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FDA chief wary of federal recommendations for Covid-19 vaccines

FDA chief wary of federal recommendations for Covid-19 vaccines

Politico2 days ago

Dr. Marty Makary, commissioner of the FDA, on Sunday made it clear he was dubious of previous federal recommendations on Covid-19 vaccinations and the agencies who made them.
In an interview with host Margaret Brennan of CBS' 'Face the Nation,' Makary responded to repeated requests from Brennan to clarify federal guidance (or the lack thereof) with variations on the same answer. 'We believe the recommendation should be with a patient and their doctor,' he said at one point, declining to give specific advice — or specifying how doctors might be able to offer guidance in the absence from direction from the federal government.
Brennan was seeking clarity from Makary in the aftermath of Health and Human Services Secretary Robert F. Kennedy Jr.'s announcement that Covid-19 vaccines would no longer be recommended for healthy children and pregnant women. The CDC subsequently offered updated advice that somewhat countered what Kennedy said but also left room for interpretation.
Makary there needed to be more controlled studies, so that decisions to approve vaccines would be more authoritative.
The CBS host tried to get Makary to say what was lacking in the current data for such vaccines, and when that information might be available to the agency, as well as the general public.
In his answers Sunday, Makary was not supportive of past guidance, criticizing the methodology of the CDC.
'We know the CDC data is contaminated with a lot of false positives from incidental positive Covid tests with routine testing of every kid that walks in the hospital,' he told Brennan.
Makary also cast doubt on the CDC's Advisory Committee on Immunization Practices. 'That panel has been a kangaroo court where they just rubber-stamp every single vaccine put in front of them,' he said.
At the time he was nominated in November, Makary was a Johns Hopkins surgeon who was best known for his criticism of the Biden administration's response to Covid, something for which Kennedy was also known. Trump said Makary was needed because 'the FDA has lost the trust of Americans.' Makary, he said, would 'course-correct' the agency.
On Sunday, when it came to discussing the shots and pregnant women, Makary was a model of consistency in his contention that the decision was a personal matter between a patient and her doctor. Brennan and Makary had this exchange:
Brennan: 'It is still unclear what pregnant women now should do until they get the data that you say.'
Makary: 'I'd say talk to their doctor.'
Brennan: 'When do they get the data you're promising? All these controlled studies.'
Makary: 'In the absence of data, they should talk to their doctor ...'
Brennan: 'So no date?'
Makary: "... and their doctor will use their best wisdom and judgment.'

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