Quote from Delaina
I was given a handout from the FDA that says they didn't KNOW the side effects the H1N1 vaccine would have on a fetus. They also added that they didn't know if the vaccine could cause future fertility problems.
I'm finding it so strange that people on the outside seem to know more than the FDA does, and that I can be told "they tested pregnant women more thoroughly this time." Really? Please show me that in their literature.
Why would they talk about future fertility if it were the exact same shot that has been tested thoroughly?
Here's what else it says that you left out from the same link:
http://www.fda.gov/downloads/Biologi.../UCM182404.pdf
8.
USE IN SPECIFIC POPULATIONS 1
Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (Fluzone vaccine) are manufactured by the same process. Available information for Fluzone vaccine is provided in this section.
8.
1. Pregnancy
Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.
--------------------USE IN SPECIFIC POPULATIONS-------
Information in this section is based on seasonal trivalent Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. (Fluzone vaccine).
14
. CLINICAL STUDIES 9
Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (Fluzone vaccine)
are manufactured by the same process. Data in this section were obtained in clinical studies conducted with Fluzone vaccine.
I stand by my original assertion. This is the SAME vaccine as a seasonal flu shot. Just as the only change between the seasonal flu shot each year is the specific strains that are contained in it. The only change between the seasonal flu shot and the H1N1 shot this year, is that there's one, novel H1N1 strain in the H1N1 shot while the flu shot has three different strains.
This is
not a
new vaccine. Quote from Delaina
Clinical trials on pregnant women only began on September 9th. So here we have a dilemma because not all of those women will give birth by the time the vaccine is distributed (if the lawsuit doesn't halt it), especially if they were "tested" in the first or second trimester.
Most people that are concerned about the vaccine are concerned about LONG-TERM effects.
I truly hope that when a patient tells one of us that they will NOT be taking something, that we stick up for their right to say no and don't try to misinform them in order to get them to consent. Seriously. They have a right to their autonomy.
So do I.
Well of course that study is ongoing....would it have been better to withhold the vaccine so the trial can continue while H1N1 is spreading?
The drug companies themselves who made the drug (that was a package insert, you linked to, created by the drug company who created the drug) are saying that this is the same vaccine they use for the seasonal flu, they've just changed the strain that's in it.
Oct 16, '09 by CuriousMeQuote from DelainaI was given a handout from the FDA that says they didn't KNOW the side effects the H1N1 vaccine would have on a fetus. They also added that they didn't know if the vaccine could cause future fertility problems.
Oct 17, '09 by amy0123If every state mandated the H1N1 vaccine like the NY government has, I wonder what the response would be from health care workers from all 50 states. Would some states refuse and rally? Would those nurses also lose their argument for free choice and be fired?
Oct 18, '09 by NRSKarenRNWhat is the design of the 2009 H1N1 influenza vaccine trial now enrolling pregnant women?