Novartis AG Researchers ID Possible Link Between GlaxoSmithKline Flu Vaccine, Narcolepsy
Published: Jul 06, 2015
July 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Researchers with Novartis have reported this week that they may have identified the connection between GlaxoSmithKline ’s flu vaccine and reported cases of narcolepsy, The Guardian reported.
During the 2009 and 2010 swine flu pandemic, about 6 million people in the U.K. received the GSK vaccine, Pandemrix, and about 31 million received it across Europe. The government reported about 100 claims that the vaccine triggered the sleep disorder narcolepsy.
In August 2014, Emmanuel Mignot, a Stanford University professor of psychiatry and behavioral sciences, asked linking the GSK H1N1 flu vaccine to narcolepsy in children be retracted. In a statement, Mignot indicated “they were unable to replicate some of the results reported in the paper.”
Now it appears that Novartis researchers, led by Sohail Ahmed, global head of clinical sciences at Novartis Vaccines, have identified the mechanism that links Pandemrix to narcolepsy and published it in the journal Science Translational Medicine.
“There’s a lot of evidence now to suggest that narcolepsy is an autoimmune disease,” said Ahmed to The Guardian. “In our study, we found antibodies that could cross-react to both the flu protein produced by the vaccine and receptors on the neurons.”
In the study, researchers analyzed components of the Pandemrix vaccine against those of the H1N1 vaccine, Focetria, manufactured by Novartis. A part of the viral protein in Pandemrix mimicked a brain receptor that binds to a hormone called hypocretin, which is involved in sleep regulation. People diagnosed with narcolepsy have lower levels of hypocretin. This protein is found in much higher levels in Pandemrix than in Focetria.
The researchers speculate that people who are predisposed to narcolepsy may have an autoimmune response to the protein in the Pandemrix vaccine that creates antibodies that attack the virus and the hypocretin receptor in the brain. However, the study does not prove that the antibodies actually get into the brain and do this. That would be the next step in the research.
“This paper is really elegant, and establishes a mechanism for how this one specific pandemic flu vaccine may have caused narcolepsy in some patients,” said Amesh Adalja, a senior associate at the University of Pittsburgh Medical Center’s Center for Health Security in a LiveScience article. Adalja was not involved in the study.
Pandremix was pulled from the market after the 2009/2010 pandemic. A spokeswoman for GSK told Reuters that the company would carefully review the study. “We are actively conducting research into the observed association between Pandemrix and narcolepsy and the interaction this vaccine might have had with other risk factors in those affected.”
The incidence of narcolepsy in people receiving the Pandemrix vaccine was about one in 55,000. The U.K. government recognizes the link, but has rejected compensation claims of about 80 people, indicating the disabilities are not “severe.” However, in June 2015, a 12-year-old boy won £120,000 in a court case based on being severely disabled by narcolepsy caused by the vaccine. This will likely initiate at least another 100 lawsuits.
A GSK spokesman, quoted in The Guardian article in June, stated, “We’re also continuing to support ongoing work from other experts and organizations investigating reported cases of this condition and we hope these efforts will enable us to provide more answers in the future. We take the safety of patients who entrust their health in our vaccines and medicines very seriously.”
After Bristol-Myers Squibb Wonder Drug Meets Endpoints, Will FDA Process Be Up to Snuff?
Our most popular story last week was about a new wonder drug that wowed the FDA. An experimental anticoagulant drug under joint development between Portola Pharmaceuticals, Inc., Bristol-Myers Squibb Company and Pfizer Inc. met all primary and secondary endpoints in a Phase III study determining safety and efficacy—and our readers responded. The hope now is it will be sped to patients as fast as possible.
That’s lead BioSpace to ask, what do you think about the drug approval process in this country? Let us know your ideas.