The FDA took the unusual step on Thursday to open a routine public meeting with an advisory group dealing with the approval of the coronavirus vaccine as the agency raised public concerns about its safety as well as political pressure from President Donald Trump fought him before the November 3rd election.
The Advisory Committee on Vaccines and Related Biological Products, an external group of researchers and doctors who advise the Food and Drug Administration on approving a Covid-19 vaccine, discussed the standards needed to ensure that a Covid-19 vaccine 19 vaccine safe and effective is a review broadcast on YouTube and C-SPAN. These are key questions among medical experts concerned that the US will approve a vaccine before it has been adequately tested.
Officials at Thursday's meeting said the public forum was "crucial" in building public confidence in the development of potential vaccines, which are being developed in record time. FDA officials promised that each vaccine would undergo rigorous testing before being distributed to the public.
"The development of vaccines can be accelerated. However, I would like to stress that it cannot and must not be accelerated," said Dr. Marion Gruber, director of the FDA's Office of Vaccines Research and Review, adding that the agency would not lower its standards.
Trump has urged the FDA to approve a drug in time for distribution by the November 3 election – a daunting task that even his closest advisers have found near impossible.
"I think we should have it before the election, but honestly, politics is involved and that's fine. They want to play their games, it will be right after the election," Trump said in a video he posted in October posted on Twitter. 7. "The FDA has acted faster than ever before in history. There has never been a time and no president has ever pushed it like I pushed it, to be honest."
The agency approves drugs "in a matter of weeks" that used to take years, he added.
Four US-backed drug makers are still conducting their late-stage studies, and medical experts expect the study data required for FDA approval to be available later this month at the earliest.
Due to the pandemic, U.S. health officials and researchers have accelerated vaccine candidate development by investing in multiple stages of research, although it could be for free if the vaccine is ultimately not effective or safe.
The FDA, under pressure from the White House, has been received with skepticism by medical experts that the vaccine approval process could be influenced by politics, not science.
Earlier this month, the FDA set updated safety standards for manufacturers of Covid-19 vaccines. The standards, published in a document on the FDA's website, would almost certainly prevent a vaccine from being launched before the November 3rd presidential election.
The FDA announced that it would approve a vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces people's risk of influenza by 40% to 60% compared to people who are not vaccinated, according to the Centers for Disease Control and Prevention. FDA Commissioner Dr. Stephen Hahn previously said the agency would not allow a vaccine that was not safe, even if it was quite effective.
The FDA has also announced that it will pursue vaccines for years after they are approved.
Dr. Doran Fink, the FDA's assistant director on vaccines, said at the meeting on Thursday afternoon that widespread use of a weak Covid-19 vaccine could do more harm than good. He said the potential vaccine could create a "false sense of security" that interferes with measures to reduce transmission.
It could also "affect the development and evaluation of potentially better vaccines that could have a greater impact on the Covid-19 pandemic," he warned. "Without sufficiently strict criteria, a Covid 19 vaccine candidate could happen to be declared effective. And the risk of declaring a poorly effective vaccine and using a poorly effective vaccine increases with the increasing number of vaccines evaluated in phase 3 studies will."
Dr. Hilary Marston, a medical doctor and pandemic preparedness policy advisor at the National Institutes of Health, said Thursday that regulatory requirements for AstraZeneca and the break for Johnson & Johnson are signs that security measures are working.
"It is expected that adverse events will occur in both the vaccine and placebo groups in these vaccine trials," she said. "We find these events because we are specifically looking for them."