RFK Jr.’s top FDA vaccine formula limits approval of two co-bid vaccines against agency scientists’ advice
A new memo from the Food and Drug Administration shows how the agency’s vaccine chief Dr Vinai Prasad personally intervened. Covidshot from vaccine makers Novavax and Modern.
Both vaccines were approved by the FDA in May after months of analysis by Rank and File FDA reviewers.
However, internal communications show that Prasad, like the previous Covid vaccine, opposed staff who planned to approve shots for everyone over the age of 12. Scientists have concluded benefits from the vaccine, and the risk of Covid-19 outweighed the risk of potential side effects.
Instead, Prasad decided that the shot should be restricted to people facing special risks from the virus, such as elderly people with underlying medical problems, children and adults.
Prasad explained that the benefits of the Covid vaccine must be reconsidered in light of lower mortality and hospitalization rates and the likelihood of vaccine side effects. It’s the latest A series of vaccine restrictions It was imposed by officials working under Kennedy. Kennedy has long questioned the benefits of the vaccine.
“Even things related to rare vaccinations are more likely to outweigh the potential benefits at present by causing harm, both known and unknown,” Prasad wrote in a five-page memo explaining his decision.
Covid-19 remains a public health threat, bringing 32,000 to 51,000 US deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control and Prevention. Most of the risk of hospitalization is for elderly people under the age of 2 and children, especially babies under the age of 6 months.
Typically, top FDA leaders are not involved in reviewing individual products. Officials like Prasad can overturn staff, but in such cases it is rare and often controversial.
News from the FDA document was first reported by The New York Times.
Prasad was hired to lead the FDA vaccine centre in May after former director Dr. Peter Marks was forced to step down from his disagreement with Kennedy. Academic researcher Specializing in cancer therapyPrasad became prominent during the pandemic to criticize public health measures, including the FDA’s approval of Covid boosters for healthy adults and children.
Since arriving at the agency, he has worked with FDA Commissioner Mark McCurry. New guidelines restricted The approval of future Covid boosters is for higher-risk Americans, primarily seniors, and those with medical conditions such as asthma and obesity.
These restrictions are consistent with the term FDA recently approved in Novavax Shot, Nuvaxovid and Moderna’s Mnexspike. The Novavax vaccine is the only protein-based coronavirus vaccine available in the US Moderna vaccine. It is the latest low-dose version of existing mRNA-based vaccines.
The Novavax vaccine review team pointed to data from a study of 30,000 adults and concluded that “risk benefit assessments for this vaccine technology remain favorable.”
FDA staff came to similar conclusions about the Moderna vaccine, finding it to be similar in safety and efficacy to the company’s original shots.
Last week, the FDA said that risk of myocarditis, rare forms of heart inflammation, and a shot of moderna Pfizeranother manufacturer of Covid’s mRNA-based shots.
Reversing the FDA staff’s decision on his “override memo”, Modanya Shot, Prasad pointed to questions about the continued risk of myocarditis and its frequency. The agency ordered Moderna to conduct further research into the risk as a condition for approval of the updated shot.
A government spokesman said Prasad has “stood concerns” about the issue.
“We do not ignore these risks and ensure that the gold standard of science is used in every decision,” Andrew Nixon issued an email statement.
External researchers have pointed out that cases of heart conditions tend to resolve quickly and are less severe than cases associated with COVID infection itself, which can cause myocarditis.