To vaccinate or not?

Vaccines must be introduced only after large scale trials

Vaccination is not just about individual health but also critical to family and public health. Vaccines prevent the spread of contagious, dangerous as well as deadly diseases. However, there has been a perpetual debate on it, with the ones against vaccination citing issues such as side effects and conflict of interest. Anti-vaxxers worldwide have seen a resurgence in the past few years. Their impact is visible across the globe. In parts of Europe and North America, for example, ailments such as mumps, pertussis, and measles have increased.

According to the WHO, not using the MMR vaccine has significantly increased the number of measles cases worldwide in 2017. An estimated 110,000 deaths – of which, most fatalities recorded were children under the age of five years. In medical literature, we have seen major reductions in cases such as measles, TB, polio etc. We observe this not only in India but in many other countries due to strict vaccination schedules in childhood. The Government of India and the Indian Academy of Paediatrics  (IAP) recommend some vaccinations that are compulsory for every child, namely — BCG – Tuberculosis; DTaP/DTwP – Diphtheria, Tetanus, Pertussis (whooping cough); Hepatitis A Vaccine – Hepatitis A; Hepatitis B vaccine – Hepatitis B; MMR – Measles, Mumps, Rubella; OPV (Oral Polio) and IPV (Injectable Polio Vaccine) – polio; Rotavirus vaccine – Rotavirus; Typhoid vaccine – Typhoid.

One other vaccine which demands to be made compulsory is the HPV vaccine. This immunises us against the human papilloma virus (HPV). A research paper published by Cochrane Library in May 2018, highlighted that the vaccines reduced risk of cervical pre-cancer associated with HPV 16/18 (high risk) from 164 to 2/10,000 women. In women aged 15 to 26 years, vaccines reduced the risk of cervical pre-cancer associated with HPV16/18 from 341 to 157 per 10,000. The HPV vaccination also reduced the risk for any pre-cancer lesions from 559 to 391 per 10,000.

There is a strong evidence that HPV vaccines protect against cervical pre-cancer in adolescent girls and young women aged 15 to 26. Recently, the FDA has recommended expanding the age group for vaccination up to 45, for both women and men. Vaccines must be introduced only after large scale trials. Multiple trials have been carried out for HPV vaccination.

There have been some sparse reports of adverse effects of the vaccine, however, nothing conclusive has been found. The most common adverse effects were localised pain at the site of injection, some swelling, and fever, but these were temporary, and till date, no serious vaccine-related adverse effects have been reported.

Medical professionals can explain the pros and cons of vaccinations to patients so that they are better equipped to make a decision on whether to vaccinate or not. Occasional cases of side effects which are reported should not form the sole basis of the decision. We must be able to distinguish between these and the benefits of important vaccinations to society as a whole.

Withholding vaccines place children at risk from infection

Multiple studies have failed to demonstrate any association between measles, mumps, and rubella or MMR vaccination and autism or other chronic diseases. However, there is an association between congenital rubella syndrome and autism, highlighting a potential role for MMR immunisation in the prevention of autism spectrum disorders [J Pediatr 1978; 93:699.].

The prevalence of autism has increased over the last two decades. The real or perceived increase in autism cases has occurred at a time when the number of recommended childhood vaccines also have increased. Parents of children with autism have identified a temporal association between immunisations and the onset of more evident symptoms of autism in the second year of life, leading to speculation that certain vaccines constituents may play a role in the development of autism. But multiple large, well-designed epidemiologic studies and systematic reviews do not support an association between the measles, mumps, and rubella vaccine and autism.

On the other hand, the administration of childhood vaccines has led to a decline in the incidence of childhood diseases that can have severe sequelae. Withholding vaccines from a child because of a hypothetical risk places the child at risk for real infection that may have real sequelae. The benefits of vaccines are clear. Several infectious diseases that were once associated with significant morbidity and mortality have been almost eliminated through the development, distribution, and almost universal administration of protective vaccines. With the declining incidence of once-common vaccine-preventable diseases, parents of young children may not appreciate the potential severity or dire consequences of the illnesses. Parents who lack such appreciation may be willing to forego immunisations for their children, particularly if unproven risks are highly publicised.

When this occurs, immunisation rates decline, and outbreaks of infectious diseases, such as measles and pertussis, may occur with significant morbidity and mortality. Although the overall prevalence of complete vaccine refusal is <2 per cent substantial numbers of parents refuse one or more vaccines or request that vaccines be administered on an alternative schedule. Concern about vaccine safety is the most common reason for vaccine refusal. Other parental concerns may focus on the belief that vaccines are not necessary or freedom of choice. Remember vaccine refusal may result in vaccine-preventable disease in the individual and/or outbreaks of vaccine-preventable disease in unvaccinated and vaccinated individuals.

Vaccines save lives during a child’s vulnerable years

Preventing a disease from ever occuring is always better than having the risk of getting a disease. Vaccines and proper hygiene are the two most effective ways to prevent infectious diseases. In today’s world, infectious diseases are still rampant, and in many parts of the world, due to overcrowding, lack of good sanitation facilities and lack of access to effective treatments, vaccines are not only critical but the only way to ensure that children are protected during the vulnerable years of their lives.

