- The man in charge of the Trump administration’s efforts to aid the development of coronavirus vaccines told Business Insider he supports a decision to require two months of safety data before approving any COVID-19 vaccine.
- “I do think it is appropriate to set the threshold of safety follow-up,” Moncef Slaoui, the scientific head of Operation Warp Speed, said in a Tuesday morning phone interview. “It’s very important.”
- That requirement will almost certainly prevent a vaccine from gaining emergency approval before the presidential election on November 3.
- Top White House officials reportedly oppose the guidance and have prevented the release of formal documents.
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In the race to develop a coronavirus vaccine, US regulators just laid down guidelines that make it difficult, if not impossible, for any COVID-19 shot to win emergency approval before Election Day.
The US Food and Drug Administration is asking vaccine developers to submit at least two months of safety data as part of an emergency-approval application, according to documents released Tuesday. The White House has reportedly opposed that measure, with President Donald Trump saying on September 23 it “sounds like a political move.”
While White House officials had blocked the FDA from publicly releasing those guidelines, the man leading the US government’s efforts to help develop a vaccine said he supports the FDA’s decision.
“I do think it is appropriate to set the threshold of safety follow-up,” Moncef Slaoui, the chief advisor to Operation Warp Speed, told Business Insider in a Tuesday phone interview. “It’s very important.”
‘A good thing to do’
Slaoui added that the “vast majority” of serious side effects from vaccines happen in about the first 40 days after getting the shot.
“Setting a two-month time window of follow-up is a good thing to do,” he said.
Trump has directly linked the timing of vaccine success with the election. In media interviews, Trump predicted that a vaccine would be ready for the public “right around” the November 3 election. He has criticized the FDA on Twitter, writing that they “obviously” are aiming to “delay the answer until after November 3rd.” And at the first presidential debate, Trump said that the US is “weeks away from a vaccine.”
Outside experts, as well as administration officials like Slaoui and Dr. Anthony Fauci, have long emphasized that getting a vaccine ready that quickly was unlikely.
Slaoui is the lead scientist for Operation Warp Speed, the US government’s ambitious program to accelerate vaccine development. He has been steering the initiative since May, and brings three decades of experience as a pharmaceutical executive at GlaxoSmithKline.
Several vaccine candidates are now in the final stage of clinical testing, with results expected before year’s end. The two frontrunners are led by Pfizer and Moderna. (Upon joining Warp Speed, Slaoui resigned from Moderna’s board and sold his stock in the biotech. Slaoui still owns about $10 million in stock of GlaxoSmithKline.)
While Pfizer has said it could know if its shot works before the end of this month, the New York pharma giant would need to wait longer for the safety data to accrue. At the earliest, Pfizer could have two months of safety data in mid-November.
The FDA is asking drug companies to submit data that includes two months of follow-up safety data for at least half the volunteers who were vaccinated.
Pfizer enrolled its 15,000th volunteer around August 24, which means they would have completed the two-dose vaccination regimen in mid-September. Two months of safety data require waiting until mid-November.
Moderna’s CEO has said that the biotech wouldn’t be able to apply for emergency approval until late November at the earliest, in order to include the required safety data.
Even if any vaccine is approved, quantities would be extremely limited in 2020. Slaoui estimated that a vaccine would not be widely available to the general public until spring 2021 at the earliest.
Despite opposition, FDA is going ahead with safety rule
The FDA’s formal guidelines for coronavirus vaccine developers haven’t been released. But the agency detailed the rules on Tuesday in a document that doesn’t require the White House’s approval.
In the briefing document, the FDA laid out the safety-data requirement in an appendix section that summarized what the agency has told leading vaccine developers.
The guidelines in the document aren’t binding, but they set the agenda for what a panel of independent experts will discuss at an October 22 meeting. At that public meeting, the group will discuss how it will evaluate coronavirus vaccines and make recommendations to FDA about whether they should be approved.
Slaoui warns against politicizing vaccine research
Speaking more broadly, Slaoui said that politicizing the coronavirus vaccine process is detrimental to the public’s trust in the ultimate product.
“Frankly, I do think it is best for the non-scientific parts of the administration to let the scientific parts drive what they are doing,” he said.
Slaoui called the reports of White House opposition to the vaccine-safety guidance “rumors.” He added that “if stuff actually happened” he’d be the first to raise his hand and call it out.
He has vowed to immediately resign if he witnesses undue interference in the vaccine process, which he confirmed to Business Insider includes the review and approval process.
“I can’t speculate about what the White House is doing or not doing,” he said. “I did read the rumors. A blanket rejection I think would not be appropriate. That’s my personal opinion.”
Slaoui raised one potential exception to the two-month requirement: if a vaccine shows early on that it’s extraordinarily effective at preventing the coronavirus. He set that bar at 90% to 95%.
“I would ask myself an ethical question. If the efficacy is very high, do I blindly follow it has to be 60 days? What if it is 49 days?” Slaoui asked. “Do I wait 11 days, or do I start the process for an EUA in order to be able to make the vaccine available.”
“But, as a whole, I do think it is appropriate for the FDA to do it,” Slaoui said later, calling these “science-based and fact-based recommendations.”