FDA Expected to Approve Pfizer Vaccine for Ages 12-15 Early Next Week
[Asia Economy Reporter Kim Suhwan] The U.S. Food and Drug Administration (FDA) is expected to review whether to grant emergency use authorization for the COVID-19 vaccine for children aged 2 to 11 within a few months.
On the 4th (local time), Pfizer announced during its first-quarter earnings report that it plans to apply for emergency use authorization from the FDA for the COVID-19 vaccine for children aged 2 to 11 in September.
Pfizer is currently conducting safety and efficacy studies of the vaccine on children aged 6 months to 11 years.
Albert Bourla, Pfizer's Chief Executive Officer (CEO), said, "We expect to have the final (clinical trial) results in September and to apply for emergency use authorization for two groups: children aged 2 to 5 and 5 to 11."
CEO Bourla also added that the application for emergency use authorization for younger children aged 6 months to 2 years is expected to be submitted in the fourth quarter of this year.
Pfizer's vaccine currently has emergency use authorization for adults aged 16 and older in the United States and the European Union (EU). Pfizer has applied to the FDA to extend the authorization to include those aged 12 to 15, and the FDA is expected to approve this by early next week.
CEO Bourla also said on the same day, "We expect to hear a response soon regarding our request to expand emergency use authorization of our vaccine to include ages 12 to 15."
He further stated that safety data from phase 2 clinical trials for pregnant women is expected to be available by late July or early August.
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