Pfizer and BioNTech SE Submit Data on Covid Vaccine for Kids 5-11 to FDA; Emergency Use Authorization Could Come By Halloween


You’re reading Entrepreneur United States, an international franchise of Entrepreneur Media.

Millions of anxious parents are one formality closer to having the option of vaccinating their kids against Covid-19. This morning, Pfizer and BioNTech SE announced that they have submitted data from comprehensive trial results of their mRNA vaccine on children ages 5-11 to the U.S. Food and Drug Administration (FDA). The statement referred to last week’s disclosure that “the safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.” 

In other words, after a three-phase trial conducted with thousands of participants from diverse backgrounds, the companies are confident that a modified dosage of their product is safe and efficacious for kids in kindergarten and up.

An important note is that, although the FDA intends to immediately start poring over the data, Pfizer and BioNTech have not yet applied for Emergency Use Authorization from the agency, the final procedural step before vaccines can be administered those in question. But per their newest statement, that “is expected to follow in the coming weeks.” 

And as Dr. Anthony Fauci has mentioned in recent days, that could mean parents who choose to vaccinate their elementary-aged children might be able to do just that by late October.

As of this writing, nearly 687,000 Americans have died from Covid-19 infection. Between June 16 and August 14, child hospitalizations due to Covid infections rose nearly tenfold over the prior six-week period.

Related: Pfizer Says its COVID-19 Vaccine is Safe and Likely to Work In Younger Children, and it’s Planning to Ask for Permission to Use it In Kids as Young as 5

Kenny Herzog

Written By

Entrepreneur Staff

Kenny Herzog is currently Digital Content Director at Entrepreneur Media. Previously, he has served as Editor in Chief or Managing Editor for several online and print publications, and contributed his byline to outlets including Rolling Stone, New York Magazine/Vulture, Esquire, The Ringer, Men’s Health, TimeOut New York, A.V. Club, Men’s Journal, Mic, Mel, Nylon and many more.

Source link