Fighting an unseen enemy

To be effective in vaccines, people need to understand how they work. Vaccines prevent
diseases by ensuring that the body’s natural defenses are ready to attack germs (such as bacteria and viruses) when a person is exposed to a disease. When bacteria or viruses invade a child’s body, the natural defences attack these germs and stops the disease from even occuring.

Many of these diseases are so rare today (due to vaccine efforts) that it is difficult to understand what we have been fighting against. Due to vaccines, we no longer see smallpox (eradicated in 1980) and polio has been almost eliminated (with only a handful of cases in a few countries). We would remember this disease if we encountered someone who was affected by it. Both are debilitating diseases, causing terrible deformaties and deaths. Smallpox kills a third of its victims and leaves any survivors scarred for life or blind. Polio could paralyse 1000 children a day at its peak.

To prevent infections, parents must bring their children for getting vaccines and believing in good health as a right for every child. Vaccines are often free, in India, for example, the country now has 13 vaccines that are a part of India’s Universal Immunisation Programme (UIP), provided to 27 million children annually at no cost in the public sector. These cover several diseases.

Lives saved over the years

Vaccines have been controversial, due to flawed information and studies. Vaccines are safe and effective and all vaccines first have to undergo careful review by scientists, doctors and governments to make sure of its safety. Vaccines do not cause autism or other diseases. There are little to no side effects of the main childhood vaccines that have been prioritised by the World Health Organisation.

Without vaccines, the World Health Organisation estimates that there would have been 5 million more deaths each year. The very vaccine under the biggest controversy, the measles vaccine has between 2000 and 2016 alone, saved 20.4 million lives. If there was no vaccination effort, the death toll would have been over 1.5 million children due to measles!

Between 2000 and 2015, vaccines for pneumococcal disease and haemophilus influenzae type b have saved the lives of 1.4 million children under the age of five years of age, the most vulnerable years. These diseases cause meningitis, pneumonia, sepsis and other serious health complications and are the biggest causes of child deaths in developing countries.

We should also not underestimate the burden that infectious disease also has on the well-
being of families. The costs associated with seeking treatment for these infectious diseases often drive people into poverty, and parents and caregivers lose wages when they are unable to work and have to care for children affected by these diseases.

I believe in the power of vaccines, and hope that more people will join in fighting the unseen enemy by promoting vaccine access worldwide. If you want to do everything possible to make sure children are healthy and protected from preventable diseases, vaccination is the best way to do that!

Benefits of vaccines highly outweigh their risks

GlobalData’s primary and secondary research into vaccine hesitancy suggests that it is caused primarily by the availability of misinformation propagated through the internet, as well as via non-scientific press articles and other media outlets. In the case of MMR specifically, the link between MMR vaccines and development disorders such as Autism Spectrum Disorder (ASD) stems from now retracted fraudulent research by Andrew Wakefield and colleagues, originally published in The Lancet. Their study only had a small cohort of participants but was still published and heavily cited before its retraction, which generated public mistrust in MMR vaccines. As part of their retraction, it was stated that the data did not show a causal link between MMR vaccines and ASD. Excluding this study, the vast majority of vaccine R&D has shown that in most situations the benefits of vaccines highly outweigh their risks, both for individuals and for public health.

MMR vaccines are live-attenuated vaccines, which often carry increased risks compared to other types of vaccines since they contain pathogens capable of replicating, but these risks are not significant compared to the protection they provide for the majority of patients; however, patients with compromised immune systems are unable to receive these vaccines. Other risks associated with vaccines generally include localised inflammation at the injection site and other systemic effects, usually mild fever, drowsiness, or vomiting. These small risks are significantly outweighed by the protection offered to the individual and communities if enough of the population are immunised to allow herd immunity to prevent disease outbreaks. Big Pharma have spent millions of dollars on combating the stigma that was generated surrounding links between vaccines and developmental disorders. Over the last decade, immunisation rates, particularly for MMR vaccines, have improved, however, in the last couple of years major outbreaks of measles have struck developed countries due to inadequate MMR immunisation coverage amongst their populations.

Merck, Sanofi, and GSK are the major players in childhood immunisations across the globe marketing DTaP, MMR, rotavirus, and influenza vaccines in many different markets. These three companies currently dominate the pediatric vaccines market, and therefore increasing immunisation rates by working with national and international initiatives and investing in future R&D efforts is essential to their short- and long-term revenue streams.

Although improvement is still possible, due to the efficacy and safety provided by the currently available range of vaccines, R&D into childhood vaccines in North America and Europe is fairly subdued. There is currently significantly more clinical development activity from native biotechnology and pharmaceutical companies in markets such as India, where Big Pharma does not dominate the vaccines market. Therefore, opportunity for newcomers to the childhood vaccines space should aim to target emerging markets across APAC, Asia, South America, and Africa in order to receive adequate return from the expensive process of developing vaccines.

