Pfizer and BioNTech have received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine (COMIRNATY Omicron XBB.1.5) in the European Union (EU).
CHMP, which is part of the European Medicines Agency (EMA), has recommended marketing authorisation of COMIRNATY Omicron XBB.1.5 for use as a single dose for people five years of age and older, irrespective of their previous Covid-19 vaccination.
The committee has also suggested approval for the updated vaccine for kids aged six months to four years old as part of the primary three-dose vaccination series, based on how many prior doses they were given.
Additionally, it has been recommended to be given as a single dose for people with a history of finishing a primary Covid-19 vaccination course or prior SARS-CoV-2 infection.
The CHMP’s opinion was based on the full body of prior clinical, non-clinical, and real-world data supporting the safety and efficacy of the Covid-19 vaccines produced by Pfizer and BioNTech.
In addition, the application of the two pharma majors included pre-clinical data that showed efficacy of Omicron XBB.1.5-adapted monovalent Covid-19 vaccine against multiple XBB sublineages in comparison to the Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine.
The updated Covid-19 vaccination induces serum antibodies that, when compared to the bivalent Covid-19 vaccine modified for Omicron BA.4/BA.5, effectively neutralised the recently identified variation of interest EG.5.1.
Pfizer chairman and CEO Albert Bourla said: “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.
“It’s been nearly a year since many citizens in the European Union were vaccinated against Covid-19 and the updated formulation provides the opportunity for them to receive a vaccine more closely matched to current sublineages.”
The European Commission (EC) will consider the CHMP’s suggestion before making a final decision, which is anticipated shortly, said Pfizer.
The updated vaccine will be available for shipping to appropriate EU member states if approved.
Pfizer and BioNTech have also applied with the US Food and Drug Administration (FDA) seeking approval of their updated Covid-19 vaccine for individuals six months of age and older.
