INFLUENZA PANDEMIC (H1N1) (65): SWEDEN, FINLAND, VACCINE REACTION

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A ProMED-mail post



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International Society for Infectious Diseases





Date: Fri 3 Sep 2010

Source: Web Wire [edited]







GSK [GlaxoSmithKline] initially became aware of possible cases of

narcolepsy following vaccination with the adjuvanted H1N1 pandemic

vaccine Pandemrix through adverse event reports received by the

Swedish Medical Products Agency, and subsequently via media reports in Finland.



Information on the individual cases remains limited at present, but

GSK is conducting its own investigation in an effort to gather as

much additional data as possible regarding the reported cases, and is

working closely with key regulatory authorities, including the

European Medicines Agency (EMA).



GSK has also proactively contacted the regulatory authorities in

other countries where Pandemrix was used extensively. The cases

reported as of 1500h GMT on 2 Sep 2010 have been primarily, but not

exclusively, in Finland and Sweden, with a small number of additional

cases reported in France. Media coverage has suggested small numbers

of cases in Norway and Germany, but as of today GSK has received no

reports from these countries.



To date, more than 30 million doses of Pandemrix have been

administered throughout Europe, with the most recent EMA

Pharmacovigilance Report (19 Aug 2010) concluding that the

benefit-risk profile of the 3 centrally-approved H1N1 vaccines,

including Pandemrix, continues to be positive.



GSK's adjuvanted H1N1 pandemic vaccine, Arepanrix, manufactured in

Quebec, was used extensively in Canada, with approximately 16 million

doses administered. There are no reports of narcolepsy in Arepanrix

recipients to date. However, given the background incidence of

narcolepsy we cannot rule out the possibility of a small number of

cases being reported in the future.



Narcolepsy is a chronic sleep disorder characterised by overwhelming

daytime drowsiness and sudden sleep onset. The precise cause of

narcolepsy is unknown, but there is growing evidence for either a

genetic or environmental basis to the condition.



Global experience with previous large-scale immunisation programmes

has shown that it is likely that a certain level of adverse events

will be reported. The adverse events that are reported may be the

result of underlying conditions, or new conditions that occur in

temporal association with the vaccination, and some events may be

related to the vaccine.



Having reviewed the currently available data and information

regarding the reported cases of narcolepsy, which continues to remain

limited, as well as GSK's own safety database, the company has

concluded that the currently available information is insufficient to

assess the likelihood of a causal relationship between Pandemrix and

narcolepsy.



--

Communicated by:

HealthMap Alerts via ProMED-mail





[This report does not provide any statistical information about the

numbers of individuals who suffered narcolepsy nor the number of

individuals vaccinated with H1N1 pandemic vaccine Pandemrix in Sweden

and Finland. Interpretation of these adverse reactions is complicated

by the absence of similar reported adverse reactions to the vaccine

elsewhere in Europe, with more than 30 million doses applied Europe-wide.



The 28 Oct 2009 edition of the Digital Journal

() reported an

unconfirmed source saying Swedish news sources reported at least 350

adverse reactions and 2 deaths to the vaccine but indicated that the

Swedish Institute for Infectious Disease Control denied a link

between the adverse reactions and the vaccine. Narcolepsy was not

mentioned as one of the adverse reactions.



More recently, a 27 Aug 2010 report from Reuters

() stated that

the European Medicines Agency had been asked by the European

Commission to conduct the review after a number of narcolepsy cases

were reported, to determine if there was a causal relationship

between the vaccine and narcolepsy. The vaccine contains the adjuvant

squalene which is a hydrocarbon and a triterpene, and is a part of

the synthesis of cholesterol, steroid hormones, and vitamin D in the

human body. Squalene is used in cosmetics, and more recently as an

immunologic adjuvant in vaccines. Its possible involvement in the

narcolepsy cases in not mentioned. - Mods.MPP,TY]



[see also:

Influenza pandemic (H1N1) (63): WHO update 112 20100807.2680

Influenza pandemic (H1N1) (61): seasonal strain replacement 200920100805.2648

Influenza pandemic (H1N1) (50): WHO update 108 20100710.2311

Influenza pandemic (H1N1) (40): WHO update 104 20100612.1970

Influenza pandemic (H1N1) (30): WHO update 20100417.1250

...................mpp/dk/ty/ejp/dk



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