The UK has become the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine for widespread use.
British regulator MHRA, says the shot, which offers up to 95% protection against Covid-19 illness, is safe for roll out beginning next week.
Immunizations could start within days for people in high priority groups.
Thessaloniki-born Pfizer CEO Albert Bourla hailed the news in a tweet and added that the company expects further regulatory actions across the globe in the coming days and weeks.
Historic day! In the U.K., we received the 1st regulatory authorization of @Pfizer and @BioNTech_Group’s #COVID19 vaccine. I applaud @MHRAgovuk for its swift & thorough review of our vaccine data & grateful for the trust they have placed in our science. https://t.co/GKhEq8bGW2
— AlbertBourla (@AlbertBourla) December 2, 2020
The UK has already ordered 40 million doses – enough to vaccinate 20 million people, with two shots each.
Around 10 million doses should be available soon, with the first doses arriving in the UK in the coming days.
It is the fastest-ever vaccine to go from concept to reality, taking only 10 months to follow the same developmental steps that normally span a decade.
The UK approval just ramps up the tension in the United States as the same American/German-produced vaccine continues to sit at the FDA awaiting approval by that body.
Drug regulators have already been under the gun from the White House for not moving with the necessary speed in the campaign to get the doses out to the public.
But it was a glorious day in the United Kingdom, with British Health Secretary Matt Hancock exultant after the approval.
“Help is on its way with this vaccine — and we can now say that with certainty, rather than with all the caveats,” he stated.
“Separate teams worked in parallel”, “day and night”, including weekends, checking all the various aspects of vaccine safety, without waiting for the results from one area before research was begun in another, explained MHRA Director June Raine.
Dr. Penny Ward of King’s College London stated after the approval that, in contrast to the European Medicines Agency (EMA), which controls all drugs and vaccines approved in the EU, “the MHRA can ask questions as it progresses and provide answers more quickly as a single service.”
The Amsterdam-based EMA follows a rapid process, which it calls “ongoing testing,” to analyze data regarding the safety and efficacy of COVID-19 vaccines as soon as they are produced.