Pfizer seeks FDA greenlight for bivalent COVID dose in children beneath 5 years

Vials of the Pfizer COVID-19 vaccine.

Enlarge / Vials of the Pfizer COVID-19 vaccine. (credit score: SOPA photographs)

With respiratory sicknesses ravaging youngsters across the US, vaccine companions Pfizer and BioNTech introduced Monday that they’re looking for regulatory authorization to supply their bivalent COVID-19 vaccine to youngsters ages 6 months to four years—however not as a booster; as an alternative it might be a part of an up to date major collection.

At the moment, the bivalent vaccine, which targets the coronavirus omicron subvariants BA.four and BA.5 along with an ancestral pressure, is barely out there as a booster dose to Individuals ages 5 years and up. Though BA.5 is now not dominant within the US, its sublineages now reign. The Facilities for Illness Management and Prevention lately revealed real-world effectiveness knowledge indicating that the bivalent boosters elevated safety in opposition to symptomatic COVID-19 an infection over safety offered by the earlier boosters.

For now, youngsters beneath 5 solely have had entry to a major collection—two small doses of Moderna’s authentic vaccine or three small doses of Pfizer/BioNTech’s authentic vaccine. Each have been first licensed on June 17 after a rollercoaster regulatory course of that lasted months.

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