Pfizer has submitted new data for approval to the US Food and Drug Administration (FDA)
Pfizer has said its vaccine can be stored at standard freezer temperature for up to two weeks – making the vaccine rollout easier to manage.
The American company and its German partner, BioNTech, have submitted new evidence to US regulators to show that their Covid vaccine can be safely stored at between -25C and -15C (-13F to 5F) while still maintaining its efficacy.
At present the vaccine is only authorized for storage in specialist ultra-cold freezers at temperatures, between -80C and -60C (-112F to ‑76F), leading health officials around the world to say that distributing the drug poses major logistical issues.
But Pfizer say this new breakthrough will allow for the vaccine to be stored in regular pharmaceutical freezers for two weeks, giving authorities flexibility when it comes to distribution.
Thew new guidance could make distributing the Pfizer vaccine easier to manage (Picture: Getty/AFP)
While the vaccine will still require ultra-cold freezer temperatures for storage and global transportation initially, Pfizer added that it could be kept in warmer freezers for 14 days, like in a vaccination center, for example.
Pfizer also said that the vials can also safely be stored in a refrigerator for five days prior to administration, as already approved globally.
The company has submitted the new stability data to the US Food and Drug Administration (FDA), who is expected to approve the new storage guidelines this week.
Pfizer and BioNTech say that short term temperature storage may be further assessed; adding that the shelf life and/or expiration of the vaccine could also be extended.
Albert Bourla, chairman and chief executive officer at Pfizer, said: ‘We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the US and around the world.
‘We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions.
So far the jabs are only approved for storage in ultra-cold temperatures (Picture: EPA)
‘If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”’
If approved by the FDA the vaccine’s Emergency Use Authorization (EUA) information will be updated to allow storage at -25C to -15C (-13F to 5F) for a maximum of two weeks, as an alternative to complete storage in an ultra-low temperature freezer.
Pfizer has not said when or if it will make the data available to the UK’s regulator, the Medicines and Healthcare products Regulatory Agency (MRHA).
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