Browsing by Subject "immunogenicity"

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    Children are the key to the Endgame: A case for routine pediatric COVID vaccination
    (Elsevier, 2021-09-07) Schleiss, Mark R.; John, Chandy C.; Permar, Sallie R.; Pediatrics, School of Medicine
    The rapid development and deployment of effective vaccines against SARS-CoV-2 infection has been a historic achievement. Children, while not the primary age group affected by severe COVID-19 disease, have endured direct and indirect negative consequences of this pandemic that warranted vaccine testing in young age groups. In March 2021, Pfizer/BioNTech announced results from a controlled Phase 3 trial of its BNT162b2 COVID-19 vaccine in >2200 children and adolescents, age 12 to 15. The 18 symptomatic cases of COVID-19 reported during the trial were all in the placebo group – yielding a vaccine efficacy of 100% [1]. Vaccine-related symptoms were mild. These results were submitted to the FDA with a request to expand emergency use authorization (EUA) for children between ages 12 to 15, which was granted on 5-10-2021. Moderna vaccines has demonstrated similar safety and efficacy data for its COVID vaccine in children aged 12–17, and the European Medicines Agency has approved the vaccine for this age group, with a similar request for approval to the FDA currently pending. Both companies are conducting studies in younger children spanning ages 6 months through 12 years.