No Link Found Between GSK’s Pandemrix Flu Vaccine and Narcolepsy
GlaxoSmithKline has been made aware of several cases of narcolepsy following immunization with Pandemrix, a vaccine for the prevention of H1N1flu. Currently, however, the European Medicines Agency (EMA) has not found sufficient evidence to link the vaccine to an increased risk of the rare sleep disorder.
Pandemrix Not Used in the United States
Pandemrix was patented by GlaxoSmithKline in September 2006. It has been used since September 2009 for vaccination against the H1N1 swine flu and has been given to almost 31 million Europeans. It is only approved by the World Health Organization for use during a pandemic, as happened in 2009. It is not the same H1N1 vaccine used in the United States.
The active antigen in the vaccine is derived from the A/California/7/2009 H1N1. In the United States, this year’s seasonal flu vaccine selected by the US Centers for Disease Control and Prevention will include protection from this strain of the virus.
The EMA’s Committee for Medicinal Products for Human Use has reviewed the available data but has concluded that “the available evidence was insufficient to determine whether there is any link between Pandemrix and reports of narcolepsy” and “further studies (are) necessary to fully understand the issue.
Narcolepsy is a disorder that causes a person to fall asleep suddenly and unexpectedly. The cause is unknown, but likely has both genetic and environmental causes. About 80 cases have been reported after immunization with Pandemrix, primarily in Sweden and Finland.
GlaxoSmithKline chief medical officer Norman Begg has said that the company is working closely with the EMA and will also continue its own investigation into the claims.