Pfizer and BioNTech have received a marketing authorisation recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the Omicron XBB.1.5-adapted monovalent Covid-19 vaccine (COMIRNATY Omicron XBB.1.5).
The updated vaccine is intended to be given as a single dose for children aged five years and above, irrespective of their previous Covid-19 vaccination history.
The recommendation is based on safety and efficacy data demonstrated in previous clinical, non-clinical and real-world studies of the companies’ prior Covid-19 vaccines.
Pre-clinical data also showed the vaccine’s improved response against the XBB.1.5, XBB.1.16 and XBB.2.3 sublineages compared to that of the Omicron BA.4/BA.5-adapted bivalent vaccine.
The vaccine has also been shown to more effectively neutralise the EG.5.1 (Eris) variant, and induce serum antibodies, when compared to the bivalent vaccine in its other pre-clinical studies.
A final decision is anticipated shortly from the European Commission. The vaccine will then be ready to ship to applicable member states of the European Union immediately.
Pfizer chairman and CEO Albert Bourla stated: “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 companies have also submitted an application to the US Food and Drug Administration seeking approval of the updated vaccine for use in individuals aged six months and above, and await a decision.
The companies also submitted data for the updated vaccine to other regulatory authorities around the world.