Indian Pediatrics 2000;37: 107-110
Universal Immunization with Hepatitis B Vaccine - What it Will Cost
In my letter "Newer Vaccines_Like Marie Antoinette" said, "Let the poor eat cake"(1), I had alluded to an increase in the incidence of vaccine preventable diseases like polio in Delhi and its surroundings. Dr. Jacob John in his reply has raised 2 points which specifically requires me to respond.
1. He says I must "publish in the journal" evidence for my assertion or else it must be recorded that I am guilty of raising false alarm.
2. What has the debate on Hepatitis B vaccine got to do with polio? he asks.
I am thankful for this opportunity to present the facts. It may be said at the onset that there will be no need to provide evidence to the government as the references I quote are government notifications in the first place.
The Government of Delhi, Directorate of Family Welfare with its covering letter F6 (49) Sur/Polio/DFW/5273 dated 9/10/97 sent to doctors a photocopy of an article from Hindustan Times dated 5 September 1997. The article entitled "Polio Strikes UP Districts" by Umesh Raghuvanshi said that "hundreds of children have fallen prey to the virus". The districts involved were Faizabad, Bharaich, Balrampur, Sitapur, Gonda, Bar Banki and Sravasti. A UNICEF team visited the area on 29 August 1997 and went to a hospital in Shanti Nagar where around 89 children have been affected.
Further the Directorate of Family Welfare Delhi in its letter F5(5)/MCH/Achievement/DFW/97-98 wrote that "due to a significant drop in vaccination coverage the incidence of vaccine preventable diseases in Delhi has gone up considerably", and in its letter F6(49) Surveillance/MCH/DFW/98-99, dated 11/12/98 was titled, "Deaths due to Diphtheria". It said that due to a considerable decline in DPT3/DT coverage in Delhi particularly in urban slums during the last three years a rise in the incidence in diphtheria has been observed.
I presume that the Government of Delhi will not write such "alarmist" letters just for a lark and I may present these in my defense. It is unfortunate that our Committee on Immuniza-tion of the IAP does not have access to these notifications.
With regard the second issue of what relevance polio has to the debate I will elaborate. The entire Central outlay under the Family Welfare Program for the Annual Plan 1997-98 was Rupees 1750 crores(2) (17500 million). Maintenance of infrastructure itself costs Rupees 950 crores, leaving a budgeted amount of Rupees 800 crores for all the Family Welfare programs including the Child Survival and Safe Motherhood Project. (The budget for this program is Rupees 300 crores).
Let us look at the cost of universal immunization with 3 doses of Hepatitis B. Each year 25 million babies are born in the country. In his reply to my letter "Newer Vaccines_To vaccinate or not to vaccinate is the Question"(3), Dr. Jacob John had said that the price of Hepatitis B could come down to Rupees 40 per dose if there were a national policy on vaccination on Hepatitis B immunization and manufacturers did not have to invest in "vigorous" marketing and promotional efforts. If we assume that this hypothetical altruistic pharmaceutical manufacturer exists, the cost of the vaccine itself (3 doses) would be Rupees 120 per child. The cost for 25 million newborns will be Rupees 300 crores - the entire Child Survival and Safe Motherhood Project budget. At the existing price of Rupees 150 per dose the cost of the vaccine will be Rupees 1125 crores which is one and a half times the total budget for all the Family Welfare programs. And the cost of administering 75 million doses of the vaccine has not been taken into the reckoning.
Other resources and funds from overseas may be mobilized but one needs a certain circumspection before setting out on an immunization scheme which will use up the entire Family Welfare program budget one and a half times over. Polio eradication and all the other programs will be affected. About the Rupees 525 crores, Finance Committee alloca-tion for Hepatitis B immunization, Professor S.K. Mittal writes that "If this money is spent to supply safe water to 1 or 2 districts, probably cost effectiveness in terms of child survival will be much more than half baked universal immunization against Hepatitis B"(4).
