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 10^{6.5-7.5 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.} 

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!  http://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 http://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 http://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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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 http://ahrcanum.wordpress.com/swine-flu-report/  

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%).    

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 http://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.    

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Sanofi-Aventis is recalling 800,000 doses of H1N1 vaccine meant for children younger than 3 because the vaccine has lost potency.

Hmmm…

From CNN:

The French manufacturer Sanofi Pasteur is voluntarily recalling about 800,000 doses of vaccine meant for children between the ages of 6 months and 35 months.

The company and the Centers for Disease Control and Prevention emphasized that the recall was not prompted by safety concerns, and that even though the vaccine isn’t quite as potent as it’s supposed to be, children who received it don’t have to be immunized again against H1N1.

The CDC emphasized that there is no danger for any child who received this type of vaccine.

When asked what parents should do, CDC spokesman Tom Skinner said, “absolutely nothing.” He said if children receive this vaccine, they will be fine.

Read more from the CDC

An estimated 800,000 doses of the H1N1 vaccine for children have been recalled because they lost their potency, the US officials say.

US manufacturer Sanofi Pasteur recalled several vaccine lots after stability tests revealed that the pediatric syringes had lost their potency after being shipped.

The doses were for children between aged between 6 to 35 months old, the Centers for Disease Control and Prevention (CDC) reported.

There were no safety concerns, the CDC emphasized, as all the doses passed tests for purity and safety.

The tests showed that the doses contained the recommended 7.5 micrograms of antigen, which is needed to stimulate immunity.

Subsequent testing revealed that some of the virus component had degraded, weakening the vaccine.

Children who had already been administered the vaccine did not need to be re-immunized, the CDC said. But those who had received just one dose should get a second shot, as is required in the case of all children below 10 years, it added.

Last week, the CDC said that swine flu has claimed an estimated 10,000 lives in the United States, more than double the estimated death toll in November.

The H1N1 virus infected about 50 million people, or one in six Americans, the November data showed.

The fatalities include about 1,100 children and 7,500 younger adults, who continue to be the most vulnerable to the H1N1 virus.

About 800,000 swine flu (H1N1) shots for children are being recalled because they aren’t quite strong enough. But CDC flu experts say there’s nothing to worry about – the vaccine is still safe.

The vaccine, made by Sanofi Pasteur, was distributed throughout the U.S. last month for children ages 6 months to 3 years, and many have already been used. But the company issued a voluntary recall after further testing showed the vaccines strength fell slightly below required levels. This means that the vaccine should have been more potent, but is still expected to be effective.

So even if your children did receive both doses from the recalled batch they don’t need to be vaccinated again, health officials said. If they haven’t, it’s still recommended that they complete the two-dose series.

While the vaccine can help protect you from the flu, it’s not a cure-all. Make sure your family continues to cover coughs, wash hands and stay healthy. Visit The Beehive for a great section on swine flu and some helpful tips to avoid it.

I have noticed that a lot of visitors to my blog have come from searches that make it apparent they are looking for information on whether the swine flu vaccines contain thimerosal/mercury, so I thought I would collate the information from the package inserts for each of the available shots here for easy reference.

Novartis, Influenza A (2009) Monovalent Vaccine -Licensed for persons 4 years of age and older

• 0.5 ml prefilled single dose syringe contains less than or equal to 1 microgram mercury per dose (residual mercury from manufacturing process)

• 5 ml multidose vial contains 25 micrograms of mercury per 0.5 ml dose (as preservative)
  

Sanofi Pasteur, Influenza A (2009) Monovalent Vaccine – Licensed for persons 6 months of age and older

• Prefilled syringe, 0.25 mL, for 6 through 35 months of age – contains no mercury (no mercury used in manufacturing process) – distinguished by a pink syringe plunger rod

• Prefilled syringe, 0.5 mL,  for 36 months of age and older – contains no mercury (no mercury used in manufacturing process)
  

• Single-dose vial, 0.5 mL, for 36 months of age and older – contains no mercury (no mercury used in the manufacturing process)
  

• Multi-dose vial, 5 mL, for 6 months of age and older, 25 micrograms of  mercury per 0.5 ml shot (as preservative).

