News | October 30, 2023
Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19
The companies plan to start a pivotal Phase 3 trial in the coming months
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
BioNTech's diverse pipeline includes multiple drugs in Phase I, II, and III clinical trials
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
Ryan has nearly 20 years of global legal and IP expertise in the pharmaceutical industry
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
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