“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.DONATE
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