CSL Limited, Influenza A (H1N1) 2009 Monovalent Vaccine – licensed for persons 18 years of age and older

• 0.5 mL single-dose, pre-filled syringe - no mercury (no mercury used in manufacturing process)

• 5 mL multi-dose vial  each 0.5 mL dose contains 24.5 micrograms of mercury

MedImmune LLC,  Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
– (Live, Attenuated Intranasal Vaccine – LAIV) Licensed for persons from 2 years to 49 years

• Prefilled single-dose intranasal sprayer containing 0.2 mL suspension (0.1 ml per nostril) – no mercury
  

Par Saïd Ahmiri

C’est l’histoire d’une grippe réapparue mystérieusement au Mexique après des décades d’absence. Tous les regards se tournent alors vers La Gloria, petit village à l’industrie porcine intense étant le lieu d’émergence situé très exactement dans l’une des fermes Caroll qui appartiennent au groupe américain Smithfiels Foods, le numéro 1 mondial de la charcuterie. La machine médiatique est lancée. La psychose d’une pandémie mondiale s’empare de tous les chaînes télévisées, de la presse allignée et des affiches de prévention apparaissent dans les couloirs du métro londonien. Des dispositifs de sécurité sont placés dans les aéroports japonais. En Egypte a lieu un génocide de 250 000 porcs. Il faut dire que la mécanique commence à être bien rôdée, après la vache folle et la grippe aviaire, les animaux sont massacrés par milliards sans le moindre procès. Qui va se soucier d’eux après tout ? WWF ? Qui se soucie aussi des vrais millions de morts chaque année à cause du cancer, de la famine, de la malaria ou des maladies cardiovasculaires ?

Dans les premiers jours, tous les médias comptent au cas par cas pour faire paniquer le commun des mortels. Dès les premiers jours, il y a des confusions dans les chiffres entre 107 et 126 morts. Véritable cacophonie. Qu’est-ce que ce sera alors quand il y en aura des millions à compter ? Au cours des premières semaines du test de guerre bactériologique chez Pancho Villa, la directrice Margaret Chan de l’OMS à Genève fait passer à plusieurs reprises ses niveaux d’alerte pandémique sans même suivre son propre protocole préétablie. Les gouvernements refusent bizarrement d’interdire tout déplacement par voie aérienne pour ne pas perturber la relance économique alors que le monde est frappée de plein fouet d’une récession, et non officiellement reconnue, pour ne pas enrayer le risque majeur de propagation à travers tout le globe de la fichue grippe porcine rebaptisée grippe mexicaine à l’image de la grippe espagnole de 1918 puis virus A/H1N1 alias Influenza A car l’économie mexicaine se plaint de ce nom absurde. Les conspirationnistes alarmistes annoncent la venue du fléau apocalyptique qui va réduire la population mondiale de 93 % d’après une vieille vidéo du site Spread the truth et en parfait accord avec le premier des dix commandements gravés sur le Georgia Guidestones : Maintenir l’humanité en dessous de 500 000 000 individus en perpétuel équilibre avec la nature.

Les semaines passent et tous les regards inquiets observent attentivement la situation dans l’hémisphère sud à l’approche de l’hiver qui s’annonce le plus meurtrier depuis le Vietnam ou la Seconde Guerre Mondiale. Les premières annonces du médicament antiviral Tamiflu développé par le laboratoire américain Gilead Sciences, ancienement présidé par Donald Rumsfeld avant son poste de Secrétaire à la Défense, et vendu au groupe suisse Hoffman La Roche s’avèrent inefficaces. Les estimations loufoques de la dévastatrice pandémie annoncée font état de 70 millions de morts à 2 milliards de morts pour septembre 2009, ensuite octobre, puis novembre et pourquoi pas décembre 2153 ? Les conspirationnistes amateurs font alors la relation directe avec les camps de concentration de la FEMA installés aux quatre coins des États-Unis. C’est la fin, ça y est, l’ange de la Mort est descendu dans la porcherie de Babylone. Les mois défilent, la paranoïa s’accentue avec la possibilité de mutation virale qui passe du cochon à l’homme, ah non, en fait c’est de l’homo sapien au sus scrofa domesticus. Bref, tout s’embrouille et plus personne ne sait très exactement de quoi il en retourne à l’exception évidemment des vrais spécialistes épidémiologiques muselés et interdits de plateau mais ce qui est sûr et certain, c’est une violente pandémie mondiale selon les illustres présentateurs du journal télévisé, vulgaires hauts-parleurs, et vous risquez fortement de l’attraper si vous serrez la main à vos collegues de travail. Oulala une poignée de porte, faites très attention ! Il y a peut-être des germes qui y ont été déposées par le dernier qui l’a ouverte.

