Official FDA vaccine has restricted approvals of the CACCIDE vaccine against the advice of the agency staff
Washington – The best official of the government’s vaccine working under the Secretary of Health, Robert F. Kennedy Jr., recently limited the approval of two COVID-19 vaccines, without taking into account the recommendations of government scientists, according to federal documents published on Wednesday.
The new memos of the Food and Drug Administration show how the agency’s vaccination chief, Dr. Vinay Prasad, intervened personally to impose restrictions on the plans of Novavax and Moderna vaccines.
The two vaccines were approved by the FDA in May after months of analysis by basic FDA examinators.
But internal correspondence shows that Prasad disagreed with staff members who planned to approve the shots for every 12 years and more, similar to previous coid vaccines. Scientists had concluded the advantage of vaccines and the risk of COVID-19 prevailed over the risk of possible side effects, which are rare.
Instead, Prasad decided that shots should be limited to those facing special risks of the virus – the elderly or children and adults with underlying medical problems.
Prasad explained that cocovated vaccine services should be reconsidered in light of the drop in death and hospitalization rates and the possibility of side effects of the vaccine. It is the last of a series of vaccine restrictions imposed by those responsible working under Kennedy, who has long questioned the advantages of vaccines.
“Even the misdeeds related to rare vaccination, both known and unknown, are now more likely to prevail over potential advantages,” wrote Prasad in a five -page memo explaining his decision.
COVID-19 remains a public health threat, resulting in 32,000 to 51,000 American deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control and Prevention. Most risks of hospitalization are older people and children under 2 years of age – especially infants under 6 months of age.
The best FDA leaders are generally not involved in examining individual products. Managers like Prasad can cancel employees, but these cases are rare and often controversial.
The news of the FDA documents was reported for the first time by the New York Times.
Prasad was hired to lead the FDA vaccine center in May, after the previous director, Dr. Peter Marks, was forced to resign for disagreements with Kennedy. A university researcher specializing in therapies against cancer, Prasad became important during the pandemic for criticizing public health measures, including the FDA approval of Boosters Covid for adults and healthy children.
Since his arrival at the agency, he has worked with the FDA commissioner, Mark Makary, on new directives that will limit the approvals of future simular boosters to high -risk Americans, mainly elderly and those suffering from medical conditions such as asthma and obesity.
These limits correspond to the terms that the FDA has recently approved for the Novavax shooting, the MNEXSPIKE of Nuvaxovid and Moderna. Novavax vaccine is the only protein -based coronavirus vaccine available in the Moderna American vaccine is a update and low -dose version of its existing mRNA vaccine.
The Novavax vaccine examination team underlined the data from a study in 30,000 adults, concluding that “risk-evantage assessment for this vaccine technology remains favorable”.
The FDA staff have reached a similar conclusion for the modern vaccine, judging it similar in terms of safety and efficiency to the origin of the company.
Last week, the FDA finalized a new warning labeling on the risk of myocarditis, a rare form of cardiac inflammation, on Moderna and Pfizer’s shots, the other manufacturer of a plan based on mRNA for Covid.
In his “replacement memo”, overthrowing the decision of the FDA staff on modern shooting, Prasad underlined the continuous risk of myocarditis and questions about his frequency. The agency ordered Moderna to conduct other risk studies as a condition for the approval of its updated photo.
A spokesman for the administration said that Prasad “had raised serious concerns” concerning the issue.
“We will not ignore these risks and we will ensure that the Order of Sciences is used for all decisions,” said Andrew Nixon, in a statement sent by e-mail.
External researchers have noted that cases of heart disease tend to resolve quickly and are less serious than those associated with an infection itself, which can also cause myocarditis.
___
The Department of Health and Sciences of the Associated Press receives the support of the Department of Science Education from Howard Hughes Medical Institute and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
