Just nine months since the Covid-19 pandemic began, the first vaccine to prevent this deadly viral disease has been approved. This huge moment was achieved after the UK’s healthcare regulator the Medicines and Healthcare Products Regulatory Agency (MHRA) approved Pfizer and BioNTech’s mRNA Covid-19 vaccine BNT162b2 for temporary emergency use.
Pfizer CEO and chairman Albert Bourla commented: “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. ”
BioNTech co-founder and CEO Ugur Sahin added: “The Emergency Use Authorization in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunised against Covid-19”.
As a result of this approval, “the vaccine will be made available across the UK from next week”, stated a spokesperson from the Department of Health and Social Care.
The UK has agreed access to 40 million doses of the Pfizer/BioNTech vaccine through its Vaccines Taskforce; this is enough two vaccinate 20 million people as two doses are required for full protection against Covid-19. The bulk of these are unlikely to be available until the new year as Pfizer and BioNTech have only committed to supplying a total of 50 million doses globally in 2020.
Pfizer and BioTech are anticipating further emergency and conditional approvals in the coming days and months, including from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Exploring the MHRA’s decision
The regulator’s chief executive Dr June Raine explained in a press conference that the MHRA’s decision is based on an “extremely thorough review” and “the most rigorous scientific assessment” of the results of Pfizer and BioNTech’s Phase III study of BNT162b2.
Final results of the trial were published on 18 November, which showed BNT162b2 was 95% effective seven days after the second dose; this efficacy rate was consistent across different demographics studied in the trial. In addition, there were no safety concerns related to the vaccine.
Dr Raine noted that the MHRA has been conducting a rolling review of the vaccine since June, which allows for an expedited review of the vaccine without cutting any corners. This work was also supported by the work of an advisory, non-governmental body called the Commission on Health.
Raine emphasised that the public can be absolutely confident in the vaccine and that the benefits of being vaccinated far outweigh any risk.
Despite this, Commission on Health expert working group chair professor Sir Munir Pirmohamed noted in the press conference that the MHRA will be undertaking long-term surveillance of the vaccine’s use in the real world. This is standard procedure for all medicines.
Experts react to the news
British Society for Immunology president professor Arne Akbar commented: “This is a momentous day for us all. Covid-19 has impacted all our lives in so many ways and hope of an exit strategy has relied on a safe and effective vaccine.
“It is only 12 months since the first recorded case of Covid-19 and in that time, researchers around the world have worked tirelessly to increase our understanding of this new disease and develop safe and effective vaccines. To achieve this within this timescale is remarkable and the researchers should be applauded.
“However, this announcement is not the end of the story and there is still much work to do. Roll out of the vaccine is going to be a logistical challenge and rely on our dedicated healthcare professionals around the country.”
The Association of the British Pharmaceutical Industry CEO Dr Richard Torbett said: “Today’s approval for the Pfizer / BioNtech vaccine in the UK is great news and another milestone in the fight against Covid-19.
“That people in the UK will be among the first to be offered a vaccine is a testament to the timely and dedicated work of our world-class health regulator, the MHRA.
“With a number of new vaccines on the horizon, it’s exciting to see that the scientific partnerships forged earlier in the year may finally be starting to lead us out of this pandemic.”
University of Southampton senior research fellow in global health Dr Michael Head added: “This is excellent news and a huge landmark in the global efforts to address this pandemic.
“Given we will certainly need more than one licensed vaccine to maximise global coverage, everyone will still be eagerly waiting for further developments from Oxford and Moderna.
“But, for now, this is wonderful news to wake up to.”