Controversies surround the pentavalent (‘five-in-one’) vaccine which is being given to children in India as part of routine immunisation since 2011
Sreelatha Menon | April 23, 2016
Every few days one more child dies after receiving the pentavalent vaccine… Yet as these deaths mount, it has been announced that pentavalent vaccine is to be introduced in 3 more states…
“These deaths have become so frequent that in Tamil Nadu, in spite of official denials, people have stopped going for vaccination and the immunization uptake has fallen by 25% in the last 4 years.”
This is an excerpt from a 2014 letter to the PMO written by 10 health experts – Dr Amitav Banerjee, Dr Arun Gupta, Dr BM Hegde, Dr JP Dadhich, Dr Jacob Puliyel, Dr KP Kushwaha, Dr Ritu Priya, Dr SK Mittal, Dr S Srinivasan and Dr Vikas Bajpai.
They seek revision of a decision taken in 2011. The pentavalent vaccine, which claims to save children from five killer diseases – diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type B (Hib) – was introduced in the universal immunisation programme (UIP) in 2011.
The letter further says that a study on Hepatitis B vaccine (now included in the pentavalent vaccine) shows that the vaccine does not protect babies from infection.
“The study conducted by the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, and the National Institute of Nutrition, Hyderabad and two editorials in the journal (Indian Paediatrics) raised several questions regarding the universal immunization programme (UIP) itself. Dr T Jacob John in his editorial noted that the frequency of chronic infection was similar in both the unvaccinated and the vaccinated – about 0.15%. The Hepatitis B vaccine was thus completely useless in this population. Professor Jacob John further observed that the immunological and epidemiological outcomes of rolling out Hib are not being monitored as UIP has no capacity for that function,” reads the letter.
“In short, expensive vaccines that have little utility are being rolled out without monitoring benefits or harms and which are causing deaths and serious adverse effects. As a result, inspite of official attempts at denial, the public are losing trust in the entire immunization programme,” the letter concludes.
While these health experts are ranged against pentavalent vaccine, leading health expert Dr T Jacob John is all for it.
Health experts are also questioning the independence and transparency of the National Technical Advisory Group on Immunisation in India (NTAGI), the machinery within the health ministry that gives the green signal for these vaccines under the UIP.
Dr Jacob Puliyel, head of the paediatric wing of the St Stephen’s Hospital in Delhi and one of the members of NTAGI, in March raised the issue of conflict of interest in the case of Bill & Melinda Gates Foundation (BMGF), which has been partially funding the country’s immunisation programme. He said that the secretariat of the NTAGI was functioning from the office of a BMGF-funded NGO rather than from the health ministry as if the government could not pay their salaries (See box on next page).
Going back to the issue of safety of the pentavalent vaccine, controversy surrounds two vaccines among the set of five, which are being given to children in a single shot. The two vaccines are meant to protect children from Hepatitis B and Hib (a bacterial infection that leads to meningitis, pneumonia and arthritis). The inclusion of Hepatitis B vaccine has been contested by many, the most recently and persistently by Dr Puliyel.
Doctors say that Hepatitis B is usually a very mild viral infection that goes undetected by majority of those who contract it. However, some who acquire the infection around the time of birth develop chronic liver disease and a fatal form of liver cancer. The incidence rate as found by the Indian Council of Medical Research (ICMR) is very low, says Dr Puliyel.
In 2014, ICMR conducted a study in Andhra Pradesh, 10 years after the vaccine was introduced, to look for benefits. The data showed that the incidence was the same in children who received the vaccine and those who didn’t. However, the vaccine is still part of the routine immunisation programme.
The second vaccine being objected to is the Hib. An editorial in the bulletin of the World Health Organisation (WHO) suggested that this vaccine was not needed in Asia. Studies in Bangladesh revealed that the vaccine was not useful in reducing meningitis or pneumonia. However, the WHO recommended that it should be included in the routine immunisation programme. And in 2011 it was included in India’s immunisation programme.
While the group of critics against the pentavalent vaccine is sizeable and armed with some evidence, scientists like Dr T Jacob John feel that they may not be getting the whole picture. The veteran virologist and vaccine expert from the Christian Medical College, Vellore, says: “In our immunisation clinic we have given 1,46,000 doses of penta with whole cell pertussis and 19,000 with acellular pertussis component. No anaphylaxis, no serious AEFI (adverse event following immunisation) and no death.
“Pentavalent vaccine is used almost universally now – there is no death related to it anywhere, to the best of my knowledge,” he adds.
In India, a study was done by IBIS first with some major hospitals to test the incidence of Hib and the efficacy of the vaccine. It failed to show much evidence and said that people probably died before they reached hospital, says Dr Puliyel. So they did a community-based study in Vellore in Andhra Pradesh for five years in a population of five lakh people. They found an incidence rate of seven per 1,00,000 children under the age five. This amounts to 175 deaths per year in 25 million children across the country, says Dr Puliyel. Hence, this study never came out for 10 years as it was too small a number, he adds.
