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Posts Tagged ‘vaccines approved’

RECALLED

MedImmune announced it is recalling it’s Nasal Spray vaccine, Flu Mist designed to maybe, prevent Swine Flu.  

“Nearly five million doses of an H1N1 swine flu vaccine were recalled today because the strength of the nasal sprays may have decreased over time and they may not be as potent as they are supposed to be, the Food and Drug Administration said. Only about 3,000 of the recalled vaccine doses produced by the MedImmune unit of drug maker AstraZeneca are believed to still be in circulation or storage. The vast majority were administered to patients in October and November, at the peak of the H1N1 vaccination process, according to a Reuters news report.” via http://www.attorneyatlaw.com/2009/12/millions-of-h1n1-vaccine-doses-recalled-due-to-potency-problem/ 

MedImmune has released a pdf with the lot numbers and additional information at http://www.attorneyatlaw.com/2009/12/millions-of-h1n1-vaccine-doses-recalled-due-to-potency-problem/

That’s millions of people who inhaled the live swine flu virus and it probably doesn’t offer any protection at all.  Want to know what else they inhaled and then breathed out on an unsuspecting population? http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf

Each pre-filled refrigerated Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU of the live attenuated influenza virus reassortant of the pandemic (H1N1) 2009 virus: A/California/7/2009 (H1N1)v. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, 0.96 mg/dose monobasic potassium phosphate, and <0.015 mcg/mL gentamicin sulfate. The vaccine contains no preservatives. 

Also on the patient insert- The following adverse reactions have been identified during postapproval use of FluMist. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Congenital, familial and genetic disorder: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome). Gastrointestinal disorders: Nausea, vomiting, diarrhea
Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema and urticaria)

Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy

Respiratory, thoracic and mediastinal disorders: Epistaxis

Skin and subcutaneous tissue disorders: Rash

Our most visited page on the Ahrcanum site is all about the Swine Flu Rash!  https://ahrcanum.wordpress.com/2009/10/19/swine-flu-rash-hives-symptoms/

Last week CDC announced that nearly one million does of H1N1 Swine Flu Vaccines intended for children were being recalled that were manufactured by Sanofi Pasteur, Inc..  http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm    

“Despite the recall, the vaccine is safe and effective; parents need not worry about unusual side effects or having their children re-vaccinated,” says Anne Schuchat, director of the Centers for Disease Control and Prevention’s Center for Immunization and Respiratory Diseases. “There’s no need for parents to call pediatricians. We think the doses given are protective and safe,” she says. http://www.usatoday.com/news/health/2009-12-15-swine-flu-vaccine_N.htm       

“We think?,” she said, We think she hasn’t a clue and neither does anyone else about these fast tracked Swine Flu vaccines.  Our take on that recall is at https://ahrcanum.wordpress.com/2009/12/16/h1n1-swine-flu-vaccine-for-children-recalled/  In November, we wrote about the Canadian Vaccine Recall from GlaxoSmith Kline at https://ahrcanum.wordpress.com/2009/11/25/h1n1-swine-flu-vaccine-pandemrix-recall/  

Will the third time be the charm that changes people’s mind about getting the Swine Flu Shot or Nasal Spray now that is it generally available to the public? 

Anyone taking bets that this is not the last of the Swine Flu Vaccine recalls?

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Our most precious of resources for the future is our children.  It will be their dreams that may will solve the numerous maladies affecting mankind.  From exploring space, to exploring Earth’s own oceans, to just maybe finding a cure against diseases like cancers and viruses like the flu.  It is our children who are exposed to a myriad of vaccines that are so toxic, they should be labeled hazardous materials.   

Say nothing of the suspected links to auto-immune disorders, almost all world governments and health organizations are advocating children receive the H1N1 Swine Flu Shot, even though little clinical testing has been done on them.  You’ll recall, “Shut up and just get your damned flu shot.”      

   

 Yesterday, the CDC announced that nearly one million does of H1N1 Swine Flu Vaccines intended for children are being recalled that were manufactured by Sanofi Pasteur, Inc..  http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm    

“Despite the recall, the vaccine is safe and effective; parents need not worry about unusual side effects or having their children re-vaccinated,” says Anne Schuchat, director of the Centers for Disease Control and Prevention’s Center for Immunization and Respiratory Diseases. “There’s no need for parents to call pediatricians. We think the doses given are protective and safe,” she says. http://www.usatoday.com/news/health/2009-12-15-swine-flu-vaccine_N.htm      

 The U.S. Government has evaluated only these vaccines that are licensed by the U.S. Food and Drug Administration. They are, with patient information links:       

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) gttp://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  Recalled lots!     

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

 Influenza A (H1N1) 2009 Monovalent Vaccine (ID Biomentical) Influenza A (H1N1) 2009 Monovalent Vaccine (ID Biomedical Corporation of Quebec) and owned GlaxoSmithKline PLC     

On December 7, Sanofi Pasteur notified CDC and FDA that the potency in one batch (called a “lot”) of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits.    

