Stop Pentavalent Vaccine Before It Is Too Late

The introduction of pentavalent vaccine in place of DPT vaccine in India’s universal immunisation programme has become one of the most controversial public health decisions in recent times. The proposal—already under implementation to push pentavalent vaccine (DPT + Hepatitis B + Hib) has been opposed by many eminent experts as well community health organisations, but this opposition based on strong evidence is being ignored due to the pressure exerted by powerful international organisations and lobbyists as well as their local partners.

The controversy peaked recently due to the deaths of several children following pentavalent vaccination in India, Vietnam, Sri Lanka, Bhutan and Pakistan.

Following several deaths 12, public health experts wrote a letter to the Health Secretary in which they stated: “We, a group of academicians, professors and teachers of public health and paediatrics, would like to draw your attention to the pattern of adverse events and deaths from the newly introduced pentavalent vaccine (DPT + Hib + Hep B).

“...It is for us as experts and the Government of India to look at all these seemingly isolated instances of death after pentavalent vaccine in a comprehensive manner, to see the underlying pattern and act, if needed to protect lives. Considering that vaccines are given to a large number of children who are well, it is crucial that they be completely safe.

“As doctors we are aware that most medicines have some side effects but repeated instances of death as side effect from a vaccination programme for a disease that itself can be treated with antibiotics cannot be acceptable.

“....Pentavalent deaths have now been repeated in different countries with use of Pentavalent vaccine from different manufacturers. It cannot therefore be explained as defects in some specific batch of the vaccine, nor can it be blamed on some programmatic error—because of incorrect storage or administration. There is no test available to identify the child who is going to react and die. We, as public health experts, understand it is our responsibility to inform you of this pattern of reactions seen with this vaccine.â€

According to news reports from Vietnam, all the babies who died had been in good health before vaccination. However, hours after receiving the vaccine, they began wailing loudly. They had convulsions and had serious trouble in breathing. They died soon after.

On May 4, 2013 the Ministry of Health of Vietnam suspended Quinvaxem, the Pentavalent combination used here, after it had caused 12 deaths and nine other serious adverse events.

Bhutan stopped the immunisation programme after the death of four infants following pentavalent vaccination. It was then persuaded to restart the programme by international organisations. The reintroduction of the vaccine was followed by four more deaths. Then use of the pentavalent vaccine was stopped again.

In India the Pentavalent vaccine was introduced first in Kerala and Tamil Nadu. There were some protests in Kerala against this. In the first six months after the introduction of the vaccine in Kerala, 40,000 children were vaccinated and five of them died of AEFI (adverse events following immunisation). By the end of a year, 14 children had died.

About 25 million children born in a year in India are supposed to be immunised. Taking the mortality from pentavalaent observed in Kerala, public health expert Dr Jacob Puliyel has observed: “If the birth cohort of 25 million were immunised and 1 per 8000-10000 of the babies vaccinated were to die of AEFI, about 3125 children would die from AEFI in a year.â€

In a strong critique of the Pentavalent vaccine Dr Puliyel writes: “Vaccines are meant to save lives. The public will cease to trust its healthcare providers if unscientific recommendations are accepted and this will have grave consequences for public health. .....21 babies have died in India following immunisation with the pentavalent vaccine. If Bhutan and Viet Nam have been capable of taking actions, there is no reason why India cannot act similarly. It has become imperative to protect the lives of children who are potential victims of the pentavalaent vaccine.â€

After these deaths some international organisations and manufacturers have swung into very high-profile activities to somehow try to disassociate the deaths from vaccination, in the process piling up lies, fabirications and misinterpretations. The reality is that even higher number of deaths and adverse events are likely to have occurred, as pointed out in a public interest petition filed in the Supreme Court by a senior paediatrician, Dr. Yogesh Jain: - “The Government adopted a system of passive surveillance where health workers only record adverse events when the patient spontaneously comes to the health centre to report adverse effects .... Experts agree that passive surveillance picks up only 1 to 10% of adverse effects.... The manufacturer had an obligation to do active surveillance and could have found a tenfold increase in adverse events. The manufacturer failed to even report the deaths where post mortem reports ruled out other natural causes of death. Clearly, the vaccine manufacturer put its profit margins above the lives of children.â€

