Pfizer seeks FDA green light for bivalent COVID dose in children under 5

Vials of the Pfizer COVID-19 vaccine.
Enlarge / Vials of the Pfizer COVID-19 vaccine.

As respiratory diseases ravage children in the United States, vaccine partners Pfizer and BioNTech announced on Monday that they are seeking regulatory clearance to offer their bivalent COVID-19 vaccine to children aged 6 months to 4 years, but not in reminder ; instead, it would be part of an updated primary series.

Currently, the bivalent vaccine, which targets the BA.4 and BA.5 subvariants of the omicron coronavirus in addition to an ancestral strain, is only available as a booster dose for Americans ages 5 and older. Although BA.5 is no longer dominant in the United States, its sub-lines now rule. The Centers for Disease Control and Prevention recently published real-world efficacy data indicating that bivalent boosters increased protection against symptomatic COVID-19 infection compared to the protection provided by previous boosters.

So far, only children under 5 have had access to a primary series: two small doses of Moderna’s original vaccine or three small doses of Pfizer/BioNTech’s original vaccine. Both were first cleared on June 17 after a roller-coaster regulatory process that lasted months.

Now Pfizer is asking the Food and Drug Administration to authorize a modified primary series to include the bivalent vaccine. The series of updates would consist of two doses of the original vaccine followed by a third dose with the bivalent vaccine.

“With the high level of respiratory disease currently circulating in children under 5, updated COVID-19 vaccines may help prevent serious illness and hospitalizations,” the two companies said in a press release. joint.

If authorized, the new primary series would not contribute to strengthening the protection of young children already vaccinated with a primary series and still under 5 years of age. But few children in this age group have received a primary series – and it is unclear whether an updated primary series would encourage more parents to have their children vaccinated.

According to the latest data from the CDC, only 2% of infants ages 6 months to 2 years and 4% of toddlers ages 2 to 4 have completed a primary series.

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