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Pfizer Inc. and BioNTech have achieved an historic first "approval" for their COVID-19 vaccine, gaining emergency authorization in the UK.

The authorization for BNT162b2 is the first anywhere in the world, and is a breakthrough against the SARS-Cov-2 pandemic, with regulators in the US and EU expected to follow suit within weeks.

Pfizer and BioNTech said the first doses of the mRNA vaccine were available for delivery immediately, and vaccinations for priority groups would begin next week in the UK.

The first supplies of the vaccine will be transported from Pfizer’s manufacturing site in Belgium. The UK has secured 10 million doses for 2020/21, with the first 800,000 doses available next week, with the majority of the vaccines available in early 2021. 

Pfizer’s vaccine needs to be stored and transported at -70°C, requiring special arrangements for administration.

While COVID-19 vaccines developed in China and Russia have been given limited distribution following emergency use authorizations in those countries, this is the first time a vaccine which has demonstrated its safety in efficacy in Phase III trials has gained approval.

The authorization came just nine days after Pfizer filed its final clinical data dossier with regulators around the world, based on its final interim Phase III results, which showed an efficacy of 95% in protecting against infection.

The UK’s regulator the Medicines & Healthcare Products Regulatory Agency (MHRA) has authorized the vaccine for emergency supply under Regulation 174, a temporary authorization which would be followed by full approval in due course.

Pfizer CEO Albert Bourla

ALBERT BOURLA

“Today’s Emergency Use Authorization in the UK marks a historic moment in the fight against COVID-19. This authorization 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 CEO of Pfizer.

“As we anticipate further authorizations 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.”

The UK was one of the fastest in the world to build up a portfolio of deals with major COVID-19 vaccine developers. It created a dedicated Vaccine Taskforce in April, headed by healthcare venture capital leader Kate Bingham.

A spokesperson for the UK’s Department of Health and Social Care stressed that it had accepted the MHRA’s recommendation to approve the vaccine only after “months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA” who had concluded that it met strict standards of safety, quality and efficacy.

The MHRA's chief executive June Raine reassured the public and media, and told a press conference: "No corners have been cut."

Gillies O'Bryan-Tear, chair of the UK’s Faculty for Pharmaceutical Medicine (FPM) and a former head of biologics development at GlaxoSmithKline said the news was both welcome and ahead of expectations. “This means that the NHS can begin to plan for the first vaccine recipients to receive it, most likely in the hospital setting. We know from hospital sources that managements have already started to plan the administration of the vaccine, when it arrives, to their healthcare and frontline staff.”

He also praised the work of the MHRA for the rapid approval of this vaccine and support for researchers over the course of the year in providing rapid approval of study protocols and accelerated reviews of all technical aspects submitted by companies.

While some are already questioning the speed of the MHRA's clearance, O'Bryan-Tear said he was sure the regulator had used the "rigorous scrutiny of efficacy and safety which the MHRA always brings to bear."

He also praised the efforts of the international scientific community which had "undoubtedly outperformed in the last 10 months and exceeded our expectations."

Attention will now turn to the expected emergency use authorizations from the US FDA and the EMA. The US regulator's special vaccines advisory committee will meet on 10 December to review the data from Pfizer/BioNTech, with a separate meeting to review the submission from Moderna a week later. An EUA is then expected to follow before the end of 2020.

The EMA plans to conclude its assessment of BNT162b2 on 29 December at the latest, if the data submitted are sufficiently robust to conclude on the vaccine’s quality, safety and effectiveness. It has said that if this is the case, it will conclude its assessment of the vaccine on 12 January.

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