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

By Rachel Arthur

- Last updated on GMT


Related tags Ema European union COVID-19 vaccine Pfizer BioNTech

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."

Related topics Markets & Regulations

Related news

Show more

Follow us