- The man responsible for the Trump administration’s efforts to help develop coronavirus vaccines told Business Insider he supports the decision to require two months of safety data before approving any COVID-19 vaccine.
- “I think it is appropriate to set the security follow-up threshold,” Moncef Slaoui, the scientific head of Operation Warp Speed, said in a telephone interview Tuesday morning. “Is very important.”
- That requirement will almost certainly prevent a vaccine from gaining emergency approval before the November 3 presidential election.
- The agency explained its needs on Tuesday by releasing guidelines for the industry. Top White House officials have reportedly opposed such guidance.
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In the rush to develop a coronavirus vaccine, US regulators have just set guidelines that make it difficult, if not impossible, for any COVID-1
According to documents released on Tuesday, the U.S. Food and Drug Administration is asking vaccine developers to submit at least two months of safety data as part of an emergency approval application. The White House has reportedly opposed such a measure, with President Donald Trump saying on Sept. 23 it “sounds like a political move.”
Despite the administration’s rejection, the FDA publicly released these guidelines on Tuesday. And the man who leads the US government’s efforts to help develop a vaccine said he supports the FDA.
“I think it is appropriate to set the security follow-up threshold,” Moncef Slaoui, the chief consultant for Operation Warp Speed, told Business Insider in a telephone interview on Tuesday. “Is very important.” Business Insider asked Slaoui about the safety guide before it was released on Tuesday afternoon.
“A good thing to do”
Slaoui added that the “vast majority” of severe vaccine side effects occur in about the first 40 days after the injection.
“Setting a two-month follow-up window is a good thing to do,” he said.
Trump has directly linked the timing of the vaccine’s success with the election. In media interviews, Trump predicted a vaccine would be ready for the public “right around” the November 3 election. He criticized the FDA on Twitter, writing that “obviously” they aim to “delay the response until after November 3”. And in the first presidential debate, Trump said the US is “within weeks of a vaccine.”
Outside experts, as well as administration officials like Slaoui and Dr Anthony Fauci, have long pointed out that getting a vaccine ready quickly was unlikely.
Slaoui is the lead scientist of Operation Warp Speed, the US government’s ambitious program to accelerate vaccine development. He has led the initiative since May and has three decades of experience as a pharmaceutical executive at GlaxoSmithKline.
Several candidate vaccines are now in the final stages of clinical trials, with results expected before the end of the year. The two forerunners are led by Pfizer and Moderna. (After joining Warp Speed, Slaoui resigned from the board of Moderna and sold his shares in biotech. Slaoui still owns about $ 10 million in GlaxoSmithKline stock.)
While Pfizer said it may know if its shot works before the end of this month, the New York-based pharmaceutical giant should wait longer for safety data to pile up. At the earliest, Pfizer may have two months of safety data in mid-November.
The FDA is asking pharmaceutical companies to submit data that includes two months of follow-up safety data for at least half of the vaccinated volunteers.
Pfizer enlisted its 15,000th volunteer around August 24, meaning they would complete the two-dose vaccination regimen in mid-September. Two months of safety data requires a wait until mid-November.
Moderna’s chief executive said the biotech would not be able to apply for emergency approval until the end of November at the earliest in order to include the required safety data.
Even if a vaccine were approved, quantities would be extremely limited in 2020. Slaoui estimated that a vaccine would not be widely available to the public until spring 2021 at the earliest.
Read more: Key Slide Reveals Who Will Be First In Line To Get A Coronavirus Shot In The US When A Vaccine Is Available
The guidelines help establish expectations for an emergency approval. They will likely be discussed by a group of independent experts at a meeting on 22 October. At that public meeting, the group will discuss how it will evaluate coronavirus vaccines and make recommendations to the FDA about approving them.
Read more: We may know if a coronavirus vaccine works in October. Here are the 7 most important events to watch for this month.
Slaoui warns against the politicization of vaccine research
Speaking more broadly, Slaoui said that politicizing the coronavirus vaccination process is detrimental to public confidence in the final product.
“Frankly, I think it’s best for the non-scientific parts of the administration to let the scientific parts lead what they are doing,” he said.
Slaoui called the reports of the White House opposition to the vaccine safety guidelines “rumors”. He added that “if things really happened” he would be the first to raise his hand and call.
He promised to resign immediately if he witnesses undue interference in the vaccination process, which he confirmed to Business Insider includes the review and approval process.
“I can’t speculate on what the White House is doing or isn’t doing,” he said. “I’ve read the rumors. A total rejection which I think would be inappropriate. This is my personal opinion.”
Slaoui raised a potential exception to the two-month requirement: if a vaccine soon shows it’s extraordinarily effective at preventing coronavirus. He set that bar from 90% to 95%.
“I would ask myself an ethical question. If the efficacy is very high, I blindly follow that it must be 60 days? What if it were 49 days?” Slaoui asked. “I wait 11 days or start the process for an EUA to make the vaccine available.”
“But overall, I think it’s appropriate for the FDA to do that,” Slaoui later said, calling these “recommendations based on science and fact.”
Read more: There are 176 coronavirus vaccines in the works. Here’s how the top drug makers see the rush for a scheduled cure in 2020 and 2021 and when the first shots may be available.