Announcing impressive results from a Phase 2/3 trial on Monday, Pfizer and BioNTech said their two-dose COVID-19 vaccine works very well on children aged 5 to 11, a potential game changer for people in that age group, their parents and caregivers, and vaccination efforts across the country.
The companies said the vaccine demonstrated “a favorable safety profile and robust neutralizing antibody responses” with a smaller treatment regimen than the one used for adults (10 micrograms as opposed to 30). The two shots are given 21 days apart.
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children,” Pfizer CEO Albert Bourla said in a statement, adding that COVID-19 infections among children have increased 240% since July.
The next step is seeking regulatory approval. Pfizer said it plans to submit the full data from the trial to the Food and Drug Administration (FDA) and request emergency use authorization “as soon as possible.”
How quickly we go from today’s announcement to shots in little arms depends on how smoothly the process unfolds. According to an estimate cited by the New York Times—based on how quickly authorization was granted for adults—children 5 to 11 could be eligible for a vaccine as soon as the end of October. Other estimated timelines are a bit more conservative. One expert who spoke with NPR said parents may still have to wait until the end of the year, even if emergency use authorization is granted. Splitting the difference is Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, who told the AP the agency would decide in “a matter of weeks” after Pfizer turned over the results.
Either way, today’s news is extremely encouraging—and a long time coming. Pfizer said it expects results for children under 5 later this year.