The first rigorously tested coronavirus vaccine was given a green light for use on Wednesday in Britain. Doses of the vaccine, made by the American pharmaceutical giant Pfizer and a small German company, BioNTech, will be injected starting next week, The vaccine is also the first to run the gauntlet of clinical studies normally required for approval. Russia and China have authorized vaccines without Phase 3 clinical trial data.
The fact that the U.K. approved a vaccine developed by an American company — in partnership with a German one — before the United States could pour fuel on the already tense relationship between President Trump and the FDA, which has taken a more deliberative process in reviewing vaccine data. The controversy over the earlier decisions and the pressure from the White House led to fears that the FDA would be forced to authorize Covid-19 vaccines without a proper review. As a result, the agency has taken pains to be transparent about its review processes and insisted decisions would be made by career staff.
But the result has been impatience at the White House. On Tuesday, the news site Axios reported that White House chief of staff Mark Meadows summoned Stephen Hahn, the FDA commissioner, to explain why the agency hadn’t already moved to authorize the Pfizer/BioNTech vaccine or another vaccine developed by the biotechnology firm Moderna. The FDA normally conducts the most rigorous reviews of medical products in the world, re-analyzing the databases from clinical trials and conducting its own reviews of the safety and efficacy of products, as well as independent statistical reviews of their clinical trials.
WHY DID BRITAIN AUTHORIZE A VACCINE BEFORE THE U.S.?
The two countries vet vaccines differently. Rather than accepting the findings of vaccine makers, American regulators painstakingly reanalyze raw data from the trials to validate the results, poring over what regulators have described as thousands of pages of documents. Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, said on Tuesday that the F.D.A. “is one of the few regulatory agencies in the world that actually looks at the raw data.”
Regulators in Britain and elsewhere in Europe lean more heavily on companies’ own analyses. Instead of sifting through raw trial data and crunching the numbers themselves, regulatory agencies often will study a drugmaker’s reports and, unless there are anomalies, ground their decisions in company-provided documents.
The question of whether Britain had authorized a vaccine in haste or the United States was wasting valuable time as the virus was killing about 1,500 Americans a day, provoked a spirited debate among scientists and industry experts on Wednesday. European regulators said that Britain’s authorization was so limited that it only applied to specific batches of the vaccine, a claim that Pfizer denied, and that British officials did not address.
RUSSIA READY FOR A MASS PRODUCTION OF VACCINE
Russia has already started production of the covid vaccine, many countries including India have their vaccine samples, And the UK is also following the same path as Russia, after the announcement of an approved vaccine, UK officials later that day said the order of mass production have been issued to the company, the country is looking for the expenses of it.
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