Today, the agency amended the EUAs of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.
Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately. A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.
Pfizer Inc. Chief Executive Officer Albert Bourla said on Monday he had tested positive for COVID-19 and was experiencing very mild symptoms.
The biopharma industry’s response to the global pandemic has propelled some COVID-19 vaccines into the leading ranks of the world’s best-selling products, with Pfizer/BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot.
The European Medicines Agency (EMA) has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, it said on Tuesday.
Booster campaigns using upgraded shots specifically targeting the Omicron variant are expected to increase demand in autumn. Pending regulatory approval, BioNTech said, both of its adapted vaccines would be available in time for the campaigns.
People at high risk of severe disease who have yet to get a second COVID-19 booster should not wait for next-generation, Omicron-targeted vaccines expected in the fall, five vaccine experts told Reuters.
Combined with 105 million doses the government already agreed to buy from Pfizer Inc. and partner BioNTech SE for $3.2 billion, the latest deal puts the U.S. booster dose supply at about 171 million shots.
Revenue from the antiviral pill, Paxlovid, exceeded market estimates by more than $1 billion, while vaccine sales surged 20%, helping the drugmaker reaffirm the combined 2022 revenue forecast of $54 billion.
Pfizer Inc. and its German partner BioNTech SE said on Wednesday they had started a mid-stage study of a modified COVID-19 vaccine which targets both the original as well as the BA.2 Omicron subvariant.