Pfizer said Tuesday that it expects to apply for an emergency use permit to administer its COVID-19 vaccine to children ages 2 to 11 in September.
The company made the comments in a earnings call on Tuesday, also saying it plans to file full approval from the Food and Drug Administration for the use of its vaccine in 16- to 85-year-olds in addition to the emergency permit granted in December. The approval would be a milestone that could help alleviate some Americans’ concerns and vaccine hesitation.
Pfizer added that a separate study on the effects of the vaccine in pregnant women will be released in late July or early August.
“Pfizer-BioNTech pediatric study evaluating the safety and efficacy of our COVID-1
The New York Times added that if the vaccine gets full FDA approval, the drug manufacturer will be allowed to market it directly to consumers, even though such a process may take months.
Pfizer said last year that it would benefit from its vaccine, which is extremely effective in preventing COVID-19 infections. The Jabs brought in $ 3.5 billion in the first three months of this year, approx. a quarter of the company’s total turnover.
The Times’ first report on Monday was that the FDA is ready to extend the approval of the Pfizer-BioNTech vaccine next week so that it can be used on children ages 12 to 15. The movement will dramatically expand access to vaccinations for millions of young Americans and be an important step in the country’s fight against the pandemic.
The vaccine is currently approved for use in 16 and older.
Vaccination of wider sections of the population raises the level of immunity in the United States and reduces the number of hospitalizations and deaths. New vaccine access for children will also allow schools to reopen with some sense of normalcy in the fall.
More than 147 million people have received at least one dose of a COVID-19 vaccine in the United States, including approx. 106 million who are now fully vaccinated. Despite these numbers, the frequency of vaccinations has declined as vaccination hesitation remains a key issue for millions of Americans.
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