CDC Director fired as FDA restricts COVID-19 vaccine use

Undermining vaccine policy

Before Monarez's confirmation, HHS Secretary Robert F. Kennedy Jr., a well-known vaccine critic overseeing the CDC, took sweeping actions against vaccine policy during the role's vacancy.  

In May, RFK Jr. ended COVID-19 vaccine recommendations for healthy children and pregnant people after universal booster recommendations were eliminated for individuals aged between 6 months and 64 years without risk factors.

The following month, he removed all 17 members of the CDC's Advisory Committee on Immunization Practices (ACIP) and replaced them with hand-picked panelists who lack vaccine expertise or are skeptics.

Then, several weeks ago, Kennedy cut $500M in BARDA-funded mRNA vaccine research.

Monarez's legal team accused the administration of undermining public health protections for political gain.

"First it was independent advisory committees and career experts. Then it was the dismissal of seasoned scientists. Now, Secretary Kennedy and HHS have set their sights on weaponizing public health for political gain and putting millions of American lives at risk," Monarez's lawyers said in a statement posted on Bluesky.

"When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda," they continued. "For that, she has been targeted."

The turmoil has triggered further instability within the agency, resulting in the resignation of four top CDC officials who oversaw vaccine recommendations, including Debra Houry, chief medical officer; Daniel Jernigan, flu specialist and director of the National Center for Emerging and Zoonotic Infectious Diseases; Jennifer Layden, head of the Office for Public Health Data, Surveillance and Technology; and Demetre Daskalakis, HIV physician and director of the National Center for Immunization and Respiratory Disease.

Updated COVID-19 vaccines

Monarez's termination occurred the same day the FDA revoked emergency use authorization for COVID-19 vaccines, granting Pfizer, Moderna and Novavax restricted approval for use in adults over 65 and younger individuals who have one high-risk health condition, such as obesity or asthma.

Previously, the agency recommended that all people six months and older receive an annual COVID-19 vaccine.

The FDA's revised COVID-19 vaccine guidelines are expected to be reviewed at ACIP's September meeting, though no formal date has been set.

Typically, the CDC director reviews the committee's recommendations before adoption, with authority to approve, modify or reject any proposal.

Industry implications

Ongoing disruptions within public agencies like the FDA and CDC could delay the rollout of new vaccines or updated formulations, creating obstacles for manufacturers that rely on federal guidance for commercialization, distribution and reimbursement.

Restricted FDA approvals also limit the eligible population, potentially reducing vaccine uptake and revenue for vaccine makers, while complicating supply chains and production planning.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.