Jacob M. Puliyel,
1. Puliyel JM. Newer Vaccines: Like Marie Antoinette said, "Let the poor eat cake". Indian Pediatr 1998; 35: 1245.
2. Ministry of Health and Family Welfare Government of India. Annual Report 1997-98, New Delhi, Government of India Press.
3. Puliyel JM. Newer Vaccines - to vaccinate or not to vaccinate is the question: Ethical and medico-legal issues. India Pediatr 1998; 35: 791-792.
4. Mittal SK. Editors reaction. Pediatrics Today 1998; 1: 356.
There are two issues to be addressed in my reply to Dr. Puliyel's letter. The first is about his earlier declaration in a letter he wrote to Indian Pediatrics in August 1998 that "in Delhi and its surroundings there is an explosive upsurge in the incidence of paralytic polio"(1). In my reply, I had requested him to provide actual data and evidence to substantiate his statement(2). I had also stated that "if evidence is lacking, then the alarm may be false and that needs to be recorded"(2). The present letter shows that the alarm was indeed false, and that Dr. Puliyel had made the earlier declaration by stretching facts beyond acceptable limits. What are the available facts?
In August of 1997, there was an outbreak of poliomyelitis in Uttar Pradesh, and the "districts involved were Faizabad, Bharaich, Balrampur, Sitapur, Gonda, Bara Bunki and Sravasti". During this outbreak many children from UP with polio were diagnosed/treated in hospitals in Delhi. Dr. Puliyel's declaration of "the explosive upsurge" was written in August, 1998 and received in the editor's office on August 28. Thus, his statement was made a clear one year after the outbreak in UP. Moreover, Dr. Puliyel's claim was that the upsurge of polio was "in Delhi and its surroundings", not in UP.
Outbreaks of disease are assigned their geographic location, not on the basis of hospitals where the cases are treated, but by the places where they got infected. It is therefore obvious that Dr. Puliyel had not verified facts until asked to explain. Let us assume that this was an inadvertant lapse on his part, which can happen if one is not very careful.
In his present letter, he states: "I had alluded to an increase in the incidence of vaccine preventable diseases like polio in Delhi and its surroundings". It was not an allusion, but a specific statement of an explosive upsurge of polio_no mistake about it. Secondly, there was no mention of "vaccine preventable diseases like polio" in his letter(1), contrary to his claim now to introduce diphtheria into the picture, obviously an after thought. In support of his present version of his earlier letter, he cites a Government circular dated December 11, 1998, some 4 months after he had already mailed his letter. Applying such elasticity of facts and logic is, to say the least, quite disrespectful of the readers.
The second issue to be addressed here is the relevance of the discussion on hepatitis B vaccine on polio. Once again, Dr. Puliyel is not able to answer the question `what has the debate on HB vaccine got to do with the incidence of poliomyelitis?'(2). His argument is: the cost of HB vaccine for universal immunization will be 300 crore rupees, which is equal to the budget for Child Survival and Safe Motherhood Project. So he makes another unsubstantiated assertion that "polio eradication and all other programs will be affected" if an equivalent amount of money is spent on HB vaccine. It is indeed a naive argument to suggest that polio eradication will be affected if we debate this issue or even if we accept universal HB vaccination. The sources of funds for HB vaccine should not and will not be diverted from what is needed for polio eradication. Much of the expenses for polio eradication comes as earmarked donations from international or bilateral agencies.
