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 preventingCOVID-19 in adults and children with a dosage dependent onprevious vaccinations.
The European Medicines Agency (EMA) said on Wednesday itshuman medicines committee (CHMP) had recommended the updatedvaccine for children six months through four years of age aspart 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 ofcompletion of a COVID-19 primary vaccination course or priorSARS-CoV-2 infection, the committee added.
Meanwhile, adults and children from five years of age whorequire vaccination should have a single dose, irrespective oftheir COVID-19 vaccination history, CHMP said.
Vaccine makers including Moderna and Novavaxhave also created versions of their shots aimed at theXBB.1.5 subvariant of the virus.
Pfizer and BioNTech have also filed applications with theU.S. Food and Drug Administration requesting approval of theupdated vaccines and a decision is expected in coming days.
Recommendations made by the CHMP will have to be formallyapproved by the European Commission.
Other Comirnaty adapted vaccines targeted the Ba.4-5 andBa.1 subvariants of Omicron.
“This season’s vaccine is ready to ship as soon as the finalregulatory decision is made, so that people across Europe canbetter help protect themselves against COVID-19 illness as therisk rises,” Pfizer CEO Albert Bourla said in a statement.
