Moderna, Inc. announced a significant milestone in its fight against COVID-19 with the U.S. Food and Drug Administration's (FDA) full approval of its Spikevax® vaccine for children aged 6 months through 11 years who are at increased risk for COVID-19 disease. This approval, transitioning Spikevax from an Emergency Use Authorization (EUA) to a full Biologics License Application (sBLA) for this specific age group, underscores the FDA's confidence in the vaccine's safety and efficacy. Previously, Spikevax had been available for pediatric populations under an EUA, and its full approval now solidifies its role as a key protective measure for vulnerable young individuals.
Moderna's CEO, Stéphane Bancel, emphasized the ongoing threat COVID-19 poses to children, particularly those with pre-existing medical conditions, highlighting vaccination as a crucial tool to prevent severe disease and hospitalization among the youngest. The company expressed its appreciation for the FDA's thorough scientific review that led to this approval.
This latest approval broadens the established indications for Spikevax. The vaccine is already fully approved for all adults aged 65 years and older, and for individuals aged 6 months through 64 years who are at high risk for severe COVID-19. This comprehensive range of approvals ensures that Spikevax is a viable option for a wide spectrum of vulnerable populations, aligning with public health efforts to reduce the burden of COVID-19 across different age groups and risk profiles.
Moderna is actively working to make its updated Spikevax vaccine readily available for eligible populations across the U.S. for the upcoming 2025-2026 respiratory virus season. This proactive step aims to provide timely protection against circulating COVID-19 variants as seasonal respiratory illnesses become more prevalent.
As a leader in mRNA medicine, Moderna has dedicated over a decade to advancing mRNA technology, revolutionizing how medicines are developed and transforming disease prevention and treatment. The company's rapid development of a highly effective COVID-19 vaccine, mRNA-1273 (Spikevax), exemplifies its commitment to leveraging its mRNA platform for infectious diseases, immuno-oncology, rare diseases, and autoimmune conditions. Driven by its core values, Moderna continues its global efforts to responsibly shape the future of human health through innovative mRNA medicines.
It is important to note that while vaccination with Spikevax offers significant protection, it may not protect every individual who receives the vaccine. As with all vaccines, recipients should be aware of potential side effects and consult with healthcare providers regarding their individual risk factors and the suitability of vaccination.