Pfizer Inc (NYSE:PFE) and BioNTech SE say their three-dose Covid-19 vaccine for children ages 6 months to 5 years old was 80% effective at preventing illness during the surge of the Omicron variant.
According to clinical trial results released Monday, a third vaccine dose was well tolerated by the children, and most side effects were mild to moderate.
The companies plan to complete their application for the Food and Drug Administration (FDA) to authorize the vaccine this week, according to BioNTech CEO Ugur Sahin.
Shares of Pfizer were up 1.6% shortly after the opening bell, while BioNTech stock fell 0.4%.
READ: Pfizer splashes $11.6bn of vaccine cash on Biohaven Pharmaceutical Holding
The clinical trial data includes 1,678 children under 5 who received a third shot at least two months after their second dose while Omicron was the main variant. During the Omicron surge, kids aged 5 or younger were hospitalized with Covid at five times the rate of the pandemic peak, according to Centers for Disease Control and Prevention data.
Kids under age 5 receive 3-microgram shots, which is one-tenth the dosage adults receive. They are the only age cohort in the US that remains not yet eligible for vaccination, and as of February, more than 75% of kids under age 5 had been infected with Covid-19, according to the CDC.
Initially, Pfizer planned to seek fast-track authorization from the FDA in February, while clinical trial results were still pending. This was delayed, however, in order to wait on data from the third dose after the first two shots were only 30% to 40% effective, Pfizer CEO Albert Bourla said in a podcast interview last month, as reported by CNBC.
An FDA committee of independent vaccine experts is expected to meet in June regarding Pfizer’s application, as well as one from fellow vaccine-maker Moderna Inc to authorize its two-dose vaccine for children under age 6. Tentative dates have been set for June 8, 21 and 22, according to media reports.
The Moderna vaccine was roughly 51% effective against infection from omicron in children younger than 2, and 37% effective for kids ages 2 to under 5.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
Follow him on Twitter @andrew_kessel