Entre temps, les côtes boursières des groupes pharmaceutiques atteignent des records historiques mais aucun média n’en parle. Les traders n’avaient certainement plus vu un tel engouement depuis les actions des compagnies aériennes américaines à la veille d’un certain 11 septembre 2001. Sur la toîle, les internautes néodruidiques expliquent comment faire des potions magiques à base de chlorure de magnésium, de ravintsara et de spirulina aromatisées au pamplemousse si riche en vitamine C. Ici, une interview des pompes funèbres se frottant les mains mais soucieux de ne pas pouvoir trouver du personnel qualifié. Là, un reportage sur les fosses communes à prévoir dans les cimetières des grandes métropoles. Le tout pour bien aggraver la hantise du téléspectateur en citant de temps en temps l’une ou l’autre célébrité l’ayant attrapée comme par exemple la femme de Tony Blair. Ou alors la menace qui pèse sur les écoles qui seront fermées ici mais pas là, ici-aussi mais pas là-bas non plus. Sur la toîle, ça chate à propos de la loi martiale ou le masque FPP3 plus efficace que le FPP2 et sur Facebook, une nouvelle application voit le jour : contamine tes amis avec le virus A/H1N1. Très drôle. Allez dire ça aux familles des morts. De leur côté, les conspirationnistes auto-proclamés inventent des scénarios hollywoodiens incluant la micropuce RFID présente dans le vaccin. La bêtise humaine frise les sommets de la stupidité, ou de l’absurdité. C’est à vous de voir.

Face à l’opinion publique, les gouvernements réfléchissent à une solution pour donner une réponse claire à leurs chers concitoyens lobotomisés depuis des lustres dans le but de remédier à l’hécatombe hivernale dans l’hémisphère nord. Pour soi-disant résoudre la crise financière, les nations au G20 de Londres ont déboursé 5000 milliards de dollars, d’euros, de roubles, de yens ou de yuans avec l’espoir de sauver leurs banques d’un cataclysme eschatologique qui devait mettre toute la planète au chômage et donner de la compagnie aux anciens SDF avec les nouveaux sans-abris expulsés. Bin tiens, pourquoi ne pas faire pareil avec la pandémie grippale ? Alors qu’un médicament est testé sur plusieurs années afin de clairement identifié tous les effets secondaires sur le long terme, devant l’urgence, le Tamiflu n’a eu droit qu’à quelques mois. Un par un, tous les pays réclament à présent leurs millions de petites doses d’oseltamivir comme de pauvres junkies en manque d’héroïne et de nouveaux milliards sont alors injectés de la poche du contribuable afin de pouvoir bâtir des stocks insuffisants de Tamiflu car la production ne peut pas suivre même si Sarkozy a ouvert un nouveau site Sanofi-Pasteur quelque part au Mexique quelques jours avant l’apparition officielle du virus A/H1N1. Mais qui sera vacciné en priorité ? Les enfants ou les vieillards ? La question est posée et les politiciens abordent ensuite le débat d’une éventuelle vaccination obligatoire. Aux États-Unis qui a basculé dans la tyrannie dictatoriale depuis la signature du Patriot Act, « une nouvelle loi votée dans l’État du Massachusetts impose 1000 dollars d’amende par jour et une peine privative de liberté pour refus de vous soumettre à la force publique si les autorités décrétent l’État d’urgence en matière de santé publique. » AgoraVox. Obama ou yes, we can save you. Quoiqu’il arrive en cas d’effets secondaires dus au vaccin, l’immunité est décrétée pour les groupes pharmaceutiques. Les coïncidences s’accumulent très étrangement.

