The UK Medicines Agency has approved the BioNTech / Pfizer vaccine against COVID-19 for emergency use, the companies announced today.
The UK is the first country to approve the vaccine for widespread use. This paves the way for some of the highest risk citizens, such as year.
The BBC reports that the UK's Medicines and Health Products Regulator (MHRA) has announced that the vaccine can be safely introduced from next week. However, it is not yet clear who exactly will receive the first doses.
BioNTech and Pfizer submitted the application for emergency approval last month to the MHRA and regulatory agencies in Australia, Canada, Europe, Japan, and the United States, none of which have yet granted approval.
In a statement, Albert Bourla, Pfizer chairman and CEO, described the UK emergency use approval as "a historic moment in the fight against COVID-19".
"This approval is a goal we have been working towards since we first stated that science will win, and we applaud the MHRA for its ability to conduct a careful assessment and take timely action to protect the people of the UK ", he said. “As we await further approvals and approvals, we are focused on delivering a safe, high quality vaccine safely around the world with the same urgency. As thousands of people become infected, every day is important to end this devastating pandemic. "
The UK approval is based on study data, including a global Phase 3 clinical trial from BioNTech / Pfizer that demonstrated a 95% efficacy rate for the vaccine and raised no serious safety concerns.
The vaccine was also shown to work both in participants who were not previously infected with the SARS-CoV-2 virus and in participants who were infected based on the effectiveness measurement seven days after the second dose .
Efficacy has also been reported to be consistent across age, gender, race, and ethnicity, with greater than 94% observed efficacy in adults 65 and older, the companies said.
British Prime Minister Boris Johnson tweeted this morning about the formal approval and wrote that the vaccine "will be available across the UK from next week". A second tweet was about how vaccinations in general will "ultimately" enable a return to business life as usual.
The UK has ordered 40 million doses of the BioNTech / Pfizer vaccine, or enough vaccine for 20 million people (as two doses are required), although it will be some time before the country receives all of the doses ordered.
"The 40 million doses will be delivered gradually in 2020 and 2021 to ensure a fair distribution of the vaccines to the regions with executed contracts," the companies write in a press release.
“After the vaccine is approved in the UK, companies will take immediate action to start dispensing vaccine doses. The first cans are expected to arrive in the UK in the coming days. Full fulfillment of the delivery is expected in 2021, ”they added.
The UK's National Health Service is preparing for what NHS chief Sir Simon Stevens has called "the biggest vaccination campaign in our country's history". Around 50 hospitals are on standby, according to the BBC, and vaccination centers in venues such as conference centers are also being set up.
Help is on the way.
The MHRA has officially approved the Pfizer / BioNTech vaccine for Covid-19.
The NHS is ready to start vaccinating early next week.
The UK is the first country in the world to have a clinically approved vaccine to supply.
– Matt Hancock (@MattHancock) December 2, 2020
"The emergency use approval in the UK marks the first time that citizens outside of the trials have had the opportunity to get vaccinated against COVID-19," added Ugur Sahin, M.D., BioNTech CEO and Co-Founder, in a statement. “We believe that the introduction of the UK vaccination program will reduce the number of people in the high risk population being hospitalized.
“Our goal is to provide a safe and effective vaccine to the people who need it once it is approved. The data communicated to regulators around the world is the result of a scientifically rigorous and highly ethical research and development program. "
One remaining question is how long the vaccine's protection will last. Given the speed at which the BioNTech / Pfizer vaccine was being developed within a few months, long-term data are not yet available to answer this.
The same applies to COVID-19 vaccine candidates that are being developed by other companies.