Pfizer to seek vaccine approval for children 5 years and older



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Pfizer and BioNTech announced this week that they will soon seek approval from global regulators for the use of its coronavirus vaccine in children 5 years of age and older.

Vaccine makers said in an interview released Friday that they are looking to produce smaller doses of the vaccine for young children.

“We will be presenting the results of our study on children aged 5 to 11 to authorities around the world in the coming weeks,” Ozlem Tureci, co-founder of BioNTech and its chief medical officer, told German newspaper Der. Spiegel.

The Food and Drug Administration (FDA) approved the Pfizer-BioNTech coronavirus vaccine for emergency use in adolescents 12 to 15 years of age in May and granted full approval of the vaccine for recipients aged 16 and over. more last month.

Vaccines for children 12 and under have yet to be approved by the FDA, according to the New York Times.

Scott Gottlieb, former FDA commissioner and member of the Pfizer board of directors, said in August that the vaccine maker “may be able” to apply for vaccine approval in children as early as October.

“This fall, Pfizer will be able (…) to file data with the FDA at some point in September, and then file the request potentially as early as October, which will put us in a time frame where the vaccine could be available. at some point in late fall, more likely early winter, depending on how long the FDA takes to review the request, ”Gottlieb said on CBS’s“ Face the Nation ”at the time .

Ugur Sahin, chief executive of BioNTech, on Friday called on those currently eligible for the vaccine to do so ahead of an expected wave of COVID-19 infections this fall.

“We still have about 60 days as a society to avoid a harsh winter,” he said, according to The Times.



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