Conclusion
Selon mon opinion et elle ne tient qu’à moi, l’attentat bioterroriste à l’échelle planétaire A/H1N1 maquillé en hold up du siècle a marché comme sur des roulettes. Des médias hystériques aux états policières, tout le monde a parfaitement joué son rôle et les groupes pharmaceutiques Gilead Sciences, Hoffman La Roche, Sanofi-Pasteur, Baxter ont non seulement eu le beurre, l’argent du beurre mais aussi le sourire de la crémière. Nous y sommes, c’est l’automne dans l’hémisphère nord et j’ignore combien il y a eu de morts très précisément. Au 6 juillet 2009, près de quatre mois après l’apparition officielle du virus A/H1N1, l’OMS annonçait un bilan de 94 512 personnes infectées, ainsi que 429 décès dans 136 pays différents. Au 7 octobre 2009, entre 5072 et 6273 morts dont près de 70 % rien que pour les Amériques du Canada au Chili et plus de 462 000 cas enregistrés de par le monde selon les sources de ce site : http://grippe-a-h1n1.over-blog.com/ . Donc, si je prend ma calculatrice, j’arriverais bien à 2 milliards de morts pour décembre 2153 à condition que le virus A/H1N1 fasse 13 888 889 morts par an durant les 144 prochaines années. « Quand la manipulation des masses en est à ce degré, on attend du Diplo quelque chose de plus rigoureux qu’un article citant autoritairement comme « spécialistes dignes de confiance » d’autres boutefeux qui ne rougissent pas de brandir le précédent grotesque de 1918, ont le triste privilège de s’être déjà ridiculisés par leur alarmisme sur la grippe aviaire (BMJ 2005 ; 331 : 981), et dont la crédibilité est de toute façon entamée par leur mépris constant des principes fondamentaux qui requièrent la transparence dans la gestion de leurs conflits d’intérêts. » Docteur Marc Girard, extrait de la lettre adressée à Serge Halimi, directeur de publication du Monde Diplomatique parue en septembre 2009.

Source : Wikipedia, AgoraVox, Mecanopolis

Quelques vidéos sur la pandémie de grippe porcine A/H1N1

Opération Pandémie

Grippe A (H1N1) : Le vaccin plus dangereux que le virus

Guillon – Le gouvernement rate sa grippe

Last updated, oct 21 2009

Here is some infos on the vaccines and their data sheets , I will update the infos ,if I get any fresh infos , meanwhile feel free to feed me  new infos if you have any ! 

Just leave comments on the post regarding new infos updates !

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Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited)

Proper Name: Influenza A (H1N1) 2009 Monovalent Vaccine
Tradename: None
Manufacturer:  CSL Limited
Indication:  Active immunization of persons ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.    

-

Product Information 

• Package Insert -

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182401.pdf

MedImmune’s nose spray( FluMist® )

FlumistFAQS.pdf

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Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)

Proper Name: Influenza A (H1N1) 2009 Monovalent Vaccine
Tradename: None
Manufacturer:  MedImmune LLC
Indication:  Active immunization of individuals 2-49 years of age against influenza disease caused by pandemic (H1N1) 2009 virus.    

Product Information 

• Package Insert -

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf

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Panvax®,CSL Ltd

 ≤ 1.0 μg, sucrose < 10 μg, neomycin ≤ 0.7 ng, polymyxin B sulfate ≤ 0.11 ng and beta-propiolactone ≤ 1.4 ng.  

VACCINE DESCRIPTION 

Panvax® H1N1 Vaccine is a purified, inactivated, monovalent, split virion (split virus)

vaccine. A single 0.5 mL dose contains antigen of the following type:

A/California/7/2009 (H1N1) (NYMC X-179A) (A/California/7/2009 (H1N1)v-like)

15 μg haemagglutinin (HA) per dose.

Each 0.5 mL dose contains, nominally: sodium chloride 4.1 mg, sodium phosphate – dibasic anhydrous 0.3 mg, sodium phosphate – monobasic 0.08 mg, potassium chloride 0.02 mg, potassium phosphate – monobasic 0.02 mg, calcium chloride 1.5 μg and thiomersal 50 μg (for multi-dose vial presentation only).

