Topline
Pfizer and BioNTech Tuesday requested emergency use authorization from the Meals and Drug Administration for a booster shot of their Covid-19 vaccine for teenagers aged 5-11, within the newest effort to increase safety to youthful youngsters, who’ve been put at larger threat of hospitalization by the omicron variant.
A baby receives a dose of the Pfizer-BioNTech’s Covid-19 vaccine.
NORBERTO DUARTE/AFP by way of Getty Photos
Key Details
The businesses submitted information from a clinical trial indicating that the booster shot created a robust immune response in youngsters with out introducing new security dangers.
Pfizer and BioNTech mentioned they plan to submit information to the European Medicines Company and to different worldwide regulatory businesses in the course of the subsequent few weeks.
The FDA has already authorized a Pfizer booster shot for youngsters 5-11 who’ve immune issues.
Key Background
The effectiveness of Pfizer’s two-dose vaccine course at stopping Covid-19 an infection waned quickly for youngsters in New York in the course of the Omicron surge, particularly these within the 5-11 age bracket, in response to data from the New York State Division of Well being, nevertheless, the vaccine remained effective at stopping extreme illness and an infection. The FDA authorized a Pfizer-BioNTech booster shot for teenagers 12-15 January 3, saying that the shot might assist fight the omicron variant, which induced a fourfold improve in little one hospitalizations, affecting principally unvaccinated youngsters. Omicron can be extra possible than different coronavirus variants to induce higher airway infections amongst youngsters, elevating the hazard of coronary heart assault, in response to a research printed April 15 by JAMA Pediatrics. In mild of this threat, public well being officers have labored to develop Covid-19 remedies for younger youngsters. April 25, the FDA authorised Covid-19 antiviral remdesivir for youngsters 28 days and older, making remdesivir the primary Covid-19 therapy absolutely authorised for youngsters below 12. Different remedies, together with Eli Lilly’s monoclonal antibody remedy bamlanivimab, had already obtained a extra conditional emergency use authorization to be used on youngsters below 12.
Additional Studying
“87% Of Youngsters Hospitalized With Covid Throughout Omicron Wave Have been Unvaccinated, CDC Says” (Forbes)
