In a recent Immunization Dialogue, Dr. Puliyel had suggested that selective hepatitis B vaccination after mandatory testing of pregnant women would be more cost effective and that universal immunization as recommended by the lAP Immunization Committee was difficult to justify(1). It is gratifying to know that Dr. Puliyel has now been convinced of the need for universal immunization as a result of thereply published in Indian Pediatrics(2). Appearing to champion the cause of the poor and the disadvantaged, Dr. Puliyel now questions whether our policy of offering hepatitis B vaccine to all those who can afford it, is ethical and scientific. For those who are not familiar with the name Marie-Antoinette, she was the queen of France and wife of King Louis XVI. He reigned during the French. Revolution and partly due to her stubborn defiance and intrigues, monarchy was thrown out in France in 1792. She was notorious for her extravagance and lack of concern for the poor. The derogatory and callous remark about the poor, "If they have no bread, let them eat cake" is attributed to her. The connection between the theme of Puliyel's letter and this quotation is flimsy, if not misfit, since lAP is not anti- poor. New vaccines are not anti-poor, but like cake, unaffordable for the poor. Pulieyl does not appear anti-poor but he has chosen the wrong quotation if he did not mean to be derogatory to poor people, lAP, new vaccines, or our not-so-rich country.

In my reply to the earlier piece by Dr. Puliyel, I had stated: "According to the WHO recommendation India should have adopted the policy of universal infant immunization with HB vaccine before the end of 1997. The government's policy clearly needs revision, and the Academy recommends to it the adoption of the WHO's recommendation as soon as possible. Universal HB immunization of all infants is in the best interests of the nation" (2). When I meet members of the Academy at various meetings it has been my singular joy to learn that they read the 'Immunization Dialogue' very carefully. In dialogue, it is important that the participants pay full attention to points and counter points. There cannot be any room for doubts about where lAP stands on the issue of universal HB immunization and to insinuate that our posture is anti-poor is certainly contrary to facts. lAP does not recommend selective immunization; we do recommend universal immunization. The official lAP guidelines on Hepatitis B Immunization are described in detail in the lAP Guide Book on Immunization published by the Committee on Immunization(3). It is worth referring to it when. questions arise in our minds regarding various vaccines.

When lAP formulates a policy, it is to be followed by the members of the Academy. One organization cannot enunciate policy for another organization. We cannot make a policy for non members of the Academy but we do hope that they will voluntarily accept our policy as their guideline. We cannot make policy for the Ministry of Health but we certainly can recommend to them a policy and that is precisely what we have done in the matter of HB immunization. In the past, an earlier Committee on Immunization had attempted to formulate a policy for the National Universal Immunization Program (UIP) of the health minis- try and that had led to unpleasant repercussions. lAP is a private, voluntary and professional organization with no mandate to formulate policies for the Ministry of Health, but our prestige and respect arising out of our principled stand is the reason why our policies are generally accepted by the Ministry, albeit after some delay.

All VIP vaccines are available from government health services free of cost and this privilege is for all children irrespective of income levels. Hepatitis B vaccine is not available free of cost since it is not yet within the government's VIP policy. Therefore this vaccine has to be purchased in the market by the parents themselves or gifted by someone else. This is simply the basis of the Academy's policy which has been appreciated by the (previous) Director General of Health Services, the Indian Association for the Study of the Liver and the WHO Global Program on Vaccines. Our policy has been ethical, scientific and practical. If Puliyel has reasons to question its ethics or scientific rationale, it is for him to spell them out rather than simply proclaim so. The need for universal HB immunization has received the attention of the Health Ministry and the 9th Planning Commission has budgeted funds to begin a national HB immunization project starting with selected geographic communities.

Dr. Puliyel's analogy of equating the immunization of children of families who can afford to pay for the vaccine, to the futility of searching for the lost coin not where it was lost but under the street lamp just because that is where there is light, shows that he has not understood the purpose of HB immunization. Paraphrased, he means that children of well-to-do families do not need this vaccine, but those of poor families do, and since we are not able to immunize the needy children but are able to offer it only to those who are able to buy it but do not need it, this whole policy is an exercise in futility. The primary purpose of any immuni2;ation is to protect that particular child from that particular disease. Such protection is the birthright of each and every child, irrespective of the income of parents. This of course is the principle of universal immunization with any vaccine.

In the absence of such. a government policy, it would be unscientific and unethical not to make HB vaccine available at least to those who can afford it. That is the main reason why the government has given licenses for it to be imported and to be manufactured in India.

The public health application of immunization is not contradictory to the individual need, but the accumulation of meeting individual needs. The public health effect of immunization becomes evident only when a large majority of individual children are immunized. It is in this context that the WHO experts had gone wrong in making a policy to use EPI vaccines solely as a public health tool for which only 80% coverage was stipulated, instead of asserting that every child needed to be vaccinated for protection. But, when coverage reaches some threshold level, perhaps 80% for diphtheria and whooping cough, the decline in incidence may be greater than 80%, perhaps reaching 95% or more. The mess we are now with polio is directly the result of ignoring the primary purpose of immunization which is personal protection. India struggled to get such public health effect of polio immunization, ignoring the fact that some 30% of vaccinated children were not being protected. Mathematical calculations based on modeling had predicted that 99.95% coverage is required to interrupt transmission of polioviruses and also that some 7 or more doses of OPV were needed for assured personal protection. Since we did not follow scientific principles, now we are forced to give some 15 doses of OPV per child and also reach over . 99% coverage.

