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 youngsters with out introducing new security dangers.
Pfizer and BioNTech stated they plan to submit information to the European Medicines Company and to different worldwide regulatory businesses throughout the subsequent few weeks.
The FDA has already authorized a Pfizer booster shot for kids 5-11 who’ve immune problems.
The effectiveness of Pfizer’s two-dose vaccine course at stopping Covid-19 an infection waned quickly for kids in New York throughout the Omicron surge, particularly these within the 5-11 age bracket, based on data from the New York State Division of Well being, nonetheless, 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 precipitated a fourfold improve in little one hospitalizations, affecting principally unvaccinated youngsters. Omicron can be extra doubtless than different coronavirus variants to induce higher airway infections amongst youngsters, elevating the hazard of coronary heart assault, based on a research revealed April 15 by JAMA Pediatrics. In mild of this threat, public well being officers have labored to broaden Covid-19 remedies for younger youngsters. April 25, the FDA accredited Covid-19 antiviral remdesivir for kids 28 days and older, making remdesivir the primary Covid-19 therapy absolutely accredited for kids underneath 12. Different remedies, together with Eli Lilly’s monoclonal antibody remedy bamlanivimab, had already acquired a extra conditional emergency use authorization to be used on youngsters underneath 12.
“87% Of Youngsters Hospitalized With Covid Throughout Omicron Wave Have been Unvaccinated, CDC Says” (Forbes)