For eight additional days, children were still receiving the flawed vaccine.  The Beatles sang “Eight days a week, I love love love you,” I see no love from the CDC in waiting eight days to begin a recall.    Pasteur’s approval was based on it’s Fluzone approved seasonal flu vaccine that was studied in all of 19 children according to their own patient insert on page 7. – link provided above-   

Ingredients on page 11- Influenza A (H1N1) 2009 Monovalent Vaccine, an inactivated influenza virus vaccine, for intramuscular use, is prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, polyethylene glycol p-isooctylphenyl ether (Triton ® X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution    

Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v-like virus per 0.5 mL dose. Gelatin 0.05% is added as a stabilizer. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and sucrose (not more than 2.0%).    

There is no thimerosal used in the manufacturing process of the single-dose presentations of Influenza A (H1N1) 2009 Monovalent Vaccine. The multi-dose presentation of Influenza A (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury   

Pregnancy Category C, found on page 10 : 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.    

Some doctors around the world have managed to draw attention to these untested vaccines.  In Israel one doctor wrote- “The combination of squalene and polysorbate 80 in a buffered solution has been shown to be an excellent anti-fertility combination, in anti-fertility research performed by scientists for the W.H.O., who were assigned the job of developing anti-fertility vaccines to reduce world population. Giving these vaccines to our young population is tantamount to sterilizing them.”  http://www.theflucase.com/index.php?option=com_content&view=article&id=1611%3Adoctors-protest-israels-decision-to-give-toxic-focetria-and-pandemrix-jabs-to-people&catid=1%3Alatest-news&Itemid=64&lang=en  Offering supporting evidence- (Fertility Impairing Vaccine And Methods of Use’ This application claims the benefit of U. S. Provisional Application No. 60/070,375, filed January 2,1998, U. S. Provisional Application No. 60/071,406, filed January 15,1998).    

Similar statements can be found regarding CSL’s AFLURIA, and Norvartis’ FLUVIRIN and are recapped in a previous post at https://ahrcanum.wordpress.com/2009/09/27/h1n1-swine-flu-vaccine-package-insert-warnings/   

In the U.K., they too are unsure of just how many shots is necessary – 

In line with adults children will be given just one dose of the vaccine, rather than the two that was originally thought might be necessary for younger age groups. However, preliminary data from two newly released trials published in the Lancet suggest that a single vaccine may not offer children sufficient immunity against the virus. Since the pandemic began earlier this year 17 children under five have died after contracting swine flu, as well as 266 older children and adults. Tests on versions of the vaccine produced by nine different manufacturers show that some offered protection to as few as 45 per cent of children under three. http://www.telegraph.co.uk/health/swine-flu/6817459/Swine-flu-giving-young-children-one-dose-of-vaccine-may-not-protect-them.html       

 In November, we wrote about a Canadian Vaccine Recall from GlaxoSmith Kline at https://ahrcanum.wordpress.com/2009/11/25/h1n1-swine-flu-vaccine-pandemrix-recall/ :       

With a rush to produce millions of H1N1 vaccines by Pharmaceutical Companies, comes the news of the first recall of the vaccine.  Will it be the last? Canadian doctors have been advised not to use a batch of 170,000 swine flu vaccines after six reports of serious allergic reactions among recipients, but there are no similar reports from other countries, pharmaceuticals company GlaxoSmithKline PLC said Tuesday. via http://www.huffingtonpost.com/2009/11/24/swine-flu-recall-h1n1-vac_n_368776.html       

GlaxoSmithKline has asked that the October batch of H1N1 swine flu Pandemrix be taken out of circulation because it produced serious and immediate anaphylactic reactions in one out of 20,000 vaccinations, compared with one out of 100,000 in other shipments. Most of the vaccine Manitoba received from the suspect lot had already been used by the time the province received the alert. Of the 63,000 doses shipped, only 630 remained unused.       

The Political Jungle summed it up nicely at  http://takeastandagainstliberals.blogspot.com/2009/12/swine-flu-vaccine-recall.html “Already used and they have no idea why the vaccine changed, or lost potency. No clue. What else do they have no clue about?”       

At least the expired Tamiflu for Oral Suspension hasn’t lost it’s potency!  Back up to July2009, The FDA authorized 4 lots of Tamiflu for Oral Suspension for use beyond their labeled expiration dates. FDA is now authorizing additional lots in an effort to ensure that Tamiflu for Oral Suspension is available for patients during this public health emergency. The lots of Tamiflu for Oral Suspension that are being authorized are part of the Strategic National Stockpile and have been tested through the federal government’s Shelf-Life Extension Program (SLEP). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm184770.htm       

From cases of anaphylactic shock and low potency levels, this recall is another setback for vaccine manufacturers who continue to profess that their products are safe, even as they have been given full immunity from prosecution in the U.S. Perhaps these recalls will have the advantage to educate and warn parents not to vaccinate in the first place.    

™©® by respective owners.

  flag tounge

Open wide, say ahhh and check out more posts from Ahrcanum including our Swine Flu report that started  in April and is updated regularly at https://ahrcanum.wordpress.com/swine-flu-report/

SUBSCRIBE NOW for further updates in the top right margin.

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