https://justthenews.com/government/federal-agencies/medical-experts-question-fdas-evidence-second-covid-booster-refusal
he federal government’s enthusiasm for COVID-19 vaccine boosters is not matched by some of its outside advisers and other medical professionals, including the head of a leading medical journal who questions the evidence behind the decisions in the past several months.
The Food and Drug Administration on Tuesday authorized a fourth mRNA dose for ages 50 and older, expanding its availability beyond immunocompromised people, without input from its Vaccines and Related Biological Products Advisory Committee.
The Centers for Disease Control and Prevention followed hours later without consulting its Advisory Committee on Immunization Practices.
The FDA previously overruled VRBPAC in November by authorizing a third mRNA dose for ages 16 and older. The agency’s top two vaccine officials, Marion Gruber and Philip Krause, resigned earlier in the fall when the Biden administration promoted boosters for all adults before the agency could weigh in.
Johns Hopkins University medical professor Marty Makary, a member of the National Academy of Medicine, asked sarcastically whether “bypassing the typical voting process” of the VRBPAC was “following the science.”
Instead, the agency plans to convene its outside experts to “discuss” the FDA’s decision, which is like “a judge issuing a verdict and then having lawyers make their arguments,” Makary wrote in a tweet thread.
“There is zero clinical data that a 4th dose reduces hospitalization risk,” he said. “There isn’t even any evidence that a 3rd dose reduces hospitalization risk in young people.”
VRBPAC member Eric Rubin, editor in chief of The New England Journal of Medicine, told CNN he has only seen fourth-dose data “for participants followed for just a few weeks.” The committee needs to know how well it protects “highly vulnerable people against serious disease and death.”