Swine flu jab wrecked our children's health: It was rushed in amid fears of a global pandemic. Now it's linked to an illness that makes victims sleep 19 hours a day

Swine flu jab wrecked our children's health: It was rushed in amid fears of a global pandemic. Now it's linked to an illness that makes victims sleep 19 hours a day

• Children developed sleep disorder after jab to protect them from swine flu
• UK Health Protection Agency found jab increased chance of narcolepsy
  
• Investigations focusing on element of vaccine called 'adjuvant'

By Steve Boggan

PUBLISHED: 17:45 EST, 27 March 2013 | UPDATED: 08:40 EST, 28 March 2013

Nobody would listen, but Caroline Hadfield knew there was something dreadfully wrong with her five-year-old son Josh. Not only was her once lively boy constantly falling asleep, but he would often stay asleep for 18 or 19 hours a day.

‘It was as if something in him was shutting down,’ says Caroline. ‘His legs would crumble beneath him. Sometimes he would just pass out. It was terrifying. We kept taking him to hospital but they said there was nothing wrong with him.

‘One day, he was sitting on a bed in a ward and he seemed to go into a trance. A nurse took one look at him at said: “I have no idea what planet he’s on, but it isn’t this one.”’

Terrified: Caroline with son Josh. who started sleeping for 19 hours a day and was diagnosed with narcolepsy

Only after months of inconclusive tests and mistaken reassurances from medics that everything was fine did the real reason for Josh’s condition become clear â€" he had developed a rare and devastating condition called narcolepsy.

Two years on, he has been identified as one of a group of children who developed this crippling sleep disorder after receiving a jab to  protect them against swine flu.

Narcolepsy is a neurological condition which interferes with the brain’s mechanisms to control wakefulness and sleep, leaving sufferers constantly tired and likely to fall asleep any time, anywhere.

In many cases, victims also suffer from cataplexy, a sudden and frightening relaxation of the body’s muscles which causes people to collapse or even pass out without warning. It usually strikes when the sufferer is experiencing heightened emotions such as laughter or anger.

So far, 11 likely victims have been identified. While for the vast majority of children the swine flu jab proved harmless and effective, the UK Health Protection Agency last month found that giving the jab to young children increased their chance of developing narcolepsy by 14 times.

It may be that the children affected would have developed narcolepsy later in life without the injection. No one knows for sure.
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What is known is that by 2011 there was already sufficient concern over the potential link for the Department of Health to issue new guidelines  banning the vaccination for anyone under the age of 20.

'He went from being a happy, playful child to a little boy who was afraid to laugh'

For Josh, that decision came too late. He was injected with the vaccine Pandemrix, made by GlaxoSmith Kline, in December 2009 and his first symptoms appeared a few weeks later.

‘Like any responsible parent, I did as much research as I could before allowing Josh to have the jab,’ says Caroline, a training analyst from Frome, Somerset.

‘The only side effect I was made aware of was soreness of the arm, so I felt re-assured. At first there were no problems, but three weeks after having the vaccine he became  dramatically sleepy.

‘He started wanting to go to bed at 6pm and then in the middle of the afternoon. By the February half-term he was sleeping for 18 or 19 hours a day.’

Josh, then aged five, became increasingly listless, says Caroline, 42. He went from being a happy, active child to becoming grumpy and angry. Over the next few months she notic ed a lack of control in his arms and legs.

Then his tongue began to hang out of his mouth and finally the sleeping began to consume the entire day.

Caroline and her husband, Charlie, a 48-year-old printer, began to worry that Josh could have a brain tumour. ‘By March, he could hardly stand up and I was getting calls from his school asking me to pick him up because he had fallen asleep at 10am and they couldn’t wake him,’ she says. ‘He was tested for glandular fever but that was negative. Then he had his first proper attack of cataplexy. He was watching the TV and laughing and then his muscles gave way, his eyes rolled into the back of his head and he passed out for about 30 seconds.

‘We were absolutely terrified and called an ambulance, but by the time it arrived he was fine again.’
What followed is common to most of the cases: months of blood tests, lumbar punctures (wh ere a sample of fluid is taken from the lower back) and brain scans. 

Missing out: Robyn, with mother Dawn, can't do things like swimming because of her sleeping disorder

Doctor after doctor pronounced Josh to be healthy even when he was passing out for anything between 30 seconds and four minutes. As luck would have it, these passing out  sessions never happened in front of the doctors.

At first, they were dismissed as being related to a mystery ‘virus’, but Caroline knew something more sinister was behind all the symptoms and pushed for more and more tests.

Eventually, Josh was sent to a specialist sleep clinic â€" one of only a handful in Britain â€" at the John Radcliffe Hospital in Oxford, where his narcolepsy was finally diagnosed.

Josh was one of the thousands of children to be vaccinated with Pandemrix in response to the deadly H1N1 flu pandemic. The virus, called swine flu because it was caused by a human virus combining with one common in pigs, was first identified in April 2009 and went on to kill almost 300,000 people worldwide.

