Landmark Approval: Pfizer And BioNTech Can Use UK As Test Bed For Cold Chain Distribution


By Emmanuel Oluebube, Correspondent UK

The news that Pfizer/BioNTech’s COVID-19 vaccine BNT162b2 received emergency use approval from UK health authorities is being received with excitement across the analysts and user communities.

Senior Infectious Diseases Analyst at GlobalData Philipp Rosenbaum, PhD offers his view: “The UK represents an ideal test bed for the delivery of Pfizer’s vaccine. The country’s small size, dense population and strong healthcare infrastructure should mean distribution of the vaccine with cold chain should go smoothly. If problems do arise, this will not bode well for distribution in countries with longer distances to vaccine distribution centers – not even mentioning countries with less developed infrastructure, or sparse and ill-equipped healthcare centers.

“Distribution remain a challenge, as mRNA vaccines require very cold storage. In fact, Pfizer’s vaccine needs to be shipped and stored at -70° C (-94°F) and lasts only five days at refrigerated conditions – compare this to Moderna’s mRNA vaccine, which showed equally good efficacy as Pfizer’s but can be shipped at -20°C (-4°F) and stored for a month at normal refrigeration temperatures. Pfizer has been planning the logistics of vaccine distribution in great detail, counting on charter flights and GPS-tracked freezer boxes to ship and store the vaccine.

“With the approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA), based on a rolling review process that started at the end of October, the UK agency beat the US Food and Drug Administration (FDA) for approval. This might lead to further tensions between the FDA and the US Government, which was unhappy with the slow regulatory process of COVID-19 vaccines. After emergency use authorizations (EUA) were given overhastily for the therapeutics hydroxychloroquine (HCQ) and convalescent plasma – of which the HCQ approval was revoked soon after – the FDA took a more serious approach with vaccine data, requiring at least two months of safety data before a COVID-19 could be submitted for EUA approval. A decision about Pfizer’s vaccine in the US could come soon after an FDA meeting on December 10, while Moderna’s meeting is scheduled for December 17.

“With the first of the secured 40 million doses to be available across the UK next week, this marks the first approved COVID-19 mRNA vaccine – giving a boost to a novel technology that could transform the vaccine landscape.”

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