Tuesday, September 21, 2010
Saturday, September 4, 2010
INFLUENZA PANDEMIC (H1N1) (65): SWEDEN, FINLAND, VACCINE REACTION
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A ProMED-mail post
ProMED-mail is a program of the
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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ProMED-mail makes every effort to verify the reports that
are posted, but the accuracy and completeness of the
information, and of any statements or opinions based
thereon, are not guaranteed. The reader assumes all risks in
using information posted or archived by ProMED-mail. ISID
and its associated service providers shall not be held
responsible for errors or omissions or held liable for any
damages incurred as a result of use or reliance upon posted
or archived material.
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.
############################################################
############################################################
A ProMED-mail post
ProMED-mail is a program of the
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
(
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
(
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
*##########################################################*
************************************************************
ProMED-mail makes every effort to verify the reports that
are posted, but the accuracy and completeness of the
information, and of any statements or opinions based
thereon, are not guaranteed. The reader assumes all risks in
using information posted or archived by ProMED-mail. ISID
and its associated service providers shall not be held
responsible for errors or omissions or held liable for any
damages incurred as a result of use or reliance upon posted
or archived material.
************************************************************
Donate to ProMED-mail. Details available at:
************************************************************
Visit ProMED-mail's web site at
Send all items for posting to: promed@promedmail.org (NOT to
an individual moderator). If you do not give your full name
name and affiliation, it may not be posted. You may unsub-
scribe at
For assistance from a human being, send mail to:
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