Pfizer and BioNTech’s COVID-19 vaccine for children receives EU recommendation

The committee has also recommended the updated vaccine for children 6 months through 4 years of age, as part of the three-dose vaccination series, depending on how many prior doses they received, or as a single dose for those with a completed vaccination cause or prior virus infection.

The European Commission (EC) will now review the CHMP’s recommendation and is expected to make a final decision imminently.

Following a decision from the EC, the updated vaccine will be ready to ship to applicable EU member states immediately.

Pfizer and BioNTech have been manufacturing the updated vaccine to ensure supply readiness ahead of the upcoming fall and winter season, when the demand for COVID-19 vaccination is expected to increase.

The CHMP’s recommendation is based on previous clinical, non-clinical, and real-world evidence supporting the ‘safety and efficacy’ of the COVID-19 vaccines by Pfizer and BioNTech.

In addition, the application included pre-clinical data showing that the updated vaccine generated a ‘substantially improved response’.

Albert Bourla, CEO and chairman at Pfizer, 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.”

Ugur Sahin, CEO and co-founder of BioNTech, added: “As COVID-19 is expected to adopt a seasonal pattern, similar to other respiratory viruses, we remain committed to providing COVID-19 vaccines that are better matched to relevant circulating variants or sublineages to people worldwide, to support vaccinations in the upcoming fall and winter season.”

“Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for the vast majority of COVID-19 cases globally. The updated COVID-19 vaccine aims to further improve protection against severe illness and hospitalization.”

Pfizer and BioNTech have also filed an application with the U.S. Food and Drug Administration (FDA) requesting approval of their vaccine for individuals 6 months of age and older, with a verdict expected in the coming days.