No myths please: In science we trust

“Vaccines are the tugboats of preventive health”, said William Herbert Foege, American epidemiologist credited with devising the strategy that helped eliminate small pox. Immunisation is a proven tool for controlling and even eradicating disease, and undoubtedly, childhood vaccines are one of the great triumphs of modern medicine. It has substantially reduced morbidity and mortality from infectious diseases in much of the developed world.
A successful immunisation programme is of relevance to India as it contributes to one fifth of global under five mortality with a significant number of deaths attributable to vaccine preventable diseases. There is no doubt that substantial progress has been achieved in India with wider use of vaccines, resulting in prevention of several diseases. However, a lot remains to be done.

Now, India has resolved to eliminate measles and control congenital rubella syndrome (CRS) by 2020. The Ministry of Health and Family Welfare has initiated measles-rubella (MR) vaccination in the age group of nine months to less than 15 years in a phased manner across the nation. The campaign aims to cover approximately 41 crore children. The aim is to rapidly build up immunity for both measles and rubella diseases in the community to knock out the disease. Fortunately, we have effective and affordable vaccines to take on all the three diseases-measles, mumps and rubella.

According to IAP Guidebook on Immunisations 2013-14, while single dose of rubella/ rubella containing vaccines is enough to provide almost 100 per cent protection against the disease, two or more doses of measles and mumps vaccines are needed to accord adequate protection. For purposes of universal immunisation, the vaccine should be introduced in areas where immunisation coverage is at least 80 per cent and can be sustained on a long-term basis.
The Guidebook also states that the MMR vaccine should be given early to have much higher coverage than introducing it late at the time of second booster of DTP. According to available evidence, both these vaccines (MR/MMR) can be given safely at different ages including at 9 months of age. It is critical to achieve minimum 80 per cent coverage of childhood vaccination which will not allow virus to circulate freely and infect women of child bearing age, thus avoiding any inadvertent epidemiological shift.

However, scepticism towards immunisation still prevails. Globally too, the opposition to vaccines has remained a concern. Public opinions about vaccination include varied and deep-seated beliefs, a result of the tension between divergent cultural viewpoints and value systems. While some of these have been triggered by philosophical and personal beliefs, most of them are due to unfounded understanding of science and modern medicine. World over there are a few voices that question the safety of the vaccines. Especially for vaccines for children, is it ethical to let these voices determine the choice one makes as parents for their children? Are these voices emerging from science and rationality? Or are they misinterpretations, myths or lack of awareness?

While, the future of immunisation depends on the success of medical research for vaccines that are simpler to administer and will provide a more substantial and long-lasting immune response, the need for continued communication and collaboration between medical and public health officials and the public regarding acceptable and effective immunisation continue to remain critical. Candidly, all vaccines do have inherent risk of adverse events following immunisation (AEFI), but the benefits are undoubtedly immense, and clearly outweigh the risks. As the world progresses, science-based evidence will deliver the proof points as vaccines continue to play an important role in improving public health.

If not for vaccines, millions would not have been alive today

The current controversies on the side effects of vaccines have again raised doubts in the minds of common masses about how efficacious are these vaccines and are they worth the side effects? But my counter point is if not for the vaccines, millions of us would not have been alive today and millions would have been left crippled for their life time.

Can we accept such a future where men, women and children are suffering and dying from a disease which could have been easily prevented? Pause for a moment to think and answer the question. Perfect example being small pox; in the 20th century itself it killed about 300 million people. Thanks to Dr Edward Jenner who developed the vaccine for it, there has not been a single case of this disease since 1980 when WHO declared it to be globally eradicated. An Indian example would be polio. Thanks to oral and injectable polio vaccines we have eradicated polio from India and from many other countries and now are on the verge of global eradication. Usually, before the vaccines are launched for use in general public they are extensively tested in animals, if found safe then they are tested in human volunteers and then if totally safe they are made commercially available for general population, hence whatever adverse reactions we see, are most of the times mild reactions like redness, pain at injection site etc.

Millions of vaccinations are given to children and adults each year. Serious adverse reactions are rare. However, because of the high volume of use, coincidental adverse events including deaths, that are temporally associated with vaccination, do occur. When death occurs shortly following vaccination, loved ones and others might naturally question whether it was related to vaccination. But, a large body of evidence supports the safety of vaccines and multiple studies and scientific reviews have found no association between vaccination and deaths except in rare cases. Usually vaccine-related anaphylaxis (an allergic reaction to vaccine) leading to death have been reported 1-2 per two million doses of injectable vaccines, which is also preventable by immediate administration of medicines, which are kept available during mass vaccination campaigns.

So, I urge everybody to go ahead with vaccination. As our technology advances we will discover new diseases and invent new vaccines to prevent them. This advancement in technology will also make vaccines safer by the day. The bottomline is accidents do kill but we do not stop manufacturing or using automobiles, we make them safer, so think of it in this perspective. Let’s prevent each and every death or diability which happens from a disease which is easily preventable by vaccines.

(Compiled by Prabhat Prakash)