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Pfizer and BioNTech Tuesday requested emergency use authorization from the Food and Drug Administration for a booster shot of their Covid-19 vaccine for kids aged 5-11, in the latest effort to extend protection to younger children, who have been put at greater risk of hospitalization by the omicron variant.
The companies submitted data from a clinical trial indicating that the booster shot created a strong immune response in kids without introducing new safety risks.
Pfizer and BioNTech said they plan to submit data to the European Medicines Agency and to other international regulatory agencies during the next few weeks.
The FDA has already authorized a Pfizer booster shot for children 5-11 who have immune disorders.
The effectiveness of Pfizer’s two-dose vaccine course at preventing Covid-19 infection waned rapidly for children in New York during the Omicron surge, especially those in the 5-11 age bracket, according to data from the New York State Department of Health, however, the vaccine remained effective at preventing severe disease and infection. The FDA authorized a Pfizer-BioNTech booster shot for kids 12-15 January 3, saying that the shot could help combat the omicron variant, which caused a fourfold increase in child hospitalizations, affecting mostly unvaccinated children. Omicron is also more likely than other coronavirus variants to induce upper airway infections among children, raising the danger of heart attack, according to a study published April 15 by JAMA Pediatrics. In light of this risk, public health officials have worked to expand Covid-19 treatments for young children. April 25, the FDA approved Covid-19 antiviral remdesivir for children 28 days and older, making remdesivir the first Covid-19 treatment fully approved for children under 12. Other treatments, including Eli Lilly’s monoclonal antibody therapy bamlanivimab, had already received a more conditional emergency use authorization for use on children under 12.