Pandemrix: Does Swine Flu Vaccine Cause Narcolepsy?

The Daily Mail is reporting that a seven year old British boy named Josh Hadfield has developed narcolepsy three weeks after the swine flu vaccine, Pandemrix, was administered on him two years ago. He was a normal boy then but, now, he often suffers narcolepsy attacks which cause him to sleep for 19 hours a day.

Says Josh’s mother Caroline Hadfield about her son’s condition:

He was a perfectly healthy energetic four-year-old before the vaccination, but within two weeks he was getting more tired and after three weeks he was sleeping for 19 hours. Things then developed quickly and he struggled to walk. Nothing could convince me it was anything but the jab which caused Josh’s conditions.

The Government had a knee-jerk reaction to swine flu and put out this vaccine, giving it to very young children.

Laughter can trigger attacks and Josh was too anxious about fear of an incident to go sledging in last week’s snow. You see other children who can laugh and enjoy things and yes Josh can laugh and enjoy things but his reaction means that he goes unconscious. We feel we are constantly treading on eggshells.

So does Pandemrix, a drug by GlaxoSmithKline, trigger narcolepsy? A recent study by the Health Protection Agency (UK) found a “10-fold increased risk in cases of the sleep disorder in children seen in sleep centres who had received the jab” (BBC report).

The increase in risk is similar to those earlier observed in Finland and Sweden.

What are government health agencies saying about the link between narcolepsy and Pandemrix? In 2011, the European Medicines Agency (EMA), after reviewing studies conducted in Finland and Sweden, recommended that the vaccine no longer be used for persons under 20 years except in cases where seasonal trivalent influenza vaccines are not available. Says the agency:

Finalising its review of Pandemrix and narcolepsy the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that in persons under 20 years of age Pandemrix may only be used if the recommended seasonal trivalent influenza vaccine is not available and if immunisation against H1N1 is still needed (e.g. in persons at risk of the complications of infection). The CHMP confirmed that overall the benefit-risk balance of Pandemrix remains positive.

The review of Pandemrix was initiated to investigate a possible link between Pandemrix vaccination and narcolepsy, following an increased number of reported cases of narcolepsy among children and adolescents in Finland and Sweden. The reported cases of narcolepsy occurred following the H1N1 pandemic vaccination campaign in late 2009 and early 2010. The current review has been conducted in the context of seasonal use.

The results indicate a six- to 13-fold increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated children and adolescents, corresponding to about an additional three to seven cases in every 100,000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). A similar risk has not been confirmed but cannot be ruled out in other countries.

The above recommendation gained the support of the World Health Organization’s Global Advisory Committee on Vaccine Safety which issued a statement that reads in part:

GACVS concurs with the recommendation, which states that in persons under 20 years of age Pandemrix may only be used if the recommended seasonal trivalent influenza vaccine is not available and if immunisation against H1N1 is still needed (e.g., in persons at risk of the complications of infection).

GACVS acknowledges also that the benefit-risk balance of Pandemrix remains positive where H1N1 influenza is prevalent. Currently data are limited on the association between juvenile narcolepsy and Pandemrix; additional epidemiological studies are underway.

The vaccine was administered to about 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic. If you are from the United States, you need not worry about your child developing narcolepsy as the drug was not used in the U.S. From the Centers for Disease Control:

Pandemrix was not licensed for use in the United States. In fact, no adjuvanted influenza vaccines are licensed in the United States, and no adjuvanted influenza vaccines were used in the United States during the influenza pandemic or in any other influenza season.

Although the link between narcolepsy and Pandemrix appears to exist only among those under 20 years old, it is possible that the link also exists among adults. From yle.fi (a Finnish news site):

Five young adults who developed narcolepsy after receiving the swine flu vaccine Pandemrix are suing the state for damages at Helsinki District Court.

The 20–26 year-old plaintiffs were not awarded damages earlier as studies have so far only confirmed that the Pandemrix vaccine increased the risk of narcolepsy among 4–19 year-olds.

Around a dozen adults are suspected of coming down with narcolepsy since taking the vaccine. The National Institute for Health and Welfare (THL) is currently investigating the H1N1 vaccine link to narcolepsy in adults.

We plan to keep you posted on how these lawsuits turn out.