FDA opens private Covid vaccine meetings to the public in bid to gain trust as Trump pressures for fast approval

The FDA took the unusual step Thursday in opening to the public a routine meeting with an advisory group that’s weighing in on approving the coronavirus vaccine as the agency battles public concerns about its safety as well as political pressure from President Donald Trump to approve it before the Nov. 3 election.



a person in a blue shirt: A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida.


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A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida.

The Vaccines and Related Biological Products Advisory Committee, an outside group of researchers and physicians who are advising the Food and Drug Administration on whether to approve a Covid-19 vaccine, debated the standards needed to ensure a Covid-19 vaccine is safe and effective in a meeting broadcast on YouTube and C-SPAN. Those are key questions among medical experts who worry the U.S. will approve a vaccine before it has been adequately tested.

Officials at the meeting Thursday said the public forum was “critical” to build public trust and confidence in the development of potential vaccines, which are being developed in record time. FDA officials promised that any vaccine would undergo rigorous testing before being distributed to the public.

“Vaccine development can be expedited. However, I want to stress that it cannot, and must not, be rushed,” said Dr. Marion Gruber, director of FDA’s Office of Vaccines Research and Review, adding the agency would not lower its standards.

Trump has pushed the FDA to approve a drug in time to distribute by the Nov. 3 election — a daunting task even his closest advisors have said is near impossible.

“I think we should have it before the election, but frankly the politics gets involved and that’s okay. They want to play their games, it’s going to be right after the election,” Trump said in a video he posted on Twitter on Oct. 7. “The FDA has acted as quickly as they’ve ever acted in history. There’s never been a time, and no president’s ever pushed them like I’ve pushed them either, to be honest.”

The agency is approving drugs “in a matter of weeks” that used to take years, he added.

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Four drugmakers backed by the U.S. are still conducting their late-stage trials, and medical experts don’t expect to see trial data needed for FDA authorization until later this month at the earliest.

Because of the pandemic, U.S. health officials and researchers have been accelerating the development of vaccine candidates by investing in multiple stages of research even though doing so could be for naught if the vaccine ends up not being effective or safe.

The FDA, under pressure from the White House, has faced skepticism from medical experts that the vaccine approval

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UK to infect volunteers with coronavirus in bid to speed up vaccine development

Researchers in the U.K. are looking for healthy volunteers who are willing to be infected with the novel coronavirus in a bid to speed up vaccination development. The approach, called a human challenge trial (HCT), is not unheard of, as similar trials take place in the U.S. each year involving the influenza virus. In fact, U.S.-based non-profit 1Day Sooner has already had over 38,000 people sign up for a potential coronavirus human challenge trial.

However, the U.K. trial is being conducted in conjunction with the government, which according to a press release posted Tuesday is prepared to put over $43 million into the study. Imperial College London, the Department for Business, Energy and Industrial Strategy, the Royal Free London NHS Foundation Trust and hVivo are all prepared to play a role in the study.

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The researchers are looking for up to 90 healthy volunteers between the ages of 18 and 30, and hope to determine the smallest level of exposure to coronavirus needed to cause the disease. According to a press release, the volunteers will be compensated for the time they spend in the study and followed for up to one year after it ends to ensure long-term well-being.

The second phase will follow the same model to study how potential coronavirus vaccines work in the body, the body’s immune response to the illness and potential treatments.

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If the trial is approved by regulators and an ethics committee, the work could begin as early as January with results expected by May.

“We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine,” Business Secretary Alok Sharma said in the press release. “The funding announced today for these ground-breaking but carefully controlled studies marks an important step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life.”

Dr. Chris Chiu, of the department of infectious disease at Imperial College London, will lead the study and said his team has been safely conducting such trials involving respiratory viruses for the last 10 years.

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“No study is completely risk-free, but the Human Challenge Programme partners will be working hard to ensure we make the risks as low as we possibly can,” he said. “The U.K.’s experience and expertise in human challenge trials as well as in wider coronavirus science will help us tackle the pandemic, benefiting people in the U.K. and worldwide.”

As of Tuesday, the Johns Hopkins University coronavirus map reported more than 744,120 confirmed cases in the U.K., and nearly 44,000 deaths.

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