Swine Flu Vaccination and Pandemrix
Handling Partners Michael Boylan and Gillian O’Connor
We are currently handling over 65 cases of Pandemrix related narcolepsy (most including Cataplexy) arising from the administration of the swine flu vaccine Pandemrix. The majority of claimants are children / infants. Narcolepsy is an incurable life-long disability.
In 2009, the World Health Organisation (WHO) declared a swine flu pandemic. The Irish government and the HSE purchased over 8 million swine flu vaccines. The Pandemrix vaccine was made by GSK. The Celvapan vaccine was made by Baxter. In contrast to the Baxter vaccine, Pandemrix contained an adjuvant, ASO3, which boosts the effect of the vaccine triggering the immune system to increase its reactogenicity to the vaccine. Essentially, less core virus (vaccine) is required once an adjuvant is added.
The HSE commenced their vaccination programme at the end of October / early November 2009. A strong media campaign was run parallel to the vaccination programme and the aim initially was to vaccinate at risks groups such as health care workers and adults / children with underlying medical conditions. Thereafter, it was intended to vaccinate the entire healthy populous.
Pandemrix was, from a logistical perspective, a far more attractive vaccine to use, since its shelf life was 24 hours in contrast to Celvapan whose shelf life was only 3 hours. Celvapan did not contain any adjuvant. The vaccination programme of healthy people (aiming to vaccinate the entire population) commenced on approximately the first week of November 2009 and ended on the 31st of March 2010. Almost one million people received the Pandemrix vaccine.
The simultaneous media campaign launched by the HSE strongly encouraged the healthy public to submit and receive the swine flu vaccine as tantamount to a prophylactic civil duty. However, the Pandemrix vaccine had very limited testing. A “mock up” vaccine which was given for license by the EMA (European Medicines Agency) did not contain the swine flu virus (antigen / H1N1) but contained the Bird Flu virus (H5N1). Furthermore, the HSE media campaign equated Pandemrix (adjuvanted vaccine) to Celvapan (unadjuvanted vaccine) and did not advise the public of the fact that Pandemrix was a largely untested vaccine.
As early as the first week of November 2009, the swine flu instance in Ireland began to fall and by early to mid January 2010, was reduced to single figures per week. Indeed, on the HSE’s own data, it became clear that the instances of swine flu after the commencement of the vaccination programme were steadily falling.
Pandemrix was licensed by the Irish Medicines Board (now known as the Health Products Regulatory Authority) for distribution and administration in the Republic of Ireland. As part of its licensing obligation, and as Pandemrix was largely an untested adjuvanted product (made in Dresden), GSK was obliged to deliver details of all Adverse Events and Serious Adverse Events regarding its product Pandemrix, but also that of its sister vaccine Arepanrix, (manufactured in Quebec) and also its non-adjuvanted vaccine sold only to the U.S (the FDA refused to purchase any adjuvanted vaccine).
We now know that in compliance with its obligations, GSK began disclosing data to the HSE from the very beginning of the vaccination program as early as October 2009. By December 2009, GSK had delivered in-depth safety data concerning Serious Adverse Events arising from the Pandemrix vaccine (with multiples of Serious Adverse Events in contrast to its sister vaccine Arepanrix and its non-adjuvanted vaccine). Serious Adverse Events included convulsions, demylination (stripping of neurologic brain and spinal cord nerve covering), guillian-barre syndrome and spontaneous abortions.
Despite receiving data of these Serious Adverse Events, the HSE continued its vaccination of the healthy population. At no stage was the vaccination programme reviewed, adjusted or modified by the HSE or the Irish Medicines Board (in contrast to their UK counterparts). The first case of Pandemrix related Narcolepsy in Ireland, as far as we can ascertain, was diagnosed by a vigilant GP in and around the summer of 2010. As time went on, more instances and diagnosis of narcolepsy / cataplexy were made and a report commissioned by the HSE and carried out by Dr. Darina O’Flanagan in 2012 confirmed a thirteen fold instance of Pandemrix related narcolepsy in contrast to recipients of alternative swine flu vaccines.
Current position of litigation
In our current lead case, we have joined the Irish Medicines Board now known as the Health Products Regulatory Authority (HPRA) as a Co-Defendant in these proceedings alleging failure to comply with its statutory obligations in the light of the data provided to them by GSK as early as December 2009.
Two Orders for Discovery have been made, one against the Minister for Health and Children and HSE on the 28th of November 2016 and a prior Order for Discovery of documents also made against GlaxoSmithKline on the 16th of July 2016. Court applications to force compliance with these Orders by the Minister for Health and HSE is still ongoing.
Further details will follow on this website as developments emerge.
If you have been affected by any of these events please contact Michael Boylan or Gillian O’Connor.