Update on the Recommendations of the Academy to other Agencies on Immunization

Introduction

The Committee on Immunization of the Academy has formulated several specific recommendations to other agencies, particularly the Ministry of Health and Family Welfare of the Government of India.These have been duly approved by the Executive Board and informed to the General Body meeting of the Academy at Jaipur, in February, 1999. In the absence of a national mechanism to review periodically the nation's requirement of newer vaccines beyond the original list of the Expanded Program on Immunization, the Academy has the responsibility to review annually the availability and advisability of such vaccines.

When the Committee on Immunization is convinced that a particular new vaccine is appropriate for universal infant immunization in India, it formulates a policy to use it regularly by the Academy members. This is the background of the IAP policy on the routine use of Measles-Mumps-Rubella vaccine and of Hepatitis B vaccine. The choice of MMR vaccine was based on the experience of several researchers on the need to protect women of child bearing age from rubella infection. There have been several published and unpublished data to show that congenital rubella syndrome occurs with some frequency in different parts of India and that medical termination of pregnancy on the basis of maternal infection with rubella virus during pregnancy is being conducted at many centers. Yet, sufficiently robust data, quantitatively and quali-tatively, have not emerged in our country, not because the problem does not exist, but because our colleagues have not yet made the needed studies. Under these circumstances, we consider that the IAP policy should be to offer the MMR vaccine to only those who are willing to pay the cost of the vaccine. Not that the cost is high, but on principle the Committee has not suggested that we recommend to the Government to include MMR for routine universal immunization.

The case of HB vaccine is different. We have sufficient data to show that HB infection and chronic carrier (or actually chronic infection) state as well as chronic liver disease due to HB virus (chronic hepatitis, cirrhosis and liver cancer) are major and urgent public health problems in India. Therefore we consider HB vaccine to be urgently required on our list of universal vaccines. Regarding its cost, some neighboring countries are able to get HB vaccine through UNICEF global tender mechanism, at 50 US cents (approximately 20-22 Rupees) per dose. Even if the Government paid for the entire vaccine for infants (which is not necessary as families who can afford private care will pay and get the immunization), the total cost will be no more than 190 crores of Rupees. If India will not invest this amount of money for the health of the people it is not because of poverty but because of ignorance and callousness.

Given below are the specific recommendations formulated by the Academy. The recommendations to the Government have already been communicated. The Government has already acted on one recommendation as will be highlighted later.

Recommendations

Recommendation to the Ministry of Health, Government of India

1. On Advisory Committee on Immunization Policies

The Academy strongly recommends to the Government of India to cosntitute an Advisory Committee on Immunization Policies, with representation from the Ministry of Health and Family Welfare, Indian Academy of Pediatrics, Indian Medical Association, Indian Council of Medical Research, National Institute of Biologicals, National Vaccine Testing Facility and independent experts.

2. On Hepatitis B Vaccine in National Immunization Schedule

The Academy strongly recommends to the Ministry of Health and Family Welfare to introduce Hepatitis B immunization in the National Universal Immunization Program without any further delay. We remind the Government that the World Health Organization, of which India is an important member, had strongly advocated the introduction of HB immunization in India by the year 1997. We recognize the financial implications of this recommendation and are convinced that it will be possible to cross that barrier with inno-vative approaches, for which purpose the Academy Experts shall be available for discussion and planning.

3. On Whole Cell Killed Typhoid Fever Vaccine

The Indian Academy of Pediatrics strongly recommends to the Ministry of Health and Family Welfare to approve and encourage the continued production of the whole cell killed typhoid fever vaccine in the public sector vaccine manufacturing units in India. Among all available typhoid fever vaccines, the killed vaccine has been adjudged to have the best protective efficacy. It is both inexpensive and completely safe. The local and systemic reactions of the killed vaccine are no more severe than those caused by the DPT vaccine, especially when given according to expert recommendations. Being inexpensive it is the vaccine which is affordable to the weaker sections of society who need it most.

4. On Discontinuing the Animal Brain Rabies Vaccine

The IAP strongly recommends to the Ministry of Health and Family Welfare to discontinue the use of the animal brain rabies vaccine with effect from January 1, 2000. Although it is already considered unethical and a violation of fundamental human rights to give this vaccine to any human being, an interim period of about one year may be accepted for ensuring the transition to use exclusively modern safe rabies vaccine. Meanwhile, any person developing adverse reaction to the brain tissue vaccine must be treated free of charge and financially compensated. We recommend that the Ministry establishes a mechanism for determining the bona fides of adverse reaction and the quantum of compensation.

Recommendation to the Federation of Obstetric and Gynecologic Societies of
India (FOGSI) On Testing of Pregnant  Women for HB Virus Infection.

The Indian Academy of Pediatrics recommends to the FOGSI, that it adopts a policy
of routine testing of all pregnant  women for HBV chronic carrier  (infection) state and if positive,to endorse a policy to give hepatitis B immune globulin plus HB vaccine to the new born, or  at least HB vaccine alone, in the   first 12 hours after birth.

Actions Already Taken - The Recommendations to the Government of India were duly
communicated to the Gove rnment soon after the General Body meeting of the Academy
in February, 1999. On March  10, the Ministry of Health  convened a meeting of experts
(including the Chairman and Convener of the IAP Committee on Immunization) to
consider the reestablishment of manufacture of the whole cell  killed Salmonella typhi vaccine
in the public sector vaccine  manufacturing units in the country. The experts unanimously endorsed the Academy views on this matter and it is hoped that the vaccine will become more widely  available soon.

 A few years ago the Ministry   had sent a directive to all public  sector vaccine manufacturing  units to discontinue the  manufacture of the killed  vaccine in order to encourage the wider use of the alternate vaccines. Since the King Institute at Guindy (Madras) and the Institute of Public Health at Hyderabad are State  run public sector units, they go by State Government directives. Therefore, while others discontinued its manufacture, the Madras and Hyderabad units continued to manufacture it without a break. The group of experts have recommended that the killed vaccine need to  contain only S. typhi and not S. paratyphi, thereby improving  its quality and reducing its adverse reactions. We have also recommended that the manufacturing units undertake some research to improve the  process of killing of the  organisms so that its immunogenicity could be better preserved and reactogenicity  further reduced.

 Members of the Committee on Immunization
Chairperson: T. Jacob John;
Convener: Anand P. Dubey;
Members: Thomas Cherian, Tapan Kumar Ghosh, Indrashekhar Rao, H.P.S. Sachdev,        Navin Thacker.
Ex-officio Members: Gajender S. Hathi, Madhu R. Lokeshwar, A. Parthasarathy,                  Raju C. Shah.