“The Pfizer-BioNTech pediatric study evaluating the safety and efficacy of our COVID-19 vaccine in children six months to 11 years of age is ongoing,” the company said in prepared remarks before an earnings call with investors Tuesday. “We expect to have definitive readouts and submit for an [emergency use authorization] for two cohorts, including children 2-5 years of age and 5-11 years of age, in September.”
The New York Times added that if the vaccine is given full FDA approval the drugmaker would then be allowed to market it directly to consumers, although such a process could take months.
The Times was the first report on Monday that the FDA is set to expand authorization for the Pfizer-BioNTech vaccine next week so it can be used in children ages 12 to 15. The move would dramatically expand access to the inoculations to millions of young Americans and be a key step in the country’s battle against the pandemic.
The vaccine is currently approved for use in those 16 and older.
Vaccinating broader swaths of the population will raise the U.S. immunity level and reduce the amount of hospitalizations and death. New vaccine access for children will also allow schools to reopen with some sense of normality in the fall.
More than 147 million people have received at least one dose of a COVID-19 vaccine in the U.S., including about 106 million who are now fully vaccinated. Despite those figures, the rate of inoculations has been falling as vaccine hesitancy remains a key issue for millions of Americans.
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