Operation Warp Speed Science Chief Supports Stricter EUA Reviews for COVID-19 Vaccines

Operation Warp Speed, the Trump administration’s COVID-19 vaccine and treatment initiative, is in “full alignment” with the FDA raising the bar on what’s required for an Emergency Use Authorization of a COVID-19 vaccine, the top adviser to the initiative says. That contradicts what President Trump has been saying.

“We completely agree with it,” said Moncef Slaoui, chief adviser to Operation Warp Speed, in reference to the FDA’s expected guidance that would require vaccine makers to track phase 3 trial participants for two months after a vaccination.

In public remarks last week, Slaoui said such a requirement is already recommended by Operation War Speed, which contradicts President Trump’s stance that the White House may reject the planned guidance as being “a political move” designed to prevent a COVID-19 vaccine approval until after the Nov. 3 presidential election.

The guidance, which had been expected to be released last week, would also require phase 3 trials of COVID-19 vaccines to include at least five severe cases of the disease and some cases in older patients in a trial’s placebo group.

FDA Commissioner Stephen Hahn and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, have pushed back against the president’s allegations and have said that any decision on vaccines will be based on science, not politics (DID, Sept. 25).

Four COVID-19 vaccines are in phase 3 trials in the U.S. Pfizer has said it should know if its vaccine works by October (DID, Sept. 18), while Moderna has said it expects to know by November. But if the FDA does issue this guidance update and it’s not overruled by the White House, those timelines could be pushed back to year’s end. — Jordan Williams