What is Narcolepsy?
Narcolepsy is a neurological condition which typically is acquired as a result of a trigger to the immune system, causing it to dysfunction and to cause damage to the part of the brain which regulates the sleep-wake cycle.
Narcolepsy is now generally accepted to be typically an acquired autoimmune condition. The trigger can be a viral infection with a pathogen such as influenza virus, or in very rare cases, it has been observed that a vaccine can trigger the immune system to dysfunction and cause narcolepsy. Narcolepsy is incurable and life-long, and requires a lifetime of treatment involving a delicate balance of stimulants to reduce sleepiness while minimising adverse effects of such stimulants and various other drugs to reduce or control cataplexy.
Excellent help and support is available for people with narcolepsy from the leading UK charity for people with narcolepsy, Narcolepsy UK.
Narcolepsy and vaccination
A causal link between the 2009 pandemic swine flu (H1N1) vaccine (“Pandemrix ®”) and some cases of narcolepsy is now generally established within the mainstream scientific consensus. However, in the first case of its kind, an English appeal tribunal has now found that a child’s narcolepsy was likely caused by the seasonal flu vaccine, and consequently found that a vaccine injury compensation payment under the Vaccine Damage Payment Act 1979 is due to the child in question.
The child (“X”) was born in 2003 and was therefore 11 years of age and in year 7, when she was immunised with the seasonal flu vaccine, Fluenz Tetra, in November 2014. Until this point X was a perfectly healthy child who slept well and had never had any significant injuries or illnesses. She was performing well academically at school and was very sociable, slim and confident.
The first signs of X’s narcolepsy emerged about 2-3 months after her vaccination, when X started to have daytime naps, at irregular times, which was something she had never done before. These naps were not considered to be anything serious at first. On 2nd March 2015 X got into trouble for falling asleep at school. It was immediately assumed by the teachers that X was staying up too late and they spoke to her mother about X’s excessive daytime sleepiness and asked her mother to make sure X was not staying up too late. X was not however staying up late. Her mother then noticed X began to have ‘horrendous facial expressions’ and then sudden unexplained falls. It was only much later that it was realised these were signs of cataplexy – a sudden and uncontrollable loss of muscle tone commonly seen in narcolepsy triggered by emotion. It was only due to these falls that X’s mother became concerned that there might be something seriously wrong, and X went to see her GP for the first time on 9th March 2015.
The GP took the history of excessive sleepiness and cataplexy symptoms for the ‘past few weeks’ and referred X urgently to be assessed in the local hospital by a paediatrician. X was seen with ‘unexplained collapse type episodes’ and was reviewed to see if she had a brain tumour but all the scans and tests were clear. X’s mother realised that it could be narcolepsy and arranged for her GP to refer X to be seen by a local narcolepsy Consultant on an urgent private basis. The Consultant immediately concluded it was likely X had narcolepsy and referred X for tests. X had a sleep study carried out and a lumbar puncture to measure her hypocretin in her CSF. Both tests unambiguously confirmed that X now had a diagnosis of narcolepsy.
The application for vaccine injury compensation
On 15th November 2015, X’s mother submitted an application to the DWP for a vaccine damage payment in respect of X’s narcolepsy being caused by her 2014 seasonal flu vaccination.
The application was determined on 20th January 2016 when the DWP found X was not entitled to a vaccine damage payment, following advice from a DWP doctor Dr Jill Elizabeth Blayney. Dr Blayney accepted X was correctly diagnosed with narcolepsy, but said that ‘current epidemiological evidence does not support such a link’. Whilst it is correct that there is no epidemiological evidence supporting a causal link between seasonal flu vaccine and narcolepsy, neither is there any such evidence demonstrating there is no such link. There is simply an absence of such evidence.
