Pfizer and BioNTech officials report three child-size doses of its COVID-19 vaccine showed a strong immune response in children between the ages of 6 months and 5 years old, according to a news release obtained by CNN on Monday (May 23).
The two pharmaceutical companies said they plan to finish submitting the Phase 2/3 trial data on the three-dose vaccine to the U.S. Food and Drug Administration later this week.
The companies said 1,678 children participated in the trials during a time period in which the Omicron variant of the coronavirus was extremely prevalent and antibody levels tested one month after the third dose was distributed showed a similar immune response to past trials involving 16-to-25-year-old participants, with an 80.3% efficacy rate against symptomatic COVID-19.
Pfizer and BioNTech reported 10 symptomatic cases among children who received the third dose at least seven days prior during the trials, though the efficacy rate won't be finalized until at least 21 symptomatic cases are found in the vaccine group and then compared against the total symptomatic cases in the participants who received a placebo during trials.
Officials confirmed the three child-size doses were "well-tolerated" among the youngest age group and did not yield safety concerns.
"These topline safety, immunogenicity and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorization," Pfizer Chairman and CEO Albert Bourla said in a statement.
The recent reported data has yet to be peer-reviewed or published as of Monday afternoon, CNN confirmed.