Later the authors of the study dismissed their work as hospital-based once again and unreliable. So they went for a probe study. They gave vaccines to one group and did not give it to another group and compared the incidence of Hib meningitis and pneumonia in Indonesia. The vaccinated kids reported more pneumonia cases, says Dr Puliyel. The same study was repeated in Bangladesh with similar results.
It merely meant that vaccine or not, pneumonia could come of any reason other than Hib, he says.
So far the only question raised against Hib vaccine was its relevance. But the moment it was added along with the hepatitis B vaccine to the existing three vaccines against diphtheria, whooping cough and tetanus (DPT vaccine) being given to children as a five-in-one cocktail, alarm bells rang in the health circles.
Now the issue was not just of relevance but of risk to children in being given a mixture of five vaccines in a single shot or the pentavalent vaccine. Three deaths were reported in Sri Lanka when the pentavalent vaccine was introduced there. Here, the deaths were probably caused by the vaccine as no other reasons were found, said critics like Dr Puliyel. Experts seemed to have flouted the standard norms of classification of adverse events following vaccinations. This was exposed in a paper published by the critics group in the British Medical Journal.
Hence, when it was introduced in India in 2011 it was restricted only to one state, Kerala. In the first year, at least 12 deaths were reported in vaccinated children, beginning with a death of a healthy child on the first day itself.
But the government went ahead and introduced pentavalent in other states before 2012 was over, despite the agreement with NTAGI to evaluate the vaccine before administering it across the country. An NTAGI sub-committee was set up to evaluate all the deaths after pentavalent was introduced in UIP. This committee met only once, for a preliminary meeting on April 22, 2013, and in spite of repeated requests it never met again.
Dr Puliyel and the group of health activists who have been speaking against the pentavalent vaccine cite a study done by the German government, called the TOKEN study, which they say has shown that the hexavalent vaccine (a six-in-one vaccine) results in sudden unexplained deaths of children within 48 hours of vaccination. But the study also says that deaths could be explained by other reasons like maternal smoking or over-heating of the environment. It said there was no increased risk of sudden death within one week after hexavalent vaccination.
Dismissing the arguments against the pentavalent, Dr Jacob John says, “The background is well argued, but the allegation that pentavalent vaccine cause deaths, and that Hib and HB vaccine are not needed in India is a jump with no logic or shred of evidence.
“The fundamental question is: why do we vaccinate against low incidence high impact disease such as Hib? Why do we vaccinate against HB infection without targeting a specific disease? Why do we combine five vaccines and give in one product? These are the elements of public health approach to health,” he adds.
“Just because international agencies are involved, it does not mean vested interests, but we have to guard against vested interests pushed by international agencies. For that we should value human lives and practice scientific medicine and public health surveillance. These will cost money – at least 5% of GDP,” says Dr John.
Dr Puliyel and a group of critics wrote a letter to the PM in 2014 hoping that the new government would make amends for the follies of the previous one. They warned that the controversies over the vaccines were making people lose faith in vaccination. They also cited falling immunisation rates in Tamil Nadu between 2008 and 2012 as per the National Family Health Survey (NFHS). Tamil Nadu, which had 85 percent immunisation a few years ago, reported 56 percent immunisation in 2012, as per NFHS.
While this could be a possible reason, the question arises that pentavalent was just a year old in 2012 and it could not have scared people in Tamil Nadu where it was introduced much later.
The other reason suggested for the drop in the immunisation rate was the over-emphasis on oral polio drops, which may have confused the parents.
Here, Dr Jacob John points out that the immunisation programme in our country is as flawed as the rest of the healthcare programmes. It is divorced from preventive healthcare or public healthcare which would mean monitoring disease, its causes and prevention. Hence, he says, “The way we immunise children in India leaves much to be desired, as pointed out by Dr Jacob Puliyel. Immunisation is for disease prevention, but in India MoH does not monitor if vaccines are preventing diseases in the community. For that ‘public health surveillance’ has to be practised, but India does not follow that principle.” In India healthcare and immunisation are like a set of rituals with no basis in reason, he adds.
It is the ritualistic approach that gives Dr Puliyel an easy stick to beat the health ministry with. He says. “We do not have a programme for ‘control of childhood communicable diseases’, while we have a robust vaccine delivery platform, giving vaccines as rituals, without accurately measuring the outcome and carefully documenting every case of vaccine failure.”
And in a final note of distress, he adds: “The point is that the Indian health ministry leaders are either incredibly stupid or absolutely compassionless. Could be both.”
(The article appears in the April 16-30, 2016 issue)