Thread by @DrEricDing

BREAKING—Pfizer and BioNTech have requested the FDA to authorize emergency use of its #COVID19 vaccine for children ages 5-11. FDA meeting scheduled on Oct. 26 to consider it. A ruling is expected between Halloween and Thanksgiving. #vaccinate
nytimes.com/2021/10/07/us/…

2) Pfizer has proposed giving children one-third of the adult dosage. That might require adding more diluent to each injection or using a different vial or syringe. The company was expected to describe the method it intended to use in its submission to the FDA.

3) A pediatric dose will also most likely require new labeling, with special codes that would allow the Centers for Disease Control and Prevention to track specific lots in case of reports of serious side effects.

4) the #Deltavariant drove nearly 30,000 kids to hospitals in August. According to @AmerAcadPeds, nearly 5.9 million Americans younger than 18 have been infected with the coronavirus. Of the roughly 500 Americans under 18 who have died, about 125 were children ages 5 to 11.

5) “It really bothers me when people say kids don’t die of Covid,” said Dr. Grace Lee, an associate chief medical officer at Stanford Children’s Health who also leads a key advisory committee to the C.D.C. “They die of Covid. It’s heartbreaking.”

I agree.

6) Here is the earlier report on the new data in kids.

https://twitter.com/drericding/status/1439913900724588545

7) here is the likely regimen for the kids 5-11 dose… 10 mcg. 2 doses.

https://twitter.com/drericding/status/1439929995980382208

8) Not holding back… we need to call out the @US_FDA to speed the review meetings up!

https://twitter.com/drericding/status/1446115115187654668