COVID vaccine meetings will be open to the public to build trust in vaccine development, according to the US Food and Drug Administration.
The Vaccines and Related Biological Products Advisory Committee, an outside group of researchers and doctors, is part of the COVID vaccine meetings. The committee provides insights about the approval of the coronavirus vaccine as the FDA addresses public concerns about its safety and political pressure.
The committee debated the criteria for the safety and efficacy of a Covid-19 vaccine in a meeting broadcast on YouTube and C-SPAN. The topics include questions among medical experts who are concerned about the approval of a vaccine in the US with no sufficient testing.
Meanwhile, participants at the meeting said the public forum will help build public trust and confidence in the development of potential COVID-19 vaccines. FDA authorities said that any vaccine would be rigorously tested before its distribution 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, noting that the agency would stick to its standards.
Trump has called on the FDA to authorize a drug in time to distribute by the Nov. 3 election.
“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 published 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.”
During the meeting, Dr. Doran Fink, deputy director of the FDA’s Division of Vaccines, said that distributing a weak Covid-19 vaccine could bring more harm than good. He noted the experimental vaccine could give a “false sense of security” that contradicts measures to minimize transmission.
The approval of such vaccines could also “interfere with the development and evaluation of potentially better vaccines that could have a greater impact on the Covid-19 pandemic,” he warned.
“Without sufficiently stringent criteria, a Covid-19 vaccine candidate could be declared effective just by chance. And the risk of declaring a weakly effective vaccine and deploying a weakly effective vaccine increases as the number of vaccines being evaluated in phase three trials increases," he added.
Meanwhile, Dr. Hilary Marston, medical officer and policy adviser for pandemic preparedness at the National Institutes of Health, said that the regulatory hold for AstraZeneca and postponement for Johnson & Johnson suggest that safety measures are being observed.
“Adverse events are expected to happen in these vaccine trials, both in the vaccine and placebo group,” she said. “We are finding these events because we are specifically looking for them.”
Not a fairy-tale vaccine
In September, Dale Fisher, professor of infectious diseases at the National University of Singapore (NUS) Yong Loo Lin School of Medicine, said that a coronavirus vaccine is not a “fairytale” ending to the pandemic as the world places its hope on such treatment.
“I would see the vaccine as only helping (the situation),” Fisher said during his interview on CNBC’s Capital Connection.
“It’s not going to be the fairytale (ending) everyone wants it to be where we’ll have a 100% effective vaccine and 100% of people will take it, and they’ll all receive it over the course of a month and we can go back to our way of life,” he noted.
