FDA to issue strict guidelines for Covid-19 vaccines, may squash Trump's plan of getting one ready by November
The new guidelines are unlikely to go the convalescent plasma and hydroxychloroquine way: both of which received emergency approval following Trump's lobbying efforts
The US Food and Drug Administration (FDA) may introduce tougher guidelines for emergency approval of Covid-19 vaccines, according to a Washington Post report. In doing so, the federal agency hopes to gain public trust. However, the development is likely to jeopardize President Donald Trump's plans of having a vaccine ready before election day in November.
The new guidelines are unlikely to go the convalescent plasma and hydroxychloroquine way: both of which received emergency approval following Trump's lobbying efforts. Instead, the FDA would ask vaccine manufacturers to follow volunteers in late-stage clinical trials for a median of at least two months after they’ve received a second vaccine shot, according to The Washington Post.
To assess a potential vaccine's efficacy, the FDA would require data on at least five severe Covid-19 cases in the placebo group, along with information on older people with Covid-19. "It’s hard to imagine how an [emergency use authorization] could possibly occur before December," Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA's advisory board on vaccines, told The Post.
Trump is keen on getting a vaccine ready before Election Day, drawing criticism from experts worried about the consequences of a rushed approval. Even a group of vaccine manufacturers pledged that they would not file for authorization unless their experimental doses prove to be safe and effective.
However, Alex Azar's recent move has worried experts as well. Azar, the secretary of Health and Human Services, barred the nation's health agencies, including the FDA, from signing any new rules regarding foods, medicines, medical devices and other products, including vaccines. In a memo, he wrote that such power "is reserved to the Secretary." It, however, is unclear how this would affect the approval of Covid-19 vaccines.
Recent surveys have captured the mood of the nation. According to an ABC News/Ipsos poll, only 9% of Americans said they have a great deal of confidence in Trump if he endorses a vaccine's efficacy, and 69% said they do not trust the President's word. About 53% of the adults reported their amount of confidence is heading towards "none at all".
There was a drop in belief among Republicans as well: about 29% expressed doubts over Trump's views on the matter. Compared to May 2020, the number of Americans who believed they could get a safe and effective coronavirus vaccine has declined. Another poll found similar results: about 50% said they would get a vaccine, compared to 72% in May, according to Pew Research Center.
Some experts think vaccines should be barred from receiving emergency approval. "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," Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told The Post. "US history is littered with good vaccines that get voted off the island because of bad public perceptions."