“We have the gold standard of a regulatory approach with the [Food and Drug Administration]. The UK did not do it as carefully and they got a couple of days ahead,” Fauci told Fox News on Wednesday.
Fauci’s comments were the opening salvo in a verbal jousting match between US and UK officials that experts said risked undermining public confidence in the safety of vaccines.
By Thursday evening, Fauci had apologized on British television for his earlier comments.
“There really has been a misunderstanding, and for that, I’m sorry and I apologize for that. I do have great faith in both the scientific community and the regulatory community at the UK,” he told the BBC.
“We do things a certain way in the United States, possibly a little different, not necessarily better or worse than what’s done in the UK, and I think that’s where we slipped, where I slipped. I made it seem one was better than the other. We just do it a little bit differently.”
Getting down and dirty
So how did the UK leapfrog the US in the race to approve a vaccine? There is one main difference in approval process between the two countries — the way regulators treat data.
The UK’s independent regulator — the Medicines and Healthcare products Regulatory Agency (MHRA) — typically uses data reports from drug makers to come to a decision on approval. This is also the approach taken by several other regulators worldwide, including the EU regulator the European Medicines Agency (EMA).
America’s FDA, however, usually re-analyzes the raw data from drug companies before signing off on approval, which can take a bit longer.
“We in the United States are in a unique position, which is that among all global regulators, we are the ones that actually don’t just look at the companies’ tables. We actually get down and dirty and we look at the actual adverse event reports, the bad spelling errors that are made by physicians sometimes, et cetera,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told an American Medical Association webinar Thursday.
Professor Stephen Evans, from the London School of Tropical Hygiene and Sciences, said he didn’t know how often the FDA’s re-analyses resulted in different conclusions to the presentation of data from drug companies. “My suspicion is that that would be rare,” he told CNN. “If it all leads to the same numbers, one might argue that it’s a delay that hasn’t given any gains.”
Evans also said the MHRA had more flexibility when it came to organizing meetings to discuss vaccine data and approvals. The FDA is required to hold public meetings which are scheduled well in advance.
“The FDA provides its own full written assessment of the application, and then both the company’s application and the FDA’s assessment are reviewed at a day-long public meeting by an independent expert advisory group,” Mark McClellan, a former FDA commissioner, told CNN in an email.
“Preparing for, conducting, and responding to the input at this meeting takes a bit of additional time. But it not only helps assure a thorough review — it also creates more public transparency about important decisions and can help with confidence in the decision in the medical community and the public. Those things are very important as well.”
In a statement on Friday, MHRA chief Dr. June Raine said that “the way in which the MHRA has worked is equivalent to all international standards. We are well aware of our national situation and therefore we have mounted teams, built our capability and worked in parallel. I want to thank the colleagues who have worked day and night, weekends, to enable us to come to this position. The public can be absolutely confident that the standards we have worked to are equivalent to those around the world.”
President Donald Trump, meanwhile, is showing frustration that America didn’t get there first. FDA commissioner Dr. Stephen Hahn was summoned to the White House several times in recent days to explain why the Pfizer/BioNTech vaccine hadn’t been approved yet.
But the US is not far behind the UK. The FDA has scheduled a meeting of its vaccine advisory committee December 10 to discuss Pfizer/BioNTech’s emergency authorization application.
Tensions over vaccines
Fauci, in his apology on Thursday, suggested that there would have been blowback in the US if the FDA had approved a vaccine as quickly as the UK.
“If we had approved it yesterday or tomorrow, there likely would have been pushback on an already scrutinising society that has, really I think, in some respects in the United States, too much skepticism about the process.”
Melinda Mills, Nuffield Professor of Sociology at the University of Oxford, criticized Fauci for initially casting doubt on the UK’s vaccine approval process at a time when governments are struggling to convince enough citizens to take the vaccine to bring an end to the pandemic.
“The allegation [from Fauci] is extremely damaging to public confidence when we already know [vaccine hesitancy] is high,” Mills told CNN, adding she was pleased that Fauci had clarified his comments.
UK Education Minister Gavin Williamson didn’t help matters when he offered his own theory on how the UK had beaten the US and European allies to the punch on approving a vaccine. “We’ve obviously got the best medical regulators, much better than the French have, much better than the Belgians have, much better than the Americans have,” he told London’s LBC radio station Thursday. “That doesn’t surprise me at all because we’re a much better country than every single one of them.”
Mills also said Williamson’s comments were “really unhelpful” and noted there was blame to be shared on both sides of the Atlantic.
Sergio Della Sala, Professor of Human Cognitive Neuroscience at the University of Edinburgh told CNN that governments and officials should stop combining politics and health policy in a bid to treat vaccine approvals as a race to victory.
“The issue is now one of communication. We should avoid mixing politics with health, alienating EU and US partners and players by claiming an alleged superiority, hence provoking their reaction which could be damaging,” Della Sala said.
Moncef Slaoui, the chief adviser to the Operation Warp Speed in the US, praised the UK’s approval earlier this week, describing the MHRA as “an external regulatory agency of the highest caliber and standards equivalent to those of the FDA” and saying it should give Americans more confidence in the Pfizer/BioNTech vaccine.
The first doses of the vaccine reportedly arrived in the UK on Thursday night, carried by a fleet of unmarked trucks through the Eurotunnel. The first shots are set to be administered next week.
US officials, meanwhile, are preparing for their December 10 meeting to consider emergency authorization of the Pfizer/BioNTech vaccine.
Despite the two countries taking different initial approaches to approval, both may begin the New Year on a similar footing.