President Donald Trump has repeatedly said a COVID-19 vaccine could be available around the election, but developments in recent days have all but nixed that possibility. Instead, officials are signaling a timeline of data releases that begins in November and continues into 2021, with emergency reviews along the way.
In a guidance document released Tuesday, the FDA detailed its advice to developers seeking emergency use authorizations for their programs, including advice that they monitor patients for two months after their final vaccine doses. That advice, if followed, would mean frontrunner Pfizer wouldn't be able to file for an emergency authorization by the November 3 election. The White House had been pushing back against the guidelines, but eventually came to accept them, the Wall Street Journal reported.
Still, late Tuesday, Trump tweeted his personal disapproval of the FDA rules.
New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA— Donald J. Trump (@realDonaldTrump) October 7, 2020
By releasing the document publicly, the FDA “appears to be protecting their integrity and reputation by putting all this regulation into the court of public opinion," SVB Leerink analyst Geoffrey Porges wrote in a Wednesday note to clients. The agency is “making it clear to their many constituencies the standards they will apply for the provision of either emergency or full approval of a COVID vaccine.”
In all, the FDA’s requirements “are more than just the results from a few patients, and suggest that an EUA could take longer than many investors are expecting," the analyst wrote.
Separately, at a coronavirus vaccine symposium Tuesday, Operation Warp Speed head Moncef Slaoui said early efficacy data on vaccines will be available over the next several months, with Pfizer and Moderna's in a first wave in November or December, Reuters reports. He expects enough doses to be able to vaccinate 30 million people during those months, according to the news service.
Johnson & Johnson could report interim results in December as well, Larry Corey, head of COVID-19 Prevention Network, said at the symposium, as quoted by SVB Leerink's Porges. Data from other vaccines are expected between January and April, Corey added.
In addition to the two months of data needed for review, the agency asked developers to provide detailed information on manufacturing, plus proposed labels and patient brochures, when they apply for emergency use authorizations. The FDA will require the same set of info for all programs, regardless of the vaccine technology used, Porges pointed out.
Later this month, the FDA will hold a meeting for independent experts to review coronavirus vaccine progress in general. In addition to that meeting, the FDA will require a public meeting for any individual vaccine program that’s under consideration for an emergency authorization.
“Given the complexity of planning, preparing for and then holding such a meeting, with all its attendant public scrutiny, we suspect these [advisory committee] meetings will also add a couple of weeks to the expected regulatory timeline, even for an EUA,” SVB Leerink’s Porges wrote to clients.
While there’s understandably an urgency to get COVID vaccines to people, some experts worry about how early emergency use authorizations will affect ongoing development. Investigators can learn much more about the programs if the trials remain blinded for seven additional weeks, Corey said.
Plus, emergency use authorizations could threaten ongoing trials as participants might choose to drop out and get the EUA vaccine instead. Another symposium panelist, bioethicist Joseph Millum, said the trials might need to unblind and include the EUA vaccine as one arm. Millum said that continuing with a placebo-controlled trial when there’s a EUA vaccine could be unethical.