Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced positive data from the Phase 2/3 trial evaluating the safety, tolerability, and immunogenicity of Omicron-adapted COVID-19 vaccine candidates against Omicron.
The companies reported positive data from two trials-one as a monovalent and the other bivalent, a combination of the Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern.
The companies noted that the trial found that a booster dose of both Omicron-adapted vaccine candidates elicited a substantially higher immune response against Omicron BA.1 as compared to the companies’ current COVID-19 vaccine.
The companies specified that the Omicron-adapted monovalent candidate given as a fourth booster dose elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg dose levels and the bivalent vaccine candidate exhibited a 9.1 and 10.9-fold increase against Omicron.
These results are being shared with the U.S.FDA and European Medicines Agency in advance of upcoming discussions with the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28 and with the International Coalition of Medicines Regulatory Authorities (ICMRA) on June 30.
The companies have also submitted additional data from their ongoing COVID-19 booster studies, including data on an additional dose of their current COVID-19 vaccine and Beta candidate, to further demonstrate the flexibility and potential benefit of mRNA-based vaccines.
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