In February last year, Robert F. Kennedy Jr was sworn in as US Secretary of Health and Human Services, bringing a longstanding scepticism of vaccine safety and efficacy into federal health policy.
During the past 12 months, his leadership has translated into tangible funding and governance changes that have adversely affected mRNA vaccine programmes.
In May, a $590m federal contract supporting Moderna’s bird flu vaccine candidate was cancelled.1 This was followed by a restructuring of the national immunisation advisory board, including the removal of all 17 members and subsequent guidance emphasising individual decision-making instead of blanket COVID-19 vaccination recommendations.
In August, the Department halted an additional $500m in vaccine development funding, impacting 22 projects and signalling that no new mRNA initiatives would be supported under current priorities. The administration stated that resources would be redirected toward alternative vaccine platforms that were considered to be more resilient to viral mutation.2
Regulatory and commercial impact
This marked change in policy tone has caused headwinds for companies that have invested heavily in the technology. Moderna recently disclosed that the FDA declined to review its application for its mRNA-1010 seasonal influenza vaccine, citing limitations in trial design and comparator selection.3 The refusal-to-file decision would have had implications beyond a single asset.
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