Norway medical officials continue Pandemrix elucidation work / News / The Foreigner

Norway medical officials continue Pandemrix elucidation work. Researchers and agencies further their studies to determine more information about the link between Swine Flu (H1N1) vaccine and narcolepsy. GlaxoSmithKline (GSK) manufactured Pandemrix in response to experts’ perceived risk of a global pandemic in 2009. The product was administered to millions of Norwegians under mass vaccination programme. Several cases of Swine Flu being reported in that year (other articles about H1N1 can be found here), and it was also fears of increased risks of pregnant women suffering complications.

swineflu, h1n1norway, pandemrixvaccine



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Norway medical officials continue Pandemrix elucidation work

Published on Wednesday, 6th November, 2013 at 13:27 under the news category, by Michael Sandelson and Lyndsey Smith      .

Researchers and agencies further their studies to determine more information about the link between Swine Flu (H1N1) vaccine and narcolepsy.

A syringe
A syringe
Photo: Wikimedia Commons


GlaxoSmithKline (GSK) manufactured Pandemrix in response to experts’ perceived risk of a global pandemic in 2009. The product was administered to millions of Norwegians under mass vaccination programme.

Several cases of Swine Flu being reported in that year (other articles about H1N1 can be found here), and it was also fears of increased risks of pregnant women suffering complications.

Whilst some parents of children chose to ignore health authorities’ move at that time, thousands of Norwegians reported side-effects in the wake of the vaccination campaign, the most notable being narcolepsy.

Moreover, studies in several European countries raised the possibility there is a connection between the chronic neurological disorder in adults and children and the vaccine. This factor concerned Norwegian researchers.

One Norwegian health expert has called Pandemrix “a vaccine catastrophe”, and many post-vaccination-affected people mulled a joint lawsuit against GlaxoSmithKline.

The Pandemrix manufacturer has recently released a statement about narcolepsy and the vaccine, and the status quo from their point of view.

GSK says that they are committed to researching the possible links with Pandemrix in those that have developed it, reported CTV News.

“Further research is needed to determine whether the observed risk is related to the vaccine, environmental effects, genetic factors, other factors or a combination of them,” company representatives explained.

They added that no doses of Pandemrix should now be given due to their being no H1N1 pandemic situation, and all vaccines would be past their shelf-life.

“GSK takes the safety of individuals and families who entrust their health in our products very seriously and is committed to the highest standards of patient safety,” they concluded.

The Foreigner asked the Norwegian Medicines Agency (NoMA), a state organisation to “evolve and safeguard public and animal health by ensuring the efficacy, quality and safety of medicines” for comment about the progress in Norway regarding Pandemrix.

NoMA’s responsibility is to inform the European Medicines Agency (EMA) about adverse reactions in Norway and inform patients in the country about all developments, according to them. This is because all vaccines are centrally- approved in Europe.

The explained that most of the scientific discussion about Pandemrix is between GSK and the EMA.

What is the status from your point of view?

“The connection between Pandemrix and narcolepsy is firmly established, however, the exact mechanism is not fully elucidated,” they said.

What have researchers told you recently?    

“There is an on-going study in Norway of all suspected cases of vaccine-related narcolepsy, with thorough registration of all clinical details, in an attempt to better understand the magnitude of the problem and possible explanations.”

How is NoMA contributing to suspected/actual cases regarding research, and any legal proceedings?

“In Norway, all suspected cases are reported to the National Institutes of Health, then transferred to the national database maintained by NoMA, and further transferred to the EMA (European Medicines Agency). However, it is important to realise that adverse event reporting is not sufficient in this case. Epidemiological studies are needed.”

“We have an independent Patient Insurance Agency that handles claims stemming from treatment injuries and adverse reactions in our healthcare system. There were about 360 claims related to Pandremix by the middle of August, 60 had been settled, of which 46 were cases of narcolepsy in children,” they concluded.



Published on Wednesday, 6th November, 2013 at 13:27 under the news category, by Michael Sandelson and Lyndsey Smith      .

This post has the following tags: swineflu, h1n1norway, pandemrixvaccine.





  
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