Health and Human Services Secretary Robert F. Kennedy, Jr., may be pulling ahead in the race to be the most active agency head during President Donald J. Trump's second term.
Last week, Kennedy appeared before both the House Appropriations Committee and the Senate Health, Education, Labor, and Pensions (HELP) Committee and gave a masterclass in how to answer inane Democratic narrative-based questioning. He also ordered a review of abortion pill safety data, worried that the real statistics indicated more adverse effects than originally advertised.
Now, the HHS has discontinued the Centers for Disease Control and Prevention (CDC) recommendations that children, teenagers, and pregnant women receive routine COVID-19 vaccinations.
This marks a significant shift in federal health policy, moving away from the universal vaccination guidance that has been in place since September 2023. The new rules also promote a new framework for the testing of annual vaccines.
According to a report published Tuesday morning by The Associated Press, the Food and Drug Administration (FDA) would recommend annual booster shots for adults over the age of 65 in addition to younger adults and children whose pre-existing conditions or health concerns put them at greater risk of hospitalization or death from contracting COVID-19.
An article published on Tuesday by the New England Journal of Medicine provides a framework for developing and testing annual vaccines that might eventually be offered to generally healthy people who don't fall into the currently recommended age and risk categories.
"For all healthy persons -- those with no risk factors for severe Covid-19 -- between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted," the article read. "Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment."
Dr. Vinay Prasad described the new approach as a "reasonable compromise" that will allow vaccinations in high-risk groups to continue while generating new data about whether they still benefit healthier people.
"For many Americans we simply do not know the answer as to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster," said Prasad, who joined the FDA earlier this month. He previously spent more than a decade in academia, frequently criticizing the FDA's handling of drug and vaccine approvals.
This move is as a major win for the Make America Healthy Again (MAHA) contingent of the Trump coalition.
As I have noted, the COVID-19 coronavirus is a quick-mutating entity that will continue to be endemic. We will all get several COVID-19 infections throughout our lives, and clearly, the vaccinations did not prevent the disease.
The only sane policy is to allow people to make fully informed choices about being vaccinated based on their own personal risk factors.
Perhaps the most important aspect of the new policy is the "new framework" being considered for fall and winter recommendations for COVID-19 vaccinations, which has already impacted the approval process for one of the COVID-19 vaccines offered.
FDA staffers were poised to approve Novavax's vaccine early last month but the decision was delayed by administration officials, including [FDA Commissioner Marty Makary, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss agency matters. The shot was approved late Friday with unusual restrictions.
Dr. Tracy Beth Hoeg -- a political appointee serving as Makary's special assistant -- was involved in the unprecedented demand that Novavax conduct a new clinical trial of its shot after approval, according to the people. The requirement came shortly after the agency's longtime vaccine chief, Dr. Peter Marks, was forced to resign.
Hoeg -- along with Makary and Prasad -- spent much of the COVID-19 pandemic criticizing the FDA's handling of booster shots, particularly in children and young adults. All three were co-authors of a 2022 paper stating that requiring booster shots in young people would cause more harm than benefit.
This sane guidance is certainly better than the "Winter of Death" Biden threatened us with.