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INFLUENZA: FRANCE, NARCOLEPSY IN H1N1-VACCINATED ADULTS Update: 9/26/2012 9:50:51 AM (GMT+7)

Date: Fri 21 Sep 2012 Source: CIDRAP New [abridged, edited] French study finds narcolepsy link to H1N1 vaccine in adults ------------------------------------------------------------ French researchers have found a significant link between one 2009 H1N1 vaccine and narcolepsy in adults, a finding that is likely to prompt some countries to take a fresh look to see if adult cases have surfaced in the wake of pandemic vaccine campaigns. The French findings are part of a larger investigation under way through the

<http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/sep2112narcolepsy.html>


French study finds narcolepsy link to H1N1 vaccine in adults
------------------------------
------------------------------
French researchers have found a significant link between one 2009 H1N1
vaccine and narcolepsy in adults, a finding that is likely to prompt
some countries to take a fresh look to see if adult cases have
surfaced in the wake of pandemic vaccine campaigns. The French
findings are part of a larger investigation under way through the
Vaccine Adverse Event Surveillance and Communication (VAESCO)
Consortium led and funded by the European Centre for Disease
Prevention and Control (ECDC). The data are from a case-control study
that was partially included yesterday [20 Sep 2012] in a detailed
technical report from the ECDC that explored the vaccine-narcolepsy
link in 8 European countries, including some that didn't report the
problem. Full findings from the French case-control study have now
appeared on the Web site of the French Agency for the Safety of
Medicines and Health Products (L'Agence nationale de securite du
medicament et des produits de sante -- (ANSM).

Only one vaccine has been linked to the narcolepsy cases, Pandemrix, a
GlaxoSmithKline (GSK) product that contains its AS03 adjuvant. The
vaccine was not used in the United States during the 2009 H1N1 vaccine
campaign, but several European countries used it alone or alongside
other vaccine formulations. Canada and Brazil also used a very similar
GSK pandemic vaccine containing the AS03 adjuvant. Yesterday's ECDC
report confirmed the [previously reported] link between narcolepsy and
pandemic 2009 vaccination in Finnish and Swedish children, and
reported that a sensitivity analysis found a narcolepsy link to
vaccinated adults when data were pooled from countries that hadn't
already noted an association. The ECDC said more data and case reports
will be needed to better understand the link between narcolepsy and
the vaccine.

The French researchers used a study protocol that was developed by
VAESCO for use in the larger ECDC investigation. However, they noted
that the study periods used by the wider study and the analysis
specific to France are different, with the French study period
starting 6 months later and ending 10 months later. In the report
yesterday, French investigators said 51 cases of narcolepsy were
reported in French patients who were immunized against the pandemic
virus; 47 received Pandemrix, but only 3 received Panenza (a
nonadjuvanted vaccine from Sanofi Pasteur), and one received an
undetermined product. All of the narcolepsy cases were confirmed by
sleep study tests, and 38 involved cataplexy episodes.

During France's pandemic vaccine campaign, about 4.1 million doses of
Pandemrix and about 1.6 million vaccinations with Panenza were
administered, according to the report. Researchers found that 22 of
the narcolepsy cases were in people 16 years old and older and 28 were
in children 8 to 15 years old. Symptom onset occurred from 2 days to
15 months after vaccination. 8 patients -- 6 adults and 2 teens -- had
a medical or family history that might explain the condition. The
investigators reported that overall the same signal seen in Finnish
and Swedish children was found in French children, but the link
between Pandemrix and narcolepsy was also detected in French adults.

They cautioned that the findings don't show a causal relationship and
that a more thorough investigation should be conducted to explore the
link further, including possible environmental or genetic factors.
ECDC spokesman Giovanni Mancarella said France is the only country in
which an association between the pandemic vaccine and narcolepsy has
been observed in adults, most of them younger adults. There are more
than 100 suspected narcolepsy cases in adults reported in the European
Medicine Agency's EudraVigilance database, the ECDC said. Finland's
National Institute for Health and Welfare (THL) said today that it is
conducting further study on adult cases, according to a statement in
Finnish posted on the group's Web site. It said the investigation will
focus on 40 to 50 adult narcolepsy cases that were diagnosed between
2009 and 2011. About half of the patients had received the pandemic
vaccine. It's not clear why France is the only country that has found
the association, Mancarella said, noting that with the data so far,
it's impossible to show a causal relationship between the vaccine and
narcolepsy in adults.

[Byline: Lisa Schnirring]

--
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