Request Aims to Include Omicron-Targeting Shot in Initial Vaccination Series

Pfizer has approached U.S. regulators with a request to authorise its updated COVID-19 vaccine for children under the age of 5, proposing that this vaccine be integrated into their initial immunisation series rather than being administered as a booster.

Currently, children aged 6 months to 4 years are recommended to receive three doses of the original Pfizer COVID-19 vaccine, each dose being a tenth of the adult amount. If the Food and Drug Administration (FDA) approves this new request, a dose of Pfizer’s bivalent vaccine, designed to target the omicron variant, would replace the third shot in their primary series.

Pfizer, in collaboration with BioNTech, stated that this updated vaccine could provide significant protection against severe illness and hospitalisation from COVID-19 in young children, particularly as children’s hospitals face increased patient loads due to various respiratory illnesses.

Despite the approval of COVID-19 vaccinations for young children in June, vaccination rates remain low. According to the Centers for Disease Control and Prevention (CDC), only 2% of children under 2 years and about 4% of those aged 2 to 4 have received their primary doses.

The FDA has already authorised the new bivalent COVID-19 vaccines from Pfizer and Moderna as boosters for individuals aged 5 and older. These revised vaccines comprise half of the original formulation and half designed to combat the BA.4 and BA.5 omicron strains, which have recently become predominant.

Last month, the CDC released the first real-world data indicating that these updated boosters provide additional protection for adults. The analysis showed that the most significant benefits were observed in individuals who had received only two doses of the original vaccine and had not previously received a booster. Even among those who had received a summertime booster, the updated shot offered enhanced protection compared to not receiving it at all.