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UK drug regulator is first to clear Pfizer, BioNTech's coronavirus vaccine.

The U.K.'s drug regulator granted authorization Wednesday to Pfizer and BioNTech's coronavirus vaccine, the first approval for a shot that's completed late-stage testing and a milestone in efforts to control a pandemic that's killed 1.5 million people.

The Medicines and Healthcare Products Regulatory Authority's decision come less than a year after the vaccine's creation in BioNTech's laboratories, reflecting an unprecedented research sprint that began when Chinese scientists first uploaded the genetic sequence of the SARS-CoV-2 virus.

The U.K. authorization is also the first approval of a human medicine based on messenger RNA drug technology, a cutting-edge approach that's shown its value in the global race to respond to the greatest public health crisis this century.

With authorization granted, Pfizer and BioNTech will begin the first deliveries of 20 million vaccine courses preordered by Britain, enough to immunize nearly 30% of the U.K.'s population. In a statement, Pfizer said the first doses would arrive "in the coming days," and continue into 2021. Vaccination requires two shots, each spaced a few weeks apart.

"I'm really pleased to say that the UK is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 — a virus that has affected each and every one of us in some way — and in helping to save lives," MHRA chief executive June Raine said in a statement.

The MHRA's authorization is a temporary one permitted under national rules to address public health emergencies. It's the first of several expected in the weeks ahead as regulators around the world complete their reviews of vaccines from Pfizer and BioNTech as well as from the biotech firm Moderna. The Food and Drug Administration has scheduled advisory committee meetings for Dec. 10 and 17 to review the two candidates, and emergency use authorizations are expected to quickly follow should the panels recommend them.

The U.K. approval was expected to come first, a fact that reportedly caused consternation within the Trump administration, which had wanted to showcase U.S. capacity to develop and approve a vaccine ahead of the world. FDA Commissioner Stephen Hahn was summoned to a White House meeting on Tuesday, at which President Donald Trump's chief of staff Mark Meadows pressed him on the pace of the agency's review, according to a report in Politico.

Both Pfizer and Moderna on Tuesday submitted conditional marketing applications to the European Medicines Agency, which could issue its decision within weeks.

The first government approvals of any vaccine came from China, which in June authorized a vaccine from CanSino Bio for use among members of its military, followed by Russia, which approved Gamaleya Research Institute's shot on Aug. 11 after testing in just 76 volunteers.

GRI has since disclosed preliminary data from the first 18,000 volunteers vaccinated in a larger study.

The U.K.'s decision on Pfizer and BioNTech's shot was accompanied by new guidance from the British government's Joint Committee on Vaccination and Immunization, which set its priority list for people most at need of a protective vaccine. Nursing home residents will be the first to get a vaccine, followed by people over 80 years old and frontline healthcare and nursing home workers.

These high-priority groups are similar to who the U.S. Advisory Committee on Immunization Practices decided this week should be first in line for vaccination. The panel voted to put nursing home residents and healthcare workers in the initial phase of immunization, which could begin later this month.

The U.K.'s "first phase" of vaccinations covers people with high-risk medical conditions and successively younger age groups down to people age 50 and over. "It is estimated that taken together, these groups represent around 99% of preventable mortality from COVID-19," the committee's guidance states.

Pfizer and BioNTech's vaccine was found to be 95% effective at preventing COVID-19 in a Phase 3 trial of roughly 44,000 participants. It's still unclear, however, how long its protective effects will last or whether it can halt transmission of the coronavirus.

The two companies expect to produce 1.3 billion doses of their vaccine in 2021. The U.S. government has pre-ordered 100 million doses for $1.95 billion and has an option to acquire another 500 million as well.

Author: Jonathan Gardner


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