Pfizer’s COVID-19 vaccine now stable at warmer temperatures

February 23, 2021
Pfizer’s COVID-19 vaccine now stable at warmer temperatures

The mRNA COVID-19 vaccine developed by pharmaceutical companies Pfizer and BioNTech late last year was advised to be kept at ultra-cold temperatures to prevent degradation – the ultra-cold storage requirement has inevitably been a difficult and expensive problem to overcome in many parts of the world.

However, new company data from Pfizer suggests its vaccine is stable for at least two weeks in more normal freezer temperatures of between -25 °C to -15 °C (-13 °F to 5 °F). This new data has been supplied to the U.S. Food and Drug Administration (FDA) in the hopes of updating the details of emergency use authorisation, shipping and storage methods of the vaccine.

CEO of BioNTech, Ugur Sahin, suggests this new recommendation has arisen out of continual stability studies that have been ongoing since mass production of the vaccine commenced late last year.

[Standard pharmaceutical freezers deliver temperatures between -25 °C to -15 °C (-13 °F to 5 °F); ultra-cold freezers, on the other hand, can keep items at temperatures between -80 °C and -60 °C (-112 °F to ‑76 °F). Pfizer has been conservative with storage recommendations for its mRNA vaccine until further data could be collected.]

“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,” said Sahin. “At the same time, we have continuously collected data that could enable storage at around -20 °C (-4 °F). The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centres an even greater flexibility.”

Closely following Pfizer’s emergency FDA approval last year was another mRNA vaccine from Moderna, which did not require the same degree of ultra-cold storage.

Moderna claims its unique lipid nanoparticle formulation in the vaccine allows for greater stability at higher temperatures compared to Pfizer’s candidate. Moderna has also garnered significant experience and insight over several years developing a number of other mRNA vaccines in various temperature conditions.

Peter English, former chair of the British Medical Association’s Public Health Medicine Committee, says it is possible Pfizer will broaden storage temperature requirements for its COVID-19 vaccine even further as it learns more over time.

“I would not be surprised if, as time goes by and the period of storage prior to testing increases, they will be able to increase this period,” says English. “This is likely to make the infrastructure requirements considerably easier.”

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Category: Features, Pharmaceuticals

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