Democratic senators on Wednesday grilled U.S. health officials about whether President Donald Trump is interfering in the development of potential coronavirus vaccines.
National Institutes of Health Director Dr. Francis Collins and U.S. Surgeon General Dr. Jerome Adams testified before the Senate Committee on Health, Education, Labor and Pensions on vaccine safety as infectious disease experts and scientists in recent weeks have said they worry the vaccine approval process in the U.S. could be influenced by politics, not science.
During the hearing, Sen. Elizabeth Warren, D-Mass., accused Trump of overruling scientists and pressuring the Food and Drug Administration of approving products based on “weak evidence.” She also criticized Trump’s suggestion that a Covid-19 vaccine could be ready before Election Day on Nov. 3, a much more optimistic estimate his own health officials have said.
“It has gotten so out of hand that companies making Covid-19 vaccines put out a public statement promising to adhere to ‘high ethical standards and sound scientific principles’ when seeking vaccine approval,” she said at the hearing, referring to a pledge from nine drugmakers released Tuesday.
Sen. Patty Murray, D-Wash, said Trump has provoked “conspiracies” and has touted unproven treatments such as anti-malaria drug hydroxychloroquine. She said Trump exerted “political pressure” on the FDA to issue an emergency use authorization for convalescent plasma, an experimental treatment that uses plasma from patients who have recovered from Covid-19. It is one of several therapies being tested as a potential treatment but hasn’t been proven to be effective.
The FDA yanked hydroxychloroquine’s emergency authorization after several studies found it didn’t save lives and could potentially put people at risk of dangerous heart issues when used to treat Covid-19.
“When it comes to a Covid-19 vaccine, we cannot allow President Trump to repeat his alarming pattern of putting politics ahead of science and public health,” she said. “FDA’s scientists’ efforts to ensure the safety and efficacy of vaccines must not be undermined by political meddling.”
Collins and Adams both vowed to U.S. lawmakers that health officials will not skimp on safety assessments in the development of a vaccine.
Collins said studying the safety and effectiveness of Covid-19 vaccine candidates is now the agency’s “top priority” as Moderna, Pfizer and AstraZeneca race to complete late-stage testing and submit approval applications to the FDA by the end of the year. On Tuesday, AstraZeneca announced that it was pausing its late-stage trial after one participant in the United Kingdom had a possible serious adverse reaction.
“There will be no shortcuts. This vaccine will be safe. It will be effective. Or it won’t get moved along,” Adams said. “And when a vaccine is either approved or authorized by the FDA, I and my family will be in line to get it.”
Collins said he will only take part in the vaccine approval process if “science and science alone” is used to decide. He added he is “cautiously optimistic” scientists will be able to find at least one safe and effective vaccine by the end of the year.
Adams said lawmakers and public health officials must encourage the public to “stop attacking” the scientific process, adding there are “protections built in.” He said there is an unprecedented levels of vaccine hesitancy in the U.S.and globally, and public health messaging has only become more difficult because of the upcoming presidential election.
Health officials have repeatedly said an independent data and safety monitoring board is reviewing the integrity of the clinical trials and continues to monitor ongoing results to ensure participants are safe.The protocols for the trials are being overseen by the U.S. government, in contrast to traditional trials in which pharmaceutical companies are solely responsible for design and implementation.
“There’s a lot of politics going on here,” he said. “People don’t like one party or the other, or one person or the other. But the process is strong … we want people to understand there are protections built in. The process is strong.”
“As a member of the coronavirus task force, there has been no politicization of the vaccine process whatsoever,” he added.
This is a developing story. Please check back for updates.
Originally published: 2020-09-09 11:53:47