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Pfizer- BioNTech Early Study Data For Omicron BA.4/BA.5-Adapted Bivalent Booster Vaccine, Positive

(RTTNews) - Pfizer Inc. (PFE) and BioNTech SE (BNTX) Thursday announced positive early data from the Phase 2/3 study of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in individuals 18 years and older.

Sera taken from participants 7 days after administration of a booster dose of Omicron BA.4/BA.5-adapted bivalent vaccine showed a significant increase in neutralizing antibodies above pre-booster levels. Similar responses were seen across individuals aged 18 to 55 years of age and those older than 55 years, the company said. "These early data suggest that our bivalent vaccine is anticipated to provide better protection against currently circulating variants than the original vaccine and potentially help to curb future surges in cases this winter," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

A booster dose of Omicron BA.4/BA.5-adapted bivalent vaccine has already received emergency use authorization from the FDA and marketing authorization from the European Medicines Agency (EMA) for individuals 12 years and older.

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