EMA approves new storage conditions for Pfizer/BioNTech COVID-19 vaccine

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Pic:getty/golibtolibov (Getty Images/iStockphoto)

The EU has approved new storage conditions for Pfizer/BioNTech’s vaccine: allowing the ultra-cold storage vaccine to now be kept at standard pharmaceutical freezer temperatures for a total of two weeks.

In the US, the FDA also authorized the new storage conditions earlier this month, following the submission of new stability data by the companies.

Up to now, undiluted vials had to be stored at ultra-low freezer temperatures of between -80ºC to -60ºC (-112ºF to -76ºF).

While the main transport and storage conditions remain at the ultra-low temperatures, the vials may now be kept at standard pharmaceutical freezer temperatures of -25°C to -15°C (-13°F to 5°F) for up to 2 weeks.

The updated storage conditions announced by the European Medicines Agency (EMA) last week ‘marks an important milestone in the vaccine roll-out’, note Pfizer and BioNTech, as they could allow storage in pharmacies to support vaccinations at local practices/doctors’ offices. “By enabling more individuals to store and administer the vaccine, the approval will help broaden access, while limiting strain on larger vaccination centers.” 

Switzerland's regulator Swissmedic, meanwhile, has today also updated the storage conditions required for the vaccine to -25°C to -15°C for up to two weeks.

"This a key factor in enabling the vaccine to be used in Switzerland in health centres, medical practices or pharmacies," says Swismedic. "The greater flexibility in the distribution, storage and administration of the vaccine may help increase the vaccination rate in Switzerland."