After the Food and Drug Administration offered shaky data to justify its approval of blood plasma to treat COVID-19, some scientists are worried the agency could bow to pressure to approve a coronavirus vaccine before it’s fully tested.
Sunday, President Donald Trump announced that the FDA issued an Emergency Use Authorization for blood plasma. The president, the Health and Human Services secretary and the head of the FDA said the treatment reduced deaths in COVID-19 patients by 35%.
It did not, and scientists questioned the FDA’s claims about the data.
“You saw FDA be bullied by the president of the United States into approving something that they didn’t want to approve earlier, because he wanted them to do that,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital in Philadelphia, in an online interview Monday with the editor of the Journal of the American Medical Association.
The data showed a lower death rate in a small fraction of those who received blood plasma, an antibody-rich liquid derived from the blood of COVID-19 survivors. Specifically, it helped people under 80 who were not on ventilators and who received the plasma within three days of being diagnosed.
Without a control group of patients who didn’t get blood plasma, it’s impossible to know whether the plasma actually saved lives.
The Infectious Disease Society of America was concerned enough that it published a statement saying that although there were “some positive signals” that the plasma helped, it shouldn’t be authorized for wider use before randomized, controlled studies are performed.
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According to an unpublished study, about 9% of patients – those who were younger, got plasma early and received high doses of antibodies – died after receiving the treatment, compared with 12% of those who got it later and in lower amounts.
That is roughly a 35% difference for that group, but it does not mean the therapy reduced COVID-19 deaths that much overall.
The overstatement, and the fact that the FDA would approve emergency use of a COVID-19 treatment based on flawed analysis of a therapy that was already available, worries scientists and researchers focused on vaccines.
They’re concerned the FDA might cave to pressure from the White House to issue an Emergency Use Authorization, or EUA, for a coronavirus vaccine to boost the president’s chances of reelection.
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FDA faces high stakes for COVID-19 vaccine
Trump said he expects a vaccine “very soon.” He has floated the possibility that a supposed “deep state” conspiracy at the FDA might delay it until after the presidential election Nov. 3.
Last week, Dr. Peter Marks, who heads the FDA’s vaccine group, told Reuters he has faced no political pressure to release a vaccine without sufficient data on safety and effectiveness. He said he would resign if that happened.
Offit said Trump is “trying to now bully FDA into approving, possibly through an Emergency Use Authorization, a vaccine or vaccines before they’ve been adequately tested. That is a major mistake.”
Treatment is given to people who are sick; vaccines are given to healthy people.
“Vaccines can be given to millions of people, hundreds of millions of people around the world, even billions,” said Eric Topol, a professor of molecular medicine at the Scripps Research Institute in La Jolla, California. “How are we going to trust this man and our FDA in the months ahead regarding a vaccine Emergency Use Authorization? We’re in the middle of a pandemic; the stakes are really high. They couldn’t be higher.”
‘I can just hear the vaccine skeptic groups rising up’
It may make sense to grant emergency use for a COVID-19 vaccine if full data from a final clinical trial showed excellent safety and clear evidence in reducing disease, and all that remained were certain “technical or administrative issues or steps,” said Dr. Jesse Goodman, director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University.
If the agency made that decision, the vaccine should be used only for people at high risk of COVID-19 exposure or illness, he said. It would be “critical that recipients understand clearly that the product is not FDA-approved and why and what is known and not known about the product’s safety and effectiveness,” he said.
More people may be protected if the FDA goes through the full licensing process for a coronavirus vaccine rather than approving it on an emergency basis, said Daniel Salmon, the director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health.
“That would require more time, but it might have more impact because if people understand that the process was the normal, proven process – it wasn’t expedited – more people would be likely to get vaccinated,” he said.
Pushing a vaccine through without rigorous review could affect the public’s trust in vaccines for years to come, said Dr. William Schaffner, a professor in the division of preventive medicine and infectious disease at Vanderbilt University in Nashville, Tennessee.
“I can just hear the vaccine skeptic groups rising up and castigating the entire vaccine assessment system,” he said. “It would be a profoundly bad thing for public health.”
A rush to approval could affect enrollment in studies of vaccines to protect against SARS-CoV-2, the virus that causes COVID-19, because the public might lose faith in the process.
“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told Reuters on Monday. “The one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy.”
FDA’s credibility in question
Barry Bloom, an immunologist and vaccine expert who is a professor of public health at the Harvard T.H. Chan School of Public Health, said he has enormous faith in the FDA’s technical staff. But this is the third time during the pandemic that the FDA has made decisions driven more by politics than data, he said.
The first was issuing an Emergency Use Authorization for hydroxychloroquine as a COVID-19 treatment, then withdrawing it. The second was the FDA’s decision to let companies market antibody tests without being approved first. And now, emergency approval of blood plasma treatment on shaky scientific ground.
The plasma of people who recovered from a disease contains antibodies that may help people fighting that disease. The treatment has been used for more than a century against different diseases, from diphtheria in the 1890s to Ebola in 2014 and 2015.
Every disease is different, and plasma can sometimes do more harm than good. That’s why careful research is needed, Bloom said.
“I would hope the leadership of the FDA would stand firm on a scientific basis,” he said Tuesday. “Otherwise, the trust in the whole scientific enterprise becomes compromised.”
Vaccine licensing takes time
The FDA licenses every vaccine used in the USA. In the final stage of testing, called a Phase 3 clinical trial, the vaccine is given to thousands of people to make sure it’s safe and effective.
When that’s over, the data is compiled in an application that is reviewed by an FDA team that includes doctors, microbiologists, chemists, biostatisticians and others.
“It’s a back-and-forth process” between the FDA and the company, with lots of communication, said Norman Baylor, CEO of Biologics Consulting and the former director of FDA’s Office of Vaccines Research and Review. “The reviewers are very thorough. They have to be; they’re the gold standard.”
Officials hinted they may speed up the process for a COVID-19 vaccine to get it to the public sooner and save lives.
The FDA’s Marks and Commissioner Stephen Hahn said no corners would be cut. Schaffner worries “they’ve left some wiggle room.”
He said the FDA might look at data from a large, Phase 3 clinical trial before it was completed and decide that based on the results at that point, a vaccine looked safe enough and effective enough to go on the market.
The Phase 3 trials for each SARS-CoV-2 vaccine include 30,000 people, 15,000 of whom get the vaccine and 15,000 who get a placebo.
“It would not do well to start using the vaccine in the public if we stopped halfway through – if we only have 7,500 people who’d gotten the vaccine,” Schaffner said.
It takes time to see whether safety issues arise among thousands of volunteers and to judge whether they are protected from infection, Topol said.
Despite Trump’s repeated statements that a vaccine is coming soon, there simply hasn’t been time for that data to become available.
“There is no way there will be any meaningful data this year, period,” Topol said. Anything that comes that quickly is “a hoax.”
This article originally appeared on USA TODAY: Could FDA be ‘bullied’ into approving a coronavirus vaccine too early?