UK Backs Pfizer's Virus Vaccine As US Decision Looms

By Adam Lidgett
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Law360 (December 2, 2020, 12:43 PM EST) -- The United Kingdom gave Pfizer and its German partner BioNTech emergency approval Wednesday for a COVID-19 vaccine after clinical studies revealed it to be 95% effective, the companies said.

Workers stand in a window at a Pfizer plant in Belgium on Wednesday. Pfizer and BioNTech have secured emergency approval in the U.K. for a COVID-19 vaccine that health officials said could be available to certain people as soon as next week. (AP Photo/Virginia Mayo)

Doses are expected to be available as early as next week, U.K. health officials said.

The approval was at the recommendation of the U.K's Medicines & Healthcare Products Regulatory Agency, and health officials in the country said that certain groups of people — like those living in care homes, health workers and others — will be the first to get the vaccine.

"Today's emergency use authorization in the U.K. marks a historic moment in the fight against COVID-19," Pfizer CEO and Chairman Albert Bourla said in a statement. "This authorization 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 U.K."

Pfizer and BioNTech have also requested emergency approval from the U.S. Food and Drug Administration, although that approval has not yet been given.

When the companies announced they were seeking FDA approval, they said that if their vaccine is approved in the U.S., they expect to be able to produce 50 million doses by the end of the year and up to 1.3 billion doses next year. The companies will be ready to distribute the first doses within hours of government approval, they said at the time.

The FDA is scheduled to meet with the Vaccines and Related Biological Products Advisory Committee on Dec. 10 to consider a request by Pfizer and BioNTech for emergency approval of their vaccine.

Moderna said earlier this week that it is filing an emergency approval request with the FDA, asking the regulator to sign off on its COVID-19 vaccine that the drugmaker claims is 100% effective at preventing severe cases and 94% effective at preventing infection.

Last week, U.K.-based pharmaceutical giant AstraZeneca said it is seeking approval in multiple countries around the world for one of its coronavirus vaccine candidates that achieved 90% effectiveness.

Pfizer and BioNTech said Wednesday that they inked a deal with the U.K. for 40 million doses to be delivered in the country this year and next year. While the vaccines will be sent out in stages, Pfizer and BioNTech "will take immediate action to begin the delivery of vaccine doses," the companies said.

"The emergency use authorization in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19," BioNTech's CEO and co-founder Ugur Sahin said in a statement. "We believe that the rollout of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized."

The U.K.'s emergency approval of the Pfizer vaccine should "give Americans additional confidence in the quality of such a vaccine" as the FDA also considers emergency approval, Health and Human Services Secretary Alex Azar said Wednesday at a press conference to discuss the progress of the Trump administration's vaccine program Operation Warp Speed.

With emergency approval pending for both Pfizer's vaccine and another vaccine from Moderna, and two other candidates currently in clinical trials, the program's chief science adviser Dr. Moncef Slaoui said he expects that sufficient doses will be available to vaccinate 100 million people in the U.S. by the end of February — 20 million in December, 30 million in January and 50 million in February.

That would be "more or less the size of the significant at-risk population — the elderly, health care workers, first-line workers, people with comorbidities," Slaoui said.

Doses will be distributed to states, territories, several "megacities" and a handful of federal agencies on a pro rata basis according to their population, said Operation Warp Speed's chief operating officer Gen. Gustave Perna.

--Additional reporting by Daniel Wilson, Kevin Stawicki and Dorothy Atkins. Editing by Rebecca Flanagan.

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