GlaxoSmithKline's full statement to W5 on Pandemrix
1. A. Studies in Sweden, Finland, Ireland, Norway and Britain have also shown the risk of developing narcolepsy is between seven and 13 times higher in children who were immunized with Pandemrix than in those who were not – What is your response to these findings?
B. Can Pandemrix trigger narcolepsy in children?
Epidemiological data currently available to GSK suggest an increased risk of narcolepsy following vaccination with Pandemrix™ (H1N1). Due to the methodological limitations of the studies, which are retrospective observational studies, further research is needed to determine whether the observed risk is related to the vaccine, environmental effects, genetic factors, other factors or a combination of them. Further research also is needed to evaluate whether there are biologically plausible mechanisms by which vaccination with Pandemrix™ (H1N1) may have triggered narcolepsy in some individuals as no such mechanism has been demonstrated to date.
GSK remains committed to the pursuit of additional research to understand the potential role of Pandemrix™ (H1N1) in those who developed narcolepsy after vaccination and continues to support the research of others who are investigating the reported cases of narcolepsy.
2. In some jurisdictions Pandemrix is no longer used in people under 20 – what do you think of that decision? Is it justified? Why? Why Not?
There is currently no H1N1/09 pandemic situation, so it is not appropriate to vaccinate with Pandemrix™ (H1N1) at this time. Further, all Pandemrix™ (H1N1) doses have reached the end of their shelf life and therefore should no longer be used.
3. To date, how many people/children in Canada have reported developing narcolepsy after getting vaccinated with Arepanrix? What provinces do they reside in Canada?
GSK reports all cases of adverse events which the company is aware of in accordance with national and regional regulations. We respectfully defer to the Public Health Agency of Canada to address this question in more detail.
4. We read that there is currently a Canadian study sponsored by GSK to assess the risk of occurrence of narcolepsy following the administration of Arepanrix – Why did you sponsor that study? When will the results of that study be published?
We are currently supporting a study that is being conducted in Quebec where Arepanrix™ (H1N1) was used. Further research is needed to evaluate the potential association between GSK`s adjuvanted H1N1 pandemic flu vaccine and narcolepsy in a country where a similar vaccine to Pandemrix™ (H1N1) was used, and where a more robust assessment of the potential association could be conducted, using a design aimed at limiting the impact of biases. The preliminary results of this study are anticipated to be published by early 2014.
5. Are there any other studies assessing the risk of narcolepsy following vaccination with Arepanrix? What are they? Who is doing them? When do you expect to get results of the studies?
We have met with regulatory agencies, public health authorities and experts in the countries reporting increased incidence of narcolepsy to learn more about the circumstances and their data and also discuss potential research activities. At this time, the only study that we are supporting that has the primary objective of evaluating the risk of narcolepsy following vaccination with Arepanrix™ (H1N1) is the study currently being conducted in Quebec. This study was identified in collaboration with European Medicines Agency (EMA), a European Union regulatory agency, to help understand the potential contributory role of GSK’s H1N1 pandemic vaccine in the association between vaccination and narcolepsy. Preliminary results are anticipated to be published by early 2014.
6. Will risk of narcolepsy be added to the product monograph for Pandemrix?
The risk of narcolepsy is part of the European labeling for Pandemrix ™ (H1N1). However, as reflected in the current Pandemrix™ (H1N1) Summary of Product Characteristics, the vaccine is indicated specifically for use as a 2009 H1N1 pandemic vaccine. There is currently no H1N1/09 pandemic situation, so it is not currently appropriate to vaccinate with Pandemrix™ (H1N1). Further, all Pandemrix™ (H1N1) doses have reached the end of their shelf life and therefore should no longer be used.
7. Will risk of narcolepsy be added to the product monograph for Arepanrix?
The Arepanrix™ (H1N1) vaccine was given a 1-year temporary license. This license has been expired since October 2010 and there is therefore no need to update the product monograph.
8. Many scientists are exploring the possible association between narcolepsy and GSK’s adjuvant vaccines - how important is it to get answers quickly?
Narcolepsy is a complex and rare disease for which the cause is currently unknown. There are a number of hypotheses regarding potential contributing factors in the development of narcolepsy, but more research is needed in order to more definitively establish the cause(s) of the disease. The required research is both complex and lengthy.
9. What do you want the public to know about the current research suggesting an association between narcolepsy and GSK adjuvant vaccine.
GSK takes the safety of individuals and families who entrust their health in our products very seriously and is committed to the highest standards of patient safety. We sympathize with those who have been diagnosed with narcolepsy and those who care for them. We remain committed to the pursuit of additional research to understand the potential role of GSK’s H1N1 pandemic vaccines in those who developed narcolepsy after vaccination, and continue to support the research of others who are investigating the reported cases of narcolepsy. We hope these ongoing research efforts will provide more answers.