EMA Approves New Storage Option for Pfizer-BioNTech’s Comirnaty mRNA Vaccine, Enabling 2-Week Storage at -25°C to -15°C

March 29, 2021/BioonBIOON/--At present, the COVID-19 epidemic overseas is still spreading rapidly. According to Baidu's "Real-time Data on the Novel Coronavirus Pneumonia Epidemic"Big DataReport》 As of 12:00 on March 29, 2021, the global cumulative number of confirmed cases exceeded 100 million (127.78 million), and the number of deaths exceeded 2.796 million.

Recently,Pfizer(Pfizer) and its partner BioNTech jointly announced that the European Medicines Agency (EMA) has approved a new storage condition for their COVID-19 mRNA vaccine, Comirnaty: storage at temperatures between -25°C and -15°C for two weeks. This label update will simplify the allocation and storage of Comirnaty doses across the EU, providing greater flexibility in vaccine distribution, storage, and administration throughout the European Union.

This approval is based on stability data under these temperatures in standard pharmaceutical freezers. The new data demonstrate Pfizer’s continued commitment to further developing this vaccine and collecting data to support broader and more flexible vaccine distribution and administration.

With this approval, Comirnaty vials can be stored for two weeks at the updated temperature range of -25°C to -15°C, as well as under ultra-cold conditions, across all 27 European Union (EU) member states. This marks a significant milestone in vaccine rollout, as it enables storage in pharmacies, thereby supporting vaccination efforts at local institutions and physicians’ offices. By allowing a broader range of facilities to store and administer the vaccine, this approval will help expand vaccine accessibility while alleviating pressure on large-scale vaccination centers.

Ugur Sahin, CEO and Co-Founder of BioNTech, stated: “From the outset, our goal has been to make our vaccine widely available to people around the world. This EMA approval will enable us to access important additional channels for the distribution and administration of our vaccine. This is a significant moment, as governments now have greater flexibility to shift from vaccination at centralized centers to a more decentralized rollout through local physicians and general practitioners, thereby accelerating our path out of the pandemic.”

Pfizer Chairman and CEO Albert Bourla stated, “We appreciate our collaboration with the EMA and other regulatory agencies worldwide to ensure that our vaccines can be transported and stored under increasingly flexible conditions. This new storage protocol in Europe will help make vaccines more accessible to people across the continent, marking another important step in our ongoing global fight against the virus.”

Image source: haber7.net

Comirnaty vaccine is based on BioNTech’s proprietary mRNA technology and was co-developed by BioNTech and Pfizer. BioNTech is the marketing authorization holder in the European Union and, prior to seeking full marketing authorization in the United States, the United Kingdom, Canada, and other countries, holds the Emergency Use Authorization (EUA) or equivalent authorizations in these nations.

Currently, the Comirnaty vaccine has not been approved or licensed by the U.S. FDA, but it has receivedFDAEmergency Use Authorization (EUA): For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 16 years and older. (Bioon.com)

Original Source: EMAapproves New Storage Option for Pfizer-BioNTech Vaccine, Easing Distribution and Storage of Doses Across European Union