Surgeon General Jerome Adams speaks during a Senate Committee on Health, Education, Labor and Pensions hearing on vaccines and protecting public health during the Coronavirus Disease (COVID-19) Pandemic September 9, 2020 in Washington, United States.
Michael Reynolds | Reuters
Democratic senators on Wednesday asked U.S. health officials whether President Donald Trump is interfering with potential coronavirus vaccine development.
The director of the National Institutes of Health, Dr. Francis Collins, and US 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 have said over the past few weeks that they fear the US vaccine approval process may be influenced by politics, not the Science.
During the hearing, Senator Elizabeth Warren, D-Mass., Accused Trump of overriding scientists and pressuring the Food and Drug Administration to approve products based on "weak evidence". She also criticized Trump's suggestion that a Covid-19 vaccine could be ready before Election Day on November 3, a much more optimistic estimate his own health officials have given.
"It is so out of control that companies that make Covid-19 vaccines are making a public statement promising to" adhere to "high ethical standards and sound scientific principles" when applying for vaccine approval. " she said at the hearing, citing a promise made by nine drug manufacturers that were released on Tuesday.
Dr. Francis Collins, director of the National Institutes of Health, speaks during a Senate Committee on Health, Education, Labor and Pensions hearing on Sept. 9 in Washington on vaccines and protecting public health during the coronavirus disease (COVID-19) pandemic , 2020.
Michael Reynolds | Pool | Reuters
Senator Patty Murray, D-Wash, said Trump had provoked "conspiracies" and touted unproven treatments like the anti-malarial drug hydroxychloroquine. She said Trump was putting "political pressure" on the FDA to issue emergency clearance 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 has not been shown to be effective.
The FDA lifted its emergency approval for hydroxychloroquine after several studies found it didn't save lives and could potentially put people at risk of dangerous heart problems while treating Covid-19.
"When it comes to a Covid-19 vaccine, we cannot allow President Trump to repeat his alarming pattern of putting politics before science and public health," she said. "The efforts of FDA scientists to ensure the safety and effectiveness of vaccines must not be undermined by political interference."
New Hampshire Democratic Senator Maggie Hassan urged health officials to see what steps were being taken to ensure the White House did not exert political influence over the vaccination process. She cited a recent poll from USA TODAY / Suffolk, Two-thirds of voters said they won't get the coronavirus vaccine once it's available.
Collins and Adams vowed to U.S. lawmakers that health officials would not skimp on safety assessments when developing a vaccine.
Collins said investigating the safety and efficacy of Covid-19 vaccine candidates is now the agency's "top priority" as Moderna, Pfizer and AstraZeneca seek to complete late-stage testing and file regulatory filings with the FDA by the end of the year. On Tuesday, AstraZeneca announced that the late-stage would be suspended after a participant in the UK had potentially serious side effects.
"There won't be any abbreviations. This vaccine will be safe. It will be effective. Or it won't get any further," said Adams. "And when a vaccine is either cleared or cleared by the FDA, my family and me will stand in line to get it."
Collins said he would only participate in the vaccine approval process if "science and science alone" is used to make a decision. He added that he was "cautiously optimistic" that scientists can find at least one safe and effective vaccine by the end of the year.
Adams said lawmakers and public health officials need to encourage the public to "stop attacking" the scientific process, adding that "safeguards are built in". He said there is an unprecedented level of vaccine reluctance in the US and around the world, and that public health messaging has only become more difficult because of the upcoming presidential election.
Health officials have repeatedly stated that an independent data and safety oversight body is reviewing the integrity of clinical trials and continues to monitor ongoing results to ensure the safety of participants. In contrast to conventional studies, the protocols for the studies are monitored by the US government, 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 or the other person. But the process is strong … we want people to understand that safeguards are built in. The process is strong."
"As a member of the coronavirus task force, the vaccination process was not politicized at all," he added.