Pfizer said Tuesday it expects to apply for emergency use authorization to administer its COVID-19 vaccine to children ages 2 to 11 in September.
The company made the comments in an earnings call on Tuesday and also said it plans to file for full approval from the Food and Drug Administration for the use of its vaccine in 16- to 85-year-olds, beyond the emergency use authorization granted in December. The approval would be a milestone that could help alleviate some Americans’ concerns and vaccine hesitancy.
Pfizer added that a separate study into the effects of its vaccine in pregnant women will be released in late July or early August.
“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.
Pfizer said last year it would profit from its vaccine, which is extremely effective at preventing COVID-19 infections. The jabs brought in $3.5 billion in the first three months of this year, about a quarter of the company’s total revenue.
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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