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.
The businesses submitted information from a clinical trial indicating that the booster shot created a powerful immune response in children 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 kids 5-11 who’ve immune issues.
The effectiveness of Pfizer’s two-dose vaccine course at stopping Covid-19 an infection waned quickly for kids in New York in the course of the Omicron surge, particularly these within the 5-11 age bracket, in line with 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 may assist fight the omicron variant, which brought about a fourfold enhance in youngster hospitalizations, affecting principally unvaccinated youngsters. Omicron can also be extra possible than different coronavirus variants to induce higher airway infections amongst youngsters, elevating the hazard of coronary heart assault, in line with a examine printed April 15 by JAMA Pediatrics. In gentle of this threat, public well being officers have labored to broaden Covid-19 therapies for younger youngsters. April 25, the FDA authorized Covid-19 antiviral remdesivir for kids 28 days and older, making remdesivir the primary Covid-19 therapy totally authorized for kids beneath 12. Different therapies, together with Eli Lilly’s monoclonal antibody remedy bamlanivimab, had already acquired a extra conditional emergency use authorization to be used on youngsters beneath 12.
“87% Of Youngsters Hospitalized With Covid Throughout Omicron Wave Have been Unvaccinated, CDC Says” (Forbes)