When Moncef Slaoui was tapped to helm Operation Warp Speed, he sought confirmation that politics would not play a role in driving certain treatments through an approval process without the proper supporting scientific data to back it up.
When Moncef Slaoui was tapped to helm Operation Warp Speed, he sought confirmation that politics would not play a role in driving certain treatments through an approval process without the proper supporting scientific data to back it up.
If a vaccine candidate is pushed through emergency use authorization to be used as a political tool, Slaoui said he will quit the initiative. In an interview with Science, the former head of GlaxoSmithKline’s vaccine operations, firmly expressed that the science will guide any approval of a vaccine against the novel coronavirus that has infected more than 26 million people across the globe and more than 6 million in the United States.
“If a vaccine is efficacious, a EUA will require that the documentation and demonstration of efficacy be flawless,” Slaoui told the magazine.
Concerns about an early, before-its-ready approval of a vaccine against SARS-CoV-2, the virus that causes COVID-19, have been palpable, particularly since President Donald Trump predicted a vaccine could be available to the public by the end of the year. There have been rumors the U.S Food and Drug Administration could grant an Emergency Use Authorization to one of the vaccine candidates being supported by Operation Warp Speed due to political pressure. However, FDA Commissioner Stephen Hahn has promised that approval of a vaccine would only be granted if the data supports the FDA’s threshold of 50% efficacy. And that is something that Slaoui said will be critical to providing the overall confidence in the vaccine, especially since, on average, about 1,000 Americans are dying daily from the virus.
“It needs to be absolutely shielded from the politics. I cannot control what people say. The president says things, other people will say things. Trust me, there will be no EUA filed if it’s not right,” Slaoui said.
With a pivotal presidential election only months away, Science pressed Slaoui on the concerns of politics playing a role in the approval of a vaccine, particularly following the FDA’s granting of EUA for convalescent plasma following a public lambasting of the agency by the president over an earlier decision to wait for more data.
“I would immediately resign if there is undue interference in this process,” Slaoui said. “I have to say there has been absolutely no interference. Despite my past, which is still my present, I am still the same person with the same values. The pandemic is much bigger than that. Before being a political person with convictions, humanity has always been my objective.”
So far, the U.S. has invested about $10 billion into multiple efforts to develop a vaccine against COVID-19. The redundancy is necessary due to statistical practicality. Like with most drug development efforts, only about one-third of vaccine candidates successfully make it through the clinical process. Earlier this week, a draft report from the National Academies of Sciences, Engineering, and Medicine speculates that at least four of the vaccine efforts supported by Operation Warp Speed will fail. The vaccine candidates typically falter in Phase III trials when the experimental drug is provided to thousands of patients. Phase III designs for vaccine candidates backed by Operation Warp Speed, which include Pfizer, Moderna and AstraZeneca, call for the coronavirus vaccine to be administered to 30,000 healthy volunteers.
