The EU Commissioner for Health and Food Safety has told i how Europe is preparing for another swine flu pandemic he hopes will avoid the previous “terrible outcome” where narcolepsy was triggered in around 100 British children following their vaccination against the disease.
Vytenis Andriukaitis, a heart surgeon, said the European Union, in conjunction with the World Health Organisation (WHO) and other agencies, is drawing up new plans following “lessons learned” on how the 2009/10 swine flu outbreak was handled.
A main goal is to “increase flexibility” by addressing the response needed for pandemics of differing severity, from unknown to mild, moderate or severe.
“More research will be conducted together with other independent and EU-funded research to shed light on the causes of narcolepsy, such as how the vaccine might be able to trigger or unmask the condition.”
Vytenis Andriukaitis, EU Commissioner for Health and Food Safety
Following the last outbreak, there were huge delays in delivering the pandemic vaccine, Pandemrix, to certain countries. Communicating the risk versus benefits of the vaccine was considered extremely difficult and some nations reported a loss of public confidence in vaccination, in general, the EU found.
It has promised to increase transparency of the decision-making process, especially in relation to vaccine procurement. Although millions of people received the swine flu vaccine Pandemrix in 2009 without complications, it was subsequently shown to have devastating side effects in a number of people, especially children.
Around 1,700 adults and children across Europe are now registered in the EU database of adverse drug reactions as suffering from the lifelong neurological condition narcolepsy following their vaccination.
Mr Andriukaitis said he was upset about hearing from some of the children and their families at a recent meeting in Brussels where they called on him to launch a pan-EU wide inquiry into the cases that were triggered by use of the Pandemrix vaccine to treat the 2009/10 swine flu outbreak.
Almost 1,700 adults and children in total across Europe are registered in the EU database of adverse drug reactions who now suffer from the lifelong neurological condition as a result.
Earlier this month, the government lost a five-year legal battle at the Court of Appeal over vaccine injury payments.
The judgment was handed down following the battle between the Department for Work and Pensions (DWP) and the family of an anonymous child known as ‘John’, following his diagnosis of the incurable neurological condition and an application in 2012 to the government’s compensation scheme under the Vaccine Damage Payment Act.
The DWP had appealed against an order ordering it to pay John, now 14, £120,000 compensation. Many other families, whose cases had been put on hold pending the outcome, should now receive the same compensation.
“I was very sorry and sad to hear again of the terrifying experience of the children and their families – and I expressed my personal words of sympathy to them [in Brussels],” Mr Andriukaitis told i.
“In the Commission, we are funding research into the sleep disorders, including narcolepsy, with nearly EUR 30 million allocated through the Seventh Framework and Horizon 2020 research programmes.”
Mr Andriukaitis said epidemiological studies relating to Pandemrix vaccination in several European countries had indicated an increased risk of narcolepsy in vaccinated – as compared with unvaccinated – individuals.
“Patient safety is paramount to me – I am a medical doctor. It is also the absolute priority of the Commission.”
The commissioner said the marketing authorisation holder, responsible for reviewing and assessing data to support a medicinal product, has committed to continue to collect and submit any new data related to narcolepsy to the European Medicines Agency (EMA), including after the expiry of Pandemrix authorisation in 2015.
“Patient safety is paramount to me – I am a medical doctor,” Mr Andriukaitis said. “It is also the absolute priority of the Commission. And I would like to reassure you that a medicine, including a vaccine, can only be placed on the EU market after an authorisation has been granted based on a positive assessment of the benefit-risk balance related to its use.
“But this is not enough. This is why, after the initial authorisation, the safety of a product is followed during its whole life-cycle. The Commission and the Member States work together in the Health Security Committee to strengthen pandemic influenza preparedness and crisis management in the EU by updating national pandemic influenza preparedness plans. To this end, work on a guide for influenza pandemic plan will be finalised in the committee soon.”
Further research needed
Mr Andriukaitis said GSK, the makers of Pandemrix, has carried out further research into the link between its drug and narcolepsy.
“More will be conducted together with other independent and EU-funded research to shed light on the causes of narcolepsy, such as how the vaccine might be able to trigger or unmask the condition. All data will be reviewed by EMA’s Committee for Medicinal Products for Human Use as soon as they become available.
“As European decision-makers, our constant objective is to prevent such terrible situations from occurring again.”
Claire Crisp, whose daughter Mathilda needs round the clock care after she developed narcolepsy following her Pandemrix vaccination, said she could only take comfort in another swine flu vaccination program if various measures were guaranteed.
They include “complete transparency” on behalf of the manufacturers GSK and the EU with respect to the content of the vaccine and potential side effects with the information available to every consenting patient.
“I am not anti-vaccine. I am pro-health, pro-science and pro-choice when it comes to vaccinations,” she said.
“Parents should have access to information pertaining to the content of vaccines and whether or not clinical trials were completed. The lack of transparency and honesty on behalf of GSK and the British government harmed hundreds of children who have been devastated by an incurable neurological disorder that requires round the clock treatment. This must never happen again.”
What is swine flu?
Swine flu is an infection caused by any one of several types of swine influenza viruses, the best known arguably the H1N1 virus. It is a respiratory disease caused by influenza viruses that infect the respiratory tract of pigs and result in a barking cough, decreased appetite, nasal secretions, and listless behavior.
The virus can be transmitted to humans.
Swine flu was initially seen in humans in Mexico in 2009. The virus appeared to be a new strain of H1N1 which resulted when a previous triple reassortment of bird, swine and human flu viruses further combined with a Eurasian pig flu virus, leading to the term “swine flu”.
Unlike most strains of influenza, H1N1 does not disproportionately infect adults older than 60. This was an unusual and characteristic feature of the H1N1 pandemic. Even in the case of previously very healthy people, a small percentage will develop pneumonia or acute respiratory distress syndrome (ARDS).