In March 2019, X’s solicitor, Peter Todd, wrote to the DWP requesting a mandatory reconsideration. Lay witness evidence from X’s mother and from an independent expert, Dr Croft, was supplied. Dr Croft had been instructed by Peter to review X’s case and to advise on causation. He opined that there would need to be a very large-scale epidemiological study to determine whether there was any association between seasonal flu vaccine and narcolepsy in children such as X, and no such study had been carried out. He considered it was biologically plausible that the vaccine had provoked the immune system to dysfunction and injure X’s brain. He noted X was well until she was vaccinated and then had the onset of symptoms of narcolepsy, without any other evident illness around this time. On the balance of probabilities, he was persuaded the likely cause of injury to X’s brain was that the vaccine had stimulated her immune system to cause that damage.
The DWP obtained further expert medical evidence from a Doctor Smith to review the request but this again opined there was no causal link between the vaccination and X’s narcolepsy. The outcome of the mandatory reconsideration by the DWP was therefore to again reject the application. Accordingly, an appeal was then filed on behalf of X for an appeal against the DWP’s refusal to the First Tier Tribunal.
Further evidence was filed with the Tribunal by Mr Matt O’Neill, Chair of Narcolepsy UK. He gave lay evidence about his own narcolepsy and of his observation of the numbers of people in the UK he had come across whose narcolepsy started after seasonal flu vaccine and who believe it was likely related to it.
The DWP obtained further expert evidence from two further DWP doctors, Dr Murphy and Dr Stecewicz. Both of these doctors accepted that the relevant circumstances were largely agreed but that a causal link could not be established due to epidemiological evidence. They did not however cite any studies and it was later accepted that there was no epidemiological evidence either for or against there being a causal link.
The appeal hearing
X’s appeal against the refusal of a vaccine damage compensation payment was heard by the First Tier Tribunal sitting at Leeds on 24th February 2020. The Tribunal consisted of a Tribunal Judge, Judge Philip Barber, and two doctors, Dr V Rogers and Dr MR McClelland.
X was represented before the Tribunal by Peter Todd, and the DWP were represented by a presenting officer, Ms Robbins. X’s mother gave live oral evidence to the Tribunal.
The Tribunal reserved its judgment and later handed down its decision on 13th March 2020. It certified it was satisfied that X was severely disabled as a result of a qualifying vaccination, such that X was entitled to the £120k vaccine damage payment. Subsequently, the DWP confirmed they had decided not to appeal against this decision.
Implications for other cases
This case has demonstrated that there is sufficient plausible evidence to persuade a tribunal that there is a probable link between a seasonal flu vaccine and the onset of narcolepsy. It is not known at this stage whether there will be any other cases which are also able to establish this. According to one study, the average time for the diagnosis of narcolepsy was 10.5 years post onset of symptoms so X’s case was very unusual as she received a diagnosis of narcolepsy within a few weeks of the onset of her narcolepsy. There was clear evidence that X was well until she was vaccinated and she did not have any viral illness or other plausible explanation for triggering the onset of her narcolepsy. It is likely to be a very rare case indeed which can establish the causal link sufficient to achieve an award of compensation. However, this is almost certainly the first such case but may not be the last. A copy of the decision notice and statement of the reasons of the Tribunal is available here.
What about vaccines?
Vaccines are generally very safe. Millions of vaccines are given every year and the rate of adverse reaction is vanishingly small, probably substantially less than one in a million. However, because many vaccines are given to large populations, it is inevitably that for a very few each year, some adverse reactions may occur. Very rarely these end up being serious and causing permanent disablement. This is why Parliament has enacted the Vaccine Damage Payment Act 1979 to provide a statutory scheme of compensation to support people who are vaccinated and in the very unlikely event that they have a severe and very rare adverse outcome.
The COVID-19 pandemic is a good time to remember that viruses can be very dangerous. About 25 million people died in the Spanish Flu pandemic of 1918, far more than the total who are likely to die as a result of COVID-19. Vaccines help prevent the spread of deadly viruses which can kill, especially older people and those with co-morbidities. So X’s case is not a good reason not to be vaccinated. In the rare event that a severe adverse event occurs, however – as happened to X, it is important for X to be supported by society to cope with her disability, which will significantly affect every day of her life.