View Full Version : H1N1 Vaccine Package Insert

11-02-2009, 04:19 PM
For those interested ...

Novartis H1N1 Vaccine package insert - from the manufacturer.

Vaccine Package Insert (http://www.fluscam.com/Vaccine_Package_Inserts_files/Novartis_A-H1N1_2009_Monvalent_VaccinePackageInsert_BasedOn19 80Approvalfor%20Fluvirin_UCM182242.pdf)

See especially Table 2 - page 8
Then all of page 11 - adverse reactions.
Page 12 - 'safety and effectiveness in kids under age 4 - "NOT ESTABLISHED"

Just FYI.

(and no, we weren't planning on getting the vaccine anyways)

11-02-2009, 10:36 PM
Don't freak..not an unusual statement at all. As society frowns on experimental testing of pregnant women, small children, targeted racial groups... most medications are not determined to be harmful/effective in specific groups until they have been out in the market for awhile.
Hence Paxil now found to be causing birth defects, i.e. the company couldn't experiment on pregnant women so they had to extrapolate that based on what it was made out of and how non pregnant people reacted, it was safe. Unfortunately in this case, they guessed wrong :(

11-02-2009, 11:03 PM
Just think how many people blindly get the shot and never even think to ask to read the insert!

11-03-2009, 02:48 AM
I had the vaccine, no worries.

11-03-2009, 10:55 AM
Just think how many people blindly get the shot and never even think to ask to read the insert!

Trust me, if you read the insert on saline solution, you'd be horrified. Lurk is right. For litigation and regulatory reasons the insert has to be kind of terrifying. All drugs have side-effects. All of them - without exception. Some drugs have unintended effects that only show up in large populations. You have to do your homework and make your bets based on your own perception of risk.

I got the regular flu shot (which also has a terrifying insert) because my MIL is as old as dirt and I wouldn't want to give her anything at her age. She's old enough that she probably partied with the original swine flu victims back in the day so I'm not worried about exposing her to this strain. For my own part, I've never had any flu (or never noticed it) but I'm sure I can survive it if I get it so I'll skip the shot.