Vaccines have performed an important role in improving public health and saving human lives. All the scientists, labs, manufacturers and medical personnel who contributed to this deserve our deepest thanks and gratitude.
However in recent years a different role of vaccines started emerging – vaccines as a source of huge profits. Things became more worrying when this role of vaccines started clashing with the role of vaccines in public health and even appeared to be superseding it.
When vaccines are treated only as means of public health then scientists, approving authorities and manufacturers are most careful about introducing vaccines for only those diseases in the case of which their need and effectiveness is well-established and when it has been confirmed, after following all the established procedures properly, that risks and side-effects are least.
On the other hand when vaccines are considered more predominantly as sources of profit then all these very important considerations of care and caution may be neglected to varying extents in the hurry to earn quick profits and super profits.
In this context let as look at some recent experiences, particularly that of oral polio vaccine.
Recent research in India has thrown up the highly disturbing fact that as a result of the arbitrary misuse of technology and undue influence by powerful sections, as many as 491,000 children in India were afflicted by non-polio acute flaccid paralysis (NPAFP) over a 17 year period 2000-17, a tragedy that was almost entirely avoidable if the required care had been taken to ensure safety. While these children lived in various states of India, perhaps the highest number of afflictions were in Uttar Pradesh and Bihar. NPAFP is described in a research paper as “clinically indistinguishable from polio paralysis but twice as deadly.” Several of these children who suffered from this affliction later died. (R1)
The tragic story starts in the late eighties when the world was preparing to embark on a campaign against poliomyelitis (polio) disease. At that time there were 350,000 cases in around 125 countries, affecting children under 5 years of age. 1 in 200 infections led to irreversible paralysis. Among those who suffered paralysis, 5 to 10 per cent died.
It was decided that instead of the more expensive and safer vaccine used in rich countries, oral vaccine will be used in this campaign which was mainly in developing countries like India. However there was a curious, suspicious start as the existing capacity to produce oral vaccine within India was sabotaged. Now India became entirely dependent on imports. Soon it was seen that there was a pressure to concentrate the country’s scarce health resources on just one program of oral polio vaccine and, what is more, the rounds of giving oral dose were increased like never before so that some experts feared that vaccine much in excess of safe limits was being given to children. While a safer alternative had been rejected on the plea that oral vaccine was cheaper, but now we were being asked to administer such high doses that even safety limits were being crossed while the expenses were increasing. We were being asked to pay more for harming our children! It was around the same time that it was seen that the number of cases of NPAFP started increasing much beyond the expected norm. (R1)
The situation worsened with the introduction around 2005 of a high-potency monovalent vaccine that contained five times the number of type 1 viruses compared to those contained in the previously used vaccine. With this new introduction the number of cases of NPAFP started increasing even more rapidly. The extra cases were sometimes five to six times of the expected number. In a single year the number of extra cases could go up to 40,000 or even 50,000.(R1)
It is by counting the number of such cases that the children afflicted by NPAFP (extra cases above expected norm) has been estimated at 49,1000 during the period 2000-17 in India alone. (R1)
Meanwhile, similar disturbing reports were coming in from other countries as well.
A question is—if the number of NPAFP cases is 491,000 in India alone, what is the total number of afflictions in all the countries where similar methods have been used.
While there are several reports and research papers on this , the most comprehensive and discussed paper was published in the reputed International Journal of Environment Research and Public Health on 15 August 2018. This paper is titled “Co-relation between Non-Polio Acute Flaccid Paralysis Rates with Pulse Polio Frequency in India”. This paper has been written by Rachana Dhiman, Sandeep C. Prakash, V. Sreenivas and Jacob Puliyal. The last mentioned author in particular has made an outstanding contribution to unearthing this evidence. The estimate of 491,000 extra afflictions is taken from this paper which has presented a table on afflictions for each of the 17 years. There was first a big increase in extra NPAFP cases and later, when pulse polio was greatly reduced or stopped, there took place a decrease in extra NPAFP cases. This paper concludes, “Our findings suggest that increase in NPAFP ( and a later decrease in such cases) was indeed an adverse effect of the pulse polio immunization programme.”(R1)
Other researchers who have contributed much to the understanding of this tragedy include S. Sathyamala whose analysis for Uttar Pradesh data revealed that mortality rate for patients with NPAFP was twice the mortality rate for wild polio. A study by M.A. Gupta and J.A Mathew (with Puliyel) revealed that in 2005 when one-fifth of the cases were followed up at 60 days in Uttar Pradesh, 8.5 per cent of them had died and 35 per cent were found to have been left with residual paralysis. Yet another study by N. Vashisht and P. Sreenivasan (with Puliyel) revealed that NPAFP rate increased sharply when more than six rounds of pulse polio were used in a year. They mentioned the likely possibility that repeated doses of the live vaccine virus delivered to the intestine may colonize the gut of the child and alter the viral microbiome of the intestine, and this can result in strain shifts of entero-pathogens. It is possible, they said, that the new neurotropic enteroviruses colonizing the gut may induce paralysis.
