Trouble at FDA as Scientists Disagree on Covid Booster Plan

On Tuesday, September 1, two of the FDA’s top vaccine regulators quietly stepped down. There have been reports that there has been internal turmoil and disagreements with the agency and lack of autonomy with regards to Covid-19 booster planning.

Political pressure continues to affect scientific work. Both Dr. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy, Philip Krause, sent in their resignations, with the FDA framing the departures as retirement effective October 31. Gruber had been with the department for 32 years. The FDA memo thanked them for their service but did not explain their departure.

According to a report published by Politico, “ 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 familiar with the matter say tensions have been bubbling under the surface as the Biden administration’s top-down approach to boosters has frustrated many of the FDA employees.

Politico spoke with 11 current and former health officials who are familiar with this matter who reported being fed up with the administration’s chaotic process for implementing the booster plan. Sources say, “There is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout.”

Currently, the booster is only recommended for immunocompromised people, such as organ recipients. Pfizer is the only company that has applied to FDA for permission to offer a booster. Moderna and Johnson & Johnson intend to seek approval but have not currently done so. “While third doses are still only authorized for immunocompromised people…others who don’t fit into that category have plunged ahead with additional vaccinations under the mistaken notion that FDA has already given the green light,” reports Daily Wire.

The Biden Administration announced the booster rollout as early as September 20. Some CDC committee members were frustrated by this announcement before scientists, and federal regulators fully endorsed the shots. They fear this announcement could lead to even more vaccine hesitancy.

In a Tuesday press Briefing, Jeff Zients, The White House Coronavirus Response Coordinator, backed up FDA as the regulatory “gold standard.” “[The booster] decision was made by and announced by the nation’s leading public health officials… and as our medical experts laid out having reviewed all the available data, it is in their clinical judgment that it’s time to prepare Americans for a booster shot,” he said.

 

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