Tag Archive for: BioNTech

New COVID-19 boosters aimed at fighting currently circulating variants of the coronavirus will be widely available this week, U.S. health officials said on Tuesday, adding that the vaccine is moving closer to an annual jab, as with flu shots.

Pfizer and its German partner BioNTech have filed proceedings at the High Court of England and Wales, seeking a judgment that their COVID-19 vaccine, based on mRNA technology, does not infringe on CureVac’s European patents, according to a regulatory filing on Friday.

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.