This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
The forecast across the seven years between 2022 and 2028 saw an average decline of 7%, resulting in a $10 billion drop in the total forecast sales between 2021 and 2028
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 booster vaccination trial is still ongoing and further data will provide more information around safety and efficacy.
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
COVID-19 Vaccine (DS-5670) in Unvaccinated Individuals in Japan
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
Proportion of the eligible population yet to receive a COVID-19 vaccine is comparatively small
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