The UK became the first Western country to authorize a Covid vaccine, paving the way for mass vaccination with the Pfizer / BioNTech vaccine to begin in people most at risk next week.
The vaccine has been cleared for emergency use by the Medicines and Healthcare Products Regulatory Authority (MHRA), ahead of decisions in the United States and Europe. The MHRA was given the authority to approve the vaccine by the government under special regulations before January 1, when it will become fully responsible for the authorization of drugs in the UK after Brexit.
The first doses of the vaccine will arrive in the coming days, the company said. The UK has purchased 40 million doses of the vaccine, which has been shown to be 95% effective in its final trials.
A spokesperson for the Department of Health and Social Affairs said: “The government today accepted the MHRA’s recommendation to approve the use of Pfizer / BioNTech’s Covid-19 vaccine.
“This follows months of rigorous clinical trials and extensive data analysis by experts at MHRA who concluded that the vaccine met its strict standards for safety, quality and efficacy.
“The Joint Committee on Vaccination and Immunization will also shortly release its latest advice for priority groups to receive the vaccine, including residents of health centers, health and care workers, the elderly and the elderly. clinically extremely vulnerable. The vaccine will be available across the UK from next week. ”
Albert Bourla, President and CEO of Pfizer added: “Today’s emergency use authorization in the UK marks a historic moment in the fight against Covid-19. This clearance is a goal we have strived towards since we first declared that science would win, and we commend the MHRA for its ability to conduct careful assessment and take timely action to help protect the British population.
“As we anticipate new authorizations and approvals, we strive to move forward with the same level of urgency to safely deliver a high quality vaccine around the world. With thousands of people infected, every day counts in the collective race to end this devastating pandemic.
Although the vaccine should be stored at -70 ° C, the companies say it can be stored for up to five days in the refrigerator, between 2 and 8 ° C. The first priority groups for vaccination are residents of nursing homes. care, who may not be able to reach an immunization center, as well as the staff caring for them. At refrigerator temperature, the vaccine may be brought to them. Next come the over 80s and NHS staff.
Data from the trial showed the vaccine was equally effective in young volunteers and those over 65 who are most at risk for Covid. Gender, race, and ethnicity also made no difference.
Pfizer and BioNTech say their combined manufacturing network has the potential to deliver up to 50 million doses of vaccine globally by 2020 and up to 1.3 billion doses by the end of 2021.
Delivery of the 40 million doses to the UK will begin immediately. Health Secretary Matt Hancock has said he expects 10 million doses to arrive this year. Delivery will continue throughout 2020 and 2021 in stages “to ensure an equitable distribution of vaccines across geographic areas with contracts executed,” the companies say.
The United States, which has ordered 100 million doses, and Europe, which has purchased 200 million, are expected to approve the vaccine within a few weeks.
The MHRA moved at unprecedented speed to grant an emergency-use authorization in just a week, after receiving final data from the companies on November 23. It went through an ongoing approval process, reviewing data from the first trials as they arrived.
“The emergency use authorization in the UK will mark the first time that citizens outside of trials will have the opportunity to be immunized against Covid-19,” said Ugur Sahin, CEO and co-founder of BioNTech.
“We believe that the roll-out of the vaccination program in the UK will reduce the number of people hospitalized in the high-risk population. Our goal is to bring a safe and effective vaccine after approval to the people who need it. The data submitted to regulatory agencies around the world is the result of a scientifically rigorous and highly ethical research and development program. ”