The following are present in each 0.5 mL dose: sodium taurodeoxycholate ≤ 5 μg, ovalbumin

Panvax® H1N1 Vaccine is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs.

 http://www.public.health.wa.gov.au/cproot/2557/2/Health%20Professionals%20Information%20Sheet%20-%20PDF.pdf

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Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited)

Proper Name: Influenza A (H1N1) 2009 Monovalent Vaccine
Tradename: None
Manufacturer:  Novartis Vaccines and Diagnostics Limited
Indication:  Active immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

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Product Information 

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182242.pdf

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Novartis,Focetria®

Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons of six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus. The pandemic vaccine has been developed using traditional influenza manufacturing processes in an egg-based formulation. Focetria contains MF59®

 http://hugin.info/134323/R/1343650/321900.pdf

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Arepanrix For Canada only :

 GlaxoSmithKline , Pandemrix® 

 A/California/7/2009 -   3.75ug
Thiomersal - 5 mg
AS03 is the adjuvant system - 0.5 ml

AS03 contains:
Polysorbate 80 also known as tween - 80 4.86 mg
Squalene - 10.69 mg
Tocopherol - 11.86 mg 

Training video from UK Department of Health :

http://www.youtube.com/user/departmentofhealth

http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/Pandemrix-PU-17-en.pdf 

——GSK Allso forget to mention that it`s PANDEMRIX VACCINE IS ALLSO CLASSED AS A BIOWEAPON BY EU & US REGULATORS
When these Vaccines start rolling out any illness occuring from it or death
they will say the person had underlying causes even if there wasn`t it will be the case.

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Baxter ,Celvapan®

http://www.emea.europa.eu/humandocs/PDFs/EPAR/celvapan/spc/emea-spc-h982pu17en.pdf

http://www.emea.europa.eu/humandocs/PDFs/EPAR/celvapan/H-982-en1.pdf

The Baxter company has been associated with two deadly scandals. The first event occurred in 2006 when hemophiliac components were contaminated with HIV virus and injected in tens of thousands of people, including thousands of children. Baxter continued to release the HIV contaminated vaccine even after the contamination was known.

The second event occurred recently when it was discovered that Baxter had released a seasonal flu vaccine containing the bird flu virus, which would have produced a real world pandemic, to 18 countries. Fortunately, astute lab workers in the Czech Republic discovered the deadly combination and blew the whistle before a worldwide disaster was unleashed.

Despite these two deadly events, WHO maintains an agreement with Baxter Pharmaceuticals to produce the world’s pandemic vaccine.

Source: http://www.newsmax.com/health/vaccin…07/232717.html

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Sanofi-Pasteur,(H1N1) 2009 Monovalent Vaccine

http://content.nejm.org/cgi/content/full/NEJMoa0907650

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182404.pdf

The U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. Sanofi Pasteur provides the only influenza vaccine licensed in the U.S. for populations as young as 6 months of age and older.

Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc.)

Proper Name: Influenza A (H1N1) 2009 Monovalent Vaccine
Tradename: None
Manufacturer:  Sanofi Pasteur, Inc.
Indication:  Active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.    

Product Information 

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182404.pdf

Here is more infos from MDH ;

Package Inserts and Influenza Vaccine Information Websites

Attention: Non-MDH links

http://www.health.mn.gov/divs/idepc/diseases/flu/hcp/vaccine/vis.html

Rozpowszechniajcie to video wszedzie gdze sie tylko da…..

Kommentar vom 28. September 2009: Erfolg bei Impfstoff gegen Aids

Diese dpa-Meldung erschien bereits am vergangenen Freitag in der Tageszeitung. In diesem Fall geht es mir gar nicht um den Sinn oder Unsinn einer Impfung. Wieder einmal werden wir mit Halbinformationen gefüttert, die für mich einfach grausam klingen:

“Eine Studie mit 16.000 Teilnehmern in Thailand belege erstmals, dass ein Impfstoff eine HIV-Infektion bei Erwachsenen verhindern könne, melden die Weltgesundheitsorganisation WHO und das UN-Aidsprogramm Unaids. [...] Nach Angaben des Herstellers Sanofi-Pasteur in Lyon gab es mit dem Impfstoff 31,2 Prozent weniger HIV-Infektionen als mit einem Scheinimpfstoff (Placebo).”

