Welcome news for anxious parents eager to have their kids vaccinated against COVID-19…
Pfizer and BioNTech said Monday that a lower dose of their COVID-19 vaccine induces a robust immune response in 5 to 11 year olds, and they plan to ask for authorization – from the FDA and other regulators - as soon as possible.
Clinical trials showed the Pfizer vaccine was well-tolerated, and generated an immune response in 5 to 11 year-olds, as it had in the older age range. The dose for younger kids was one-third the size.
The companies said the safety profile was also generally comparable.
Top U.S. health officials believe regulators could make a decision on whether a lower dose shot is safe and effective for this age group within three weeks of the companies submitting a request for authorization, according to sources.
A rapid authorization in the U.S. could help stem a potential surge of coronavirus cases in the fall, with schools open across the country.
Pediatric cases have risen sharply in recent months - as have hospitalizations - due to the highly contagious Delta variant.