In a landmark judgment yesterday, the Court of Justice of the European Union ruled that courts could consider vaccines to be the reason for an illness despite the absence of any concrete evidence to support the connection.
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Vaccines are agents that have been used for nearly a century to prevent several infections. They have protected millions of children and adults from life threatening infections such as small pox, diphtheria, tetanus, whooping cough, measles, polio etc. These agents are used in an otherwise healthy individuals or children as a protective measure. Any untoward reaction or a side effect to a vaccine therefore is seldom tolerated and immediately leads to concern. Not choosing to vaccinate a child for fear of side effects has put many children in danger of these preventable infections.
Yesterday EU's highest court ruled that if a person receiving the vaccine was well before or did not have a personal or family history of the disease and if significant number of similar cases of the disease is reported among people receiving a certain vaccine, the vaccine may be considered as a culprit.
This landmark judgment comes in the wake of a case of a French man known as J.W. He was vaccinated against hepatitis B in 1998. He went on to develop multiple sclerosis a year later. Multiple sclerosis is a severely damaging ailment in which the body’s own defense mechanism or immune system turns back at the nerve cells of the brain and spinal cord and begins to damage them. It leads to severe disabilities and finally death. J.W. succumbed to multiple sclerosis in 2011.
Before his death, J.W. sued the pharmaceutical company Sanofi Pasteur that produced the vaccine. He blamed the vaccine for his failing health. The case came up to the Court of Appeal in France. This court did not find any scientific agreement and evidence that linked hepatitis B vaccine and multiple sclerosis development. Thus the action was dismissed. The judgment was appealed and was taken to the French Court of Cessation. From there the case reached the European Court of Justice.
According to the European Court of Justice, despite the lack of scientific evidence, there is evidence regarding the timelines of the event occurrence. The court ruled that there may be four points to consider;
- Timelines of the disease occurrence (i.e. disease occurs after the vaccination).
- History of good health or lack of this disease prior to the vaccination.
- No family history, i.e. no one in the blood relation of the patient suffered from this ailment.
- Multiple similar cases as a result of the vaccine.
In J.W.’s case, the first three criteria were fulfilled leading to this ruling.
A representative from Sanofi Pasteur said in a statement that they do not wish to comment against the legal decision but “reiterate” that their vaccines are “safe and effective and protect against infectious diseases”. Their hepatitis B vaccine has been approved and used for over three decades they said and has been deemed safe and effective. The EU court has authorized national courts now to make similar judgments regarding causality association between a vaccine and an ailment.
Professor Tony Fox from the pharmaceutical medicine group at King's College London said that this precludes expert opinion on such cases. Experts believe that there is no connection between the vaccine and the disease and this ruling could be potentially harmful for development of new vaccines and drugs.
Experts in the field believe that this could be confusing to the public and threaten the mass use of vaccines leading to an upsurge of vaccine-preventable ailments.
One expert questioned why there were so many patients of multiple sclerosis who have never been vaccinated? The only clause among the four that is acceptable, is the presence of similar cases that could implicate the vaccine, explain the stalwarts of the field.
Experts and physicians have reiterated that vaccines save lives and those that refuse to vaccinate their children are putting them at risk. To prove or disprove if a vaccine could be blamed was a scientific question and not a legal one they say.