Overnight Health Care — Departing FDA vaccine regulators argue against COVID-19 booster shots

Overnight Health Care — Departing FDA vaccine regulators argue against COVID-19 booster shots
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Welcome to Monday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.

 

The Dude Abides, and is COVID-free. Actor Jeff Bridges said COVID-19 made “cancer look like a piece of cake” when announcing his lymphoma is in remission. 

Two of the FDA's top vaccine regulators were among the co-authors of a paper arguing that the evidence doesn't support giving booster shots of COVID-19 vaccines— it could be a preview of FDA's vaccine advisory committee meeting on Friday.     

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For The Hill, we’re Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

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Departing FDA leaders join other experts to rebuff Biden booster plan

 

coronavirus COVID-19 community spread food and drug administration fda vaccinations approval children under 12 biontech pfizer

We now have a pretty good idea what led two leading FDA vaccine regulators to announce their retirement.

Marion Gruber and Phil Krause, two longtime FDA officials who have been leading the agency's review of COVID-19 vaccine applications, were among the co-authors of a paper in medical journal The Lancet published Monday that threw cold water on the Biden administration's plan for booster shots.

The paper argued that none of the current evidence on the COVID-19 vaccines shows a need for booster doses in the general population.

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The Lancet paper's authors noted the effectiveness of all available COVID-19 vaccines against severe disease remains strong, even as protection against symptomatic infection has decreased slightly due to the delta variant. 

"Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high," the authors wrote.

Neither FDA official has spoken publicly about their reasons for leaving their longtime posts, but the announcement they were stepping down came as the agency defended the Biden administration's approach to vaccine booster shots.

The paper's publication comes as the administration is pushing for boosters to be widely available to all Americans beginning Sept. 20, despite disagreement from outside scientists and some health agency officials who argue it's premature, and that the data are not strong enough to support such a move.

Coming attraction: An FDA advisory group is scheduled to meet on Friday to discuss the evidence around Pfizer's application for a booster, and is almost sure to address the wider issue of boosters in general. 

FDA's Peter Marks, the agency's top vaccine official, said he thinks the data will be very clear. Speaking during a conference of regulatory affairs professionals on Monday, Marks said he is "fully confident"  that people attending the meeting will leave with "a good rationale for why boosters might be necessary."

U.S. first: Marks also pointed out that taking care of U.S. citizens is his top priority. "As a United States government employee it is my obligation to ensure that the health of the United States population is best cared for and not to make global political decisions. So, if it turns out that a third dose is appropriate for everyone in the world to help prevent COVID-19 from coming around in cycles, we should be doing that, and if we happen to get to it before others realize that that's the right thing to do, that's just the way it is."

Read more here.

DeSantis: Local governments will face $5K fines for imposing vaccine mandates 

Cities and counties in Florida that require COVID-19 vaccines as a condition of employment will be fined $5,000 per violation, Gov. Ron DeSantisRon DeSantisDemocrats lean into vaccine mandates ahead of midterms California dreaming did not become reality for Republicans Florida landlord requiring proof of vaccinations from tenants MORE (R) said Monday.

During a press conference, DeSantis said government agency vaccine mandates violate the state's law banning private businesses from requiring "vaccine passports" for customers.

What he’s saying: "We are gonna stand for the men and women who are serving us. We are gonna protect Florida jobs," DeSantis said. "We are not gonna let people be fired because of a vaccine mandate."

DeSantis said any local government that imposes vaccine requirements could risk millions of dollars in fines. He specifically mentioned first responders who refuse to be vaccinated.

"You don't just cast aside people who have been serving faithfully over this issue, over what's basically a personal choice on their individual health," DeSantis said. "We cannot let these folks be cast aside. We cannot allow their jobs to be destroyed."

Big picture: DeSantis, who is seen as a likely presidential contender in 2024, has framed vaccination as a personal choice. 

DeSantis's ban on vaccine mandates represents another warning shot at the Biden administration and its efforts to try to ensure as many Americans as possible are vaccinated against COVID-19.

Read more here

GOP SEES BIDEN VACCINE MANDATES AS ENERGIZING MIDTERMS ISSUE

Republicans are seizing on President BidenJoe BidenSunday shows preview: Coronavirus dominates as country struggles with delta variant Did President Biden institute a vaccine mandate for only half the nation's teachers? Democrats lean into vaccine mandates ahead of midterms MORE’s latest coronavirus vaccine mandates as a campaign issue as the party looks to galvanize its base ahead of the 2022 midterms and 2024 presidential election.

