An FDA announcement means COVID-19 vaccines are one step closer to being approved for young children, according to AP News.
- Pfizer: The FDA reported on Sunday that Pfizer’s kid version of the COVID-19 vaccine appears to be safe and effective for kids younger than 5.
- Moderna: Last week, the FDA released a similarly positive analysis about Moderna’s shots for children under 6.
Eligibility: Kids younger than 5 are the only group not eligible for COVID-19 vaccinations in the U.S. If the kid-sized doses are approved, 18 million babies, toddlers and preschoolers will become eligible for COVID-19 vaccination.
What’s next: On Wednesday, the FDA will make its official decision after an independent panel of vaccine experts debates both companies’ data.
- Assuming the FDA votes “yes,” the CDC will convene its own panel and make recommendations on how to use the vaccines.
- If regulators approve the shots, vaccinations could begin as soon as next week with drugmakers ready to quickly ship doses ordered by the government.
Why it matters: Experts say vaccinating America’s youngest children is important because COVID-19 hospitalization and death rates are higher in that group than among older children.
In related news: A vaccine designed to fight the omicron variant of COVID-19 produced a strong response in two new studies, offering new tools to fight the virus amid continuing mutations, according to The Wall Street Journal (subscription). Sanofi and GSK developed the vaccine.