- Reports say the White House disagrees with new coronavirus vaccine approval guidelines from the FDA which would make it impossible for a vaccine candidate to seek emergency use authorization before the presidential election.
- The FDA wants volunteers to be followed for at least two months after receiving the shots to identify potential side effects. This would prevent frontrunners from seeking approval before the election.
- Trump administration and FDA officials said that the new guidelines are already known to pharmaceutical companies, which plan to adhere to the requests.
The White House and the Food and Drug Administration (FDA) are at odds over new vaccine guidelines for the novel coronavirus. President Trump has politicized vaccine research, with recent reports saying that the administration is looking to fast-track the emergency use authorization of at least one COVID-19 vaccine to have the drug approved in time for the November 3rd presidential election. Public health officials, including Dr. Anthony Fauci and FDA scientists, have insisted that vaccines’ safety will not be compromised to speed up approvals.
COVID-19 vaccine development has moved at tremendous speeds, and at least one vaccine candidate might be approved for emergency use by the end of the year. Fauci confirmed as much in recent interviews. China and Russia have already started using Phase 3 vaccines on the general public, with the latter drawing intense scrutiny for the decision to advance the vaccine without proving that it’s safe and effective first.
The FDA has established new guidelines for emergency approval that would make it impossible for a vaccine to roll out publicly before the elections. There has been pushback from the White Hous, but it might not produce any results, as the FDA already shared the guidelines with the companies making vaccines.
Reports from The New York Times and Associated Press detailed the new FDA guidelines on vaccine approvals. According to The Times, the FDA sent the White House the revised guidelines on September 21st, but Trump’s chief of staff, Mark Meadows, raised concerns over the requirements.
The FDA wants vaccine researchers to follow up volunteers for two months, which appears to be the main contention point between the parties. The most advanced vaccines have started trials in July, and most of them require volunteers to get two shots a few weeks apart. Each Phase 3 trial has to enroll at least 30,000 volunteers. These rules, combined with the FDA requirement for two months of follow-up data, would make it impossible for pharmaceutical companies to seek emergency approval before the election.
Of the three frontrunners, AstraZeneca/Oxford is paused in the US following a safety incident in early September — that Phase 3 trial is still underway in Europe and elsewhere. Moderna, the first US company to start Phase 1 trials back in March, and the first to start Phase 3 research, said recently that its mRNA vaccine will be ready only in 2021. The company would seek emergency approval only after the elections. This leaves Pfizer/BioNTech as the sole company that might provide early Phase 3 trial data this month and seek authorization. That’s just speculation based on the recent developments in the industry.
The proposed guidelines also include a detail about the kind of efficacy conclusions the FDA will look for. The agency said there should be at least five severe infection cases in the placebo control to prove the vaccine is effective at preventing the illness.
Johnson & Johnson started its own massive vaccine trial that will enroll 60,000 volunteers for a vaccine that requires a single shot. The company has publicly indicated that it would follow the FDA’s recommendations regardless of the White House stance on the matter.
Health Secretary Alex Azar acknowledged but played down the conflict about the new guidelines. “What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers,” Azar said on Friday, per The Times. “The FDA has already told the manufacturers what they’re going to look for.”
Dr. Peter Marks, the head of the FDA’s vaccine division, confirmed Azar’s statement in an online interview last week. “There’s no ‘there’ there to get all excited about this guidance,” the official said, according to AP. “The companies know what we’re expecting.”
But Marks confirmed that the guidelines are “an attempt to help the public see what we’re requiring of COVID-19 vaccines.” The Times says that Marks acknowledged privately that an angry tweet from Trump attacking FDA scientists over the guidelines would further damage public confidence in vaccines.
Ironically, as coronavirus vaccine research progressed rapidly, the US public became more reluctant to the prospect of imminent vaccination campaigns. A Pew Research Center survey found last month that 51% of Americans would probably or definitely get a COVID-19 vaccine, which represented a significant drop from 72% in May. Vaccination would play a significant role in beating the pandemic, Fauci explained during various interviews. But vaccine-based herd immunity hinges on public trust in vaccines. A large percentage of the population would have to be vaccinated and keep adhering to safety measures for the US to have a chance to beat the pandemic by late 2021.