LONDON — British drug manufacturer GSK (GSK.L) said on Thursday that its previous flu pandemic vaccine, which used some of the same ingredients as currently under production COVID-19 vaccines, was not associated with an increase in sleep disorder narcolepsy.
A GSK spokesman said the “research has moved on” as questions have been raised about the linkages between narcolepsy and its H1N1 vaccine, called Pandemrix, which was produced 10 years ago during the flu pandemic.
He said evidence now indicates the connection is with the flu virus H1N1 itself, not the vaccine itself.
Past research in many nations, including Britain, Finland, Sweden, and Ireland, where GSK’s Pandemrix vaccine was used in the flu pandemic in 2009/2010, indicated that its use was correlated with a substantial increase in children’s narcolepsy.
Pandemrix ‘s ingredients included a booster, or adjuvant, known as AS03, which GSK said it intended on Thursday to manufacture in large quantities for potential use in COVID-19 vaccines currently being developed to counter the disease caused by the new coronavirus.
AS03 could potentially be an ingredient in at least seven COVID-19 experimental vaccines including one produced by Sanofi with whom GSK signed a cooperation agreement in April.
The vaccine Pandemrix H1N1 combined portions of viral protein with the adjuvant AS03, intended to trigger a stronger immune response. The shot was never used in the United States and as links to narcolepsy appeared, it was removed from use in Europe.
In a statement to GSK said available scientific evidence now indicates that “the unusual incidence of narcolepsy during the flu pandemic in 2009/10 has been caused by the body confused a protein in the wild type H1N1 flu virus with a human protein related to controlling the sleep cycle.”
It said studies during that period also showed spikes in narcolepsy cases in unvaccinated populations.
Because this rare occurrence is believed to have been specific to the wild type H1N1 flu virus, it is highly unlikely there would be any implications for a future COVID-19 vaccine,” said GSK.
Narcolepsy is an incurable, lifelong disorder that interferes with normal cycles of sleep-wake, causing severe nightmares and daytime sleep attacks that can strike at any time.
Wendy Barclay, a professor, and chair of flu virology at Imperial College London said that since it is believed that the correlation between narcolepsy and the 2009/10 flu pandemic was due to cross-reactivity between sections of the H1N1 virus and human proteins that regulate sleep patterns, the adjuvant of the Pandemrix vaccine may have played a role.
If the cause or reason is the virus/host cross-reactivity, then using an adjuvant in the vaccine to improve the immune response might have increased the chances of producing this cross-reactivity,” “We still don’t know whether that was the case or not.”
GSK was not available immediately to respond to a request from Barclay.
Your email address will not be published. Required fields are marked *