EMA Update On The Pandemrix-Narcolepsy Investigation

 

 

# 4929

 

 

 

While stating that further research is warranted (and will take months), for the second time in about two weeks we’ve received word from regulatory agencies in Europe that no link has been found between the Pandemrix vaccine and recent reports of narcolepsy.

 

On September 9th, I ran a story called Sweden: No Link Between Pandemrix And Narcolepsy, which linked to a CIDRAP report on the findings of Sweden’s Medical Products Agency’s investigation into the matter.

 

Today, the European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use had reviewed all available data and found insufficient evidence to confirm a link between cases of narcolepsy and the vaccine.

 

An excerpt from their press release follows:

 

European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy

Available evidence does not confirm a link; more research needed

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has reviewed all available data on the suspected link between narcolepsy and Pandemrix. The Committee concluded that the available evidence was insufficient to determine whether there is any link between Pandemrix and reports of narcolepsy, and that further studies were necessary to fully understand this issue.

 

The Committee agreed that at present the benefit-risk balance for Pandemrix continues to be positive, and that while the review is still ongoing there was no need for Europe-wide restrictions on use.

(Continue . . . )

 

 

While further investigation might turn up evidence of a link down the road, the feeling right now at the EMA is that any risk – if it exists at all – is too slight to warrant restrictions on using the vaccine.

 

All drugs can have side effects, and while historically very safe, even flu vaccines had the potential to cause rare, serious  health problems.

 

But then, so can catching the flu.  And almost always at a far greater rate than from the vaccine.

 

 

Eurosurveillance has a brief report on this update as well:

 

Eurosurveillance, Volume 15, Issue 38, 23 September 2010

European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy

Eurosurveillance editorial team 

 

 

As does Reuters News with this report:

 

UPDATE 1-EU drug body finds no narcolepsy link to Pandemrix

  • 15:35:08 BST

Thu Sep 23, 2010 4:28pm BST

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