Mich erstaunt einmal die Zahl der Teilnehmer. Normalerweise sind Studien, die aktiv mit einem neuen Medikament durchgeführt werden, wesentlich kleiner. Eine Studie ist schon groß, wenn 2000 Teilnehmer gewonnen werden können. Dann frage ich mich: Warum Thailand? Ist Thailand ein Land mit einer besonders hohen HIV-Infektionsrate? Oder sind dort leichter Studienteilnehmer zu gewinnen? (Weil sie sich vielleicht eine finanzielle Entlohnung dafür versprechen? Darüber wird nichts gesagt.)

Aber der wirkliche Hammer sind doch die praktischen Überlegungen. Normalerweise werden Arzneimittel eben im Vergleich mit Scheinmedikamenten geprüft. Ein vereinfachtes Beispiel: Wenn ein neues Hustenmedikament geprüft wird, erhalten von 100 Teilnehmer  50 einen roten Hustensaft mit Wirkstoff und 50 einen roten Hustensaft mit Placebo. Am Ende wird dann ausgezählt, wie viele der Wirkstoffpatienten nach einer bestimmten Behandlungsdauer keinen Husten mehr hatten und wie viele von den Placeboteilnehmern. Die Pharmafirma hofft natürlich, dass 80% mit dem Wirkstoff keinen Husten mehr haben und dass das dann nur für 10% der Placeboteilnehmer gilt. Bei lebensgefährlichen Krankheiten werden normalerweise gar keine Scheinmedikamente eingesetzt, weil das als unethisch gilt. Ist ja auch verständlich: Wenn ein Medikament vermutlich ein Leben rettet, wie kann ich da einem Todkranken ein wirkungsloses Tablettchen in die Hand drücken? Nun ist AIDS eine so gefährliche Krankheit, dass ich eigentlich davon ausgegangen wäre, dass es unethisch ist, Menschen in dem Glauben zu lassen, dass sie ein wirkungsvolles Heilmittel bekommen, während man sie mit dem Scheinmedikament quasi vor die Wand laufen lässt.

Auch geht es bei diesem Medikament nicht um Heilung von AIDS, sondern darum, das Auftreten von HIV zu verhindern. Das heißt doch für mich, dass man Tausende von gesunden Menschen der Gefahr einer HIV-Infektion ausgesetzt hat, wohlgemerkt nicht einem Schnupfen! Im Übrigen lesen wir doch auch immer wieder, dass Kondome der beste Schutz vor AIDS bzw. einer HIV-Infektion ist. Wurden jetzt diese 16.000 Teilnehmer bewusst nicht darüber informiert, dass sie durch Kondome geschützt sind? Wie wurde denn überhaupt dafür “gesorgt”, dass diese 16.000 Thailänder und Thailänderinnen “ausreichend” Kontakt mit diesem Virus hatten?

In Studien muss normalerweise jedem (!) Teilnehmer eine gründliche Information gegeben werden, in der er über mögliche Risiken aufgeklärt wird. Er muss dann vor Eintritt sein schriftliches Einverständnis geben und erhält diese Infos noch einmal schriftlich. Und das wurde bei diesen 16.000 Menschen ordnungsgemäß durchgeführt? Soll ich das glauben?

Dass sind doch menschenrechtliche Überlegungen, die einen erschaudern lassen! Vielleicht ging ja alles mit rechten Dingen zu, ich gestehe: Ich weiß es einfach nicht. Aber ich wette mit euch: Die Chefredakteure der Tageszeitung oder wer sonst für die Auswahl dieser Meldung verantwortlich ist, wissen es auch nicht! Haben sie sich diese Fragen nicht gestellt? Haben die ersten Redakteure, die diese Pressemeldung von Sanofi-Pasteur erhielten, nicht sofort bei dem Unternehmen angerufen und diese Fragen gestellt?

The FDA announced today that it approved four Swine Flu (H1N1) vaccines manufactured by Sanofi Pasteur, Novartis, MedImmune and CSL Limited and expects that the vaccines will be  available in approximately four weeks.  Vaccines will be available both with and without thimerosal.

