The Pandemrix Swine Flu Vaccine and Narcolepsy
The Pandemrix vaccine was authorised in September 2009 and was used by various states within the EU during the 2009 H1N1 flu pandemic – also referred to as swine flu. More than 30 million people were vaccinated with the drug in the EU with some 900,000 receiving it in Ireland from HSE clinics and through their local GPs.
In August 2010 the Swedish pharma authority reported that it was investigating 6 cases of narcolepsy reported by health care professionals as a possible adverse effect following the use of Pandemrix. This was followed shortly by reports from the Finnish National Institute for Health and Welfare (THL) noting there had been a more than expected number of cases of narcolepsy in children and adolescents that year. On the 26th August 2010 the European Medicines Agency (EMA) announced that it was conducting a review of the safety of Pandemrix.
Each individual EU State chose their own vaccine brands to tackle the problem in their country. In Ireland, two pandemic vaccine brands were used during the 2009/2010 pandemic influenza vaccination campaign: Pandemrix and Celvapan. Celvapan was a whole cell killed vaccine produced on a Vero cell line and did not contain any adjuvant. Pandemrix was an inactivated split influenza virus vaccine produced in eggs. It contained the adjuvant ASO3.
Meanwhile in Finland, their National Institute for Health and Welfare recommended that vaccination with Pandemrix be discontinued following reports of a link to narcolepsy, as did Sweden.
Common narcolepsy symptoms include:
Cataplexy (loss of muscle control). Often, narcolepsy may cause you to have a sudden loss of muscle control while awake, usually triggered by strong emotions, such as laughing or crying.
Hallucinations. Some people with narcolepsy experience vivid, sometimes frightening, visual or auditory sensations while falling asleep or upon awakening.
Sleep paralysis. You may be unable to move or talk at the beginning or end of sleep.
Microsleep is a very brief sleep episode during which you continue to function (talk, put things away, etc.), and then awaken with no memory of the activities.
Night-time wakefulness. If you suffer from narcolepsy, you may have periods of wakefulness at night with hot flashes, elevated heart rate, and sometimes intense alertness.
Rapid entry into REM sleep. Narcoleptics have unique sleep cycles where he or she may enter the REM or dream phase of sleep right after falling asleep, whereas most people take about 90 minutes to enter REM. Therefore, you’ll experience the characteristics of REM sleep (vivid dreams and muscle paralysis) at the beginning of sleep, even if that sleep is during the day.
Pandemrix was produced by ‘GSK’, Glaxo Smith Kline plc – the world’s sixth largest pharmaceutical company with revenue of 28 billion last year. The Irish Government gave indemnity cover to drug maker GlaxoSmithKline at the time the vaccine was issued in 2009 (It has been suggested by commentaries that this may be evidence of the lack of confidence of GlaxoSmithKline in the safety of their Pandemrix vaccine) They have also pledged to provide whatever support is needed to children and their parents.
All the research would seem to indicate that whole Pandemrix ‘problem’ was brought about by the rushing through of a manufacturing licence to GSK to facilitate timely manufacture and distribution of Pandemrix, in what was by now an environment of increased global hysteria surrounding the pandemic. In the ensuing rush, and much to the misfortune of those who would later be effected, the usual pre-licence safety checks and protocols were simply sidestepped by the EMA.
The current advice from the EMA is that the drug should not be used on persons under age 20 unless the recommended seasonal influenza vaccine is not available in cases where immunisation against H1N1 is needed. The HSE has said the use of the vaccine is no longer recommended, and that GPs have been advised to return any remaining stock of the vaccine.
Over 70 cases have been initiated in Ireland so far against ‘GlaxosmithKline (GSK) Biologicals S.A’ and the Health Products Regulatory Authority (HPRA), formerly known as the Irish Medicines Board (IMB). The HPRA is a State body whose role is to protect and enhance public health by regulating medical products.
At Coleman Legal Partners we are taking enquiries from those affected by the Pandemrix vaccination. Contact us at 01-5313800 or at [email protected] if you would like more information.