EU regulators backs Pfizer’s updated vaccine for dominant Omicron subvariant

(Reuters) -EU regulators have recommended authorizing an updated COVID-19 vaccine from Pfizer and its German partner BioNTech which targets the dominant XBB.1.5 variant of Omicron, putting it on track to become the third adapted shot by the two companies to be approved in the bloc.

The vaccine, dubbed Comirnaty, is to be used for preventing COVID-19 in adults and children with a dosage dependent on previous vaccinations.

The European Medicines Agency (EMA) said on Wednesday its human medicines committee (CHMP) had recommended the updated vaccine for children six months through four years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they had received.

It could be a single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection, the committee added.

Meanwhile, adults and children from five years of age who require vaccination should have a single dose, irrespective of their COVID-19 vaccination history, CHMP said.

Vaccine makers including Moderna and Novavax have also created versions of their shots aimed at the XBB.1.5 subvariant of the virus.

Pfizer and BioNTech have also filed applications with the U.S. Food and Drug Administration requesting approval of the updated vaccines and a decision is expected in coming days.

Recommendations made by the CHMP will have to be formally approved by the European Commission.

Other Comirnaty adapted vaccines targeted the Ba.4-5 and Ba.1 subvariants of Omicron.

“This season’s vaccine is ready to ship as soon as the final regulatory decision is made, so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises,” Pfizer CEO Albert Bourla said in a statement.

(Reporting by Eva Mathews and Yadarisa Shabong in Bengaluru; Editing by David Holmes)