Executives at Moderna, another frontrunner whose vaccine relies on a yet-to-be-proven technology, have said they will not be ready to file an emergency permit application with the FDA before the end of November. Meanwhile, Pfizer continues to extend its trial period – first to enroll thousands more adults and most recently to include teens. These moves could further push its timeline back because the FDA expects companies applying for emergency permits to submit two-month data on at least half of the trial participants.
“Just because we’re waiting for the end of the year instead of October – just to keep things in perspective, this is still a land speed record for vaccines,”
But the rapid pace of Coronavirus shot development so far has not satisfied Trump, whose administration has put the search for a vaccine at the center of its efforts for pandemic response.
“We will get the vaccine soon, maybe before a special date. You know what date I’m talking about, “he told a news conference in early September. When the FDA pushed for raising its standards for approving emergency use of coronavirus vaccines, he called it” a political step more than anything else. ”
The agency revised its guidelines to ensure that drug manufacturers submitted sufficient data to detect any side effects from their shots, Hotez said. It “was not done to punish the president, it was done to protect the public to make sure we have vaccines that work and are safe,” he said.
As vaccine timelines became hazy, Trump turned his attention to drugs known as monoclonal antibodies. He declared an experimental antibody to the drug as a “cure” earlier this month after receiving treatment during his admission to Covid-19. The president has repeatedly promised that cocktails will soon be available to any American who needs them.
But within a week of his initial promise, Eli Lilly – the second company with an antibody drug in late-stage clinical trials – stopped its investigations due to safety concerns.
The bumps in the road towards a vaccine or an antibody drug leave health officials with tools that Trump and other White House officials have long questioned: mask-wearing, social distance, and widespread testing.
Trump’s antibody rhetoric “was a focal point when it was clear that the vaccines would not fill his timeline. And it is quite clear that the antibodies will not fill his timeline either, ”said Emanuel.
But the longer timeline for vaccines could help public confidence in a possible shot. Most registered voters want manufacturers to fully test vaccines, even if it delays the delivery of the shots to Americans, according to a recent poll by POLITICO / Morning Consult.
Nearly half of those voters, across party lines, said they believe Trump is pushing the FDA to deliver shots faster, and 35 percent believe it will take at least six months before vaccines are available in the United States.
Continuing a theme from previous polls, voters also said they still trust Biden more than Trump on vaccine development, testing and approval.
“The choice and the vaccine have nothing to do with each other,” Gostin said. “They are both important, but they are completely different. Science is not an election issue. It must be something that everyone, regardless of your political beliefs, must stand behind. Because that is the only thing that gets us out of this.”