The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
First-quarter 2024 revenues totaled $14.9 billion, a decrease of $3.6 billion, or 20%, compared to the prior-year quarter
Anticipates approx. US$8 billion in revenues for Comirnaty and Paxlovid
Revenue in the three months ended on Oct. 1 also slipped by 42% to US$ 13.23 billion
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.
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