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FDA in Disarray as Two Vaccine Officials Resign Over Biden’s COVID Booster Plans

FDA in Disarray as Two Vaccine Officials Resign Over Biden’s COVID Booster Plans

“It is very frightening to me that healthcare providers, trying to do the best job that they can, are taking guidance from HHS and White House, and now have put themselves at risk.”

The Food and Drug Administration is in disarray because of political tension surrounding the COVID booster shots.

Politico spoke to people involved in the situation, including 11 former and current health officials.

The FDA lost two top vaccine officials because President Joe Biden’s administration is not minding its own business:

FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters’ benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team’s top-down booster plan and former President Donald Trump’s attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.

On Tuesday, two top FDA vaccine regulators resigned — a decision that one former official said was rooted in anger over the agency’s lack of autonomy in the booster planning so far. A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA’s top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.

Those administration officials include acting FDA Commissioner Janet Woodcock and COVID Czar Jeff Zients. Both approve of the booster. Woodcock praised vaccine regulators. Zients praised the FDA “as the regulatory ‘gold standard.'”

Those within the FDA hate that Biden’s administration has pushed the boosters without input from the FDA’s top scientists:

Woodcock and Marks were instrumental in crafting an Aug. 18 statement from HHS officials on the Sept. 20 booster timeline, said one senior official. That person said that the timeline was informed in part by Woodcock and Marks’ estimation of when they would get key data from vaccine makers, but also could shift based on new data, echoing the joint statement.

Another senior health official with direct knowledge of the situation said that political appointees within the White House largely steered the mid-August booster announcement.

The tension within the administration plus open skepticism from outside experts has fueled finger-pointing and divisions among health agencies. Career scientists in particular have been confused and surprised by the process, multiple people involved in the talks said.

Then Biden made matters worse (what a shock!) when he announced people can get the booster shot five months after their second shot. His administration proposed eight months.

The administration justified Biden’s remarks by saying the administration has to show they are taking the lead along with Zients and Dr. Fauci.

However, only Pfizer has submitted the initial booster application on August 27. We do not know when Moderna and Johnson & Johnson will submit their applications.

Pfizer still has more data to submit in October to help determine if we need the booster between four or eight months after the second shot.

I don’t trust the government, but people within the FDA’s vaccine department has way more experience and knowledge than Biden:

But the abrupt departure of two top officials from FDA’s vaccine department, the Center for Biologics Evaluation and Research, has shaken many current and former officials who say it resonates at a critical moment in vaccine regulation. “Supporting the career staff at CBER is extremely important right now, they have a tremendous amount of experience,” Bush-era FDA Commissioner Mark McClellan told POLITICO.

While third doses are still only authorized for immunocompromised people, including organ-transplant patients, others who don’t fit into that category have plunged ahead with additional vaccinations under the mistaken notion that FDA has already given the greenlight. Nearly one million booster doses have already been administered in the U.S. according to the latest CDC data.

So yeah. The confusion has caused people to get it whether they need it or not. I always say to talk to your doctor, but they rely on data and studies. One specialist cannot believe healthcare people take advice from the White House:

“Many, many, many” providers in southern states with coronavirus case surges are dosing health care workers and patients with boosters absent an FDA approval because of confusion over Biden booster remarks, said Helen Talbot, an infectious-disease specialist at Vanderbilt University and member of CDC’s Advisory Committee on Immunization Practices, the panel that recommends how vaccines are used.

“This highlights, critically, the need for any vaccine recommendations to go through the normal avenues and not come out from outside,” she said during a Monday meeting of the panel. “It is very frightening to me that healthcare providers, trying to do the best job that they can, are taking guidance from HHS and White House, and now have put themselves at risk.”

They wonder why people have vaccine hesitancy. They admit that remarks by Biden and administration people are okay because they promised to lead. That makes it political. Their appearance is more important than actual science.

