Medical groups sue RFK Jr. over COVID-19 vaccine policy shift

Concerns over regulatory bypass

Filed in Massachusetts federal court, the lawsuit argues that Kennedy unlawfully bypassed the Advisory Committee on Immunization Practices (ACIP), the CDC body statutorily mandated to provide evidence-based vaccine recommendations.

Kennedy previously removed all 17 ACIP members, replacing many with individuals holding anti-vaccine viewpoints, a move critics say undermines established scientific and regulatory processes.

The complaint emphasizes the lack of any declared emergency or credible scientific evidence justifying the change, citing extensive peer-reviewed data supporting COVID-19 vaccine safety and efficacy among children and pregnant individuals.

The key issues highlighted in the lawsuit include the following:

• A lack of declared emergency or scientific rationale.
• Insurance reimbursement complications.
• Increased complexity and burden on healthcare providers.

Industry implications

Given this recent shift in policy, experts anticipate potential declines in vaccine demand among pediatric and maternal populations due to reduced public trust.

The lawsuit also highlights industry concerns about increased regulatory uncertainty, which could complicate clinical trial planning, disrupt vaccine pipeline developments and cause reputational challenges for companies associated with vaccine advocacy.

Looking ahead

Industry stakeholders are closely monitoring this legal action, recognizing it could set a precedent encouraging further litigation against regulatory decisions -- potentially affecting approval timelines and rollout strategies.

The plaintiffs have requested an expedited preliminary injunction, aiming for resolution by September. A favorable ruling could compel the reinstatement of CDC-backed COVID-19 vaccine recommendations for healthy children and pregnant people.

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