Guest guest Posted February 25, 2011 Report Share Posted February 25, 2011 > WHO statement on narcolepsy and Pandemrix vaccine > > http://www.who.int/vaccine_safety/topics/influenza/pandemic/h1n1_safety_assessin\ g/narcolepsy_february2011/en/ > > " 8 February 2011 > > Since August 2010, following widespread use of vaccines against influenza (H1N1) 2009, cases of narcolepsy, especially in children and adolescents, have been reported from at least 12 countries. Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. The rates reported from Sweden, Finland and Iceland have been notably higher than those from other countries. The National Institute for Health and Welfare of Finland issued a preliminary statement on 1 February 2011 following an investigation into the cases in Finland. A systematic retrospective registry-based review was conducted of all new narcolepsy cases diagnosed during 2006-2010 and cases in 2009-2010, born in 1990 or later, were reviewed using newly developed Brighton collaboration criteria for the disease. During 2009-2010 they found a higher risk of narcolepsy among those aged 4-19 years old who had received the vaccination against influenza (H1N1) 2009 compared with those who had not been vaccinated. The only pandemic vaccine used in Finland was Pandemrix, an adjuvanted influenza (H1N1) 2009 monovalent vaccine manufactured by GlaxoKline. Pandemrix vaccine was used in 47 countries worldwide during the 2009-2010 season. Studies are ongoing to determine if the apparent increased risk of narcolepsy reported in Sweden is higher in vaccinated persons. > > The National Institute in Finland (on the advice of the Finnish National Narcolepsy Task Force) has concluded that the risk of developing narcolepsy among those vaccinated aged between 4 and 19 years is about nine times greater than those unvaccinated in the same age group, corresponding to a risk of about 1 case of narcolepsy per 12,000 vaccinated in this age group. The increased risk has not been seen in younger or older age groups. Narcolepsy is a condition that has a strong genetic linkage, being almost uniquely seen in persons who have the (HLA) DQB1*0602 genotype. Of the cases of narcolepsy tested so far in Finland (n=22), diagnosed during 2009-2010, all have that genotype. The National Institute considers it probable that the Pandemrix vaccine was a contributing factor to this observed increase, and has called for further investigation of other co-factors that may be associated with the increased risk. . . " > > MY (Meryl's) COMMENT: > > In the US, an average of about 75 children/year die from flu-related causes. Most of these children have underlying, chronic medical illnesses. Usually about 15-20 child deaths/year occur in otherwise healthy children in the US. > > There are over 50 million children in the US. If half were vaccinated, and their rate of developing narcolepsy was the same as in Finland (one in 12,000), we might expect 2,000 new cases of narcolepsy in vaccinated children. They would need a certain HLA type (a specific genetic predisposition). But most people with that HLA type do not develop narcolepsy; in Finland narcolepsy appears to have been triggered by vaccination and possibly other unidentified exposures. > > Narcolepsy is a serious medical condition, and in Finland, post-vaccination, it has been associated with other neurological problems including personality changes. Narcolepsy may be deadly when someone with the disorder falls asleep at the wheel of a car. > > A risk benefit analysis might look something like this: two thousand narcolepsy cases caused by flu vaccination versus 18 child deaths prevented. (This assumes that 50% of children were vaccinated and the vaccine was 70% effective. These are reasonable assumptions for a year in which the vaccine is a good match to circulating flu strains.) [75 child deaths x 50% vaccine uptake x 70% vaccine efficacy = 26 child deaths prevented. I have not thrown in a factor for herd immunity since current vaccine uptake rates are not felt to lead to significant herd immunity for influenza.] > > Granted, it is unclear what the risk of narcolepsy is for use of swine flu vaccine in the US; and it is unclear whether the novel Glaxo adjuvant used in Pandemrix swine flu vaccine outside the US may have contributed. But I just did the math. And it appears that if Finland has a similar childhood death rate from flu as the US, it could be seeing 80 cases of narcolepsy for every flu death prevented. > > These are serious numbers, and WHO, EMEA, CDC and other public health agencies must be terribly concerned about the findings and implications. Meryl Nass, MD Mount Desert Island Hospital Bar Harbor, Maine 04609 W 207 288-5081 ext. 1220 C 207 522-5229 H 207 244-9165 pager 207 818-0708 http://anthraxvaccine.blogspot.com On Feb 25, 2011, at 11:41 PM, Pandemic Response Project wrote: > Yesterday (Thurs 2-24), PReP Manager Rich and Director Alan met with the NC Public Health Director, Dr. Engel; our state senator, Senator Kinnaird; and the NC Public Health's Chief of Regulatory and Legal Affairs, Hoke, JD. Senator Kinnaird set up the meeting after previously meeting with Rich and Alan in late December, in which meeting we discussed points made in the Swine Flu Review (recently updated, at www.pandemicresponseproject.com). The purpose of yesterday's meeting was to see if we could get the state's support for exemptions to emergency vaccines and the right to quarantine in homes. It was of course an uphill battle, and we expected a 'no', but if we did happen to get a 'yes' to anything, it should be easy to achieve with their blessing, and not require the much larger effort of rallying the grass-roots troops and getting a majority of legislators on board to oppose state health officials. > > To our surprise, the Chief assured us that state policy would allow exemptions in a declared emergency, but I was confused; the religious exemption statute, for example, states that it applies only to the vaccines required in that same chapter, and the emergency laws are in a different chapter. So, I argued, that policy is unclear (but I will review both chapters again as soon as time allows). So, I asked if they would support an amendment clarifying this policy, and they agreed. We will be working together to draft a proposed amendment, and with public health's agreement, getting it passed should be a straightforward process. > > I was previously criticized, understandably, for agreeing to soften the approach when talking to state health officials, by leaving out information about corruption and conflict of interest, at the request of the Senator. Please be assured that we surrendered nothing in doing this, we simply were being practical with this specific audience. It gets us nowhere to address state health officials in a manner likely to cause them to dismiss us altogether. We intend to address our concerns fully with state legislators, or to the fullest extent that we determine any given one can hear what we have to say. We have spent years along our own learning curves, and so must realize that others may not be able to immediately grasp the full scope of what we have to say. But the end goal does not change--truth and freedom accordingly. > > The State Health Officials predictably if disappointingly drew the line at anything that would require them to surrender any authority. Specifically, they do not agree to a philosophical exemption in any context (it is a " slippery slope " ), and assured us that the policy regarding quarantine is to use the least restrictive means necessary in any given situation, and so were not willing to put limitations on their ability to enforce that, ultimately, in locations of their choosing. > > Meeting with state health officials was our senator's idea, and not ours; she indicated that getting health legislation passed requires (or is most easily accomplished) by getting state health officials on board. But this was only a first step of many to come. We got clarity on state policy, and know where we will and won't have to get citizens and legislators on board to get the level of freedom that we feel the true science and facts compel. So, we consider the day to have been a resounding success--we expect to have clarification in NC law allowing medical and religious exemptions in the emergency context soon--more than we expected to come away with--and while that's only a first step, a small victory, it was unexpected and therefore for us a big step forward. As the saying goes, the journey of a thousand miles starts with the first step... > > [i may have previously misstated that we were meeting with NC's Secretary of Health and Human Services. I apologize for that. Alan] > > -- > Alan , J.D., Director > Rich , Manager Quote Link to comment Share on other sites More sharing options...
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