Britain Approves Pfizer Vaccine
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From the New York Times:

U.K. Approves Pfizer Coronavirus Vaccine, a First in the West

Emergency approval of the vaccine, ahead of the United States and the European Union, clears the way for Britain to begin mass inoculations.

By Benjamin Mueller
Dec. 2, 2020, 2:12 a.m. ET

LONDON — Britain gave emergency approval on Wednesday to Pfizer’s coronavirus vaccine, leaping ahead of the United States to become the first Western country to allow mass inoculations against a disease that has killed more than 1.4 million people worldwide.

China, Russia, and the United Arab Emirates have approved at least one vaccine previously.

The authorization to use the vaccine developed by Pfizer, a U.S. pharmaceutical giant, and BioNTech, a much smaller German firm, kicked off a vaccination campaign with little precedent in modern medicine, encompassing not only ultracold dry ice and trays of glass vials but also a crusade against anti-vaccine misinformation.

The specter of Britain beating the United States to approval — on a vaccine co-developed by an American company, at that — may intensify pressure on U.S. regulators, who are already under fire from the White House for not moving faster to get doses to people.

The FDA meeting to consider the Pfizer application is scheduled for Thursday, December 10, nine days from now. Pfizer and its logistics partners are already doing dry runs of the type of air deliveries that it hopes to begin immediately upon FDA approval in the U.S.

And it has stirred up a global debate about how to weigh the desperate need for a vaccine with the imperative of assuring people that it is safe.

Russia and China have already approved vaccines without waiting for the results of large-scale efficacy tests, a decision that scientists in some cases have said poses serious risks. …

The Pfizer-BioNTech vaccine must be transported at South Pole-like temperatures, a requirement that is already dictating who will be vaccinated: Nursing-home residents were supposed to be Britain’s top priority under an advisory committee’s plans, but a limit on how many times officials believe the vaccine can be moved before it loses effectiveness means that National Health Service staff members will receive the shots first.

A question is how many times can you open the freezer door to take out more vials?

The government has been coy about how quickly it could stock hospitals after approval, but doctors and nurses were preparing to begin vaccinating their colleagues within days.

For Britain, which has suffered one of Europe’s highest per capita death tolls from the virus, the decision by its drug regulator testified to a vaccination strategy that has been the most aggressive in the West.

After the government strengthened an old law that allows Britain to step out from under the European Union’s regulatory umbrella in public health emergencies, its Medicines and Healthcare Products Regulatory Agency fast-tracked a review of the vaccine developed by Pfizer, based in New York, and BioNTech, a small German firm.

Britain has pre-ordered 40 million doses of the vaccine, which was 95 percent effective in a late-stage clinical trial. The government has ordered a catalog of different vaccines that are in development — in all, more than five doses for each person in the country.

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