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This brings us to a critical aspect of the entire controversy—the ganging up of big business interests and international alliances/organi-sations to somehow push the pentavalent vaccine into India’s universal immunisation programme. They have made highly exaggerated and unethical statements about the threats posed by Hep. B and Hib meningitis to justify adding new vaccines to DPT. One joker dressed up as an expert extrapolated data from Taiwan to show 250000 Hep B deaths in a year, when available ICMR data from India reports 5000 Hep B deaths a year. The bogus research of another ‘expert’ was exposed by health activists using RTI who found that this gentleman did not really conduct a study and looked only at some patients with liver problems coming to his unit! As for Hib meningitis, the most scientifically conducted study (the Minz study) found that only seven in every 100,000 children had this disease.

While the two expensive vaccines being added to DPT are not justified on the basis of their real need, there is also the additional factor that benefits of single vaccines can be reduced in larger combination. Citing several studies, Dr Y. Madhavi, the Principal Scientist at the National Institute of Science, Technology and Development Studies, writes in her paper, “Vaccines and Vaccine Policy for Universal Health Care’, (Social Change, June 2013), citing several studies: “Scientific literature show that in general the safety and efficacy aspects of combination vaccines are not proven beyond doubt, and it is reported that they are less protective when compared to their individual components. In pentavalent vaccine (DPT-HB-Hib), lower immunological responses to Hep-B and Hib were observed when compared to their separate administration.â€

Dr Madhavi also raises the question whether the universal immunisation programme (UIP) is being used to provide huge markets for those vaccines of dubious benefits to India which can not find a significant market on their own merit: “Why is it that every combinations vaccine is a product of a combination of a UIP vaccine and a non-UIP vaccine? Is it because lack of demand-pull for individual new vaccines (for example, Hepatitis B, Hib) is sought to be covered up by the UIP vaccines that enjoy higher legtimacy? Virtually all combinations are a means by which new vaccines are gaining a back-door entry through the captive UIP market by riding piggyback on UIP vaccines such as DPT, measles, IPV, OPV etc. If a new vaccine can stand on its own merits (especially epidemiological merit), why does it need a piggyback ride?â€

Another crucial question is whether these efforts, aided and abetted by international organisations, are part of a larger design for big inroads of vaccine multinational companies and their subsidiaries into India’s captive market for UIP. What is already well known is that many public sector vaccine making plants in India have been arbitrarily shut down or vaccine manufacture there has been stopped. The controversy reached its peak in 2007-08 when vaccine production including DPT was stopped in three public sector units. This closure was condemned by the Parliamentary Standing Committee. In addition, legal action was initiated against it. In the process hope for continuation of vaccine production in public sector units was renewed.

The pressures to introduce Pentavalent vaccine as a replacement for DPT may also be related to snatch away the DPT market from public sector units. This, moreover, may be one of several other efforts to give a larger role to private sector, multinational companies and imports to sell their expensive, patent-protected combinations in India, using the captive market of UIP and in other ways.

In the process the costs of immunisation may well be increased several fold. The international financial support for pentavalent is limited to 2015, and after that India may be forced to find its own resources to support an unnecessarily expensive and much more risky immunisation programme providing huge benefits to private sector and foreign companies, ignoring the potential available in the country for a much cheaper, less risky, self-reliant, reliable programme based on public sector and rational products.

In other words, serious health hazards are being accepted in the ruthless promotion of big business interests. Developed countries do not themselves use pentavalent vaccine, but their companies and lobbyists are pushing it ruthlessly in India and some other developing countries. They seem to have several powerful collaborators sitting in high positions in developing countries. With their help health risks for children are being played down using crude methods, while benefits are being exaggerated in equally questionable ways. Isn’t it time for citizens to stand up and ensure that national interests, interests of our health system and above all the interests of our innocent children are completely and firmly protected beyond any shadow of doubt?

Bharat Dogra is a free-lance journalist who has been involved with several social initiatives and movements.