So much for “following the science.” It is nice to know that people within the FDA actually give a damn about their job and the well-being of people.

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Comments

“Then Biden made matters worse (what a shock!) when he announced people can get the booster shot five months after their second shot. His administration proposed eight months.”

Ya canna repeal the laws o’ biology, Jim Joe.

“One specialist cannot believe healthcare people take advice from the White House”

One specialist needs to review the proportion of healthcare providers’ income that comes directly from bureaus in Washington DC.

Nothing says “THIS CRAP DOESN’T WORK” like demanding ever more frequent “booster” shots (and, now, daily pills).

    Brave Sir Robbin in reply to txvet2. | September 2, 2021 at 5:15 pm

    I’ve been looking at Biden for a while and thinking the he needs a booster – maybe one or two a day.

    txvet2 in reply to txvet2. | September 3, 2021 at 11:28 am

    And then there’s this:

    “”Governor Jim Justice: I’m gonna give you a few stats now about what’s going on in West Virginia. West Virginia is seeing a 26% increase in positive cases of people that are fully vaccinated over the last eight weeks. I’ll read that one more time. West Virginia is seeing a 26% increase in positive cases in people that are fully vaccinated and a 21% increase in breakthrough cases requiring hospitalization for people that are fully vaccinated. We have also seen a 25% increase in deaths of people that are fully vaccinated over the last eight weeks. Now, that’s not a 25% increase of the total numbers or whatever, it is a 25% increase of deaths of people that are fully vaccinated over the last eight weeks.””

      Think38 in reply to txvet2. | September 3, 2021 at 1:07 pm

      As a statistic, those figures don’t mean much. It tells me more people who have had the jab are getting COVID compared to the earlier time period. It doesn’t tell me how the vaccinated population compares to the unvaccinated population. The vaccines are not 100% effective.

      Entirely possible that there is an increase in both hospitalizations and death rate among those that had the vaccine, and the vaccine to provide a large degree of protection. The changes in the rate doesn’t tell us the degree (or non-degree) of protection offered by the vaccine.

“outside experts, and some within the agency, see uncomfortable similarities between the Biden team’s top-down booster plan and former President Donald Trump’s attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments”.

Calling BS on the Trump comments. What Trump wanted was for the drug companies to not try to give Biden the accomplishment

Depending how you see it, not sure it’s an accomplishment at this point. When the dust settles amd the truth emerges, maybe , just maybe we will know

    The vaccines have a conditional value for high risk cases, but marginal, low, and negative value in the general population, where most people… persons either have preexisting or naturally acquired immunity, and others are eligible for early, safe, inexpensive, effective therapeutic treatments, and there is generally a conditional risk of infection and disease progression.. They should have followed the advice of domain experts (Atlas et al) behind the Great Barrington Declaration to minimize, injury, death, and collateral damage.

      randian in reply to n.n. | September 2, 2021 at 9:52 pm

      “others are eligible for early, safe, inexpensive, effective therapeutic treatments”

      They would be, if those treatments weren’t being attacked by the FDA as dangerous (despite decades of data saying otherwise), and therefore forbidden. The FDA is doing everything possible to prevent any therapeutic treatment for covid from being available.

Vaccines that promote production of dysfunctional antibodies (thus higher antibody titers and two and booster shots), limited and short-lived immunity, correlated with excess adverse events, symptom suppression and transmission. and complete with compromised short-term safety data, suitable for limited distribution based on individual risk assessments. Vaccines that key of the spike protein that is pathogenic in a minority of the population. A conditional risk of infection vs an absolute risk of vaccination. An elixir and mandates offered as a placebo and viable legal indemnity.

former President Donald Trump’s attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.

Emergency-use authorization for vaccine development and distribution based on risk assessment is “=” but not equal to normalization and celebration of an experimental treatment with only short-term safety data.

