FDA and EMA Authorize Longer Storage Time for Pfizer/BioNTech Vaccine

The FDA and European Medicines Agency (EMA) have eased the ultra-cold storage requirements for the Pfizer/BioNTech COVID-19 vaccine, permitting doses to be held longer at normal refrigeration temperatures.

The regulators said unopened, thawed vials may be held at temperatures of 35 degrees to 46 degrees Fahrenheit (2 degrees to 8 degrees Celsius) for up to one month, instead of five days as previously authorized. The revised authorizations were based on new stability data submitted by the companies.

The change is expected to have a significant impact on distribution as the vaccine’s previous ultra-cold storage requirements, -112 degrees to -76 degrees Fahrenheit (-80 degrees to -60 degrees Celsius), required the use of special thermal containers for shipping, which kept the vaccine viable for up to a month but only if dry ice was added every five days (DID, Feb. 22).

The higher holding temperatures “should make this vaccine more widely available … by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store and administer the vaccine,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Earlier this year, the FDA and EMA revised their authorizations of the Pfizer/BioNTech vaccine to allow it to be stored at temperatures of -13 degrees to 5 degrees Fahrenheit (-25 degrees to -15 degrees Celsius) for up to two weeks, allowing shipping in nonspecially designed containers during this limited timeframe (DID, Feb. 26).

In other news of the Pfizer/BioNTech vaccine, the European Commission signed a new supply contract with the companies for an additional 1.8 billion vaccine doses to be delivered by the end of 2023. The agreement includes the purchase of 900 million doses of the vaccine, with an option for an additional 900 million doses tailored to variants.

The contract adds to the commission’s existing order for the supply of 600 million doses to the trading bloc in 2021. The new contract reflects the EU’s increased focus on messenger-RNA- based vaccines rather than the adenovirus-based vaccines from AstraZeneca and Johnson & Johnson. ― Jason Scott