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December 4, 2020

Pfizer and BioNTech’s mRNA Covid-19 vaccine receives approval in the UK, bringing ultra cold chain distribution to a first test

By GlobalData Healthcare

Pfizer and BioNTech’s Covid-19 vaccine BNT162b2 received emergency use approval from UK health authorities, making the island the first country for large-scale vaccine distribution and a testbed for cold chain distribution. The first Covid-19 vaccine approval based on Phase III data, after Russia’s Sputnik V vaccine was approved in that country based on data from a Phase I/II study, is a milestone in vaccine development. Less than a year after the genetic sequence of the virus was shared by Chinese authorities, Pfizer’s mRNA vaccine showed 95% efficacy in a Phase III trial with more than 43,000 participants. Furthermore, this will be the first approved mRNA vaccine, giving a boost to a novel technology that could transform the vaccine landscape. A survey by GlobalData, conducted in August 2020, found that mRNA was seen as the most promising technology to develop Covid-19 vaccines by 38% of respondents, now confirming the hope many industry insiders put in the new technology.

The first vaccine doses will be available across the country next week, according to Prime Minister Boris Johnson. The UK has secured 40 million doses of BNT162b2 in supply deals through 2021. Vaccine distribution will remain a challenge, as mRNA vaccines require very cold storage. Pfizer’s vaccine needs to be shipped and stored at -70°C (-94°F) and lasts only five days at refrigerated conditions. Moderna’s mRNA vaccine, which showed equally good efficacy as Pfizer’s, can be shipped at -20°C (-4°F) and can be stored for a month at normal refrigeration temperatures. The UK represents an ideal testbed for the delivery of Pfizer’s vaccine based on several logistical and geographic factors. Based on its small size as compared to the US, dense population, and healthcare infrastructure, distribution of the vaccine with cold chain should theoretically go smoothly, but if problems arise in these conditions, this would not bode well for vaccine distribution in countries with longer distances to vaccine distribution centres, not even mentioning countries with less developed infrastructure and sparse and less well-equipped healthcare centres. However, 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.

The UK Joint Committee on Vaccination and Immunisation (JCVI) has prioritised older residents in care homes and care home workers as first recipients of a Covid-19 vaccine, followed by elderly people ages 80 years and older and health and social care workers, and subsequently lower age groups. In the US, the Advisory Committee on Immunization Practices (ACIP) that advises the Centers for Disease Control and Prevention (CDC) on immunisation recommendations recommended to prioritse healthcare workers and patients in long-term care facilities for the first doses of an approved Covid-19 vaccine. In an additional poll conducted by GlobalData in July, 46% of respondents said that people in high-risk groups, such as the elderly and patients with comorbidities, should receive first access to a Covid-19 vaccine, followed by 21% for people in areas with high infection rates, while 33% of respondents thought that everyone should have the same access. However, enough vaccine doses to vaccinate the entire population will most likely only be available in the summer of 2021 in most countries.

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 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 authorisations (EUA) were given over-hastily for the therapeutics hydroxychloroquine (HCQ) and convalescent plasma, of which the HCQ approval was revoked soon after, the FDA took a stringent approach with vaccine data, requiring at least two months of safety data before a Covid-19 vaccine could be submitted for EUA approval. A decision about Pfizer’s vaccine in the US could come soon after an FDA meeting on 10 December, while Moderna’s meeting is scheduled for 17 December.

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