UK Authorizes Use of Pfizer, BioNTech’s COVID-19 Vaccine
The UK government said Wednesday that it accepted a recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to grant temporary authorization 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 authorization following a worldwide phase 3 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 in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection. Later in the month, findings from the final efficacy analysis suggested that the vaccine demonstrated an efficacy rate of 95%.
First doses in the coming days
Ugur Sahin, CEO of BioNTech, said that the MHRA’s decision means this will be “the first time citizens outside of the trials will have the opportunity to be immunized 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 doses. The companies noted that the delivery of the 40 million doses will occur throughout 2020 and 2021, with the first doses expected to arrive in the UK in the coming days.
The UK’s Joint Committee on Vaccinations and Immunisations previously indicated that nursing-home residents and staff would be the first to receive a vaccine against COVID-19, followed by health and social care workers, along with other vulnerable groups. 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.
Review began in October
The MHRA started its rolling review of BNT162b2 on October 30, with the government formally asking the regulator to assess the vaccine last month, with approval 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 authorization 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.”
EMA criticizes speedy process
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. On Tuesday, the EMA disclosed that it would decide by December 29 whether to provisionally approve the vaccine, after Pfizer and BioNTech submitted an application seeking conditional marketing authorisation.
Meanwhile, former EMA head Guido Rasi criticized 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 to be able to say that without Europe you come first.”
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.”