Did The FDA Act Too Fast In Suspending Rotarix?

Let's not mince words - YES!!!

Did The FDA Act Too Fast In Suspending Rotarix? // Pharmalot

 

I do believe the "FDA error" was done from a concern for safety and out of conservatism from a regulatory point of view.  However, I also believe they now have corrected their error by allowing both Rotarix and RotaTeq to be administered.  I buy the argument that the risk of NOT getting a vaccine is higher than the possible risk of receiving some PCV virus DNA. It will be prudent to continue the studies on PCV though.

Posted using ShareThis by Bruce Lehr May 10th 2010.

Comments

[bigredbruce]

EU agrees with FDA position on allowing use of Rotarix
http://regulatoryaffairs.pharmaceutical-business-review.com/news/gsk_rotarix_vaccine_safe_to_use_european_medicines_agency_100524/

[Bruce Lehr]

Here's a reminder as to why vaccines are important in public health and benefits more often than not far outweigh risks of complications.
http://bit.ly/caX5FR

[Bruce Lehr]

Another article from thepharmaletter with a contrarian view point to my post.
http://www.thepharmaletter.com/file/94878/us-coalition-for-vaccine-safety-calls-on-fda-to-immediately-suspend-all-contaminated-rotavirus-vaccines.html

[Bruce Lehr]

Just came across this article in Forbes which offers a differing opinion as to actions that should be taken with Rotavirus vaccines.

Full disclosure I always say.

http://www.forbes.com/feeds/businesswire/2010/05/10/businesswire139454776.html