A recent judgment in a vaccine compensation case in Europe has set alarm bells ringing globally. The case involved a French national, known as “J.W” in court documents, who had developed multiple sclerosis (MS) a year after he had been vaccinated against hepatitis B in 1998.
J.W had been vaccinated with the hepatitis B vaccine between the end of 1998 and mid-1999. According to the court documents, in August 1999, J.W developed symptoms of MS, an autoimmune disorder in which the body’s immune system attacks its own tissues. In 2006, he sued pharmaceutical company Sanofi Pasteur, which had made the vaccine, claiming that it had caused the illness. He died in 2011.
Given a lack of scientific consensus over the safety profile of the vaccine, the European Union (EU) court has allowed circumstantial evidence to determine the cause. The judgment has got the global public health community worried as it may set a precedent for similar cases.
Why vaccines are crucial
Vaccines are among the most effective public health interventions that save an estimated 2.5 million lives each year. However, they can have side effects, including serious ones, in a small proportion of people. Most of these are minor, from mild fever, headache or soreness which resolve quickly. The benefits far outweigh the risks.
The use of the hepatitis B vaccine for example, highlighted in the EU case, has led to a significant decrease in disease levels in many countries. Within 10 years of its introduction, the U.S. reported an 80% fall in the incidence of all acute hepatitis B infections; Taiwan recorded a 50% drop in liver cancers among children. Several studies have also investigated the link between the vaccine and multiple sclerosis. While some experts are sceptical, a majority believe the vaccine to be safe. The lack of consensus does not indicate a lack of safety. All reported side effects of vaccines need to be evaluated scientifically.
Besides, the onset of disease after vaccination is not sufficient to attribute the cause. Most countries have now established effective vaccine pharmacovigilance programmes. India’s adverse events following immunization (AEFI) surveillance programme, for example, has recorded a nearly 90% success rate in assessing AEFI cases using global protocols set by the World Health Organisation (WHO). It has helped India to win similar legal battles against pentavalent vaccine use in 2013, following AEFIs.
Rapid investigations were carried out and the vaccine got a clean chit from the country’s highest scientific body, the National Technical Advisory Group on Immunization (NTAGI), which was accepted by the Indian court. This helped the country to continue using the life-saving vaccine, protecting children against childhood killers such as bacterial meningitis and pneumonia.
For the larger good
Public health interventions must be guided by such scientific panels, weighing the pros and cons for the larger public good. Therefore, the EU court verdict is worrying. Although it may not be generalised, it may still sow the seeds of doubt about proven vaccines and potentially put millions of lives at risk. Hesitancy over vaccine use could cause a rise in vaccine-preventable diseases and lead to outbreaks of deadly infections such as diphtheria and whooping cough. Measles outbreaks have been reported recently in Europe and previously in the U.K. following rumours of a vaccine-autism link. The need of the hour is to ensure effective surveillance, compensation for those affected and to promote public confidence in vaccines, without which we would be foregoing the most remarkable health advances so far.