‘India’s presence in global vaccine research is miniscule’

Dr Nitin Shah is president elect for Indian Academy of Paediatrics (IAP) and co-chairman with IAP’s committee on immunisation. A consultant paeditrician with P D Hinduja Hospital and haemato-oncologist, BJ Wadia Hospital for Children, Dr Shah was also honorary senior scientific officer with LTMG Hospital, Mumbai. He is the editor of of magazines like Pediatrics Today, Paediatric Clinics of India and Immunisation in Clinical Practices. Dr Shah spoke to Rita Dutta about trends and research related to vaccination.

What are the various trends in vaccination?

We have the government-run Expanded Programme on Immunisation (EPI), which has effectively brought down the incidence of major killer diseases like poliomyelitis by more than 99 per cent, diphtheria, pertussis and tetanus by more than 90 per cent and measles by more than 70 per cent. The current uptake of most of these vaccines is more than 90 per cent (measles vaccine 70 per cent). The IAP committee on immunisation also recommends certain other vaccines like Hepatitis B vaccine, Hib vaccine, typhoid vaccine and MMR vaccine for children. Besides, we also recommend using Hepatitis A vaccine and Varicella vaccine on a one to one basis after discussing with the parents.

Please comment on the research going on in vaccine in India. Are enough funds coming for vaccine research? Is India participating in enough multiple global trials on vaccination?

The vaccine research in India is in infantile stage. There are not many research projects going on at present, funds are also scanty. Merely 15 centres are conducting research. Our presence in the world research on vaccines is miniscule.The scene is now improving as some companies have realised the need for research in India, especially as pediatricians now insist on results from indigenous studies when a new vaccine is introduced in India.

Minister of State, Science and Technology Kapil Sibal had once said that vaccine research is very critical. Please comment.

I entirely agree with this view. Though vaccines do not behave differently in people from different parts of the world, it may not always be true. Hence we need to prove that the efficacy, immunogenicity and safety of a vaccine is the same in Indian subjects too as found in subjects from other countries. Also, we have a different need for the type of the vaccines required in India and our priorities also are different. Like, we need vaccines for typhoid, diarrhea, malaria, dengue etc on a priority basis.

What is preventing India from becoming a global hub for vaccine manufacturing?

There are many reasons for India not being a favourite destination for vaccine research. Lack of institutes with proper infrastructure to carry out such trials, lack of enthusiasm of companies, absence of proper record keeping of data, lack of long term follow up from our patients which is a must in long term efficacy trials, dearth of physicians trained in research methodology are some of these factors. Besides, Indian physicians are too busy coping with the load of clinical patient oriented curative services to be able to spare time for research-related activities.

Why is the indigenous vaccine manufacturing market losing to MNCs? What strategies do we need to adopt to give it a boost?

Indigenously-produced Indian vaccines have of late captured world attention and share. There are many Indian companies which are now WHO pre-qualified for supply of vaccines for the global tenders like Hepatitis B vaccine, OPV vaccine, measles vaccine and some other vaccines.

In fact, one of the Indian company supplies more than 90 per cent of the world’s measles vaccine. Very soon, this will extend to other vaccines including the combination vaccines. The authorities need to encourage the Indian companies, besides the end users insisting on good quality Indian vaccines. We have state of the art manufacturing units now, and that is one of the reasons why the transfer of technology is happening of late. However, the Indian manufacturers lack an effective R&D unit and hence while we can manufacture already known and existing vaccines, we have very few, if any, indigenously invented vaccine. We need to spend enough time and money to explore the possibilities of inventing future vaccines, at least those vaccines which are our need, as the western manufacturers may not be interested in investing in these vaccines for which there may be no western market.

Please tell us about the usage of various vaccines throughout the country. Which vaccines are yet to enter the country?

Under the EPI, six diseases are targeted. These include tuberculosis (BCG vaccine), diphtheria, pertussis and tetanus (DPT vaccine), and measles (measles vaccine). These vaccines are available through government agencies free of cost to each and every child who requires them. Besides, six more vaccines are recommended by the IAP committee on immunisation of which four are recommended for every baby i.e. MMR vaccine, Hepatitis B vaccine, Hib vaccine and Typhoid vaccine. Two more vaccines- Hepatitis A vaccine and Varicella vaccine are recommended after an one to one discussion with the parents. All these vaccines are available in India. We also recommend the use of only tissue culture, Rabies vaccines, which are freely available in open market. We also recommend combination vaccines wherever applicable.

We still do not have pneumococcal conjugate vaccine, expected to be available soon. We also do not have effective vaccines against malaria, diarrhea, dengue etc, which are still in various stages of development and trials.

Combination vaccines seem to be the latest fad. What are the advantages of using combination vaccine?

Combination vaccines are used when more than one antigen is required to be used at the same time. Instead of giving separate pricks, the vaccines are given as a combination vaccine which means only one prick to the child. Combination vaccines have advantages like less number of pricks, less number of visits, fewer side effects like pain or swellings at multiple sites. It also is well acceptable to children and parents because of reduced number of injections. This improves the compliance and reduces the chances of missing doses and helps in timely completion of the vaccine schedule. Indirectly, it also helps to reduce the number of syringes required, which is an important consideration when one thinks of mass immunisation at the national level (with 25 million deliveries occurring every year) as one injection less would mean 25 million doses and syringes less every year for the nation!

What is the role of IAP’s immunisation committee? How successful has the committee been? What are the various challenges?

The committee meets once in six months to discuss and deliberate on various issues on childhood immunisation and comes out with annual guidelines which help its members to update and follow the correct immunisation practices. Besides, these guidelines are also helpful to other practitioners, like the family physicians. On various occasions, we are invited by the National Health authorities for their meetings on immunisation policies. The biggest challenge for the committee is to promote ethical practice guideline for its members from time to time without any pressure. So far, it has been successful in fulfilling these expectations from its members.

rita@expresshealthcaremgmt.com