The agency is expected to introduce new, tougher standards to get emergency approval for the vaccine in an effort to boost public confidence.
The Food and Drug Administration is expected to announce new and more stringent standards for authorizing a coronavirus vaccine.
The new standards are meant to encourage public trust, but experts say it will also make access to a vaccine by Election Day unlikely. Public trust in a vaccine has waned in recent months due and public President Donald Trump’s repeated claims that there could be a vaccine by November 3 and what individuals view as a politicization of the vaccine process. Public health experts have cited concerns that the American people will reject any vaccine that first becomes available and would be hesitant to receive it.
According to the Pew Research Center, the percentage of people who said they would get the vaccine if it were available today has declined from 72% to just over 50%. In order for life to return to some semblance of normalcy, large swaths of the US population would need to be vaccinated or have immunity from contracting the coronavirus.
The new guidance is significantly more rigorous than the guidelines the agency used to approve the emergency use of hydroxychloroquine or convalescent plasma. Under the new guidelines the FDA would ask vaccine manufacturers looking for an emergency use authorization to follow participants in late-stage trials for an average of at least two months, according to the Washington Post.
To be sure the vaccine is effective, researchers would look for at least five cases of severe COVID-19 among the placebo group of trial participants.
These new standards would increase the amount of time the potential vaccines are under strict observation and would make it difficult to have a vaccine that meets all the benchmarks before mid-November or early December.
The agency and its officials have made some public missteps in dealing with the coronavirus pandemic. For instance, officials approved hydroxychloroquine, an existing drug usually used to treat malaria, to treat COVID-19 patients back in March. Trump repeatedly touted the drug’s effectiveness, but studies quickly showed that the drug did not help patients and even posed safety risks to some. Later, FDA Commissioner Stephen Hahn overly exaggerated the benefits of plasma treatments for patients with COVID-19 during a briefing. The data he cited was from a very small study and did not back up his claims.
The FDA’s efforts to shore up trust are being pitted against almost daily contradictory information from Trump who has claimed repeatedly that there will be a vaccine before the election. He also has recently claimed that the U.S has “turned a corner” with the pandemic although the nation recently hit 200,000 deaths from the coronavirus and experts predict thousands more deaths before the end of 2020.
Some experts are concerned about the agency issuing an emergency use authorization for a vaccine at all for fear of public distrust.
“Things are so revved up right now that there is quite a possibility that the American public won’t accept a vaccine because of all the things that are going on,” said Peter Hotez to the Washington Post. Hotez serves as dean of the National School of Tropical Medicine at Baylor College of Medicine. “U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions.”