Early on Tuesday morning, Food and Drug Administration Commissioner Stephen Hahn was summoned to the White House. The meeting, fueled by concerns that Britain was going to approve a coronavirus vaccine before the United States, saw Chief of Staff Mark Meadows ask Hahn exactly what the hold-up was. On Wednesday, Meadows’ fears were realized.
Britain has become the first Western country to approve a coronavirus vaccine, leaping ahead of the U.S. and the rest of Europe. British regulators authorized the immediate roll-out of a vaccine made by U.S. pharma giant Pfizer and its German partner BioNTech, with the first immunizations expected to take place within days. Meanwhile, FDA regulators aren’t even expected to meet to discuss the vaccine until next week, and Britain’s big call has now piled even more pressure on them.
Britain has managed to rush ahead for two main reasons: First, unlike in America, British regulators are said to rely heavily on trial analysis provided to them by pharmaceutical companies—in this case, Pfizer. The head of the British regulator, Dr. June Raine, explained Wednesday that the amount of information provided to them by Pfizer since the summer has allowed them to carry out “rolling” analysis for months—and then issue rapid approval when final results came through.
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Insisting no corners had been cut, the head British medical regulator explained, “If you're climbing a mountain, you prepare and prepare. We started that in June. By the time the interim results became available on 10 November we were at base camp. And then when we got the final analysis we were ready for that last sprint that takes us to today.”
People who have worked with the British agency this year told the Wall Street Journal that it had been much more proactive in interacting with drug companies than other agencies, often requesting additional data and explanations to help speed its rolling analysis.
In America, the FDA is behind. It’s now expected to pore through a staggering volume of raw data before it comes to its decision. An agency spokesperson explained the laborious process to Axios earlier this week, saying, “The amount of data submitted to the FDA includes thousands of pages of technical information that must be divided up and reviewed by experts from different disciplines. Once the reviews by the various experts are completed, they are then integrated into an overall review.”
Commissioner Hahn has urged patience, explaining, “We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision.”
The second reason that Britain managed to move first is the government’s decision to run its own vaccine approval process separately from Europe.
Inside the European Union, decisions on medicines and vaccines are usually taken by the European Medicines Agency. While Britain has left the EU, it’s still in a legal transition process, so the EMA will cover the U.K. until the end of the year.
However, the British government used a long-standing provision to take the decision out of European hands and rely on the London-based Medicines and Healthcare Products Regulatory Authority for vaccine approval instead. The MHRA approved the Pfizer vaccine on Wednesday while the EMA has said it might not make a decision until the end of the month.
The MHRA has previously handled a significant chunk of the Europe-wide portfolio of medicines awaiting authorization, so a lot of its staff were already experienced in how to scrutinize a new vaccine.
A British government official told The Guardian that breaking away from the EMA gave Britain the advantage, saying, “It means we will have a three-week head start on every other country in Europe in terms of deploying this vaccine... Germany might have a better diagnostics industry than we do, but when it comes to deploying vaccines we are number one.”
Britain’s swift decision drew some criticism from the EU’s drug regulator, which said that it believed its slower approval process was the “most appropriate regulatory mechanism” for the vaccine.
Nevertheless, the rapid approval is some welcome good news for Britain’s Prime Minister Boris Johnson, whose handling of both the pandemic and his Brexit project have been criticized. He called the Wednesday development “fantastic,” and added that vaccines will soon “allow us to reclaim our lives and get the economy moving again.”
Britain has ordered 40 million doses from Pfizer, enough to vaccinate 20 million people with the two-shot jab. It’s expecting an initial 800,000 doses to arrive next week, when immunizations will begin. The first vaccinations are likely to be given in the UK before the FDA approves the vaccine.