Last week the two of the four companies who manufacture the approved vaccines had findings published in the New England Journal of Medicine:   CSL Limited and Novartis.

The worrying aspect of all of this rush to make H1N1 vaccines available is the seemingly small numbers of people on whom the vaccines are being tested before they are approved.

Details from the website of the National Institute of Allergy and Infectious Disease at the National Institute of Health detail five clinical trials taking place under the support of the NIAID in addition to trials that are being (or have been) undertaken by the manufacturers.

The NIAID-supported trials have tested two strengths of H1N1 vaccines made by CSL Limited and Sanofi Pasteur in 200 people, each receiving two doses of the vaccine given 21 days apart.  Half of the people tested were 65+ years old, the other half were between 18-64.

The other three NIAID trials are testing pediatric doses of the vaccine,  (these trials are expected to be completed in April of 2010), and the H1N1 vaccines given simultaneously and sequentially with the seasonal flu vaccine, both in adults and in children (these trials have the largest enrollment, up to 800 persons).

At the end, this means that 200 people between the ages of 18-64 were trialed with two doses of either the Sanofi Pasteur and CSL H1N1 vaccines, half of which got a larger dose of vaccine, and half of which got a smaller dose.  In CSL’s NEJM article, an additional 240 people were trialed (half less than 50 years old, half equal to or greater than 50 years old).

There was a good deal of the unsurprising injection-site tenderness, and symptoms like headache and pains, but no deaths and no serious adverse events.

But it’s not terribly surprising that there aren’t any serious adverse events showing up in very small group of people receiving a vaccine (100-200). The question is whether we will see any adverse events emerge in four weeks when the vaccines are made available to the public.

Bom… ainda trazendo um pouco mais sobre a gripe, inspirado por um dia chuvoso em Curitiba, notícia do G1 sobre a produção de vacinas pelo Instituto Butantan. Vamos torcer para que corra tudo bem, e que, especialmente, as pessoas, se conscientizem que a postura preventiva (e não estou falando do famigerado álcool gel, apenas) e hábitos de higiene saudáveis ajudam, e muito, a segurar a onda!

Quem tiver interesse, no portal G1 tem o infográfico da fábrica. Legal.

Daniel Pinheiro

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Butantan começa a fazer vacina antigripe em outubro

Instituto prevê que em 2014 poderá concorrer com estrangeiras.

Emilio Sant’Anna e Ricardo Muniz Do G1, em São Paulo

Em outubro, Brasil e Austrália serão os dois únicos países do Hemisfério Sul capazes de produzir a vacina contra a nova gripe. A fábrica brasileira, construída no Instituto Butantan, em São Paulo, depende apenas de uma autorização da Sanofi Pasteur, a divisão de vacinas do grupo francês Sanofi-Aventis – responsável pela transferência de tecnologia – para começar a funcionar. A inspeção será realizada no fim do mês que vem. Os primeiros lotes do produto devem estar prontos em janeiro.

O projeto levou quatro anos para ficar pronto e começou a ser construído quando a gripe aviária, causada pelo vírus H5N1, era uma ameaça de pandemia (que felizmente não se concretizou). Além das 30 milhões de doses que serão produzidas no Butantan, outros 18 milhões serão importados ainda este ano. Deste total, 17 milhões serão processados no Brasil e 1 milhão de doses já chegarão prontas ao país.

Ainda é impossível dizer se a produção nacional será “suficiente”. O plano é imunizar prioritariamente profissionais da saúde, grávidas e pacientes imunodeprimidos. Mas não se sabe ainda, por exemplo, se vai ser preciso tomar uma ou duas doses da vacina – e isso, evidentemente, faz toda diferença. Se uma dose bastar, quase 16% da população brasileira, de 190 milhões de habitantes, estaria coberta. Somando a parte que será importada (18 milhões de vacinas) e assumindo, mais uma vez, que uma dose resolve, a parcela de brasileiros que seriam imunizados subiria para 25%.

