Britain grants Pfizer coronavirus vaccine emergency authorization

December 2, 2020.
Britain granted emergency approval on Wednesday to the coronavirus vaccine developed by Pfizer and BioNTech, becoming the first country to do so. Distribution is expected to begin next week.

In a statement, Britain’s Department of Health and Social Care said that the decision to approve the vaccine “follows months of rigorous clinical trials and a thorough analysis of the data” by a panel of experts who concluded that it met the standards for safety and effectiveness. Data previously released from large-scale clinical trials showed that the vaccine had nearly 95 percent efficacy and people who were immunized displayed no serious side effects.

Britain has been racing to become the first Western country to approve a coronavirus vaccine, and its government has already ordered 40 million doses of the Pfizer/BioNTech vaccine. The first of those doses are expected to arrive in the coming days, the drugmakers said in a joint statement.

Starting next week, the vaccine will be available across the country, the Department of Health and Social Care said. “Help is on its way,” British Health Secretary Matt Hancock tweeted on Wednesday. “The NHS stands ready to start vaccinating early next week.”

Hancock told the BBC that he was “absolutely thrilled” by the decision and “very proud” that Britain was the first country to approve the vaccine. Approximately 800,000 doses are expected to arrive next week, with first priority going to nursing home residents and workers, and the most elderly citizens. Health-care workers and other extremely vulnerable populations “are also high on that priority list,” he said.

Pfizer CEO Albert Bourla described the vaccine’s authorization as “a historic moment,” and noted that the company anticipates that it will soon be approved by other governments around the world. Pfizer and BioNTech filed for emergency use authorization in the United States on Nov. 20, with the goal of distributing the vaccine to high-risk populations by mid-December.

Drug regulators in Britain, where being first to launch a mass vaccination effort would be a point of national pride, have a reputation for being tough but quick-moving. Their decision is likely to intensify the focus on the U.S. Food and Drug Administration, which has faced increasing pressure from the Trump administration to approve Pfizer’s vaccine. On Tuesday, White House Chief of Staff Mark Meadows summoned Stephen Hahn, the head of the FDA, to ask why the agency was not moving faster.