The USFDA has approved the first protein-based adjuvanted COVID-19 vaccine for emergency use in adolescents aged 12–17 years. The use of the vaccine in a two-dose primary series can begin once a policy recommendation from the CDC is received. Evidence The FDA’s decision was based on phase 3 clinical trial that evaluated 2,247 adolescents aged 12–17 years across 75 USA sites. The primary endpoint consisted of the first PCR-confirmed COVID positive report with a minimum onset of seven days after the second dose on serologically negative participants at the base level.
The antibody titer results supported the analysis, which showed higher efficacy in adolescents than in young adults. Supply and storage This vaccine, based on an innovative approach to recombinant protein vaccine, will be available as a suspension in a carton with ten multidose vials (0.5 ml each). Unpunctured vials should…
