Thread by @profshanecrotty

Good news! Pfizer data today indicate they have a safe and effective COVID-19 vaccine for kids ages 5 to 11. Kids vaxxed by Halloween? 🧵
🔵  Antibody titers as high as adults
🔵  "Favorable safety profile" with 10 microgram dose used
🔵  Filing with FDA

pfizer.com/news/press-rel…

🔵  Antibody titers were as high as adults

The fact that the peak antibody titers are equal between the kids 5 to 11 years old and young adults indicates the COVID vaccine will be protective in the kids.

🔵  "Favorable safety profile" with the 10 microgram dose used

Pfizer used a dose of 10 in the kids instead if the 30 used in adults. That was a reasonable decision, and they see fewer side effects with the lower kid dose (fevers, chills, etc). Other doses were tested early on.

It will be good to see the full data set, but Pfizers reports have been accurate before, and dropping the dose from 30 to 10 is likely to result in fewer side effects than seen in the 12-15 year olds with the 30 dose.

The vaccine study enrolled 2,268 kids.

"The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA’s Marks said pediatric studies should be large enough to rule out any higher risk to young children."

That’s from this article

apnews.com/article/busine…

🔵  Filed with the FDA

It looks like they are filing this with the FDA ASAP, with the hope of having FDA EUA authorization before the end of October.
The antibody data are clear evidence the vaccine will work in the kids,

The FDA will have to make a judgement call on the safety data relative to “rule out any higher risk”, but one can expect the FDA to make a judgement relatively quickly.

(Reposted thread to fix an annoying autocorrect typo)