FDA Backs mRNA Vaccines, But Taxpayers Shouldn't Pay, Says Commissioner Makary

• HHS cut more than $700 million in Moderna funding for mRNA vaccines against pandemic threats like bird flu, despite an ongoing outbreak infecting workers
• Makary argued companies making mRNA vaccines earned over $50 billion and should self-fund research rather than rely on taxpayers
• The FDA has approved two mRNA vaccines for RSV from Moderna and GSK during Makary's tenure, and he expressed interest in reviewing mRNA cancer treatments

Summary

FDA Commissioner Marty Makary defended the agency's support for mRNA vaccine technology while justifying the decision to end taxpayer funding for its development. Speaking at a February 23 event, Makary stated that pharmaceutical companies generating over $50 billion from mRNA vaccines should fund their own research rather than relying on taxpayers.

Key Policy Changes:

The U.S. Department of Health and Human Services (HHS) has significantly reduced mRNA funding, including canceling over $700 million allocated to Moderna in May for developing vaccines against pandemic-potential pathogens like bird flu. HHS Secretary Robert F. Kennedy Jr., a known vaccine skeptic, had claimed mRNA vaccines "fail to protect effectively" against respiratory infections, contradicting scientific consensus.

Companies Affected:

• Moderna: Lost $700+ million in government funding; received FDA approval for RSV vaccine
• GSK: Also received RSV mRNA vaccine approval
• Pfizer/BioNTech: Self-funded their COVID mRNA vaccine development
• Merck: Collaborating with Moderna on mRNA-based cancer treatment combined with Keytruda

FDA's Position:

Despite funding cuts, the FDA approved two mRNA RSV vaccines during Makary's tenure and expressed interest in mRNA applications for cancer and other conditions. Makary argued government research funding should prioritize underfunded areas like rare diseases rather than technologies profitable companies can self-finance.

Market Implications:

The policy shift signals reduced government support for mRNA vaccine development, potentially impacting future pandemic preparedness. Companies must now rely more heavily on commercial funding, which could slow innovation in less profitable therapeutic areas while the government redirects resources toward orphan diseases.