FDA APPROVES NEW AND UPDATED COVID-19 VACCINES

FDA Approves New and Updated Covid-19 Vaccines

The U.S. Food and Drug Administration (FDA) announced the approval of new COVID-19 vaccines for both adults and children for the 2024-2025 season.

 

Among these FDA approvals:

  • COMIRNATY® vaccine for adults, developed by BioNTech and Pfizer
  • A vaccine for children aged 6 months to 11 years, developed by Pfizer and BioNTech
  • An updated SPIKEVAX™ vaccine for adults, developed by Moderna
  • A new formula specifically designed for children aged 6 months to 11 months by Moderna

Emergency room visits for COVID-19 among working-age individuals (ages 18 to 64) hovers around 2%. The overall U.S. death rate remains 5% to 10% higher than pre-pandemic levels, influenced by both the direct impact of COVID-19 and its effects on routine healthcare and the broader healthcare system.

 

EMPLOYER CONSIDERATIONS

Employers offering fully funded health plans and self-insured employer-sponsored health plans are required by the Affordable Care Act to cover these vaccinations without any cost-sharing for patients.