Fonte: FirstWord Pharma
(Texto original, publicado em inglês)
FDA authorises Omicron boosters for kids as young as 5
The FDA on Wednesday broadened the eligibility of bivalent COVID-19 booster vaccines targeting Omicron by allowing their use in even younger children. Specifically, the agency has cleared the way for Pfizer/BioNTech’s modified vaccine to be given to children as young as five years old at least two months after they completed their primary series or received a prior booster dose, while Moderna’s adapted shot can be given to children as young as six years old following a similar time lapse.
The modified shots contain mRNA components that target the original SARS-CoV-2 strain as well as the BA.4 and BA.5 subvariants. The latest nod extends the emergency-use authorisation (EUA) that had been granted to both bivalent vaccines in late August. At the time, Pfizer/BioNTech’s shot was cleared for people 12 and older, while Moderna’s was permitted for use in adults. Both Omicron-adapted booster vaccines are to be given at smaller doses for the younger population cleared on Wednesday.
Back to pre-pandemic life
“Since children have gone back to school in person and people are resuming pre-pandemic behaviours and activities, there is the potential for increased risk of exposure to the virus,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalised… Vaccination remains the most effective measure to prevent the severe consequences of COVID-19,” he said.
For the updated Pfizer/BioNTech vaccine, the FDA relied in part on its previous analysis of immune response and safety data of adults over 55 who had received a booster dose of the companies’ BA.1-targeting vaccine. The agency also looked at a prior analysis of safety and effectiveness data for Pfizer/BioNTech’s monovalent COVID jab in children ages 5 through 11 years.
Meanwhile, Moderna’s application also included data for an investigational BA.1-targeting vaccine given to people over 18 years old. In addition, the FDA looked at data regarding a single booster dose of Moderna’s monovalent vaccine in children ages 6 years through 17 years, and said the extra shot induced immune responses that were “comparable” to those seen in adults after a two-dose primary series. The data for Moderna’s monovalent vaccine “are relevant to the [bivalent version] because these vaccines are manufactured using the same process,” the agency said.
Pfizer/BioNTech, which have submitted a similar filing to the European Medicines Agency and plan more “in the coming weeks” with other regulatory bodies, said they expect trial results of testing their updated boosters in children in the months ahead. Moderna is also testing its updated booster shot in children.
Meanwhile, US Centers for Disease Control and Prevention (CDC) director Rochelle Walensky signed off on the Omicron-adapted shots just hours after the FDA authorisation, allowing pharmacists to soon start administering the shots. Walensky made the decision without a meeting of the CDC’s independent panel of vaccine experts.
