Posted by: debstake | October 2, 2009

H1N1 Swine Flu Vaccine Package Insert, Warnings


Thanks to my friend ahrcanum for forwarding this information to me.

DEB

====================================================================================================

H1N1 Swine Flu Vaccine Package Insert, Warnings

September 27, 2009 by ahrcanum

The U.S. Government has evaluated only these vaccines that are licensed by the U.S. Food and Drug Administration. They are-

Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited)http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181975.htm

Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181973.htm

Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc)  http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181971.htm

Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181970.htm

Lot release information will be updated weekly.  Last update: 9/24/2009.  http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm181956.htm

Manufacturer Total Number of Lots Released by FDA
MedImmune LLC 9
Novartis Vaccines and Diagnostics Limited 3
Sanofi Pasteur, Inc. 3

From the CSL package insert: Influenza A (H1N1) 2009 Monovalent Vaccine, Manufactured by CSL Limited, Suspension for Intramuscular Injection, Initial U.S. Approval: 2007 [sic- approved TWO YEARS AGO!)

From the CSL package insert-

Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals.

5.4 Limitations of Vaccine Effectiveness

Neurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported.

8.1 Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA. 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.

8.3 Nursing Mothers

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in nursing mothers. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman.

8.4 Pediatric Use

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in children. Safety and effectiveness in the pediatric population have not been established.

Similar warnings from the Novartis insert-http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182242.pdf

8.3 Nursing Mothers-It is not known whether FLUVIRIN or Influenza A (H1N1) 2009 Monovalent Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman

8.4 Pediatric UseSafety and effectiveness in pediatric subjects below the age of 4 years have not been established. [see ADVERSE REACTIONS (6) and CLINICAL STUDIES (14)]

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN. It is also not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN 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.

The government is starting an unprecedented system to track possible side effects as mass flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.

“Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone,” said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services. http://www.philly.com/philly/wires/ap/features/health/20090927_ap_swineflushotintensetrackingforsideeffects.html

Just how did CSL Limited, Suspension for Intramuscular Injection get Initial U.S. Approval in 2007?????? TWO YEARS before the explosion of H1N1 around the world.  These patient inserts appear to be from the respective manufacturers of the seasonal flu vaccine, only adding the text for H1N1 with no large clinical studies.

US officials say the first swine flu vaccine will be available on Oct. 5. http://www.presstv.ir/detail.aspx?id=107252&sectionid=3510210 Women and children first please.

About these ads

Responses

  1. if you’re interested in a personal story about vaccines and the government check out http://bennymay.wordpress.com/

  2. Thank you for letting me in here. Please let me know what should I put in for your anchor text in my site. We are on the process now of building a huge nursing directory list and I wanted your site to be included.

    Shameless plug: We will be posting the November 2009 nursing board exam result in our website. Please let your Filipino visitors know about it. CIAO!

  3. Thank u for the honor! I will have to begin writing again now. My interests do change however and my blogs reflect that. Right now I am into genealogy; So topics have just expanded a good bit. As to the “anchor text” I have no HTML for copying. A suggestiong though; use the graphic of the billboard that I have in my header and link it to this link:——> http://www.debstake.wordpress.com

    Again Cherie thanks for the honor.

    DEB

  4. Hello, I’m searching for nursing related blogs like mine http://nursingcrib.com and I stumbled your site, nice blog!. I hope you could also include me in your blogroll.

    By the way, you have a very good writing skills here. Keep up the good work.

  5. Cherie,
    Thank you for the compliments. I love to write and am planning on writing a book about autism. Tentative title is “The Lighter Side of Autism”. The funny things we have experienced because of our beloved JR.

    Now not trying to be rude here but tell me what is your take on vaccinations in general? The vaccine autism issue and the H1N1 debacle? I will be pleased to add u to my blog rolls.

    DEB

  6. Thanks for the info friend

  7. There is little or no justice for the victims of vaccine and pharmaceutical caused conditions and death. These companies circumvent and corrupt government agencies meant to protect the public. In todays world, they are protected from us, we are their legal lab rats as governments allow the use of improperly safety tested products to be given freely in a “lets see what happens” form of experimentation. It saves these companies the expense of safety testing and when issues arise they blame the victim by insisting its from an underlying disorder, or its based on genetics, and governmemt agencies support this coverup.

  8. Ross everything you say is right on the mark. Which makes it imperative that we as just human beings need to network and spread the word about the dangers of ALL drug cartel (pharmaceutical companies) products. There is no such thing as a safe product when it has been manipulated at the hands of soulless individuals all for the sake of making money. It is the capitalist mentality that has jeopardized so many. I am all for making a buck but not at the expense of a human life. As a society America has become nothing but a bunch of blood sucking leaches who doesn’t care a bit about the big picture and the long term effects.

  9. According to the patents on two of these vaccines–MedImmune and Sanofi-Pasteur, the vaccines are genetically engineered. MedImmune is the live nasal vaccine and one has to wonder about possible “new” side effects. These vaccines have been fast tracked because the government declared an emmergency pandemic. Yet the test kits for this “novel” swine flu, are just becoming available. So do people have this particular flu or just the usual run-of-the mill flu? Thanks for writing about this issue. People need to be informed and should have the right to decide for themselves what risks they want to take regarding their health care.

  10. hi there – isee this post is linked to my blog. My 13 yr old has swine flu RIGHT NOW and I had it last week ( I am pretty sure as i have the same symptoms as my daughter and a doctor diagnosed her today) it isnt that bad.. certainly not so bad that you need to run out and get a vaccine for 9 and one that has worse side effects than the actual flu itself!!) I felt like i had a cold for 2 days and that was it.. my 13yr old had a fever but it broke two days ago. We all take supplements already but once sick i hae given echinacea ( not cheap store brand homeopathic tincture) Pure vit c powder, cayenne, goldenseal herb, and whole food mutlivitamins and she is doing just great and healing right up.
    Just thought I would share- now I am off to write a blog post on this LOL

  11. Nancy,
    I am not surprised that the medical establishment isn’t being upfront and honest with their patients. That is why people like us MUST do their jobs for them.

    I have a very dear friend who is pregnant now. She worked my son his first year at Vista as a TSS. She is now a special education teacher with a focus on autism. She is well aware of the dangers of the flu and particularly the swine flu vaccine. I send info about ALL vaccines to her. She gets the info out to her pregnant friends and so it goes.

    The government is more interested in recouping it’s costs in buying the swine flu vaccine so they aren’t going to be spreading any truths that for certain. It’s up to us the common joe on the street to inform our neighbors and loved ones.

    The swine flu vaccine is a conversation being discussed all over America. Now is the time for the informed to inform the uninformed.

    DEB

  12. Great job getting the word out. My dtr a PT and I a nurse have been actively fighting for philosophical exemption from vaccines in NYS. My dtr had a conversation with a doctor from the CDC. It was a long conversation with no ans as to the safety and effectiveness of vaccines in general. Pregnant women are not told that it is not know if the H1N1 can cause fetal harm or affect reproduction. The doctor stated they have to be careful in what they say or the women may not take the vaccine. It is chilling. Anyway, thanks for your efforts and keep up the good work. Nancy Doxsee

  13. I want to thank everyone for their support. This blog entry has gotten the most comments of any blog I have posted.

    I hit a nerve here and it has made me think. My Gardasil post also drew many to this blog. I think I am going to do a series.


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Categories

Follow

Get every new post delivered to your Inbox.

Join 149 other followers

%d bloggers like this: