Since August 2010, following widespread use of vaccines against influenza (H1N1) 2009, cases of narcolepsy, especially in children and adolescents, have been reported. 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. Swedish and Finnish authorities have presented preliminary statements on their investigations in the first quarter of 2011.
On 1 February 2011, the National Institute for Health and Welfare of Finland issued a preliminary statement following an investigation into the cases of narcolepsy in Finland1 . A systematic retrospective registry-based review was conducted of all new narcolepsy cases diagnosed during 2006-2010. Cases from 2009-2010, who were born in 1990 or later, were reviewed using newly developed Brighton collaboration criteria for the disease. During 2009-2010 they found that the risk of narcolepsy among people aged 4-19 years old who had received pandemic influenza vaccine was nine times higher than that among those who had not been vaccinated. This corresponds to a risk of about 1 case of narcolepsy per 12,000 vaccinated in this age group. No increased risk has been seen in younger or older age groups.
CONFLICTS OF INTEREST
The Finnish governmental research institute vaccine department was instrumental in recommending and acquiring the vaccine for Finland and is also involved in the investigation regarding a possible link between the vaccine and narcolepsy.
The conflicts of interest are obvious.
A similar situation applies in Norway, where the same few people in the health authorities were responsible for recommending the purchase of the vaccine Pandemrix,ordering, information and recommendation to the public and media about the vaccine,collection and handling of side effects statistics – and investigating a possible link between the vaccine and narcolepsy.
Health authorities in Norway have extremely close connections with the pharmaceutical industry.
SQUALENE ADJUVANTED VACCINE
It was mainly the Nordic countries which
broadly used the adjuvanted vaccine, even in vulnerable groups like pregnant women and children. In many other countries, another type of vaccine was used for vulnerable groups.
There are also big differences in vaccine coverage – in many other countries, the vaccine coverage was 10% or less, while for example over 80 % of Finnish children received the vaccine.
Virus antigen is expensive. Adjuvants are far cheaper and are used to boost the immune response (which is not the same as immunity). The less of the antigen, the more adjuvant squalene is used.
INCREASED RISK OF NARCOLEPSY SHOULD HAVE BEEN EXPECTED
Squalene is suspected by serious and unbiased researchers of increasing the risk of autoimmune diseases, including narcolepsy.
Pandemrix is one of the vaccines on the market with the highest amount of squalene. Therefore the increase in risk of narcolepsy should have been expected.