$PFE #Comirnaty's FDA approval comes with 6 myocarditis post-marketing study requirements, as well as expected further pediatric study. Approval letter: fda.gov/media/151710/d…
The picture shows what is currently included the PI about myocarditis. PI: fda.gov/media/151707/d…
This section also references the following CDC link:
cdc.gov/vaccines/covid…
4 additional vax post-marketing study requirements: pregnancy registry,
immunogenicity and safety of lower dose in 12 through <30 yrs of age,
post-EUA safety surveillance study in the Veteran’s Affairs Health System, and
effectiveness study - Kaiser Permanente Southern California

• • •

Missing some Tweet in this thread? You can try to force a refresh
 

Keep Current with Jessica Adams

Jessica Adams Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @RxRegA

23 Aug
There it is! FDA PR: FDA Approves First COVID-19 Vaccine fda.gov/news-events/pr…
@US_FDA Link to PI not working fda.gov/about-fda/page…
@US_FDA There's also an issue with the FAQ link. wcms-internet.fda.gov/vaccines-blood…
Read 5 tweets

Did Thread Reader help you today?

Support us! We are indie developers!


This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!

:(