Pfizer and BioNTech Get Positive Opinion in Europe for Omicron XBB.1.5-adapted COVID-19 Vaccine

On Aug. 30, 2023, Pfizer and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, given as a single dose to those 5 years of age and older. The recommendation comes regardless of COVID-19 vaccination history. Additionally, CHMP recommended the updated vaccine for those 6 months to 4 years old; it would be given as part of or all of the main three-dose vaccination series (depending on prior dosage amount), or as a single dose for individuals with a complete COVID-19 primary vaccination course (or SARS-CoV-2 infection).

The vaccine is based on BioNTech’s messenger RNA (mRA) technology and was developed by both companies. The CHMP’s recommendation relied on previous clinical, non-clinical, and real-world evidence showing the safety and efficacy of COVID-19 vaccines from Pfizer and Biotech. The application also contained pre-clinical data demonstrating the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine has a significantly stronger response against multiple XBB sublineages as compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. There was also pre-clinical data showing that the updated vaccine induces serum antibodies that neutralize the recently World Health Organization-designated variant of interest EG.5.1 (Eris).

Once the European Commission finishes its review of the CHMP’s recommendation the improved vaccine with be ready to ship in the EU immediately. The companies have been manufacturing the vaccine to secure supply ahead of the fall and winter season, when COVID-19 vaccination is predicted to increase. Pfizer and BioNTech have also submitted an application with FDA and are expecting a decision soon. The companies have given data to other regulatory authorities worldwide.

“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,” said Albert Bourla, Chairman and chief executive officer at Pfizer in a Pfizer press release. “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."

Source: Pfizer