Highlights:
• Pfizer-BioNTech stated that they have submitted a formal request to the FDA seeking EUA for its Covid-19 vaccine for children aged 5-11
• Pfizer added that they are dedicated to working with the FDA with the ultimate goal of helping protect children against this serious public health threat
• Earlier, the FDA stated that they will complete its review in a matter of weeks rather than months once a formal submission was completed

On Thursday, Pfizer and BioNTech stated that they have submitted a formal request to the U.S. Food and Drug Administration (FDA) seeking emergency use authorization (EUA) for its Covid-19 vaccine for children aged 5-11. Pfizer added that they are dedicated to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.

Earlier in September, the company stated that its Covid vaccine was safe, and it produced a robust immune response in children aged 5-11 during the 2/3 phase of clinical trials. They added that for children between the age group of 5 and 11 years, the vaccine would be administered in a two-dose regimen of 10 micrograms with a 21 days interval.

Children are considered less at risk of severe Covid, however, the latest coronavirus wave driven by the Delta variant resulted in a higher number of infections among them. Furthermore, administering vaccines to young people is also seen as a key to keeping schools open and helping end the pandemic.

Jeff Zients, the Covid coordinator of the White House, stated that he thinks everyone can agree that getting a safe and effective vaccine for kids aged 5-11 is a really important next step in the fight against the pandemic. Earlier, the FDA stated that they will complete its review in a matter of weeks rather than months once a formal submission was completed.

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