Is the FDA “doubling down” on a failed strategy?

 The FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the future of covid vaccines. The panel voted 21 to 0 in favor of moving towards a more simplified vaccine schedule - an annual shot which would be updated as new variants emerge - much like the annual flu shot

Still no correlate of protection

• Three years into the pandemic, the FDA has still not established a "correlate of protection" for the vaccines
• The idea is, the more antibodies produced, the better you are protected
• But neutralizing antibodies do not predict the degree to which someone is protected from infection... and the FDA knows it
• We are at risk of doubling down on a failed strategy
• Ofer Levy, VRBPAC member and Professor of Pediatrics at Boston Children's Hospital, voiced his concern that we may be using poor man's immune correlates of protection here
• Peter Marks, FDA's top vaccine official, agreed that there is not a clear, perfect immune correlate
• Fast forward to this latest meeting, and it becomes clear that we're all still in the dark
• Doctors are refusing to give any more COVID shots until there are better studies

No Update on Subclinical Myocarditis

• Pfizer is obligated to conduct a study involving people aged 16 to 30 to look at rates of subclinical myocarditis (i.e. underlying damage to the heart muscle without causing symptoms).
• The final report was due 31 December 2022, but that deadline lapsed, and the FDA said nothing.
• Jessica Adams, an expert in drug regulatory affairs, pointed out that the FDA had quietly changed the due date for the study to 30 June 2023.

FDA still working from home

• Since all federal employees have been mandated to take the COVID-19 vaccine to "protect themselves and those around them," why aren't they conducting face-to-face meetings?
• "FDA leaders are in a bubble. How much longer will the FDA (18,000-employees) continue to work remotely?" asked Marty Makary, surgeon and public policy researcher at Johns Hopkins University.

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