Three small doses of Pfizer and BioNTech's COVID-19 vaccine proved more than 80% effective at eliciting a strong immune response in children between the ages of 6 months and 5 years old, the companies said in a release this morning.
Why it matters: Pfizer is seeking an emergency use authorization to vaccinate children in this age group — one of the last groups of Americans still largely ineligible to receive a coronavirus shot. The companies said they will submit the trial data to the FDA this week.
How it works: A group of 1,678 children under five received a dose of about one-tenth the dosage given to adults for each injection in the Phase 2/3 study and it was "well-tolerated," the companies said.
- The efficacy data from three doses was observed during a time when Omicron was the predominant variant.
What they're saying: "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," said Pfizer CEO Albert Bourla said in a statement.
What's next: The FDA has said its key advisory committee will meet in June to consider emergency use authorization requests from both Pfizer and Moderna for kids five and under.
- Most recently, the CDC director authorized Pfizer's COVID booster for children 5-11 years old.
