One-sixth of all re-issued ‘sleep disorder’ jabs unaccounted for
MORE than one-sixth of the re-issued stockpile of a drug, now at the centre of narcolepsy or sleep disorder fears, is effectively unaccounted for.
The revelation came as it emerged an unknown number of Irish children received a second dose of the Pandemrix vaccine in 2011 after the Health Service Executive (HSE) admitted it did not handle all subsequent vaccine stock disposals.
Pandemrix was re-issued by the HSE to Irish GPs and clinics amid fears of a shortfall in the normal winter flu vaccine in early 2011.
However, it was withdrawn just weeks later when studies in Finland and Sweden indicated Pandemrix could be linked to a surge in the number of narcolepsy or sleep disorder cases being reported.
Now, the Irish Independent has learned that the HSE did not handle all vaccine disposals in 2011.
While two-thirds of Ireland’s GPs and clinics accepted at least one box of Pandemrix doses in 2011, the HSE only received returned vaccine stocks from half of those practices from March 28, 2011, when the vaccine was recalled.
The remainder, slightly less than half the national distribution stock, was disposed of by GPs and clinics themselves through alternative methods to the HSE drug return scheme.
That makes it difficult, if not impossible, for the HSE to discover precisely how many children may have received doses.
Sligo TD and narcolepsy campaigner Marc MacSharry said the issue raised obvious concerns.
“Most worryingly, when the HSE did recall the Pandemrix vaccines provided to GPs and clinics nationwide for use as a substitute for the ordinary flu vaccine, just less than 50pc were ever returned.
“Some worrying questions arise: were they used on patients? Were they disposed of ?
“And in any event, how many were administered to patients? To whom? Have they been told?
“And how many are suffering the symptoms of narcolepsy following this?”
The Fianna Fáil TD said it was clear there was a responsibility to inform anyone who may inadvertently have received Pandemrix in 2011.
Sound, the group campaigning on behalf of narcolepsy sufferers, expressed alarm at the revelation.
“Potentially more than onesixth of the vaccines issued to GPs is unaccounted for – so where are they?” asked Sound co-founder Tom Matthews.
The HSE insisted it was “likely that very few doctors prescribed Pandemrix” during the three month re-issue period in 2011.
However, the Irish Independ- ent revealed that at least one family had a mother and two children treated with Pandemrix in 2011.
The children got a second dose having already been treated in 2009 with the vaccine at the height of the swine flu fears.
The family only discovered the Pandemrix double dose when they demanded their vaccination records after one child developed chronic narcolepsy.
Pandemrix was initially used from autumn 2009 to March 2010 but was then withdrawn and placed into storage.
The Government, as demanded by the vaccine manufacturer GlaxoSmithKline (GSK), granted the firm a full indemnity in 2009 to fast-track the drug.
Stockpiles of the German-made vaccine were then re-issued in January 2011 when fears mounted that GPs and clinics could run short of the normal winter flu vaccine.
The Government had originally sourced a total of eight million doses of Pandemrix at a reported cost of €80m.
“In early January 2011, there were increasing levels of influenza illness with a considerable demand for seasonal flu vaccine and a resulting pressure on existing vaccine supply,” a HSE spokesperson explained.
“The HSE had a limited supply of seasonal flu vaccine with more expected within the following two weeks.
“In order to ensure that all GPs had sufficient vaccine supplies, the HSE National Cold Chain Service offered all GP practices one box of 50 vials of Pandemrix vaccine (equivalent to 500 doses but likely to be much less as the vaccine came in multi-dose vials and once a vial was opened it had to be discarded after 24 hours).”
Across Ireland, two-thirds of GPs and clinics accepted supplies.
“(But) the delivery of seasonal flu vaccine arrived sooner than expected and this was distributed to all who required it,” the HSE official explained.
“As we were not informed of any site that ran out of seasonal flu vaccine, it is likely that very few doctors prescribed Pandemrix.”
However, all vaccine stocks were not returned to the HSE.
“GP practices were asked to return any unused Pandemrix and over half of the practices returned stock.
“GPs are not obliged to use the vaccine returns service and may dispose of unwanted vaccines through other waste disposal services.”
A United Drug worker with a delivery of swine flu vaccine in October 2009.