In England, the parents of a quarter of all under-fives followed Government advice to have them protected against the flu. Among children aged 15 and under with underlying health conditions, such as asthma, the take-up was even higher at 37 per cent.

'Our children may never be able to drive or hold down a job'

Robyn Ballingham, now seven, was given the jab in January 2011. Within weeks, she started becoming more and more sleepy. But it wasn’t until she suffered her first attack of  cataplexy, five months after the injection, that doctors at the Royal Hospital for Sick Children in Yorkhill, Glasgow, diagnosed  narcolepsy. Like Josh, she has become moody and sad too.

‘It was terribly upsetting to see Robyn change from a happy, active child', says her mother Dawn, 39.

‘She became very serious because she was afraid of laughing. If she laughs, it could bring on an attack of cataplexy. This affects her muscles, and eyelids are held up by muscles so it causes her eyelids to suddenly drop down and she can’t see. She panics because then she falls over, so I constantly need to be there.’

Dawn, a beauty therapist, and her husband John, 49, feel they cannot leave Robyn alone even for a moment.

‘She gets upset when we tell her she can’t do the things other children can. For example, we couldn’t risk her swimming without us being right at her side because she could drown if she had a bout of cataplexy.’

It was a similar story for Lucio Decicco, now aged eight, from Hawkinge, Kent, following his swine flu vaccination in January 2010 â€" the listlessness, the passing out, the incessant sleeping.

He, too, underwent batteries of tests before finally being diagnosed with narcolepsy at Guy’s and St Thomas’ Hospital in South London. ‘Lucio had more tests than any child should ever have to go through â€" blood tests, lumbar punctures, MRI and CAT scans on his brain,’ says his mother, Karen, a pre-school teacher. 

Uncertain future: Lucio, now eight, and mum Karen

‘The staff at St Thomas’s were wonderful, but they couldn’t find out what was wrong with him.’

Then Karen, 34, saw a story in the Daily Mail highlighting suspicions about Pandemrix in Finland. ‘I wrote to the hospital about the article, they quickly tested Lucio for narcolepsy, and the mystery was solved. It was heartbreaking to see the change in him.

‘He went from being a happy, playful child to a little boy who was afraid to laugh.’

So, with all the supposed stringent checks on new drugs, how could this have happened and what is being done about it?

Investigations are focusing on an element of the vaccine called an ‘adjuvant’ which effectively boosts the potency of the medicine.

In the case of Pandemrix, an adjuvant called AS03 was used. It is a combination of squalene (an oil derived from shark livers), a form of vi tamin E called DL-alpha-tocopherol and a mixing agent called polysorbate 80. The adjuvant was not included in the vaccine used in the US, and there has been no increased incidence of narcolepsy there.

But even if the vaccine is ultimately proven to cause narcoplepsy, there could be a tough battle ahead for adequate compensation for the affected children. GlaxoSmithKline was given a legal indemnity by the Department of Health because, with the pandemic looming, it was not possible to conduct years of tests before rushing the vaccine into production.

Sleep sufferers

Around 30,000 people in the UK have narcolepsy and it also affects animals, including dogs

There is a state compensation scheme for people who suffer ill effects from vaccines, but it is capped at £120,000 and the cost of helping these children through life is expected to amount to consi derably more than that.

The future for these children is now unclear. Doctors are unsure how long the condition will last. The seriousness of symptoms can fluctuate, but the condition never goes away.

Professor Paul Gringras, a paediatric sleep consultant at Evelina Children’s Hospital in London who diagnosed Lucio, describes  narcolepsy as a lifelong condition.

‘We need further studies to see how it will progress and to see whether there are other cases out there,’ he says. 

Investigation: Checks are being carried out on whether the swine flu jab can cause sleep disorders in children (posed by model)

A Department of Health spokesman said: ‘Pandemrix was developed specifically for use in a flu pandemic when the number of lives lost could have been enormous. The decision to recommend that children got this vaccine was based on evidence available at the time. We keep all emerging evidence under review and that’s why the use of Pandemrix in those less than 20 years old was stopped in the UK in 2011.’

In the meantime, the children affected get through life with the help of a variety of medications â€" from stimulants such as Ritalin and Modafinil to see them get through their school days to Xyrem, a medicine that can regulate sleep.

But Xyrem can cost up to £13,000 a year and not all NHS Primary Care Trusts will pay for it.

There are the inevitable concerns over the long-term effects of taking powerful stimulants, but Lucio, Robyn and Josh are now, thankfully, coping at school wit h extra help, from one-on-one academic support to on-site sleeping facilities. The families are now considering bringing legal action against the Department of Health.

Lucio’s mother Karen says: ‘Our children may never be able to drive or hold down a job and, of course, forming relationships may be difficult if you pass out when you are excited or happy.

‘We’ve had to accept that the old Lucio is gone, and we’ve grieved for him. But the new Lucio is  fighting this the best he can and we love him just as much.’