September 24, 2020

FDA is planning to issue stricter criteria for the agency to use to evaluate coronavirus vaccine candidates for emergency use authorizations (EUAs), but President Trump on Wednesday said the White House "may or may not" approve the more robust guidelines.

A vaccine approval is coming. Get ready to ask these 8 questions.

US new coronavirus cases near 7M, deaths approach 202K

Trump's comments come as U.S. officials as of Thursday morning reported a total of 6,959,400 cases of the novel coronavirus virus since the country's epidemic began—up from 6,917,900 cases reported as of Wednesday morning.

According to the Axios' "Vitals," the latest data suggests that the rate of new coronavirus cases is once again beginning to surge in the United States, with spikes in new cases occurring primarily in the West and Midwest. Over the past week, seven states—Arizona, Colorado, Minnesota, Montana, Texas, Utah, and Wyoming—have seen their rates of newly reported coronavirus cases increase by at least 60%, according to "Vitals." Overall, the country this week has reported an average of 43,000 new coronavirus cases per day—up 16% from last week's daily average.

According to data from the New York Times, the rates of newly reported coronavirus cases are "staying high" in Puerto Rico and 18 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Arkansas, Idaho, Iowa, Kansas, Kentucky, Minnesota, Mississippi, Missouri, Montana, Nebraska, North Dakota, Oklahoma, South Carolina, South Dakota, Tennessee, Utah, and Wisconsin.

Meanwhile, the rate of newly reported cases over the past seven days is "going down" in Guam, which had previously seen elevated case rates.

Eleven states that have had comparatively low case rates are now seeing those rates "going up," according to the Times. Those states are Arizona, Colorado, Connecticut, Maine, Massachusetts, New Jersey, New Mexico, Oregon, Rhode Island, Texas, and Wyoming.

In the 23 remaining U.S. states and territories, rates are "staying low," according to the Times' analysis.

U.S. officials as of Thursday morning also reported a total of 201,822 deaths linked to the coronavirus since the country's epidemic began—up from 200,731 deaths reported as of Wednesday morning.

FDA plans to issue stricter guidance on EUAs for coronavirus vaccines

As the coronavirus continues to spread throughout America and related deaths continue to rise, researchers are scrambling to develop a vaccine against the virus, with some companies already conducting late-stage trials on coronavirus vaccine candidates. However, some experts and observers have raised concerns over whether FDA is facing political pressure to authorize a coronavirus vaccine before robust clinical trial data on the candidates' efficacy and safety is available.

In response to the public's dwindling trust in federal health care officials, FDA in recent weeks has sought to bolster Americans' confidence in the agency by promising to share as much data on potential coronavirus vaccines as possible and ensure that officials will adhere to science when reviewing the vaccine candidates.

For example, FDA Commissioner Stephen Hahn last week said the agency plans to issue stricter criteria that it will use to evaluate coronavirus vaccine candidates for EUAs. The new guidance, which cleared a review by HHS on Tuesday, is now subject to the White House's review, according to two people familiar with the matter, Politico reports.

According to the Washington Post, the new EUA guidance could make it less likely that FDA will authorize a coronavirus vaccine before the upcoming general election, which is a target Trump has touted for authorizing a vaccine.

During a Senate committee hearing on Wednesday, Hahn said, "Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA through our thorough review processes and science will guide our decisions." He continued, "I will fight for science. … I will fight for the integrity of the agency, and I will put the interests of the American people before anything else."

Hahn added that "FDA will not authorize or approve a vaccine we won't be confident in giving to our families."

Trump calls FDA's move 'political,' says White House 'may or may not' approve new criteria

But Trump during a press conference on Wednesday said the White House "may or may not approve" FDA's tougher EUA guidelines.

Trump questioned whether FDA needed to revise its EUA guidance, and he suggested that issuing the new criteria "was a political move more than anything else." He added, "I have tremendous trust in these massive companies that are so brilliantly organized in terms of what they've been doing with the tests. … I don't see any reason why [a vaccine] should be delayed further because if they delay it a week or two weeks or three weeks, you know, that's a lot of lives you're talking about."

Politico reports that Trump's comments came only hours after he reviewed FDA's proposal for the stricter guidelines with HHS Secretary Alex Azar, according to two people familiar with the situation. FDA, HHS, and the White House declined to comment on Azar's meeting with Trump about the proposal, Politico reports  (Owens, "Vitals," Axios, 9/24; McGinley/Johnson, Washington Post, 9/22; Fernandez, Axios, 9/23; Wang, Inside Health Policy, 9/23 [subscription required]; Morello/Cancryn, Politico, 9/23; New York Times, 9/24).

Your top resources for Covid-19 response and resilience

Get best practices and expert insights for safely treating Covid-19 patients, protecting and empowering staff, and navigating the road ahead for your organization.

Access Now
Download Now

Topics