Trump says he might reject stricter FDA vaccine guidelines
The FDA has reportedly proposed stricter emergency authorization standards, which are now under review by the White House Office of Management and Budget.
President Donald Trump said Wednesday that the White House may not approve tougher FDA guidelines for authorizing the emergency use of any coronavirus vaccines.
“That has to be approved by the White House,” Trump said. “We may or may not approve it.”
Trump also suggested that the FDA’s decision to revise the standards, first issued in June, “was a political move more than anything else.” The president has repeatedly vowed that a vaccine would be available by Election Day, although prominent scientists within his administration have said it’s extremely unlikely.
The stricter FDA standards cleared a review by the Department of Health and Human Services on Tuesday, with the expectation that the White House would soon approve them, according to two people with knowledge of the timeline.
Trump’s remarks came hours after he spoke with HHS Secretary Alex Azar about the FDA proposal, two people familiar with the situation said. The president’s criticism throws into jeopardy an effort viewed as key to boosting public confidence in any eventual coronavirus vaccine.
Redfield said that preliminary results from “the first round” of a CDC survey examining the coronavirus’ spread found that roughly 90 percent of the American public was still susceptible to infection. The agency published those results, which cover the early months of the pandemic, in July.
Redfield added that the CDC study was ongoing.
Atlas — a neuroradiologist without experience in public health, infectious disease or immunology — said the CDC chief “misstated something” and relied on old data. Atlas also criticized the CDC study for using the presence of coronavirus antibodies in a person’s blood as a proxy for immunity.
The body produces antibodies in response to infection, so having antibodies to the novel coronavirus is a sign that a person has been exposed to it. But scientists don’t know what level of antibodies might confer immunity to reinfection. And there are signs that immune cells called T cells may also protect against the virus.
In his critique of Redfield, Atlas mentioned studies that have examined the role of T cells in fighting Covid-19. He also suggested that exposure to related viruses may help safeguard against infection by the novel coronavirus.
“The combination of those make the antibodies a small fraction of the people who have immunity,” Atlas said.
But that notion, also put forth by Sen. Rand Paul at the Senate hearing, was shot down by the government’s top infectious disease expert, Tony Fauci. Fauci said that no study has found evidence of such “cross immunity” from earlier exposure to other coronaviruses.
Sarah Owermohle contributed to this report.