How quickly could approval come: Regeneron said it requested an emergency authorization from FDA just hours after Trump touted the antibody cocktail in a video Wednesday afternoon. Lilly said it sought authorization earlier on Wednesday.
Trump, who has put unusual pressure on FDA to quickly approve coronavirus treatments and vaccines, is now vowing federal regulators will green-light antibody therapies from both companies.
“Emergency use authorization is all set, and we gotta get it signed now,” Trump said in the Wednesday video.
It’s not clear how quickly FDA will decide on either company’s application for an emergency use authorization, but this raises another inflection point for an agency that has seen its independence challenged by political pressure during the pandemic. The FDA previously provided emergency use authorizations for two treatments touted by Trump — hydroxychloroquine and convalescent plasma — despite scant evidence of their effectiveness. The FDA later revoked the hydroxychloroquine authorization after rigorous trials found the anti-malarial didn’t work on Covid-19 patients.
An early emergency use authorization for antibody treatments could also make it difficult for companies to attract volunteers for clinical trials that could prove whether they work and at what dosage. That has been a concern for ongoing convalescent plasma trials after FDA provided an emergency authorization about six weeks ago.
There’s likely not enough drug for everyone: In the upbeat video posted by the White House on Wednesday evening, Trump promised he would provide antibody treatments free for every American. But experts are predicting shortages of the treatments, which are costly to produce, and few manufacturing facilities are equipped to make them.
Operation Warp Speed, the Trump administration program speeding coronavirus vaccines and therapeutics, has provided $450 million to Regeneron to supply as many as 300,000 treatment doses, or 1.3 million prevention doses, for Americans at no cost before the end of the year. It’s unclear how the next doses will be distributed or what they might cost.
Regeneron said its deal with Roche to boost manufacturing capacity could result in 650,000 and 2 million doses to treat Covid-19, or between 4 million and 8 million doses to help prevent people from getting sick. Regeneron has yet to provide any data showing that its antibody cocktail prevents illness.
Lilly has said it could supply as many as 1 million doses of its treatment before the end of the year, but it’s unclear if all those doses would be reserved for the U.S. or if Warp Speed would purchase them to provide to Americans at no cost.
Warp Speed officials are hoping that the antibody treatments can be rolled out quickly and act as a bridge to vaccines. It will likely take months to widely distribute a coronavirus vaccine, even if one gains approval before the end of the year.
Vaccine politics: Trump has conceded that a vaccine is unlikely to be authorized before the Nov. 3 election after this week’s release of FDA guidance toughening standards for emergency approval. The White House for weeks had opposed the guidance, which Trump has claimed without evidence was part of a political plot within FDA to prevent a vaccine approval before the election.
“I think we should have it before the election but frankly the politics gets involved and that’s okay,” Trump said. “They want to play their games, it’s going to be right after the election.”
Of the four vaccine candidates in late-stage U.S. trials, only Pfizer says it’s possible to know if its vaccine works by the end of October. FDA’s top vaccine official Peter Marks said Wednesday that he thinks a vaccine may be ready in November or December.
What’s next: FDA in a statement said it wouldn’t comment on the pending applications for antibody treatments, citing agency policy. Investment analysts predict that an emergency authorization could come sometime between next week and the end of the year.