This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
Complaints to be filed in both United States and Germany alleging that Pfizer and BioNTech's COVID-19 vaccine Comirnaty unlawfully infringes patents Moderna filed between 2010 and 2016
This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.
105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses
Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine
Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series
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