Outro parâmetro útil para que se tenha ideia do que significam 30 milhões de doses: neste ano, de 25 de abril a 8 de maio, a campanha anual de vacinação contra a gripe comum aplicou 15,8 milhões de doses em idosos, segundo informações do Sistema de Informação do Programa Nacional de Imunizações, disponível no site do Ministério da Saúde.

Cerca de R$ 100 milhões foram investidos na planta da fábrica, a maior parte desembolsada pelo governo paulista. “Dois terços vieram do governo estadual e o resto do governo federal”, diz o biólogo e presidente do instituto, Isaías Raw. A construção só foi possível graças ao convênio de transferência de tecnologia entre o Butantan e o laboratório francês que, segundo Raw, facilitou a compra da vacina contra a gripe sazonal enquanto a fábrica não estava pronta. “Nesse período, o governo federal economizou cerca de R$300 milhões”, afirma. “Em 2014 poderemos até mesmo já estar concorrendo no exterior.”

Intercâmbio

Os quatro anos que se passaram até o início de atividades da fábrica de vacinas foram predominantemente gastos em licitações para compra de equipamentos e na edificação propriamente dita das instalações. Segundo Cosue Miyaki, bióloga responsável pela produção da vacina contra a influenza A (H1N1), a planta é similar à da Sanofi Pasteur. São três pisos, que totalizam cerca de 10 mil metros quadrados.

A produção em si ocorre exclusivamente no térreo. Subsolo e mezanino abrigam serviços de suporte técnico, como controle do ar condicionado e manutenção elétrica. A ideia, sempre, é evitar que profissionais das áreas auxiliares circulem pelas instalações de produção.

Cosue visitou a unidade da Sanofi que serviu de referência, nos arredores de Paris, em 2005 e 2006. Dois outros técnicos também fizeram intercâmbio – tudo isso na etapa de planejamento da fábrica brasileira. Antes disso, a primeira fase do acordo de transferência de tecnologia, que capacitou o Butantan a fazer formulação e envase de vacinas importadas, já havia envolvido o envio de brasileiros à França.

Mercado

Para Raw, “ser independente significa muito”. No entanto, a independência não vem de graça. “Essa fábrica só está pronta hoje porque foi uma decisão do instituto há quatro anos”, diz. “Cerca de seis empresas dominam esse mercado e, para elas, o Brasil ser independente é quase obsceno.”

Ele avalia que a construção de outra fábrica na região da América do Sul hoje é quase impossível. No caso do Butantan, o processo só se tornou viável porque o acordo com o laboratório francês é antigo e firmado desde quando ele ainda se chamava Instituto Pasteur. “Depois que anunciamos que íamos construir, recebemos muitas propostas internacionais de parceria. Não é errado, é um jogo do capitalismo, mas nosso objetivo é atender as necessidades do País”, afirma Raw. “Não somos como um laboratório comercial, precisamos ter responsabilidade social.”

A fábrica do Butantan poderá funcionar durante praticamente o ano inteiro. Quando não estiver produzido a vacina para a nova gripe, pode intercalar com a produção do imunizante contra a influenza sazonal. Hoje, cerca de 70% da fabricação dessa vacina se concentra nos Estados Unidos e na Europa.

Produção

A produção tem data para começar. Assim que receber o aval do laboratório francês, as primeiras cepas do vírus A (H1N1) podem ser inoculadas nos primeiros ovos. É dessa forma que o imunizante será produzido, com a utilização de ovos fecundados de galinha.

Uma granja selecionada pelo Butantan é a responsável pelo fornecimento dos ovos fecundados. “A produção da granja precisa atender a parâmetros rígidos, estabelecidos pelo instituto, como não utilizar antibióticos na alimentação das galinhas”, explica Cosue.

Uma vez inoculado, o vírus se replica dentro do ovo a cada vez que penetra no embrião. No líquido alantoico, resultado da excreção do embrião, o vírus pode continuar seu ciclo.

Para cada 100 mil ovos que chegam à fábrica, cerca de 800 litros de líquido alantoico, contendo milhões de vírus replicados, serão colhidos. No final do processo, após sucessivas filtragens, a quebra do vírus em milhares de pequenas partes nanométricas e sua inativação, restam pouco mais de 500 litros da vacina.