Regarding HB vaccine we should, and we do, try to bridge the gap between need and availability, between manufacturers and the purchasers including the government; but it is not a question of doing it instead of fulfilling our call of duty and responsibility in protecting those who can be protected. These two objectives (scientific policy and humanitarian advocacy) are not mutually contradictory as indicated by Puliyel. We need not choose one in favor of the other, we need to do both and we are doing both.

When a vaccine is found to be safe and effective against a disease, but the Immunization Committee does not consider it to be appropriate at the present time for universal immunization, such a vaccine is placed in a category of 'optional vaccine'. I do understand that it takes some serious thinking to grasp this concept. To. the pediatrician who uses such a vaccine by applying the option, the message is that it is a safe and effective one, and if there is justification to use it, the Committee approves it. If you see much typhoid fever in your area, you must exercise the option to immunize all children who might be at risk. If you do not see the disease among children of a community, there is no particular need to give it. This is the spirit of the option. Let me cite another example. A baby born after in vitro fertilization should not be put to the risk of any preventable disease including Haemophilus influenzae type b (Hib) meningitis or pneumonia, however small the actual risk is. If it is preventable, it must be pre- vented. A child to be splenectomized should be given pneumococcus vaccine. So there are practical ways of exercising the option for vaccines that cannot be recommended for universal application on ac- count of lack of necessary epidemiological data and also on account of the high cost of the vaccine. In one family the cost may appear easily affordable. In another family, the cost of Hib vaccine, if expended, might seriously affect the nutrition of the infant or of the mother. In such case, Hib vaccine is not the priority. The discomfort of the need to use the paying capacity of a family in choosing health care, particularly in the voluntary and private sectors, is more glaring in the case of expensive therapies such as for insulin dependent diabetes mellitus, leukemia or congenital heart disease, for example. When bone marrow transplantation costs several lakhs of rupees, is it optional or mandatory for the provider to give it without counting the cost? It would be very good if we were to have a national health service like in the UK, but our gross domestic produce will not be sufficient to cover all the health costs required for the whole country. Poverty actually limits options. Those who live in glass houses should not throw stones.

Historically, we accepted the expanded program on immunization with the various vaccines before we had sufficient data on the frequency of diphtheria, or even on the efficacy of BCG. Thus, opening up an option to use Hib vaccine is not the first time immunization is being used even before defining the magnitude of the problem. The absence of evidence should not be taken for evidence of absence of a parameter. In our hospital, Hib is the number one cause of pyogenic meningitis in under- fives. I would strongly urge Dr. Puliyel to report in the columns of Indian Pediatrics the number of children with pyogenic meningitis that his Department had encountered each year and the specific organisms causing it, over the last 5 or 10 years, so that he helps in the generation of the data that he laments the lack of.

I find the last paragraph of Puliyel's letter with a flight of unrelated ideas. What has Immunization Dialogue and the debate on HB vaccine got to do with the incidence of poliomyelitis? If Pulieyl knows about even one case of acute flaccid paralysis, it is important to make sure that it has been re- ported to the designated authorities and if he knows about 'an explosive upsurge in the incidence of paralytic polio', he has the imperative responsibility to alert the public health system without delay. I sincerely hope that this has already been done. This dialogue section is not the forum to report cases of AFP. Now that he has come out public with this information in our journal, he has got to provide actual data and evidence to us and to the government agencies. If evidence is lacking, then the alarm may be false and that needs to be recorded. Even if there has been an upsurge in polio cases, has it been contributed by the Academy members giving HB or Hib vaccine? To say that pediatricians who counsel parents about HB or Hib vaccine are frittering away their energies is an allegation both frivolous and unfounded. Those who discuss newer vaccines with parents are actually serving the cause of the future health of children. To insinuate that such 'frittering away' of energies have somehow contributed to poliomyelitis is totally without basis. Finally, Puliyel's attempt to associate these newer vaccines with some dream shattering effect on DIP immunization is another wild allegation. What is promised by the year 2000 is not 'universal protection with the EPI', but 'health for all' and eradiation of polio. There is no evidence that can link newer vaccines to the delays in achieving either target. If Puliyel has any, he must spell them out. Puliyel implies that the Academy has not stated priorities clearly by urging it to do so now. If anyone has not understood the priorities of the Academy, it must be corrected, for there may be many others also who might not have understood them. The Academy's priorities are clear; first and foremost to improve the professional standards of its members and through it to serve the children of India. The Academy's priorities on immunization are clearly defined in the Guide book(2). If Dr. Puliyel has suggestions to fresh prioritization, he must write to the Secretary General of the Academy.
 

T. Jacob John,
Chairman, Committee on Immunization
 and President Elect,
Indian Academy of Pediatrics,
 Thekkekara,
2/91 E2, Kamalakshipuram, Vellore,
TN 632 002, India.