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Sunday, June 13, 2021

COVID-19 vaccine: FDA grants Pfizer emergency use for children aged 12 to 15

The Food and Drug Administration has expanded the emergency use authorization for the Pfizer COVID-19 vaccine to children aged 12 to 15, which means entry for tens of millions extra adolescents. The Pfizer vaccine is to date nonetheless the one one accepted for use in 16-to-18 year olds. 

The emergency use authorization had been anticipated. An evaluation that included 1,005 vaccine individuals on this age group discovered the vaccine was 100% efficient in stopping COVID-19. 

In a press convention Monday night time, FDA appearing commissioner Janet Woodcock mentioned that the vaccine could be distributed to adolescents in the identical routine and dose as adults.

“This vaccine is just the exact same dose and regimen as what has been given out already, so all those places, those pharmacies, those vaccine centers, all those sites can simply extend down to the younger age group,” Woodcock mentioned.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” mentioned appearing FDA commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

The emergency use authorization may significantly profit college students and households when it comes to colleges, making it simpler for college students to return to common education in individual by fall if they are not now. 

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Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, known as increasing the vaccine to this age group a “critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.”

Marks mentioned Monday night time that there could be extra points for youthful age teams they wished to talk about.

“As we get down to younger children, age 11 and below, different doses of the vaccine will need to be used,” Marks mentioned. “And there are also different benefit risk considerations because we know that younger children have been susceptible to this interesting multi inflammatory syndrome with COVID-19, and we have to make sure that we’re not going to see anything untoward in the youngest children.”

Pfizer has additionally requested the FDA for full approval of its vaccine, which suggests it could now not be distributed beneath an emergency use authorization. 

Alex Tin contributed reporting.

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