Moderna's COVID Vaccine Receives Full Approval for At-Risk Children Amid Regulatory Shifts

The Food and Drug Administration (FDA) has granted full approval for Moderna's COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years who are at an increased risk for COVID-19 disease. This approval, announced on Thursday, marks a significant milestone in the ongoing efforts to combat the pandemic, even as regulatory changes reshape the vaccine landscape.

FDA Approval and Vaccine Availability

Spikevax, previously available under emergency use authorization for this age group, now joins the ranks of fully approved COVID-19 vaccines. Moderna anticipates having an updated version of the shot ready for the 2025-2026 respiratory disease season, aligning with the evolving nature of the virus.

The approval comes at a time of regulatory upheaval within the Department of Health and Human Services (HHS). In May, HHS Secretary Robert F. Kennedy Jr. announced that COVID vaccines would no longer be recommended for healthy children and pregnant individuals. This shift has led to a new approach by the Centers for Disease Control and Prevention (CDC), which now recommends shared clinical decision-making for healthy children regarding COVID-19 vaccination.

Regulatory Changes and Industry Impact

The pharmaceutical industry, particularly vaccine manufacturers, faces increased scrutiny under Kennedy's HHS leadership. FDA Commissioner Marty Makary and Deputy Commissioner Vinay Prasad have implemented a new, more stringent vaccine framework. This updated criteria requires drugmakers to gather additional data for approval of booster shots in healthy adults and children, potentially slowing down vaccine development processes.

In a controversial move, Kennedy recently dismissed all 17 members of the CDC's Advisory Committee on Immunization Practices (ACIP), replacing them with his own selected advisers. This new panel, which met earlier this month, has taken a more critical stance on COVID vaccines, aggressively questioning evidence supporting their efficacy and safety.

The regulatory shifts have had a particular impact on Moderna. The company recently withdrew its initial application for a combination influenza and COVID shot in response to the FDA's new approval rules. However, recent study data may provide a path for Moderna to resubmit its application.

Despite the regulatory challenges, Moderna's stock rose by more than 3% on Thursday morning following the FDA's approval announcement for Spikevax in at-risk children.