FDA Approves Moderna's Next-Generation COVID-19 Vaccine with Limited Use

The Food and Drug Administration (FDA) has granted approval to Moderna's new COVID-19 vaccine, mNexspike, marking a significant development in the ongoing fight against the pandemic. However, the approval comes with restrictions that limit its use to specific population groups.

Approval Details and Vaccine Specifications

Moderna's mNexspike has been cleared for use in healthy adults aged 65 and older, as well as individuals between 12 and 64 years old who have underlying risk factors. The vaccine, which is targeted at the JN.1 coronavirus variant, is expected to be available in the fall of 2025.

The FDA's decision was based on data from a Phase 3 study comparing mNexspike to Moderna's original vaccine, Spikevax. Results showed that mNexspike was "non-inferior" to Spikevax overall and slightly more effective in people over 12 years old on a relative basis.

Moderna CEO Stéphane Bancel hailed the new vaccine as an "important new tool" in protecting people from COVID-19, citing that over 47,000 individuals in the United States died from the disease in the previous year.

Regulatory Landscape and Policy Changes

The approval of mNexspike comes amid a shifting regulatory landscape for COVID-19 vaccines. FDA Commissioner Martin Makary and top vaccine official Vinay Prasad recently announced that the agency would require placebo-controlled trials for new COVID-19 shots in healthy children and adults, departing from previous practices of accepting comparative immune data for some decisions.

Additionally, Health and Human Services Secretary Robert F. Kennedy Jr. stated that the Centers for Disease Control and Prevention (CDC) would remove COVID-19 shots from the recommended immunization schedules for pregnant women and healthy children. However, subsequent CDC communications have indicated that the shots remain an option for children, creating some confusion in messaging.

Industry Implications and Future Outlook

The approval of mNexspike is seen as an "incremental positive" for Moderna, according to Jefferies analyst Michael Yee. It demonstrates that FDA leaders remain "rational" in their approach to vaccine approvals, provided that data packages show good efficacy and are well-conducted.

However, concerns remain about Moderna's ability to meet its sales guidance due to persistently low vaccination rates. The pharmaceutical industry is closely watching how these regulatory changes and market dynamics will impact the development and distribution of future COVID-19 vaccines.

Advisers to the CDC are scheduled to meet in late June to discuss COVID-19 vaccine use recommendations for the upcoming fall and winter seasons, which may provide further clarity on the role of mNexspike and other vaccines in ongoing pandemic management efforts.