Overview

• The FDA has granted full approval to Moderna’s Spikevax for children aged six months to 11 years who face elevated risks from COVID-19.
• Under the approval, eligibility is limited to pediatric patients with underlying health conditions rather than a universal recommendation.
• The CDC endorses updated COVID-19 vaccines for all individuals aged six months and older through shared clinical decision-making between clinicians and families.
• Moderna anticipates its reformulated Spikevax will be ready for the US 2025–26 respiratory virus season.
• On July 7, a coalition of doctors’ and public health groups sued the government over the removal of vaccine recommendations for healthy children and pregnant women.