Pfizer and BioNTech SE Submit Data on Covid Vaccine for Kids 5-11 to FDA; Emergency Use Authorization Could Come By Halloween制药companies are confident they're one step closer to making vaccination an option for millions of younger children.
ByKenny Herzog•
Millions of anxious parents are one formality closer to having the option of vaccinating their kids against Covid-19. This morning,辉瑞和BioNTech SE宣布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 tolast week's disclosurethat "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 Faucihas 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 havedied from Covid-19 infection. Between June 16 and August 14, child hospitalizations due to Covid infectionsrose nearly tenfoldover the prior six-week period.
