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

2-12-2020

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. 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. 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. While the go-ahead bodes well for Britain, which broke from the European Union�s regulatory orbit to approve the shot early, it will have no effect on the distribution of the hundreds of millions of doses that other wealthy countries have procured in prepaid contracts. It also offers little relief to poorer countries that could not afford to buy supplies in advance and may struggle to pay for both the vaccines and the exceptional demands of distributing them. 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. 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.