Keeping tabs on Covid-19: UK approves safety of Pfizer and BioNTech’s Covid-19 vaccine

UK regulator MHRA authorizes 40-million dose supply of Covid-19 mRNA vaccine for emergency use in the UK

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After news of Pfizer and BioNTech’s authorization achievement in the UK dominated the global headlines, nostalgia hit the Pharma IQ office as we thought back to our very first news announcement on the Covid-19 pandemic – Pfizer teams up with BioNTech to tackle Covid-19.

After an incredible milestone for science, this week we bring our readers news from Pfizer and BioNTech on the promise of a Covid-19 vaccine result.

Pfizer and BioNTech achieve first authorization use for their Covid-19 vaccine in the UK

Pfizer and BioNTech have announced the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency use for their Covid-19 mRNA vaccine (BNT162b2), against Covid-19. Following a worldwide Phase 3 trial of BNT162b2 and results indicating the vaccine to be more than 90 per cent effective in preventing Covid-19 cases where participants have shown no evidence of being infected with coronavirus, Pfizer and BioNTech are anticipating further regulatory decisions and approvals to be made around the world.

In July 2020, Pfizer and BioNTech published an agreement with the UK to supply 30 million doses of BNT162b2 once authorized for emergency use. According to the companies, now that the vaccine has been authorized for use in the UK, they will take immediate action to deliver an increased dosage of 40 million vaccines in the coming days. Complete delivery fulfillment is expected by the end of 2021. The distribution of the vaccine in the UK will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunization.

Albert Bourla, chairman and CEO of Pfizer, said: “Today’s Emergency Use Authorization (EUA) 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 its ability to conduct a careful assessment and take timely action to help protect the people of the UK.

“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,” Bourla continued. “With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”

Ugur Sahin, MD, CEO and co-founder of BioNTech, said: “The EUA in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunized against Covid-19.

“We believe that the roll out of the vaccination program in the UK will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”

The companies have filed a request for Emergency Use Authorization with the US Food and Drug Administration and have submitted the final Conditional Marketing Authorization Application following rolling submissions with the European Medicines Agency and several other regulatory agencies around the world.

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