Key Points:
FDA fully approves Moderna’s COVID-19 vaccine for high-risk kids 6 months to 11 years.
CDC. recommends use via physician-parent consultation, but no longer advises it in all children.
HHS policy shift, including restructuring advisory panel, has been challenged by medical societies.
Key Background :
Moderna Spikevax vaccine, the object of US pandemic policy, has finally moved from emergency to standard regulation for younger children who are most at risk from COVID-19. They include children who have underlying medical conditions or with immune-compromised illness. The new authorization guarantees that such high-risk groups will continue to have access to the vaccine before seasonal respiratory epidemics.
The approval is a symbol of continued controversy surrounding public health policy. The administration of HHS Secretary Robert F. Kennedy Jr. has released sweeping changes, most notably the firing of all 17 members of the CDC vaccine advisory panel. The move has prompted medical societies to go to court with lawsuits, causing concern over political interference in science-based advice.
During Kennedy’s time, the CDC also altered its policy for routine COVID-19 vaccination. While as much as the vaccine is no longer routinely administered to healthy children and pregnant women, the agency specifically said that the vaccine is still accessible to individuals who, upon advice from their physicians, decide that it is suitable. This transition is from a one-size-fits-all framework to more of a tailored framework.
Assisting the maddening regulatory apparatus, Dr. Vinay Prasad, now head of the FDA’s vaccine center, overrode staff guidance for general approvals and instead limited both Novavax and Moderna COVID-19 vaccines to high-risk populations. Prasad invoked side effects of vaccination, including myocarditis, and reduced need due to reduced hospitalizations.
Such policy revisions have left providers and the public confused as agencies give out conflicting advice. Nonetheless, FDA’s full approval of Spikevax in high-risk children does extend some degree of protection to vulnerable families, particularly prior to seasonality of return of the virus.
The market reacted positively, as Moderna stock rose modestly, as investors bet on future possible use of the vaccine. However, the final influence of the coming regulatory landscape remains to be seen, since scientific, political, and public interests continue to cross in formulating U.S. vaccine policy.