Ironically, it was the press, social, media, and steering that discouraged and stigmatized early, effective, inexpensive with long-established safety data treatments that mitigate infection and disease progression. It was select domain experts who advised for extreme treatments (e.g. intubation), ineffective mandates (e.g. masks), and to tolerate collateral damage (e.g. planned parent/hood) in the cause of “science”, equity, inclusion, and viable legal indemnity.

Another example of the govt fumbling the ball. Frankly if they were a QB trying to make an NFL roster they would have been cut some time ago. The public health overlords keep throwing into double coverage trying to force the throw but come unglued when their errors are pointed out.

I have no doubt that boosters are a good idea for a segment of the population. The question is what is the profile of that population and how many people fit into those categories.

I guess I’m more of a “vaxxer” here and many of you don’t always agree with me for it. I hope we can still respect each other’s opinions and have discourse.

I will say this without hesitancy: I am not getting a booster without having a good idea what my titer looks like.

You know all those people that had a 2nd shot that put them on their ass for a day or so? You can look for that or more if you wake the sleeping giant of a cytokine storm without doing this right first.

    CommoChief in reply to healthguyfsu. | September 2, 2021 at 6:21 pm

    As long as you’re not calling for mandatory vax or masks or to effectively exile those without a vax then I have no problems. Live and let live.

      healthguyfsu in reply to CommoChief. | September 2, 2021 at 6:44 pm

      Agreed…to an extent.

      I don’t like the idea of showing my vax card. I think it is protected private health information.

      I don’t think anyone should have to disclose it. That said, some people are put in danger in rare situations where they can’t get a vaccine. I support protecting those people, but unlike the left, I don’t think the exception proves the rule (like how the left likes to say that rape abortions somehow magically make the case for everyone to have abortion on demand).

        CommoChief in reply to healthguyfsu. | September 2, 2021 at 7:50 pm

        For the people who can’t get a vax being protected…. maybe, as long they have made every effort to eliminate all potential co morbid conditions first then maybe I would be willing to consider that. Of course I will insist upon everyone on the mandatory side complying as well.

        Have these folks all hit their target BMI? Have they gotten their diet under control? Do they exercise effectively? Eliminated fats and carbs? Stopped eating fatty cakes?

        Until someone has exhausted every means within their control to protect themselves they shouldn’t ask for anyone else to modify their lifestyle.

          I’m one of those rare people who cannot get vaccinated, and I do indeed do everything within my control to protect myself, including the things you mention.

          However, I have no desire to ask or even suggest that other people modify their lifestyle to accommodate me. The reasons for my inability to get vaxxed are what they are. Life goes on. The only person responsible for protecting me, is me.

          CommoChief in reply to CommoChief. | September 2, 2021 at 8:33 pm

          SField,

          The last line sums it up; ‘the only person responsible for protecting me is me’. Unfortunately this philosophy isn’t widespread.

          Take a look at the teacher union officials and members demanding mask for kids and pushing hard for vax mandates. They are by and large overweight if not obese. They don’t take responsibility for their decisions or their health.

          randian in reply to CommoChief. | September 2, 2021 at 9:55 pm

          I see no significant number (zero, as far as I can tell) of unvaccinated individuals demanding anything of others. It’s the vaccinated people acting like the unvaccinated are lepers that are demanding things.

        Milhouse in reply to healthguyfsu. | September 3, 2021 at 2:37 am

        .

        I don’t like the idea of showing my vax card. I think it is protected private health information.

        I don’t think anyone should have to disclose it.

        Must quibble here. There is no such thing as “protected private health information” in that sense. HIPAA only forbids your health providers (doctors, insurers, and anyone working for them) from disclosing your information without your permission. That’s the tradeoff for their being allowed to disclose it to each other. But there’s no protection against someone requiring you to disclose it.

        It’s absolutely routine that if you sue someone in a case where this information is relevant you will be required to give your permission for your providers to disclose your information to the defendant. Otherwise your suit is dismissed. HIPAA just means they can’t bypass you and deal directly with your providers.

