Swine Flu Vaccination: Compensation

Jim Shannon Excerpts

Tuesday 12th January 2016 Westminster Hall

[Stephen Twigg (Liverpool, West Derby) (Lab/Co-op)]

I beg to move,

That this House has considered the compensation for people with narcolepsy and cataplexy linked to swine flu vaccination.

It is a pleasure to serve under your chairmanship, Mr Chope. I thank Mr Speaker for allowing this debate on an important issue, and I thank the Minister for being here to respond to the concerns that I will raise on behalf of my constituent, Lucas Carleton.

I begin by saying something about vaccinations in the broad sense. We are fortunate in this country to have a robust and comprehensive vaccination policy. The policy has saved countless lives since its incarnation almost 100 years ago. Through our vaccination programmes, and those of other nations, we have successfully eradicated diseases such as smallpox across the world, and have reduced the number of people affected by polio by something like 98% over the past three decades. To this day, the advice from mainstream medical professionals and the national health service is that everyone should be vaccinated, not only to protect themselves but for the wider benefit of the communities in which we all live.

Historically, we have seen the tragic consequences of terrible epidemics that vaccinations can protect us against. For example, during the ’20s and ’30s, Spanish flu killed more people than the first world war had. Vaccinations, which are often brushed off in our everyday lives as a painful exercise, save thousands of lives a year, reducing human suffering and misery on a huge scale.

There is no serious scientific debate among mainstream scientists about the benefits of vaccination to public health—medical advice is clear that vaccination is one of the most successful and cost-effective public health measures—but vaccination is not without controversy. There have been a small number of instances when vaccinations have been responsible for adverse reactions, causing sometimes long-term and sometimes irreversible problems. I stress that that is rare, but tragically it is the reason we are here today.

During 2008 and 2009 there was a global swine flu pandemic, also known as the H1N1 pandemic. The particular strain of flu originated in Mexico, but it quickly spread, leading to the World Health Organisation issuing its first ever “public health emergency of international concern” declaration. Cases were confirmed in 171 countries and more than half a million people are thought to have died as a consequence.

During the outbreak, the British Government decided to purchase enough swine flu vaccine to immunise the entire population with two doses, meaning that 120 million doses were ordered. Almost 99% of the vaccines that were given out were Pandemrix, manufactured by GlaxoSmithKline—GSK.

Vaccines, as with all pharmaceutical products, are subject to extensive clinical trials. However, it is recognised that during a pandemic the trials may not be as rigorous as they would otherwise be, because of the demand to safeguard lives. Completing mass trials can takes months or even years. For that reason, the European Union intervened and licensed Pandemrix for use within the EU, including the UK, without the completion of the normal rigorous trials. That was followed by advice from the UK’s Joint Council for Vaccination and Immunisation, which advised that the Government begin immunisation to protect against a swine flu pandemic in this country.

As a consequence of the speeding up of the licensing process by both the EU and national Governments, GSK was not prepared to supply the vaccine to Governments unless it was given indemnity from any liability. The UK Government gave GSK that indemnity. For a number of reasons, other countries were much more cautious about granting an early licence. For example, the Food and Drug Administration in the United States had a policy of not licensing adjuvant vaccines—that is where a substance is added to vaccines to increase the body’s immune response—without robust clinical trials demonstrating that they are safe. Adjuvant vaccines have additional chemicals that speed up the body’s immune reaction to the antigen, and it is considered that that sometimes increases the risk of adverse reactions. That possibility led other countries, such as Switzerland, to license Pandemrix only for adults and not for children.

Pandemic swine flu vaccinations were added to the Vaccine Damage Payment Act 1979 by the Vaccine Damage Payments (Specified Diseases) Order 2009 in September 2009. The vaccine was added to the Act for the duration of the pandemic campaign, which lasted from October 2009 to August 2010. The campaign ended when the Swedish and Finnish Governments expressed concerns about a vast increase in the number of paediatric narcolepsy cases in children under 10. The condition usually shows symptoms in those in the 15 to 30 age bracket. It was not until August 2010 that the Swedish and Finnish Governments discovered a link with Pandemrix. On 1 September 2010, Finland stopped vaccinating with Pandemrix. The UK Government discontinued the pandemic campaign from the same date, but encouraged GPs to continue vaccinating with Pandemrix where no seasonal flu vaccine was available.

[Jim Shannon (Strangford) (DUP)]

Figures indicate that one in 2,000 people have narcolepsy that is not related to vaccination. When it comes to compensation, how would the hon. Gentleman ensure that those who are vaccinated and are due compensation actually get it?

[Stephen Twigg]

The hon. Gentleman’s intervention is timely, because he raises the issue to which I now turn. Lucas Carleton is a young boy who lives in my constituency in Liverpool. On 17 January 2011, he was vaccinated with Pandemrix. He was seven years old at the time and was in good health. His mother, Pauline, asked her GP to vaccinate Lucas because a family friend had recently been very ill with swine flu and, perfectly understandably, she believed it was a responsible step to get her son vaccinated. A week or two after Lucas received the vaccination, he began to experience excessive daytime sleepiness, which is a common characteristic of narcolepsy. He also started falling when he laughed or got excited, made strange facial expressions and experienced a loss of control of his tongue. That is known as cataplexy and is a common symptom of narcolepsy. After two to three weeks, Pauline sought medical help from a GP and Lucas was taken to hospital on a number of occasions. In August 2011, he was diagnosed with narcolepsy.

Narcolepsy is an incurable neurological disorder that until 1999 was classified as a psychiatric condition. Its main symptoms involve excessive daytime sleeping, hallucinations, sleep paralysis, temperature control problems and cataplexy. Cataplexy is a side symptom of narcolepsy that causes involuntary muscle relaxation brought on, for example, by laughing or anger. Narcolepsy begins in the hypothalamus, the part of our brain that controls our autonomic nervous system, which involves processes such as breathing and the regulation of the heart. Narcolepsy occurs when the brain cells that produce neurotoxins in the hypothalamus are destroyed, either through a trauma or through the body’s immune system mistaking those cells as foreign bodies.

The Department for Work and Pensions has accepted that the Pandemrix vaccine is capable of causing narcolepsy in children. It has also accepted that, in many cases, Pandemrix did in fact cause narcolepsy in children. However, it disputes that narcolepsy amounts to a severe disability. That is an issue on which the DWP has been defeated in court, but I understand that it is appealing against the decision. Herein lies the issue: the 1979 Act recognises that there can be adverse reactions to vaccines that can cause severe and irreversible damage to patients. Since the Act was passed, around 900 people have been awarded compensation, which is a very small number when compared with the 650,000 children vaccinated every year. Compensation can range from £120,000 into the millions.

The pandemic swine flu vaccine was part of the 1979 Act from September 2009 until it was removed by the Vaccine Damage Payments (Specified Disease) (Revocation and Savings) Order 2010. That is preventing Lucas from claiming compensation, as he had the vaccine administered outside that period, in January 2011. If the pandemic swine flu compensation period was simply extended to April 2011, Lucas and others who had adverse reactions could claim compensation for the reaction to the vaccine.