United States say 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 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 (36⁰F and 46⁰F).

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.

Addressing another possible update to the vaccine, the companies are evaluating the use of the vaccine during pregnancy. The Phase 2/3 trial is designed as a randomized, placebo-controlled, observer-blind study in approximately 4,000 healthy pregnant women 18 years of age or older vaccinated during 24 to 34 weeks of gestation.

The study will evaluate the safety, tolerability, and immunogenicity of two doses of BNT162b2 or placebo administered 21 days apart. After a participant’s infant is born, maternal trial participants will be unblinded and those who were in the placebo group will receive the vaccine.

Prior to conducting their COVID-19 vaccine clinical trial in pregnant women, studies showed no evidence of fertility or reproductive toxicity in animals.

Pfizer and BioNTech expect to start additional studies in children between the ages of 5 and 11 over the next couple of months, and in children younger than 5 later in 2021.

Visit Pfizer for more news