The European Union’s drug regulator on Monday backed more flexible storage for Pfizer-BioNTech’s COVID-19 vaccine, allowing for unopened thawed vaccine doses to be stored in a normal refrigerator for up to one month. The decision, endorsed by the Emergency Medicines Agency’s human medicines committee, is “expected to have a significant impact on planning and logistics of vaccine roll-out in EU Member States.”
In March, the EMA had previously approved storage of the vaccine at -25 degrees Celsius to -15 degrees Celsius for two weeks. The regulator had first recommended conditional marketing authorization for the vaccine in people ages 16 and older in December 2020. Under the initial authorization, unopened frozen vials were to be stored at -90 degrees Celsius to -60 degrees Celsius for up to 6 months before use.
In the latest update, the EMA noted that it is “in continuous dialogue with the marketing authorization holders of COVID-19 vaccines as they seek to make manufacturing improvements to enhance vaccine distribution in the EU.”
In April, Pfizer-BioNTech announced a new deal with the EU that would bring the total number of doses delivered in 2021 to 600 million.
“We remain committed to moving quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent,” Albert Bourla, Pfizer chairman and CEO, said following April’s dose agreement. “To date, we have met all of our supply commitments to the [European Commission] and we plan to deliver 250 million doses to the European Union in Q2, a four-fold increase on Q1’s agreed quantity.”