Pfizer Inc PFE and BioNTech SE's BNTX COVID-19 vaccine elicited a robust immune response, with a favorable safety profile similar to a placebo.
The Phase 2/3 trial evaluated the third 3-µg dose of its COVID-19 vaccine in children from six months to less than five years.
Vaccine efficacy, a secondary endpoint in this trial, was 80.3% in the youngest group.
In February, the FDA pulled back on its plan to authorize the Pfizer vaccine for children aged six months to 4 years as the agency asked for more information.
Ten symptomatic COVID-19 cases were identified from seven days after the third dose and accrued as of April 29.
The trial protocol specifies that a formal analysis will be performed when at least 21 cases have accrued from seven days after the third dose. Final vaccine efficacy data will be shared once available.
In the Phase 2/3 trial, 1,678 children received a third dose of the 3-µg formulation at least two months after the second dose. Non-inferiority was met for both the 6- to 24-month-old and the 2- to under 5-year-old populations for both co-primary endpoints.
Three 3-µg doses of the vaccine were well-tolerated in this age group, and no new safety signals were identified. The majority of adverse events were mild or moderate.
Price Action: PFE shares are up 0.23% at $52.59, and BNTX stock is up 0.37% at $163.60 during the premarket session on Monday's last check.
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