On Friday, former Vice President Mike PenceMichael (Mike) Richard Pence'Justice for J6' organizer calls on demonstrators to respect law enforcement Ethics group files complaint against former Pence chief of staff Marc Short Pence aiming to raise M ahead of possible 2024 run: report MORE and South Dakota Gov. Kristi NoemKristi Lynn NoemSouth Dakota lawmakers release petition to impeach state attorney general OSHA faces big challenge with Biden vaccine mandate Overnight Health Care — Departing FDA vaccine regulators argue against COVID-19 booster shots MORE (R) took to Fox News’s airwaves to lambast the president’s move, while Texas Gov. Greg AbbottGreg AbbottBiden administration announces federal support for patients, abortion providers in Texas California dreaming did not become reality for Republicans Judge schedules Oct. 1 hearing on DOJ request to halt Texas abortion law MORE (R) called the mandates “an assault on private businesses” in a tweet.

Meanwhile, the Republican National Committee vowed on Thursday to sue the Biden administration over the mandates.

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Nationwide polling shows vaccine mandates are generally popular, but Republicans see an opportunity to use the issue to appeal to their staunchest supporters.

“I think this is going to be a motivating factor,” said Republican strategist Keith Naughton. “In an off-year election it’s always hard to get people to turnout for the president except in a crisis, but you do get the people who are angry with him to turnout.”

Read more here.

Poll: Majorities support vaccine requirements in workplaces, schools, sporting events

Majorities of Americans support vaccine mandates for workplaces, schools and sporting events, according to a CNN and SSRS poll.

Fifty-four percent of those polled by CNN and SSRS said they would support requiring office workers to be vaccinated against COVID-19 to return to their workplaces.

For schools, 55 percent of respondents said they support a vaccine requirement for children attending in-person classes, and 55 percent of respondents said they are in favor of a vaccine requirement for attendance at sporting events or concerts.

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Public opinion is split when it comes to requiring proof of COVID-19 vaccines for everyday activities outside of the home, with 51 percent of respondents saying they believe requiring vaccines for everyday activities is an acceptable way to increase the vaccination rate and 49 percent saying it is an unacceptable infringement on personal rights.

The survey results come as different entities in the U.S. are mandating vaccines throughout the country, after the Food and Drug Administration granted full approval to the Pfizer-BioNTech vaccine. 

Since the poll, President Biden has announced that employers with 100 or more workers have to require vaccines or weekly testing.

Read more here

HOCHUL TO FACEBOOK: ‘CLEAN UP THE ACT’ ON ABORTION MISINFO

New York Gov. Kathy HochulKathy HochulNY governor orders immediate release of 191 inmates from Rikers Island Letitia James holding private talks on running for New York governor: report Governors brace for 2022 after year in pandemic spotlight MORE (D) called on Facebook to "clean up the act" on abortion misinformation on Monday, as part of her state’s response to Texas’s "fetal heartbeat" abortion ban. 

The new governor said at a briefing that New York is sending a letter to Facebook on Monday requesting the social media giant’s assistance in “a war against misinformation” about abortion, as well as COVID-19 vaccines.  

“I'm asking Facebook starting today to help clean up the act, help us wage a campaign of truth and not lies, with respect to what is going on in Texas and what is going on here in the state of New York because misinformation spreads like wildfire,” she said.

“I want to make sure as we enter this new chapter after what the Supreme Court upheld on Sept. 1 is that we ensure we don’t allow those lies to continue — that there’s accountability and responsibility at the top of those companies to help tell the truth across this nation,” Hochul said.

Follows: The Supreme Court declined to block the Texas law as it went into effect earlier this month, sparking concern among activists about the future of reproductive rights in the country. 

In response to the Texas legislation, Hochul also said she plans to address “unfinished business” with the state’s Reproductive Health Act to improve reproductive rights and access.

Read more here.

WHAT WE'RE READING

  • A man died after being turned away from 43 ICUs at capacity due to COVID, family says (NPR
  • Israel preparing for potential second round of coronavirus booster shots (Axios
  • Why at-home rapid Covid tests cost so much, even after Biden’s push for lower prices (Kaiser Health News)
  • Our most reliable pandemic number is losing meaning (The Atlantic)

STATE BY STATE

  • The delta variant is wreaking havoc on most of Texas — but not El Paso. Here’s why. (Texas Tribune)
  • Florida hospitals continue to report fewer COVID hospitalizations and ICU patients (Miami Herald)
  • ‘Their crisis’ is ‘our problem’: Washington grapples with Idaho Covid cases (The New York Times)

OP-EDS IN THE HILL 

That’s it for today, thanks for reading. Check out The Hill’s healthcare page for the latest news and coverage. See you Tuesday.