Pfizer said on Tuesday that it plans to apply for emergency use authorization to administer its COVID-19 vaccine to children aged 2 to 11 in September.
The company made the comments in an earnings call on Tuesday and also said it plans to file a full approval application with the Food and Drug Administration for the use of its vaccine in people aged 16 to 85, at -beyond the emergency use authorization granted in December. The approval would be an important step that could help allay the concerns and hesitation of some Americans about vaccines.
Pfizer added that a separate study on the effects of its vaccine in pregnant women will be published 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 ahead of a call for results with investors Tuesday. “We expect to have final readings and to submit for a [emergency use authorization] for two cohorts, including children aged 2 to 5 and 5 to 11, in September. “
The New York Times added that if the vaccine was fully approved by the FDA, then the drug maker would be allowed to market it directly to consumers, although such a process could take months.
Pfizer said last year it would take advantage of its vaccine, which is extremely effective in preventing COVID-19 infections. The jabs grossed $ 3.5 billion in the first three months of this year, or about a quarter of the company’s total revenue.
The Times was the first report on Monday that the FDA is set to expand the authorization of the Pfizer-BioNTech vaccine next week so that it can be used in children between the ages of 12 and 15. This move would dramatically expand access to vaccines for 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 people 16 years of age and older.
Vaccinating large sections of the population will increase the level of immunity in the United States and reduce the number of hospitalizations and deaths. New access to vaccines for children will also allow schools to reopen with a 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 about 106 million who are now fully vaccinated. Despite these numbers, the inoculation rate has declined as vaccine reluctance remains a key problem for millions of Americans.
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