        So I have no objection in principle to this “show your papers” business. I just don’t like it.

          SuddenlyHappyToBeHere in reply to Milhouse. | September 3, 2021 at 8:47 am

          Once again, Milhouse offers sanity to the ranters here. And gets down voted for it! Never ceases to amaze what passes for coherent thought on this site.

        If anyone asks me for my vaccination card, i will tell them “All my important papers are in my safe, next to my AR-15. Where is your green card? because American citizens do not ask American citizens for papers!”

      ….but….that’s NOT what the left will do here. You will SUBMIT!

        CommoChief in reply to audax. | September 3, 2021 at 8:31 am

        Will I? Will others? Who will make us? Will we allow ourselves to be made? How will we be made? If we allow it today does that preclude consequences in the future for the folks pushing this? What form will those consequences take?

        I would submit that live and let live is a much more healthy course for our Nation. Today it’s Rona and vax/masks. What’s on the mandatory agenda tomorrow?

        SField in reply to audax. | September 3, 2021 at 11:04 pm

        Nah, not happening.

    Dathurtz in reply to healthguyfsu. | September 2, 2021 at 8:01 pm

    We disagree, but I think there is room for honest disagreement here. Especially because it basically boils down to a trust issue.

    As long as you don’t try to make me and mine get the covid vax, I’m good with ya even if we disagree.

These Vaccine Regulators should serve as role models for the Army’s senior leadership.

Are the cake!!!

https://thefederalist.com/2021/09/02/candace-owens-i-was-denied-a-covid-test-because-of-what-i-believe/

Since the government is paying for these tests, isn’t this against the law?

“It is nice to know that people within the FDA actually give a damn about their job and the well-being of people”

If that were true the FDA would have halted the vaccine about 13,000 (official count, real count much, much higher) deaths ago. The SARS vaccine was halted at 53 deaths.

That’s just the immediate deaths. The five year survival rate of heart inflammation is about 33%, so that’s thousands more deaths (mostly of men, so not much of concern to a good progressive) coming in the future just from that single side effect. Probably many more undiagnosed cases caused by the vaccines, especially among those aged 50+. It makes no sense that the vaccines would cause heart inflammation in the young more than the old, because age pretty much always makes you more vulnerable to anything not less. None of those deaths will be attributed to the vaccine though, too much riding on hiding the true risks of the covid vaccines, and it’s too easy to say “5 years later, nothing to see here”.

That’s just one side effect. The vaccines also cause kidney inflammation, and kidney failure is awful not to mention frequently lethal.

The vaccines have been claimed to be safe for pregnant women, but I’m pretty sure nobody has studied if the spike proteins cross the placental barrier. Not that it matters, what with them talking about experimenting with the vaccine on babies.

Sorry, I’m with Biden on this one. Or rather, his side is the lesser of two evils here. The real enemy is civil servants who forget that they work for the president and think they are the real government, and so resent when the president “interferes” with their jobs. For better or worse he is the president, and they’re his employees, and therefore whether he’s wise or foolish he gets to tell them what to do. And that principle is more important than the specific issue at hand here, or than the fact that this president is working against the public interest and has both the IQ and the integrity of a slug.

    CommoChief in reply to Milhouse. | September 3, 2021 at 8:47 am

    Milhouse,

    I mostly agree. The fed employees have forgotten that they don’t make policy. Policy is made by POTUS and his senior political appointees. The fact is the fed employees should give recommendations and their best advice based upon their specific expertise. Then execute the decisions made.

    Once those recommendations are made they either accept the decisions made by the elected POTUS or resign. Make a stink post resignation if they feel strongly,

    henrybowman in reply to Milhouse. | September 8, 2021 at 8:25 pm

    In my opinion, it’s way past time for a Democrat to be getting kneecapped by it.

How often do we need to take our other vaccines? Polio, measles, rubella, smallpox etc??

Why don’t we? A: Because they actually work

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