MHRA approves Pfizer & BioNTech Covid-19 vaccine for UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Pizer/BioNTech Covid-19 vaccine for use, making the UK the first country to approve a vaccine for the virus.
“The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s Covid-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness,” a spokesperson from the Department of Health and Social Care (DHSC) said.
Pfizer and BioNTech have agreed to supply the UK with 40 million doses of its BNT162b2 Covid-19 vaccine which will be delivered throughout 2020 and 2021 in order to ensure an equitable allocation of doses.
The vaccine will be rolled out to priority groups including care home residents, healthcare staff, the elderly and those considered clinically vulnerable once the Joint Committee on Vaccinations and Immunisations (JCVI) publishes it final advice.
The vaccine will be made available in the UK next week though the government hasn’t said in what capacity.
“To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed,” the DHSC added.
Pfizer and BioNTech are now awaiting further regulatory approval decision from other countries.
“Today’s Emergency Use Authorisation in the U.K. marks a historic moment in the fight against Covid-19. This authorisation 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 chief executive officer, Pfizer. “As we anticipate further authorisations 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 Emergency Use Authorisation in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunised against Covid-19,” said Ugur Sahin, CEO and co-founder of BioNTech. “We believe that the roll-out of the vaccination programme in the UK will reduce the number of people in the high-risk population being hospitalised. 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 programme.”
Pfizer and BioNTech are anticipating that they have the manufacturing capacity to supply 50 million vaccines across the globe in 2020 and 1.3 billion doses by the end of next year.
The companies have developed temperature-controlled shippers that can maintain storage conditions between conditions (-70°C ±10°C) for 10 days unopened, allowing the vaccine to be transported around the world. Once open, the shippers can be used by vaccination centres as temporary storage for up to 30 days with re-icing every five days to maintain the correct temperature.