Executives at Moderna, another pioneer whose vaccine is based on yet unproven technology, said it would not be ready to submit an emergency clearance application to the FDA until late November. Pfizer, meanwhile, continues to expand its trial – first to recruit thousands more adults, and more recently to include teenagers. The steps could further delay its timeline, as the FDA expects companies seeking emergency clearance to submit two months of data on at least half of the trial participants.
“Just because we’re waiting until the end of the year instead of October – to keep things in perspective, this is still a land speed record for vaccines,” said Peter Hotez, virologist and dean from the National School of Tropical Medicine at Baylor College of Medicine. Hotez worked on multiple plans, including a potential SARS vaccine, each of which took years, if not decades, of work to develop and test.
But the rapid pace of coronavirus vaccine development so far has not satisfied Trump, whose administration has placed vaccine research at the center of its pandemic response efforts.
“We will have the vaccine soon, maybe before a special date. You know what date I’m talking about, ”he said at a press conference in early September. When the FDA pushed to tighten its standards to allow emergency use of coronavirus vaccines, it called it a “political movement more than anything.”
The agency revised its guidelines to make sure drugmakers submit enough data to reveal side effects from their injections, Hotez said. “This was not done to punish the president, but to protect the public to ensure that we have effective and safe vaccines,” he said.
As vaccination timelines became blurry, Trump turned his attention to drugs called monoclonal bodies. He declared an experimental antibody by drug “cure” at the beginning of the month, after having received the treatment during his hospitalization for Covid-19. The president has repeatedly promised that cocktails will soon be available to all Americans who need them.
Yet, less than a week after his initial pledge, Eli Lilly – the other company with an antibody drug in advanced clinical trials – suspended studies for safety reasons.
Bumps in the road to a vaccine or antibody drug leave health officials with tools that Trump and other White House officials have long questioned: mask wear, social distancing, and widespread testing.
Trump’s rhetoric on antibodies “was a pivotal point when it was clear that vaccines were not going to fill his schedule. And it’s quite clear that the antibodies won’t fill its timeline either, ”Emanuel said.
But the longer timeframe for vaccines could help the public have confidence in a possible vaccine. Most registered voters want manufacturers to fully test vaccines even if it delays the delivery of vaccines to Americans, according to a recent POLITICO / Morning Consult poll.
Nearly half of those voters, all affiliated with parties, said they believed Trump was pressuring the FDA to distribute vaccines earlier and 35% believe it will be at least six months before the vaccines are released. available in the United States.
Continuing a theme from the previous poll, voters also said they still trust Biden more than Trump in vaccine development, testing and approval.
“The elections and the vaccine have nothing to do with each other,” Gostin said. “They’re both important but they’re entirely different. Science is not an electoral issue. It should be something that everyone, regardless of your political beliefs, should support. Because that’s the only thing that will get us out of it. “