ON THURSDAY 8th December 2022, the U.S. Food and Drug Administration (FDA) expanded its emergency use authorisation of the Moderna (Cambridge, Massachusetts, USA) and Pfizer-BioNTech (Pfizer, New York City, New York, USA, and BioNTech, Mainz, Germany, respectively) bivalent Omicron-targeting booster vaccines to include children as young as 6 months of age.
The move comes as the USA experiences a rise in COVID-19 cases. According to the American Academy of Pediatrics (AAP), 28,604 new paediatric COVID-19 cases were reported across the USA during the week ending 1st December 2022, representing almost 11% of all weekly reported cases.
Regarding the eligibility criteria, children aged 6 months–5 years who have already received Moderna’s two-dose primary series are now eligible for an Omicron booster 2 months after finishing the initial vaccination round. Pfizer’s vaccine is given as a three-dose primary series for children aged 6 months–4 years. For those who have not yet received the third dose in the series, this will now be the updated Omicron shot rather than the original formulation. However, children in the same age group who have already completed Pfizer’s three-dose primary series are not yet eligible for an updated Omicron booster. According to the FDA, new data should be available in January concerning the updated booster shot in this population, and the agency will assess this “as quickly as possible.”
In a press release, FDA Commissioner Robert Califf stated: “More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so, especially as we head into the holidays and winter months where more time will be spent indoors.”
In the release, Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, highlighted that “vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalisation and death.”