In addition there have been highly distressing reports regarding the very harmful impacts of other vaccines including the HPV Vaccine, the dengue vaccine, etc.
All this should be seen within the wider framework of how various vested interests have tried to dominate vaccine production and research to carve out markets and maximize profits. This is explained well in an editorial of the Indian Journal of Medical Research, written by Jocob M. Puliyel and Yennapu Madhavi.
“The methods used by economically well-off nations to gain control over economically poor countries by accessing their markets and creating demand for medical technologies/vaccines, irrespective of local needs, have been documented extensively. As a new product is being readied, research is published to highlight the number of deaths in the country caused due to the absence of that vaccine. The estimates are often outright exaggerations or reflect poor research design. The limitations of such models have been pointed out previously….
“In the face of bourgeoning and aggressive marketing of vaccines of doubtful utility, we have a widening demands-supply gap in Expanded Programme on Immunization (EPI) vaccines. Over the last few decades, due to the decline of the public sector and the growing disinterest of the private sector, the number of firms supplying EPI vaccines has declined drastically both in India and abroad, prompting the UNICEF to express its serious concerns about the short supply of EPI vaccines. Private manufacturers prefer to sell them as ‘value-added cocktail vaccines’ at exorbitant prices in the open market, rather than supply to EPI. The universal tendency to combine EPI vaccines with non-EPI vaccines not only creates an artificial scarcity for affordable EPI vaccines, but also creates a backdoor method for the entry of expensive and perhaps unnecessary non-EPI vaccines into the universal immunization programme, riding piggyback on the EPI vaccines.”
Coming now to the present-day debate on Covid-19 vaccine, it needs to be highlighted that this is the fastest vaccine being developed in human history as this is planned to be developed and mass produced within a year or so, while the normal average time for developing a vaccine is a decade and the fastest vaccine ever developed was for mumps in four years. It is likely that this vaccine once available will spread very fast in terms of its actual use and its spread may be as unprecedented as its development and manufacture time. Very powerful forces which dominate the world health scene will push this spread.
So it is very important that safety and efficacy aspects of this vaccine should get widespread attention and closest scrutiny by scientists who are guided only by public interests of health and safety of all and not by any narrow interests.
Unfortunately the overall safety record of some important players in the current vaccine race is not a reassuring one.
Dr. N.K. Mehra, Indian Council of Medical Research emeritus scientist and former Dean of the All India Institute of Medical Sciences, New Delhi, has written recently,
“The critical aspect of the process is to develop a protein that must be close to the original virus, and against which the body is able to raise antibodies for neutralizing the virus. Any deviation could lead to the development of “blocking factors’’ through a process called Antibody Dependent Enhancement.
“Simply put, rather than neutralizing the virus, such antibodies could do the opposite, namely facilitate further virus entry into cells. This has happened earlier for the dengue virus where the vaccine, rather than conferring protection, actually acted like a silent primary infection.” (R2)
In a widely discussed article in the Financial Times (May 22) Hannah Kuchler has written,
“Scientists have still not ruled out the grim prospect that a vaccine could make the disease worse. In some conditions including dengue fever and the common childhood respiratory infection RSV, vaccines have actually enhanced the disease.”(R3)
In this context it may be pointed out that the Dengvaxia vaccine, which took about 20 years to develop, has led to public protests, inquiry and ban following allegations of deaths of 600 children related to this in the Philippines. Problems and complexities relating to possibilities of disease enhancement reported in this context have been reported also in the context of earlier work on coronavirus vaccines. Scientists involved in this work have testified about unique potential of safety problems.
Several scientists have expressed concern that there is no precedent for such rapid development of a vaccine. Dr. Peter Hotez of the Baylor College of Medicine has said, “I don’t see a path by which you can collect enough efficacy and safety data by the end of the year.” (R3)
The Financial Times article quoted above also pointed out that advances being publicized in the context of COVID-19 vaccine work like the messenger RNA programming have never been used yet to create products approved by a regulator. This article concluded, “Easing requirements for approval could put vaccines on the market before we discover all the side-effects.”(R3)
Hence it needs to be emphasized that the safety and efficiency aspects of Covid-19 vaccine should get very, very careful attention.
References
R1: “Corelation between Non-Polio Acute Flaccid Paralysis Rates with Pulse Polio Frequency in India”, paper written by Rachana Dhiman, Sandeep.C. Prakash, V. Sreenivas and Jacob Puliyel, International Journal of Environment Research and Public Health, August 15, 2018.
R2: “Covid-19: Decoding the global search for a vaccine”, article by Dr. N.K. Mehra, The Hindustan Times, August 11, 2020.
R3: “Scientists and Politicians—the reality check for ‘warp speed’ vaccine research”, The Financial Times May 22, 2020.
(Bharat Dogra is a journalist and has written extensively on public health related issues.)
