The UK government said Wednesday that it accepted a recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to grant temporary authorisation of Pfizer and BioNTech's mRNA-based COVID-19 vaccine BNT162b2. A Department of Health and Social Care spokesperson said "the vaccine will be made available across the UK from next week," starting with an initial 800,000 doses.
Pfizer and BioNTech noted that the move marks "the first emergency-use authorisation following a worldwide Phase III trial of a vaccine to help fight the pandemic." The companies reported interim data from the study on November 9, with results showing that BNT162b2 was more than 90% effective at preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection, while a final efficacy analysis released almost 10 days later demonstrated an efficacy rate of 95%.
Ugur Sahin, CEO of BioNTech, noted that the MHRA's decision means this will be "the first time citizens outside of the trials will have the opportunity to be immunised against COVID-19." In July, Pfizer and BioNTech reached an agreement with the UK to supply 30 million doses of BNT162b2, with the number later increased to 40 million. The companies said delivery of the 40 million doses will occur in stages throughout 2020 and 2021, with the first batches expected to arrive in the UK "in the coming days."
The UK's Joint Committee on Vaccinations and Immunisations (JCVI) on Wednesday reaffirmed that nursing-home residents and staff would be the first to receive a vaccine against COVID-19, followed by front-line health and social care workers, along with those aged over 80. The JCVI noted that once all adults aged 50 and over are vaccinated, as well as people deemed "clinically extremely vulnerable" and those above 16 years with underlying health conditions that put them at higher risk, groups representing around 99% of preventable mortality from COVID-19 will have been immunised. BNT162b2 is given as two doses, 21 days apart.
Health and Social Care Secretary Matt Hancock said the speed at which vaccinations will take place will depend on how quickly BNT162b2 can be manufactured at a plant in Belgium, but the government is expecting "many millions" of doses by the end of the year. "This will start small and ramp up. The vast majority of vaccinations we expect to be in the New Year," Hancock added.
The MHRA started its rolling review of BNT162b2 on October 30, with the government formally asking the regulator to assess the vaccine last month. The decision to approve was made under Regulation 174 of the Human Medicines Regulations, which allows the temporary supply of medicines or vaccines in response to a public health need. The government indicated that the temporary authorisation of BNT162b2 also follows advice from the Commission on Human Medicines, its independent expert scientific advisory body.
MHRA chief executive June Raine remarked "we have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness," adding that the review was "equivalent to all international standards." Raine explained "our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data."
However, in response to the news, the European Medicines Agency (EMA), which started its own rolling review of BNT162b2 on October 6, said that its approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by the UK. Earlier this week, the EMA disclosed that it would decide by December 29 whether to provisionally approve the vaccine, which Pfizer and BioNTech have recently filed for conditional marketing authorisation.
Meanwhile, former EMA head Guido Rasi criticised the speed of the MHRA's assessment, noting "if you evaluate only the partial data as they are doing they also take a minimum of risk." Rasi added "personally I would have expected a robust review of all available data, which the British government has not done."
In response, Sean Marett, BioNTech's chief business and chief commercial officer, said that "the MHRA asked the same level of detailed questions as any other agency and focused on efficacy, tolerance and the quality of reduction." Marett added "these three elements are key elements to any vaccine that any regulator will look in detail and I think the MHRA has been no different in this respect."
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