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There now appear to be a couple of casualties of the politicization of the FDA: Marion Gruber and Phil Krause, respectively the director and deputy director of the Office of Vaccines Research and Review. These gentlemen have resigned from the FDA, apparently over the political pressure for vaccine approval and use.
The particular issues appear to be Biden’s public announcement that he will be pushing boosters for everyone as of the third week in September, despite lack of FDA approval for such use (the FDA has approved the vaccine boosters for immunocompromised individuals only). Another issue appears to be the pressure on the FDA to approve vaccines for children. Also, it appears these officials objected to the CDC driving vaccine policies while infringing on FDA authority. No mention is made regarding the pressure for full FDA approval of the vaccines (superseding the EUA) which was announced about a week ago.
One wonders if that rush to full approval was part of the problem that led to these resignations. There are a number of straws that could have broken the camel’s back in regard to recent (as well as long-standing) FDA behavior, which has always factored in a large political component and pressures unconnected to the “science” that is supposed to underpin drug and vaccine approval.
These resignations are a blow to confidence in the FDA, the CDC, the Biden administration (confidence in which is plummeting due to the Afghan pull-out debacle), and in the use of the vaccines. These resignations won’t help encourage the vaccine-hesitant to get vaccinated, nor those already vaccinated to get the boosters. To the contrary. The resignations will tend to sow confusion and chaos in the Administration’s approach to COVID-19. Not surprising for this Administration.
I for one am impressed that there exist officials in the Federal Government with sufficient backbone to stand up and say enough is enough. It’s a tragedy that no one with such integrity exists in the Defense Department, the Joint Chiefs of Staff, or the State Department.Published in