@Pharma_Pro @SteveFDA @US_FDA Agree, Daniel. But, isn't there a history of BLAs/NDAs being approved for drugs meant to treat large population without AdCom mtngs/over-ruling AdCom vote? I am asking for issuing EUA for the 2 vaccines asap with only FDA review so that they could be started to be given asap..1/
@Pharma_Pro @SteveFDA @US_FDA ...and still have the AdCom meeting on the 10th Dec (to decide whether to keep or revoke the EUA) as well as in say 6 months to determine if the EUA should be kept/revoked based on real-world safety and effectiveness data, and even prior to a BLA, which is rarely revoked..2/
@Pharma_Pro @SteveFDA @US_FDA ...Considering what we are going to expect massive 4th #COVID19 wave during Christmas period due to mass get together during Thanksgiving, it is even more important that especially healthcare workers and the elderly are vaccinated a day after Thanksgiving. ..3/
@Pharma_Pro @SteveFDA @US_FDA ...Not many would be vaccinated between now and Dec 10th so the risk of say what happened in 1976 with the swine flu vaccine is low. As you know active EUAs are very frequently reviewed with every submission of real-world data so there is plenty of opportunities to revoke EUAs 3/
@Pharma_Pro @SteveFDA @US_FDA ...That is what I am saying. Is my logic flawed? Thoughts? 4/end

• • •

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

Keep Current with Ken Kengatharan, Ph.D.

Ken Kengatharan, Ph.D. 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!


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!

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!