EU regulators have recommended authorising 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 their third adapted shot to be approved in the bloc.
The vaccine, dubbed Comirnaty, prevents COVID-19 in adults and children with dosage dependent on previous vaccinations.
The positive European Medicine Agency opinion on a new COVID-19 variant adapted Comirnaty vaccine is important ahead of autumn and winter to ensure strong protection levels for those in need, said EU Health and Food Safety Commissioner Stella Kyriakides.
Kyriakides posted on the X platform that EMA announced the human medicines committee (CHMP) has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant.
According to EMA, the vaccine – known as Comirnaty Omicron XBB.1.5 – is to be used for preventing COVID-19 in adults and children from 6 months.
The Committee assessed new laboratory data showing a strong response of the adapted vaccine against XBB.1.5 and related strains of the virus that causes COVID-19.
In line with previous recommendations by EMA and the European Centre for Disease Prevention and Control (ECDC), adults and children from 5 who require vaccination should have a single dose, irrespective of their COVID-19 vaccination history.
Children from 6 months to 4 years may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19.
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.
Vaccine makers, including Moderna and Novavax, have also created versions of their shots aimed at the XBB.1.5 subvariant of the virus.
“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.