The U.S. recommends 72 vaccine doses for children from birth to 18, a number significantly higher than 20 other developed nations. To combat falling vaccination rates and rebuild trust, the FDA is now highlighting a "core essential" list of approximately 38 vaccines.
Newly appointed FDA leaders exhibit an ideological "dualism" by promoting unproven therapies like bone marrow stem cells while showing deep skepticism towards vaccines with robust safety data. This signals a concerning shift where regulatory decisions may be driven more by ideology than by rigorous biomedical science, creating uncertainty across the industry.
The CDC's recent decision to remove six pediatric vaccines from its recommended list without input from its advisory committee (ACIP) signals a potential shift in public health governance. This move may sideline traditional scientific bodies, creating a vacuum that other groups, like the American Pediatric Association, are trying to fill.
The CDC's updated website on vaccine safety now states the claim "vaccines do not cause autism" is not evidence-based because studies haven't "ruled out the possibility." This shifts the burden of proof to an impossible scientific standard—proving a negative—which undermines public trust and established evidence.
By leveraging bulk purchasing, Gavi vaccinates children in developing countries for just $24 (compared to $1,300 in the US). This small investment saves one life for every 50-60 children vaccinated, yielding a cost-benefit ratio unmatched in healthcare or philanthropy.
Effective vaccines eradicate the visible horror of diseases. By eliminating the pain and tragic outcomes from public memory, vaccines work against their own acceptance. People cannot fear what they have never seen, leading to complacency and vaccine hesitancy because the terrifying counterfactual is unimaginable.
An ideologically driven and inconsistent FDA is eroding investor confidence, turning the U.S. into a difficult environment for investment in complex biologics like gene therapies and vaccines, potentially pushing innovation to other countries.
The revamped CDC advisory panel (ACIP) is not seeking to ban vaccines outright. Instead, its strategy is to use purported safety concerns to sow public doubt and introduce "regulatory friction." This approach creates confusion and barriers to access, which can be just as effective at reducing vaccination rates as an outright ban.
The FDA is shifting policy to no longer allow reliance on immunogenicity data (immunobridging) for approving new or updated vaccines. This move toward requiring full clinical efficacy trials will make it harder to combat evolving pathogens and would have prevented past approvals of key vaccines like those for HPV and Ebola.
A CDC website statement questioning the evidence base for the "vaccines do not cause autism" claim is now being leveraged by anti-vaccine advocates. The campaign is expanding to target vaccines containing aluminum adjuvants, potentially threatening essential public health programs for polio, measles, and pertussis by weaponizing scientific nuance.
The market has broadly punished vaccine stocks, but the US administration's negative focus has been primarily on COVID-19 vaccines. In contrast, recent HHS guidance specifically recommended pneumococcal vaccines for all children, suggesting a positive macro environment for companies like Vaxite.