UPDATE JAN 30 (CIDRAP): "The investigators identified 2,608 narcolepsy cases in nearly 280 million person-years of follow-up, with a pooled incidence rate of 0.93 (95% confidence interval [CI], 0.90 to 0.97) per 100,000 person-years. Narcolepsy peaks were found between ages 15 and 30 years, with slightly more women affected than men, a pattern that was most pronounced in women of childbearing age.
Narcolepsy incidence in children ages 5 through 19 increased after the start of pandemic vaccine campaigns in Finland and Sweden, consistent with previously reported safety signals. However, the new study found increases in two Danish age-groups, children ages 5 to 19 and adults ages 20 to 59, even though Denmark had relatively low vaccine coverage." (Note that the affected groups include everyone from age 5 through age 60.--Nass)
Researchers also found a narcolepsy increase after September 2009 in Finnish adults older than age 60..." WHAT DID I TELL YOU? Vaccine-induced narcolepsy is not simply a disease of children, and narcolepsy may not be the only disease caused by Pandemrix. When the authorities who excitedly contracted for fast distribution of novel adjuvanted-vaccines are responsible for identifying the adverse consequences to the public health, they are no longer excited about fast results.
IMHO, either the reason why the vaccine caused these illnesses will be found and appropriate measures taken, or if no reason is found, then no more Pandemrix and ASO3 should be used in anyone, since it has clearly been shown that the net harm from the vaccine is much greater than the net benefit--number of lives that may have been saved. If you don't know what happened, you won't be able to avoid the next disaster.
See comments from Sweden here.
A Health Protection Agency study found a 10-fold increased risk in cases of the sleep disorder in children seen in sleep centres who had received the jab.
An increased risk of narcolepsy has been found among English children vaccinated with the swine flu vaccine, Pandemrix.
Manufacturer GlaxoSmithKline (GSK) has been ordered to investigate the link.
Families who believe they were affected are now considering a group legal action.
Pandemrix was most widely used in the UK during the 2009-10 flu pandemic and given to almost a million British children between six months and five years old. The vaccine, which is no longer used, has already been linked to narcolepsy in youngsters from Finland, Sweden and Ireland.
Narcolepsy is a rare sleeping condition. The main symptom is falling asleep suddenly and it may also cause muscle weakness.
The HPA abstract paper, from Developmental Medicine in Childhood Neurology, was presented to a conference of paediatricians in Manchester and is now being considered for publication in full by the British Medical Journal. It estimates the risk was one in 52,000 in those vaccinated.
Specialists reviewed 75 children aged four to 18 who developed narcolepsy about the time Pandemrix was rolled out. Of these, 18 had received Pandemrix.
They found a 10-fold increased risk of the condition within six months of having the jab which "suggests a causal association consistent with reports from Finland and Sweden".
An expert in vaccines who was in charge of one of the paediatric clinical trials of Pandemrix, Prof Adam Finn from the University of Bristol, said: "The risk is so much increased that it seems very unlikely that this is a biased result.
"The bottom line is they have found they were somewhere between 10 and 16 times more likely to have had Pandemrix than other children. So that confirms what you would expect to see based on other studies done in Finland, Sweden and Ireland, which are all the same."
Research programmeThe European Medicines Agency (EMA) warned in 2011 that Pandemrix should only be given to children and teenagers at risk of H1N1 flu if other jabs are unavailable because of concerns of potential link to narcolepsy.
It has ordered GSK to commit to a complex research programme to look at the root causes.
GSK say they take the safety of patients very seriously and are working hard to better understand the research emerging from a select number of countries.
A spokesperson said: "Narcolepsy is a complex disease and its causes are not yet fully understood but it is generally considered to be associated with genetic and environmental factors, including infections.
"It is crucial that we learn more about how narcolepsy is triggered and how Pandemrix might have interacted with other risk factors in affected individuals. Throughout development there was no data suggesting a potential for an increased risk of narcolepsy among those vaccinated."
It is understood that one possible trigger is the high levels of adjuvant in the vaccine used to enhance the recipients response.
The UK government, which gave GSK a legal indemnity against having to pay compensation, could now face the prospect of a group legal action by families affected.The Department of Work and Pensions, which is responsible for administering Vaccine Damage Payments Scheme says there is currently insufficient medical evidence to show that the swine flu vaccine causes narcolepsy.
A spokesperson for the Medicines and Healthcare products Regulatory Agency said: "The results of the HPA study are consistent with earlier evidence from some other EU countries and support the regulatory action already taken in Europe to restrict the use of Pandemrix in those aged under 20 years."
No comments:
Post a Comment