CHMP recommends EU approval of Bivalent COVID-19 Vaccine.- Pfizer and BioNTech SE
Pfizer and BioNTech SE announced a 30 microgram booster dose of their Omicron BA.1- Bivalent COVID-19 Vaccine (Comirnaty Original/Omicron BA.1 15/15 microg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older.
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
The CHMP recommendation is based on previously announced safety, tolerability and immunogenicity data from a Phase II/III trial of participants 56 years of age and older who received a 30-microgram booster dose of the Omicron BA.1-adapted bivalent vaccine. In this study, a booster dose of the Omicron BA.1-adapted bivalent vaccine (n=178) elicited a superior immune response against Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine (n=163) as demonstrated by an approximately 9-fold improvement in neutralizing titers. In additional analyses of a SARS-CoV-2 live virus neutralization assay tested on sera from participants in this trial, neutralization titers improved by approximately 4-fold for BA.4/BA.5 (n=100). The BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile.
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