Executives at Moderna, another frontrunner whose vaccine is based on an unproven technology, said it would not be ready to submit an emergency approval application to the FDA until late November. Meanwhile, Pfizer continues to expand its trial – first to enroll thousands more adults, and most recently to include teenagers. Those movements could further restrict its timeline, as the FDA expects companies applying for emergency permission to submit two months of data to at least half of test participants.
“Just because we wait until the end of the year instead of October – to keep an eye on things, this is still a record of ground speed for vaccines,”; said Peter Hotez, a virologist and dean of the National School of Tropical Medicine at the Baylor College of Medicine. Hotez worked on many shots including a potential SARS vaccine, each of which took years if not decades of work to produce and test.
But the rapid pace of the coronavirus shooting so far has not satisfied Trump, whose administration has put the quest for a vaccine amid efforts to address the pandemic.
“We’ll have a vaccine soon, maybe before a special date. You know what date I’m talking about,” he told an early conference in September. When the FDA pushed its standards to allow the emergency use of coronavirus vaccines, he called it “a political movement more than anything.”
The agency revised its guidelines to ensure drug makers submit sufficient data to reflect any effects from their shot, Hotez said. “It was not done to punish the president, it was done to protect the public to ensure we have vaccines that are safe and secure,” he said.
As vaccine timelines have become blurred, Trump has shifted his focus to drugs known as monoclonal anitbodies. He declared an experimental antibody by drug “medicine” earlier this month, after receiving treatment while he was hospitalized for Covid-19. The president has repeatedly promised that cocktails will soon be available to every American who needs them.
However, within a week of his initial commitment, Eli Lilly – the other company that provided antibody medication in the final stages of the clinical trial – stopped studying about safety concerns.
Bumps on the road to a vaccine or an antibody drug leave health officials with tools that Trump and other White House officials have long questioned: wearing a mask, social exclusion and widespread test.
Trump’s antibody rhetoric “is a pivot to clear that vaccines do not fill his timeline. And it is clear that antibodies do not fill his timeline,” Emanuel said.
But a longer timeline for vaccines will help public confidence in a late shot. Most registered voters want manufacturers to fully test vaccines even if it delays the delivery of shots to Americans, according to a recent POLITICO / Morning Consult poll.
Nearly half of those voters, across party affiliates, say they believe Trump is forcing the FDA to deliver shots earlier and 35 percent believe that at least six months before vaccines are available in the US.
Continuing a theme from the previous polls, voters also said they trust Biden more than Trump in vaccinating, testing and approving.
“Elections and vaccines have nothing to do with each other,” Gostin said. “They are both important but they are different. Science is not an election issue. It should be something that everyone, regardless of your political beliefs, should avoid. Because this is the only thing that will get us out of here.”