3 Additional real-world evidence collected between September 2022 and December 2022 shows that among older adults, receiving an mRNA-based bivalent booster provided greater vaccine effectiveness against COVID-19 hospitalization compared to receiving two or more doses of the companies’ original wild-type vaccine administered two months earlier. 1īased on the latest real-world evidence, Omicron BA.4/BA.5-adapted bivalent vaccines appear to be protective against symptomatic COVID-19 disease in adults caused by both BA.4/BA.5 and XBB Omicron sublineages, 2 the latter of which currently account for more than 85% of COVID-19 cases in the U.S. The safety and tolerability profile of the bivalent vaccine was similar to that of the original vaccine. Safety and immunogenicity were assessed in a subset of study participants 6 months through 4 years of age (n=60), demonstrating that a booster (fourth) dose of the Omicron BA.4/BA.5-adapted bivalent vaccine elicited improved Omicron BA.4/BA.5-neutralizing antibody responses compared to participants who received three doses of the companies’ original vaccine. The EUA is based on data from substudies within the companies’ Phase 1/2/3 study ( NCT05543616) evaluating the safety, tolerability and immunogenicity of a fourth dose of the bivalent vaccine in children 6 months through 4 years of age (n=300). The bivalent vaccine is also authorized in this age group as the third dose of a three dose-primary series for these children, a booster (fourth) dose is not authorized at this time. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to provide a single booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years of age) at least 2 months after completion of primary vaccination with three doses of the Pfizer-BioNTech COVID-19 Original Vaccine. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. NEW YORK and MAINZ, GERMANY, Ma-Pfizer Inc. Research and Business Development Partnerships. Unleashing the next wave of scientific innovations
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |