The Indian Academy of Pediatrics Committee on Immunization (IAPCOI) thanks the authors for raising the issues and is pleased to offer the following clarifications.

The IAPCOI has a clear responsibility assigned to it which is to provide guidelines on the use of licensed non EPI vaccines for the members of IAP and NOT for public, parents or children. The regulatory authority does not give guidelines for their use by health care providers. The UIP or its advisory committee (NTAGI) also does not provide guidelines for their use. The vaccine brochure gives product information and contraindications if any etc. Thus, the COI has the responsibility to help members in their choice of vaccines for children whose health care and preventive medicine is their responsibility. Therefore it is very important that IAP issues guidelines for the use of these vaccines, in a standardized way and guides its members about prioritizing the non-EPI vaccines into what are to be actively promoted (Category 2) and what need not (Category 3). Furthermore, the committee feels that on the strength of whatever data that is available none of the currently licensed vaccines can be put in the "not recommended" category. Understandably, individuals may hold their own opinions. That is precisely the reason why IAP has to evolve a consensus among the COI members and have collective guidelines.

Naturally, COI will deal with only vaccines that are licensed in the country – hence only those that are available. Conducting epidemiological research and pointing out the need for licensing unlicensed vaccines is the prerogative of all members of IAP. Similarly, creating demand for research and development of vaccines for infections without available vaccines is also for researchers to undertake.

The process of formulating the recommendations and logic behind categorization of vaccines has been adequately explained in the document and needs no further elaboration. The document explicitly states that these guidelines/ recommendations are expert opinion, based on what ever information is currently available and are subject to change as new information emerges. It should be kept in mind that these collectively made guidelines that represent the official view of the Academy are not regulations or even rules but points to guide – to help paediatrician’s make the optimum choice regarding available vaccines in the best interests of the children whom they care for. Hence the aim is children’s health and NOT bringing about financial gains to paediatrician’s and/or vaccine manufacturers.

Another point of debate has been recommendation regarding rationale behind combined use of both OPV and IPV. It is reiterated that when a shift from OPV to IPV in most countries has been gradual with first moving towards a combined/ sequential OPV, IPV schedule to then an all IPV schedule. In fact, the switch in the national program post polio eradication is envisaged to be a gradual switch and OPV would be withdrawn under an IPV umbrella. In keeping with these strategies and to minimize any disruption of the national program the committee had recommended a combined schedule. Future committees may consider an only IPV schedule. The committee has already made a clear recommendation to the government about the role of IPV in India in the polio eradication and the post eradication era(1). A recommendation about only IPV use in immunocompromised children cannot be made as it is known that children with HIV infection can safely receive OPV(2).

The committee does not feel that there is any ambiguity in the document regarding categorization of vaccines including Hib, DTaP, varicella and hepatitis A. Such ambiguity only arises if statements are picked up and quoted out of context. Readers are referred to the recently published immunization guidebook for more detailed discussion on individual vaccines(3). The listing of brand names has been done for clarity and understanding of readers and is congruent with all international recommendations where brand names are consistently listed(4).