WASHINGTON (Pakistan Point News / Sputnik - 31st March, 2021) A phase 3 coronavirus vaccine trial of more than 2,200 adolescents aged 12-15 demonstrated nearly 100 percent efficacy and robust immune responses that exceeded results of earlier trials of participants aged 16-25, Pfizer-BioNTech said on Wednesday.
"We plan to submit these data to FDA [Food and Drug Administration] as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year," Pfizer CEO Albert Bourla said in a press release.
The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. Eighteen cases of COVID-19 were observed in the placebo group versus none in the vaccinated group, the release said.
Last week, Pfizer and the joint developer, BioNTech, began dosing healthy children aged 5 to 11-years-old in what the company described as a "global Phase 1/2/3" trial.
The trial will later expand to include younger children in groups aged 2 to 5, followed by babies and toddlers aged 6 months to 2 years old, according to the release.
The Pfizer/BioNTech vaccine is currently authorized for individuals at least 16 years old.
