Senior FDA leaders stepping down

| September 13, 2021

Two senior officials have resigned from their positions within the US Food and Drug Administration (FDA) over frustrations with the current administration’s plans to move forward with COVID-19 booster shots without their prior approval, according to a report.

32-year veteran of the agency Marion Gruber, director of the FDA’s Office of Vaccines Research & Review (OVRR), will leave at the end of October. OVRR deputy director Phil Krause, who’s been at the FDA for more than a decade, will leave in November. The news is a massive blow to confidence in the agency’s ability to regulate vaccines.

The bombshell announcement comes at a particularly crucial moment, as boosters and children’s shots are being weighed by the regulator. The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of 20 Sept.

COVID-19 vaccine boosters unnecessary for most, say FDA advisers reportedly resigning over issue

FDA’s Marion Gruber and Phil Krause argued current evidence doesn’t indicate a need for booster shots among most Americans

Kayla RivasBy Kayla Rivas

Available evidence doesn’t yet indicate a need for COVID-19 vaccine booster shots among the general population, an international group of scientists said Monday, including two senior FDA officials reportedly stepping down from their posts over a disagreement with the White House on the administration of booster shots.

Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, set to leave in October and November, published a viewpoint in The Lancet on Monday along with other experts worldwide, arguing that the COVID-19 vaccines remain effective in preventing severe disease, including against the highly transmissible and dominant delta variant.

“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics,” authors wrote, adding in part: “Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

The comments come after Dr. Janet Woodcock, acting commissioner of the FDA, and Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, recently advised the White House that regulators need more time to review necessary data before approving a COVID-19 booster shot plan. The guidance from the FDA and CDC is that both agencies have so far only accumulated enough data to suggest that some individuals who received the Pfizer vaccine should get a booster shot.

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Gruber, Krause and other authors urged caution over drawing conclusions about vaccine efficacy from preliminary observational studies possibly affected by “confounding and selective reporting” to inform the country’s booster shot rollout.

Or, less politely, cherry picking data to further the agenda.

Fox News.com

Category: Biden, Covidiot, Usual Suspects

Comments (12)

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  1. Mason says:

    Did anyone actually believe Biden when he said they’d “Trust the science?” Literally everything out of that guy’s mouth is a lie. This surprises nobody who’s paid attention.

    I’ve done some dumb things, and I’ll do dumb things again. I’ve done some dumb things as senator, and I’ve done some dumb things as a lawyer. Ladies and gentlemen, I’ve been dumb.

    -Joe Biden, 1988

    100% true quote too. Most popular presidential candidate in history, folks.

  2. KoB says:

    Gotta wonder if they are resigning on their own v being told to resign? Either way, won’t matter. I’m sure that these two, and any other that don’t toe the official party line, will be replaced with those that WILL DO the biden of the political masters.

    • UpNorth says:

      And, the news of their resignations, and their reasons for doing so, will be buried on page 48G of your local fish wrap.
      Or it’ll be covered on the TV news, at 3:30am, once, then filed in the vaults.

      • Hack Stone says:

        The Mainstream made front page articles over any person in the Trump Administration resigning because of Presidential policies. Have yet to see one senior leader at State or Defense resign over the Afghanistan disaster, so they all must be on board, Riding With Biden, right over that cliff. He’s been in office almost nine months, didn’t he promise to cure cancer? And what about that Covid Plan he spoke of during the campaign? It should have been resolved by now.

  3. Hatchet says:

    Or maybe they’ve resigned because they’ve been made aware that a bunch of ‘em are going to be indicted..? Mishandling, misconduct, etc. *shrug* Not without historical president..

    • Hack Stone says:

      President/precedent. Reminds Hack when the Master Sergeant Comm Chief was talking about an upcoming exercise, and it went something like this:

      MSgt: Division messages will take presidents.

      Sgt Hack Stone: Precedence.

      MSgt looks up from the paper he is reading from)

      MSgt: What?

      Sgt Hack Stone: Precedence. The word is precedence, not presidents. As in preceding, coming before.

      (MSgt looks at the paper)

      MSgt: There’s no S in there.

      Sgt Hack Stone: That’s right Master Sergeant, there is no S in that word.

      And don’t go around accusing Hack Stone of being homonymphobic

      • Hate_me says:

        In defense of E-8s everywhere….

        “Hell, if I’d’ve wanted schoolin’ I woulda gone to school.”
        – Jayne Cobb

  4. ChipNASA says:

    Then there’s this…

    “ ‘F**K Joe Biden’ Chants Break Out at College Football Games Across the Country“
    https://www.google.com/amp/s/www.newsweek.com/joe-biden-chants-break-college-football-games-country-1626438%3famp=1

  5. Poetrooper says:

    As this vaccine hysteria grows, just keep reminding yourselves that it’s based totally on a logical fallacy:

    If a vaccine is effective it protects you from further infections.

    Biden is telling America this Covid-19 vaccine is highly effective.

    Therefore, if the Covid-19 vaccine is effective, how can those who have been vaccinated be infected by exposure to those who haven’t?

    If those who have been vaccinated cannot be infected by those who have not been vaccinated, then why are we being subjected to this irrational and hysterical fear campaign that the unvaccinated pose a threat to our national health?

    It is a glowing example of a logical fallacy and like most liberal programs, it defies common sense. Which is why they so fervently believe it.

    They’re totally and completely fucking nuts…

  6. Forest Bondurant says:

    …and now Faux-Chi also disagrees with the FDA officials who have resigned.

    The science is settled. Anthony says you’re good to get the booster, so go get it.

    /sarc off/