Pfizer’s Covid-19 Vaccine Approved in UK

The Washington Post reports that the British government has granted emergency approval to the coronavirus vaccine from pharmaceutical giant Pfizer and the German company BioNTech, becoming the first Western country to authorize mass inoculations that could lead to an end of the pandemic.

Drug regulators in Britain have a global reputation for being tough but fast, employing a system of continuous “rolling review” of incoming data from drug companies. But to see a potentially lifesaving shot invented, tested and approved in less than a year smashes all speed records. Scientists point out that the genetic sequence of the novel coronavirus, which first struck Wuhan, China, was published only 260 days ago.

The British government, led by Prime Minister Boris Johnson, has been keen to be first in the West to roll out a vaccine — especially after months of criticism for having the highest death toll in Europe. British officials said a mass immunization program would start almost immediately, with distribution of the first 800,000 doses to begin next week. At an evening news conference, Johnson said: “We’ve been waiting and hoping for the day when the search lights of science would pick out our invisible enemy and give us the power to stop that enemy from making us ill. And now, the scientists have done it.”

The giddy news from Britain prompted some griping in the United States and the European Union — though they may not be far behind in granting their own approval. A U.S. Food and Drug Administration advisory committee is expected to meet Dec. 10, and a decision by the agency on authorizing the vaccine could come soon after that. The E.U.’s drug regulator said it would make a decision by Dec. 29.

In the United States, the FDA reviews all aspects of the data submitted with a vaccine application, including manufacturing and individual patient-level data. The British Medicines and Healthcare Products Regulatory Agency instead relied largely on summary data submitted by Pfizer and BioNTech, according to experts.

In Europe, some E.U. leaders suggested Britain had moved too fast — and indicated annoyance at the nationalistic tone coming from the British government. “We have member states, including Germany, who could have issued such emergency authorization if they wanted to, but we decided against this. And what we opted for was a common European approach to move forward together” in Europe, the German health minister Jens Spahn told reporters. “It’s important that we do this to help promote trust and confidence in this authorization,” Spahn said.

And British authorities did not hold a public meeting involving the Pfizer application, though it did confer with an independent expert panel on the medical assessment and conditions of authorization. The FDA, by contrast, committed months ago in the name of transparency to convene a public meeting of its vaccine advisory committee to solicit its recommendations on an emergency authorization and to make public the data that was submitted by the manufacturer.

Robert Califf, who was FDA commissioner during the Obama administration, said it was important for the U.S. regulators to have a “public airing” of the Pfizer application and data, given the level of anti-vaccine sentiment in the United States, even if it takes a little more time. “We have a lot of skepticism and a need to follow public procedures to provide transparency,” he said.

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