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Pfizer’s COVID-19 vaccine will be available for children ages 5-11 by the end of October 2021. If their data supports its use and submits its emergency use authorization (EAU) by the end of September, the vaccine will be ready mid-October. Twenty-five percent of new infections represent children two years and older. Thus, the clinical trials of its two-dose vaccine are crucial in helping combat the spread of the Delta variant in schools.
Sources said Pfizer developed the shot with Germany’s BioNTech and is seeking an EAU from the U.S. Food and Drug Administration (FDA) when they have enough data from clinical trials by the end of October. They expect the FDA to decide within three weeks of the EUA submission whether the shot is safe and effective in younger children. FDA is anticipating a similar timetable for Pfizer.
Amid a wave of the Delta variant, millions of American parents of children who started school in recent weeks are anticipating. Dr. Scott Gottlieb, a former FDA Commissioner, encourages parents to consult with their pediatricians if they are wary of their children receiving vaccines under emergency use.
Additionally, Moderna will take two to three weeks longer than Pfizer to collect and analyze their data on children ages 5-11. Their shot will be available in November.
Approval of Vaccine for Emergency Use
Two months of safety data on trial participants is required from companies to submit the emergency authorization and six months for full licensure.
Once the companies submitted their data, FDA said it could quickly approve the COVID-19 vaccines for children based on a faster path to use it for an emergency.
According to Pfizer BioNTech, the preparation for the launch of global authorization for the COVID-19 vaccine in children as young as five are on track.
Written by Janet Grace Ortigas
Edited by Cathy Milne-Ware
Sources:
Reuters: U.S. could authorize Pfizer COVID-19 shot for kids age 5-11 in October; Bb Maria Taylor, and Dan
Levine
CBS News: Gottlieb says vaccine could be approved for kids 5-11 by end of October; by Melissa Quinn
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Inline Image Courtesy of International Monetary Fund’s Flickr Page – Creative Commons License