Elusive shots

North Gujarat is fighting an outbreak of hepatitis-B. Several people have died and there?s panic in the region as hundreds have been spotted with symptoms. Could the outbreak have been avoided? Leading vaccine manufacturers?MNC as well as Indian?believe so, provided proper vaccinations had been carried out.

Globally, vaccines have been repeatedly proven to be the most cost-effective intervention in terms of disease prevention. The same does not hold true for India where outbreaks of bacterial meningitis, Japanese encephalitis, polio and rabies are common. The fact that North Gujarat is fighting an outbreak of hepatitis-B points out the well-known malaise that ails our system?government inaction. World Health Organisation (WHO) recommends immunisation of all the children with three doses of hepatitis-B vaccines administered at various months of age.

Sadly, the government has so far not shown any concrete measures to include vaccination of some of the common diseases like hepatitis-B into its national health programme. Perhaps, the Gujarat outbreak could have been avoided if proper vaccination measures, which underline the need for 100% vaccination of children and adults similar to the oral polio programme, had been carried out effectively.

Vaccines are in spotlight again not only because of the latest outbreak of hepatitis-B, but also due to the acute shortage of essential vaccines to protect children against six diseases? diphtheria, pertussis, tetanus, poliomyelitis, measles and childhood tuberculosis. This follows government?s decision last year to close down the manufacturing units of three public sector vaccine makers?Pasteur Institute of India (Coonor), BCG Vaccine Laboratory (Chennai) and Central Research Institute (Kasauli).

The net result is that 15 states and several union territories have voiced their concern about the severe shortage of vaccines. The current immunisation coverage in the country is 44%, which indicates that the government has to make substantial efforts to completely eradicate vaccine preventable diseases. The government?s nationwide immunisation programme covers most of the essential vaccines like BCG (Bacillus Calmette-Guerin), polio, diphtheria-pertussis-tetanus (DPT), measles and tetanus toxoid. Though hepatitis-B is covered in some states, it is not mandatory across all the states in the country.

Recent incidents show that the domestic demand for vaccines?pediatrics, oncology and adult (flu and hepatitis)?is growing rapidly. The size of the Indian vaccine market is around Rs 1,000 crore and growing at 25-30% per annum. It is projected to cross $1 billion by 2012. While pediatric vaccines comprise 60% of the domestic market, there is growing demand for new generation of combination vaccines.

Not surprising, MNC vaccine makers like Merck, Wyeth, GlaxoSmithKline, Sanofi-Aventis and Eli Lilly, along with domestic vaccine makers like Bharat Biotec, Shantha Biotech, Serum Institute and Panacea Biotec are seeking to partner the Central as well as various state governments to sell their vaccines under various immunisation programmes. They are hard-selling their combination and pentavalent vaccines, since they combine five antigens into a single dose, thus eliminating the need for multiple injections to infants. Such vaccines also prove to be more cost-effective to the patient than individual vaccines.

?If the government takes the lead and announces inclusion of the necessary vaccines in its immunisation programmes, general public would understand the need and those who can afford will go for vaccination at their own cost,? says Varaprasad Reddy, managing director, Shantha Biotechnics. According to him, the implementation of the vaccination programme must be standardised across various regions in India. ?While polio is already mandatory, most of the countries have hepatitis-B vaccination mandatory for children and many countries have vaccinated adults to combat the disease effectively.? Unfortunately, the same is yet to happen in India.

?It is not an easy task. Due to some reason or the other, stray incidents of polio keep on coming every year. Outbreak like the one in Gujarat come unannounced,? says Rajesh Jain, joint managing director, Panacea Biotec. According to him, diphtheria, pertussis, tetanus, typhoid, tuberculosis, polio, measles and a number of other diseases can be effectively controlled by vaccinations.

In order to meet the demands of the affected states, a health ministry official points out that the government is looking towards domestic vaccine manufacturers. It plans to introduce pentavalent vaccines in its Universal Immunisation Programme (UIP) from 2010 onwards. Such vaccines would provide immunity cover against DPT, hepatitis-B and haemophilus influenzae type B, or Hib. Other vaccines that could possibly be included in the foreseeable future are for rotavirus, typhoid and pneumococcal, informs Krishna Ella, chairman and managing director, Bharat Biotech. Central and various state governments have already established a detailed tendering process to manage the procurement and deployment of essential vaccines.

Need of the hour, therefore, is fast execution of the plan into action. That is, timely availability of vaccines, enhanced follow-up to reduce dropout rates and ensuring high quality of vaccines. Interestingly, a subtle fight is brewing between the government and private vaccine makers in terms of supply and demand. ?There is sufficient capacity available with the private players. In such a case, practical pricing would have to be considered. Several vaccines are currently being provided at very low costs, which is not feasible as a modern plant requires huge investments for meeting global standards,? insists Jain.

A way forward could be the public private partnership (PPP) model which can boost sales of the domestic vaccine makers and serve the access and affordability motive of the government. ?It will be a win-win situation for both as private players will be benefited by government reach while the government will benefit from their scale and capability,? says Ajit Mahadevan, partner (advisory services), Ernst & Young. He adds: ?There has been a shortage of vaccines which affected the immunisation programme of some Indian states. This is mainly attributed to the shutdown of three government plants which were manufacturing some of the vaccines being used in the immunisation programme.?

Generally, it has been observed that MNC vaccine makers focus on newer vaccines which are proprietary and costly. However, new trends are emerging from the domestic vaccine market in terms of popularity of combination vaccines and those for lifestyle diseases like cancer. Combination vaccines offer huge advantage over regular vaccines because of fewer injections for infants, lesser visits to a doctor and lower dropout rates. They are also highly recommended by WHO and other regulatory bodies.

According to Jain, developing countries would need a combination vaccine to the tune of around 300 million doses annually. The combined demand for combination pediatric vaccines worldwide was valued at $600 million in 2005 and is estimated to grow up to $1.6 billion by 2012. ?Pentavalent vaccine market is estimated to cross a mark of $1 billion, out of which UN agencies are likely to procure this vaccine worth more than $350 million by this year itself,? he adds.

MNCs are aware that countries like India and China offer an expanding market for vaccines and would account for a significant amount of their future growth in vaccines and biologics, informs Ella. Design and development of lifestyle vaccines would follow shortly once the demand for essential vaccines has been satisfied. There is a lot of work going on for development of an effective cancer vaccine.

That?s not all. Both domestic and MNC vaccine companies are investing in research and new technology to develop vaccines for AIDS, dengue, malaria, allergy, rheumatoid arthritis and hypertension, among others. The growing healthcare market in the country also provides an opportunity to vaccine players to provide contract research and manufacturing services.

India?s huge population and a birth rate of 24.5 million per annum make it among the world?s largest market for vaccines of all types. However, immunisation coverage in the country has so far been hampered by improper implementation of various immunisation programmes along with affordability of vaccines. Therefore, the way forward for vaccines makers is to increase their penetration by introducing effective vaccines at lower costs so that a greater segment of population can get the benefits from them.

Promising future

• Indian vaccine market is around Rs 1,000 crore and growing at 25-30% per annum

• Pediatric vaccines comprise 60% of the domestic vaccine market

• Combination vaccines to become part of government?s immunisation programme from 2010 onwards.

Vaccines for

• Diphtheria

• Pertussis

• Tetanus

• Poliomyelitis

• Measles

• Childhood tuberculosis

• Rabies