Pfizer is likely to apply to the US Food and Drug Administration (FDA) in September for emergency authorization to administer its COVID-19 vaccine to children between the ages of 2 and 11, according to a report in the New York Times.
According to the NYT report, Pfizer also plans to apply for full approval of the vaccine for people in the 16 to 85 years age group this month and it expects to have clinical trial data on the safety of its vaccine in pregnant women by early August.
The report stated that FDA may issue an emergency use authorization for vaccines for use in children aged 12 to 15 years by early next week to step up the US response to COVID-19, the report mentioned.
In December, the Pfizer-BioNTech vaccine had got an emergency use authorisation. The vaccines are now being administered to adults and a full FDA approval would allow the companies to market their vaccines directly to consumers, said the newspaper adding that the approval process may take months.
The Pfizer-BioNTech COVID-19 vaccine was the first to get emergency authorization in the United States.
Emergency authorizations are part of the temporary measures and are generally revoked after a public health emergency ends. FDA’s full approval would allow the vaccine to be sold in the market as the pandemic fades.
Government agencies, schools, and other entities can have direct access to the vaccine once the full approval of the FDA is obtained, said the report.