EMA narcolepsy review restricts Pandemrix use in kids, teens

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EMA narcolepsy review restricts Pandemrix use in kids, teens

Schnirring * Staff Writer

Jul 21, 2011 (CIDRAP) – Europe's drug regulatory agency today released its final

review of a link between narcolepsy and the Pandemrix 2009 H1N1 vaccine, which

recommends a labeling change that limits the vaccine's use in children and teens

to when protection is needed and seasonal trivalent vaccine isn't available.

Some countries, primarily Scandinavian ones, have reported link between the

vaccine and narcolepsy in young people. Pandemrix, made by GlaxoKline

(GSK), is one of the 2009 H1N1 vaccine used in Europe during the pandemic, and

it's unclear how many doses are still on the market. It contains the AS03

adjuvant.

The European Medicines Agency (EMA) said today in a press release that its

Committee for Medicinal Products for Human Use (CHMP), however, has confirmed

that the vaccine's overall risk-benefit balance is positive.

The agency said in the release that " in persons under 20 years of age Pandemrix

may only be used if the recommended seasonal trivalent influenza vaccine is not

available and if immunisation against H1N1 is still needed (eg, in persons at

risk of the complications of infection). "

The CHMP launched a review of the vaccine-narcolepsy in August 2010, based on a

request from the European Commission. Today's labeling change recommendation

follows an interim one in April asking GSK to warn about the risk in young

people and advise healthcare providers to perform an individual benefit-risk

assessment before administering Pandemrix.

In making its recommendation today, the EMA said it took into consideration

epidemiologic studies conducted in Finland and Sweden, safety and surveillance

data from several other EU countries, and preliminary findings from an

eight-country study coordinated by European Centre for Disease Prevention and

Control (ECDC). It also incorporated feedback from an expert meeting that

discussed that link.

The EMA said the Finnish and Swedish studies were well designed, showing a 6- to

13-fold increase risk of narcolepsy in young people who had received the

Pandemrix vaccine. It added that link has not been found in adults 20 and older.

Though the preliminary ECDC findings confirmed the narcolepsy link in Finland,

the EMA cautioned about extrapolating the findings to other countries,

especially ones where vaccination coverage with Pandemrix was lower.

The vaccine likely interacted with genetic or environmental factors that could

boost the risk of narcolepsy, the EMA said, adding that several studies in the

European Union are under way to explore other possible connections.

" Exposure to specific infectious diseases (including H1N1) at different ages,

particularly upper respiratory infections, may have contributed to the

observations in the Nordic area, " the EMA said, adding that more research is

needed to address such possibilities.

GSK said in a statement today that the labeling change will replace the advisory

to clinicians that the EMA recommended in April. The company said it would

continue to work closely with the EMA and other regulators to explore the

possible link. It added that final results from the ECDC study and an

epidemiological study that it is conducting in Canada are needed to shed more

light on narcolepsy cases in people who received Pandemrix.

The company also said it will conduct more research on the possible link and

include input from independent experts, per an agreement with the EMA.

So far 31 million doses of Pandemrix have been administered in 47 countries, GSK

said. It has received 335 reports as of Jul 6 of narcolepsy in people who were

immunized with Pandemrix, of which 68% were from Finland and Sweden.

http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/jul2111narco.ht\

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