WuXi Bio provided technical services, based on the companies' versatile integrated service platforms, to support various manufacturing and process development activities of these ADC product candidates.
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
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