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

Aug 30 (Reuters) – EU regulators have recommended authorizing an updated COVID-19 vaccine from Pfizer. (PFE.N) and its German partner BioNTech (22UAy.DE) targeting Omicron’s dominant XBB.1.5 variant, putting it on track to become the third ported injection from the two companies approved on the block.

The vaccine, called Comirnaty, will be used to prevent COVID-19 in adults and children with a dose that depends on previous vaccinations.

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

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

Meanwhile, adults and children aged five years and over who require vaccination should receive a single dose, regardless of their COVID-19 vaccination history, the CHMP said.

Vaccine manufacturers, including Moderna (RNAM.O) and Novavax (NVAX.O) They have also created versions of their vaccines that target the XBB.1.5 subvariant of the virus.

Pfizer and BioNTech have also filed applications with the US Food and Drug Administration seeking approval of the updated vaccines, with a decision expected in the coming days.

Recommendations made by the CHMP must be formally endorsed by the European Commission.

Other Comirnaty-adapted vaccines targeted Omicron’s Ba.4-5 and Ba.1 subvariants.

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

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