Finally, Puliyel quotes Dr. Mittal in support of his argument against IAP's recommendation for including HB vaccine in our UIP. About the 525 crores of rupees ("Finance Committee allocation"), it is said that "if this money is spent to supply safe water to 1 or 2 districts, probably cost effectiveness in terms of child survival will be much more than half baked universal immunization against hepatitis B" (italics mine). Even if this money is not spent on HB vaccine, it will not be available to 1 or 2 districts for safe water supply. Safe water supply and HB immunization are not in competition with each other for one fund allocation. At the rate of 525 crores spent on 1 or 2 districts each year for safe water supply, it will take 250 to 500 years to cover all our Districts, further weakening this line of argument. The major error of Dr. Puliyel and Dr. Mittal (if he had been quoted correctly) is to consider that the purpose of universal HB vaccination is to improve child survival. The purpose of universal infant immunization against Hepatitis B is not directly to reduce infant mortality or to improve child survival, but to protect against chronic HB virus infection with its consequence of chronic liver disease in later life, and also to reduce the size of the pool of chronic carriers in the community. Therefore, its prevention by immunization cannot be compared with the supply of clean water for cost effectiveness for child survival. About the expression `half baked universal immunization', all I need to say is that this style tinged with sarcasm is only a fig leaf which hardly hides the `half baked' knowledge about the need and purpose of universal HB immunization.
It seems to me that Dr. Puliyel's main issue is that he does not want India to adopt universal HB immunization and accordingly he does not want IAP to recommend it to the Government of India. At first he tried to raise ethical and medicolegal issues to bolster his argument(3). They were refuted(4). Then he tried to ridicule the Committee on Immunization by quoting the derogatory phrase of Mary Antoinette and by comparing HB immunization of children whose parents could afford the cost to the searching for the lost coin not where it was lost but where it is lit by the street lamp(1). He also tried to bring in arguments that IAP members who followed the IAP guidelines of HB immunization were somehow contributing to an outbreak of polio, and that has been shown to be unfounded. So far I have not seen a single cogent argument, epidemiological, immunological or program-matic, in Puliyel's letters to oppose IAP recommendation for including HB vaccine in our UIP. The one that comes close to some respectability is the argument of unaffordability.
India must learn to spend funds wisely, especially in development, and not to adjust the need to the previous year's budget, but to adjust the next year's budget according to the need. India faced a similar debate when measles vaccine was recommended in 1984, but the Planning Commission made the correct and bold decision to include it in our UIP in 1985. I had to argue that case even against the opinion given by a stalwart of IAP then, but she had better arguments than Puliyel has against HB vaccination today. Immunization is to be looked upon as investment, not as expenditure without returns. Indeed, education and health care (especially preventive and promotive) are to be viewed as investment for development. They should not be mistaken as an avoidable or low priority expenditure. Without attempting to calculate the benefit, the mere presentation of the cost is indeed `half baked' cost benefit analysis. Why are we eradicating polio now at an exhorbitant cost? Because it will save for us much more than we spent, for all time to come. And, if we delay it, it will cost more to eradicate.
The IAP, the Indian Association for the Study of Liver, the Indian Society of Gastro-enterology and the World Health Organization are unanimous on the urgency for introducing HB vaccine in our UIP. I am not surprised that there is a very small minority of pediatricians like Dr. Puliyel and Dr. Mittal (if he had not been misquoted) who are against it. I respect difference of opinion and the boldness with which dissent is expressed, but there is no need to be derogatory of those who hold the opposite view.
The recommendation to the Government of India for the inclusion of HB vaccine in UIP was drafted and passed by the Committee on Immunization (January 1999), approved unani-mously by the Executive Board (February 1999), received by the General Body without any dissention (February 1999) and has been already communicated to the Government. If Dr. Puliyel remains unconvinced and has con-vincing arguments to the contrary, let him address them to the Convenor of the Committee who is at New Delhi, or to me, and the Committee will consider his views and respond to him in correspondence.
T. Jacob John,
1. Puliyel JM. Newer vaccines: Like Marie Antoinette said, "let the poor eat cake". Indian Pediatr. 1998; 35: 1245.
2. John TJ. Reply. Indian Pediatr 1998; 35: 1246-1249.
3. Puliyel JM. Newer vaccines - to vaccinate or not to vaccinate is the question: Ethical and medico-legal issues. Indian Pediatr 1998; 35: 791-792.
4. John TJ. Comments. Indian Pediatr 1998; 35: 792-795.