Narcolepsy link to swine flu jab

OVER eight thousand doses of the swine flu vaccine Pandemrix - linked to an unexpected spike in juvenile narcolepsy cases in Europe and now restricted for children and teenagers - were dispensed at Altnagelvin over the past two years, the Sentinel can reveal.

The Public Health Agency (PHA) says there are no plans to use the drug here in 2011.

But between 2009 and 2010 8,690 doses of the vaccine were dispensed at the Londonderry Hospital whilst a total of 12,780 doses were dispensed across Altnagelvin, the Erne Hospital and the Tyrone County Hospital over the two years.

Hide Ad
Hide Ad

Concerns over the drug were first raised back in August 2010 when Sweden reported an unexpected increase of cases of juvenile narcolepsy following immunisation with Pandemrix.

Finland subsequently suspended the use of the vaccine as a similar spike was seen in that country.

And last July the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended restricting the use of Pandemrix in persons under 20 years of age on a precautionary basis but indicated that overall the benefit-risk of the vaccine remained positive.

Narcolepsy is a rare sleep disorder characterised by excessive daytime sleepiness, sometimes accompanied by cataplexy.

Hide Ad
Hide Ad

Pharmaceutical giant GlaxoSmithKline, which makes the drug, pointed out that over 31million doses of Pandemrix had been administered worldwide in 47 countries and that a total of 335 cases of narcolepsy in people vaccinated with Pandemrix had been reported to GSK as of July 6 2011, with 68 per cent of these cases of narcolepsy originating from Finland and Sweden.

Vaccine

But in September Northern Ireland’s Chief Medical Officer Dr Michael McBride confirmed that two suspected cases of narcolepsy in people who had received the vaccine had been reported although no link between narcolepsy and the swine flu virus or the Pandemrix vaccine had been established.

“Two suspected cases have been reported to the Medicines and Healthcare Products Regulatory Agency. At this stage it is a precaution,” stated Dr McBride.

The PHA told the Sentinel there were never any plans to use Pandemrix this year despite the widespread use of the vaccine over the last two years.

Hide Ad
Hide Ad

“The Pandemrix flu vaccine has not been ordered or distributed this year (2011). There were never any plans to use it. The flu vaccine being used this year is the seasonal flu vaccine and there is no suggestion at all that narcolepsy may be connected with the seasonal flu vaccine,” a spokeswoman told the paper.

She advised the drug had not been withdrawn due to the narcolepsy association but was not being used because the new seasonal flu vaccine protects against swine flu and two other strains of flu.

“The Pandemrix vaccine was not withdrawn, it was produced for a specific purpose i.e. to protect against swine flu in the year of the pandemic at a time when the seasonal flu vaccine did not protect against that strain,” she stated.

“That purpose is no longer relevant as the seasonal flu vaccine now protects against swine flu as well as two other strains of flu whereas the Pandemrix vaccine only protects against one strain of influenza – H1N1 (swine flu).

Hide Ad
Hide Ad

“There is no suggestion at all that the current seasonal flu vaccine could be associated with narcolepsy. There are no remaining stocks of Pandemrix,” she concluded.

The EMA investigative committee considered that the epidemiological studies relating to Pandemrix in Finland and Sweden were well designed and the results showed an association between Pandemrix vaccination and narcolepsy in children and adolescents in those countries.

The results indicated 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).

Narcolepsy’s precise cause is still unclear, but it is generally considered to be triggered by a combination of genetic and environmental factors. Narcolepsy occurs naturally at a rate of around 1 new case per 100,000 people every year.