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Pfizer/BioNTech’s COVID-19 vaccine gets first approval from UK

The UK has already signed a supply deal for 40 million doses

Pfizer and BioNTech’s mRNA-based COVID-19 vaccine has been granted authorisation for emergency use in the UK, making it the first nation to approve the novel vaccine.

The vaccine’s path through conceptualisation, development and approval has advanced at an unprecedented rate, taking only ten months.

Typically, in non-pandemic situations, it takes years for a potential vaccine to move from the development stages toward authorisation, with the current COVID-19 vaccine timelines reflecting the urgency involved in finding an effective vaccine.

Following approval from the UK’s Medicines & & Healthcare Products Regulatory Agency (MHRA), the Pfizer/BioNTech vaccine will be available from next week, said Health Secretary Matt Hancock.

The approval closely follows final analysis of the vaccine, BNT162b2, which found that it has an efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective).

The company added that the efficacy rate was consistent across age, gender, race and ethnicity, with the observed efficacy in adults over 65 years of age coming in at over 94%.

The UK has already signed a supply deal for 40 million doses of BNT162b2, with the first of these set to be delivered ‘immediately’.

BNT162b2 is being manufactured in Belgium, among other locations, although this particular Pfizer manufacturing site is ‘critical to distribution in the UK’.

The vaccine will be rolled-out to priority groups first, with care home residents, health and care staff and the elderly slated to become the first to be offered the shot.

“The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large-scale vaccination programmes and will begin putting its extensive preparations into action to provide care and support to all those eligible for vaccination,” commented a Department of Health and Social Care spokesperson.

According to the BBC, approximately 50 hospitals are prepared to administer the vaccine, while vaccination centres are also currently getting ready to roll-out BNT162b2.

BNT162b2 has a recommended storage temperature of minus 70˚C (minus 94°F), which is well below the typical vaccine storage temperature of +2˚C to +8˚C. This means it will likely be easier to administer the vaccine in a hospital setting, rather in the community.

Pfizer/BioNTech have developed novel temperature-controlled shipping containers, which they say can maintain this temperature for ‘extended periods of time’. The companies added, however, that once the vaccine vial has thawed, the vial can also be stored for up to five days at typical refrigerated conditions.

A US Food and Drug Administration (FDA) expert panel is due to meet on 10 December to discuss BNT162b2, and Pfizer/BioNTech has also submitted the vaccine to the European Medicines Agency (EMA) for emergency approval.

“Today’s emergency use authorisation in the UK marks a historic moment in the fight against COVID-19. This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said Albert Bourla, chairman and chief executive officer of Pfizer.

“As we anticipate further authorisations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic,” he added.

Article by
Lucy Parsons

2nd December 2020

From: Regulatory



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