In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives
The companies plan to start a pivotal Phase 3 trial in the coming months
The partnership is part of BioNTech’s strategy to develop novel prophylactic vaccines for the prevention of high-medical-need infectious diseases
The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine
First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose
Product candidates will be based on BioNTech’s proprietary mRNA technology and on Pfizer’s antigen technology. Clinical trials are expected to start in the second half of 2022
First emergency use authorization in the United States for a Covid-19 vaccine booster in adolescents 12 through 15 years of age
In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year
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