Previously, the vaccine - which uses mRNA technology and was the first in the world to be approved, by UK regulators - had to be “deep frozen” at between -60C and -80C, temperatures colder than the Antarctic winter.
The
Pfizer-BioNTech coronavirus vaccine no longer needs to be kept at super-cold
temperatures, new results suggest, a development which will make it
considerably easier to distribute in the UK and internationally.
According to the updated stability data, which has been submitted to regulators in the United States, the vaccine can be kept in a normal medical freezer at between -15C and -25C for as long as two weeks.
The vaccine’s
instability has been a major hurdle for distribution efforts. Doses are shipped
in specially-designed containers that must be topped up with dry ice every five
days and, once it arrives at a clinic, it can be kept in a fridge for only five
days.
These
stringent requirements have complicated the UK’s vaccine’s rollout,
particularly in care homes and pharmacies, and are considered a major stumbling
block for lower income countries with fewer resources to establish a super-cold
chain.
In a
statement on Friday Ugur Sahin, BioNTech’s chief executive, said the finding
would offer “greater flexibility” for vaccination centres.
“We will
continue to leverage our expertise to develop potential new formulations that
could make our vaccine even easier to transport and use,” he added.
If approved
by the US Food and Drug Administration (FDA), the new data suggests the jab can
be stored at between -25C and -15C for two weeks, followed by up to five days
in a standard fridge.
“This sounds
like a minor change, but in the real-life challenge of global roll out it will
have tremendous impact,” said Professor Danny Altmann, an immunologist at
Imperial College, London.
“It was
inevitable that a protocol that started out very constrained and limited by the
precise conditions defined by the initial trials would eventually be found safe
in a simplified form.”
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