MONDAY, JUNE 18, 2018

EMA says probe into narcolepsy-vaccine link six months away

The European Medicine Agency announced on September 23 that it would take three to six months to probe a possible link between cases of narcolepsy and the Pandemrix flu vaccine for the H1N1 strain in 2009.

The EMA’s Committee for Medicinal Products for Human Use concluded that the issue needs further study, according to CIDRAP. The panel, in the meantime, agreed that there is, as of yet, no need to restrict the vaccine’s use.

On August 27, the EMA launched a review of Pandemrix after receiving reports of narcolepsy in patients, mainly those from Sweden and Finland. GlaxoSmithKline manufactures the product, which contains an adjuvant as well. It was given to 30.8 million Europeans during the H1N1 pandemic.

As of September 17, CIDRAP reports, healthcare professionals reported 81 cases of narcolepsy that are believed to be potentially related to Pandemrix. Of these, 34 cases came from Sweden, 30 from Finland, 10 from France, six from Norway and one from Portugal. The reports all came from spontaneous reporting systems.

"The ongoing review is complex and will take some three to six months to complete," the EMA announced, according to CIDRAP. "The agency is working with experts from across the European Union to carefully scrutinize all available reports. Owing to a potential overlap of narcolepsy symptoms with several other neurological and psychiatric disorders, diagnosis is very often not confirmed until several years after symptom onset."

Approximately two weeks ago, regulators from Sweden announced that their preliminary investigation demonstrated no known link between the vaccine and narcolepsy.

On September 1, the U.S. Centers for Disease Control and Prevention announced that it had reviewed its own evidence and found no link between cases of narcolepsy and H1N1 vaccines used in the United States, where Pandemrix has no license.