EU Takes Emergency Measures Over Glaxo’s ‘Flu Vaccine – Causes Narcolepsy in Children

GlaxoSmithKline’s ‘Flu vaccine causes four-fold increase of cases of narcolepsy in children and adolescents (below 20 years of age) who received Pandemrix compared with unvaccinated people  of the same age according to preliminary results of the Swedish registry study from October 2009 to December 2010 on Pandemrix.  

Clearly this vaccine was not properly tested, like many other childhood vaccines.

Full Text of EMEA news release 15 April 2011 below.  Download links below to French and Swedish agencies’ reports on the narcolepsy problem.

And do vaccines cause autistic conditions? If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered when the Hannah  Poling story broke in the USA [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. In the US Federal Court children have been compensated after findings they developed autism and other injuries. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines. [Blue Text added 10 April 2011]

_____________________________

News Release

European Medicines Agency recommends interim measures for Pandemrix – 15/04/2011

Updated prescribing advice highlights preliminary results from epidemiological studies on narcolepsy; further research needed

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological studies on Pandemrix and narcolepsy, and to perform an individual benefit-risk assessment when considering the use of Pandemrix in children and adolescents. This is an interim measure pending the outcome of the European review, expected to conclude in July 2011.

The CHMP reviewed all available data, including new findings from Sweden and France on the suspected link between narcolepsy in children and adolescents and Pandemrix. The CHMP concluded that, following the earlier results of an epidemiological study from Finland, the new evidence strengthened the signal in children and adolescents, but that the data had methodological limitations. The relationship between Pandemrix and narcolepsy is still under investigation.

Preliminary results of the Swedish registry study from October 2009 to December 2010 on Pandemrix vaccination and the risk of narcolepsy indicates a four-fold increase of cases of narcolepsy in children and adolescents (below 20 years of age) who received Pandemrix compared with unvaccinated people of the same age. The additional risk corresponds to an additional 3-4 narcolepsy cases per 100,000 vaccinated subjects. These results are broadly in line with the study results from Finland indicating an association between Pandemrix and narcolepsy in children and adolescents. The study did not identify any increased risk in adults. The CHMP concluded that the study was well conducted, although it has inherent limitations.

An analysis of narcolepsy reports in France provides some further evidence.

The lack of a clear increase in reports of narcolepsy following Pandemrix in other EU and non-EU countries may point towards the influence of other unknown factors affecting the trend seen in some countries. Also, there is currently no clearly identified biological plausibility for an association between Pandemrix and narcolepsy, and further non-clinical studies, especially in the juvenile setting, are needed.

The CHMP considers it important to gather more data on the use of Pandemrix and related vaccines in a variety of countries to further assess this concern. A variety of research efforts are now ongoing. These include an epidemiological study of narcolepsy and pandemic vaccines conducted by the European Centre for Disease Prevention and Control (ECDC) through a network of research and public health institutions (VAESCO) in nine European Union Member States, and an epidemiological study conducted by Glaxo Smith Kline (the marketing authorisation holder of Pandemrix) in Canada. Preliminary results of the VAESCO study and of the Canadian study are expected by July 2011.

The CHMP is working with experts from across the EU to assess the possible safety concern and any impact on the benefit-risk balance of Pandemrix. The CHMP plans to hold an expert meeting with participation of international experts, the World Health Organization (WHO) and ECDC.

The European Medicines Agency will provide updates as new information becomes available.

Notes

  • The exact wording to be included in the Pandemrix product information reads as follows:“Preliminary reports form epidemiological studies in two countries (Sweden and Finland) have indicated a 4-9-fold risk increase of narcolepsy in vaccinated as compared with unvaccinated children/adolescents, corresponding to an absolute risk increase of about three to four additional cases in 100 000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). Similar epidemiological studies have not yet been conducted in other countries.The relationship between Pandemrix and narcolepsy is still under investigation.When considering the use of Pandemrix in children and adolescents, an individual benefit risk assessment should be performed taking this information into account.”
  • Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. Its precise cause is unknown, but it is generally considered to be triggered by a combination of genetic and environmental factors. Narcolepsy occurs naturally at a rate of around 1 case per 100,000 people every year.
  • Pandemrix, an (H1N1) v influenza vaccine, has been authorised since September 2009, and was used during the 2009 H1N1 influenza pandemic in at least 30.8 million Europeans.
  • The H1N1 influenza strain continues to be the predominant strain in this season.
  • The review of Pandemrix and the occurrence of cases of narcolepsy was initiated at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004, on 27 August 2010, following an increased number of reports on narcolepsy in Finland and Sweden. Related press releases dated 27 August 2010, 23 September 2011 and 18 February 2011 are available on the Agency’s website.
  • The report from the Swedish registry study can be found on the website of the Swedish Medicines Agency (MPA).
  • The report from the French observed expected study can be found on the website of the French Medicines Agency.
  • More information about the network of research, public-health institutions and regulatory agencies VAESCO, funded by the European Centre for Disease Prevention and Control, can be found on its website.

News Stories From Google

European Regulators: Weigh Potential Narcolepsy Risk of Glaxo’s Pandemrix

Wall Street Journal (blog) – Katherine Hobson – ‎14 hours ago‎
Since last August, European regulators have been investigating reports that GlaxoSmithKline’s H1N1 vaccine, Pandemrix — which isn’t approved for use in the US — may be tied to the sleeping disorder narcolepsy in some children and

EU agency flags narcolepsy risk on GSK flu shot

Reuters – ‎17 hours ago‎
By Ben Hirschler LONDON (Reuters) – European regulators have recommended changes to the product label for GlaxoSmithKline’s pandemic flu vaccine Pandemrix to highlight the potential risk of narcolepsy in children or adolescents.

EU Panel Recommends Pandemrix Product Information Be Amended

Wall Street Journal – Ian Walker – ‎21 hours ago‎
LONDON (Dow Jones)–The Committee for Medicinal Products for Human Use, or CHMP, said Friday it has recommended that the product information for Pandemrix (Influenza vaccine (H1N1)) (split virion, inactivated, adjuvanted), from GlaxoSmithKline

Glaxo Pandemic Flu Vaccine’s Narcolepsy Risk Highlighted

Fox Business – ‎19 hours ago‎
By Sten Stovall LONDON -(Dow Jones)- European regulators have recommended changes to the product label for GlaxoSmithKline PLC’s (GSK) pandemic flu vaccine Pandemrix to reflect a potential higher risk of the sleeping disorder narcolepsy in children or

European Medicines Agency Recommends Interim Measures For Pandemrix

Medical News Today (press release) – ‎20 hours ago‎
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological


One Response

  1. Squalene is extremely controversial and is used as an adjuvant to boost the immune response. (This is not the same as immunity).

    Virus antigen is expensive, squalene adjuvant is cheap. To make the vaccine cheaper, a low concentration of virus antigen is used and therefore a high concentration of squalene.

    Pandemrix has the highest concentration of squalene in all vaccines which are on the market.
    Squalene, like other substances, reacts differently according to whether it is ingested or injected. Medical students and others learn this fact at university.

    Squalene is suspected by many serious research workers to be the cause autoimmune diseases including the Gulf War Syndrome.

    Its use has been forbidden in US for several years, but it is used in Europe. There is strong pressure on US to use it, “to show solidarity” with Europe.

    Because Pandemrix contains a very high concentration of squalene, the risk of autoimmune diseases including narcolepsy should have been expected.

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