India’s struggle to introduce dengue vaccines

New Delhi : Dengue is a dangerous debilitating disease that occasionally kills people and has no known cure or treatment.

Two vaccines against the dreaded disease one foreign and one Indian await regulatory clearances. A multi-national pharma giant seeks waiver for a large clinical trial to be done so that the vaccine can be introduced as soon as possible looking at the emergency.

A promising Indian candidate vaccine rusts on the shelf of a laboratory in Delhi even as millions suffer. So should India bite the bullet and go ahead tough and not easy choices need to be made?

But how big is the dengue problem, occasionally the authorities have behaved like ostriches. A landmark 2014 study by the government’s National Institute of Health and Family Welfare (NIHFW), New Delhi, found that India could have had “an annual average of 5,778,406 clinically diagnosed dengue cases, or 282 times the reported number per year” between 2006-2012.

The study reported that the “National Vector Borne Disease Control Programme captures only 0.35 per cent of the annual number of clinically diagnosed dengue cases in India”.

In 2013, an assessment by a team of 18 researchers from seven countries, published in the British journal Nature, said “India alone contributed 22-44 million dengue infections” in the world which suggested that the Ministry’s estimate could be lower by a 1,000 times.

“The government numbers are just the tip of the iceberg,” said Dr Soumya Swaminathan, Director General of the Indian Council of Medical Research (ICMR).

She added that nobody really knew the real burden of dengue, and the truth lay somewhere between the 282-times-more and the 1,000-times-more estimates. It is for this reason that the country desperately needs a vaccine against dengue.

It is a bite from the blood sucking tiger mosquito that causes dengue, India has been fighting a losing battle against this disease. There are at least two vaccines in the pipeline that can help.

Globally the most advanced is a vaccine made by pharma giant Sanofi and recommended by the WHO that is only effective in the age group 9 years to 45 as a tool to tackle dengue.

Earlier this year the Indian health ministry rejected the introduction of the Sanofi dengue vaccine to India as the company wanted fast track introduction and sought a waiver of the Phase III clinical trial in India.

The Ministry of Health and Family Welfare noted that “the evidence was not sufficient to waive conducting a clinical trial in India.”

In the last few weeks the company has approached the regulatory authorities to re-consider the rejection and a committee headed by clinicians from the All India Institute of Medical Sciences and Maulana Azad Medical College have suggested that the vaccine be introduced under strict post marketing surveillance. But there are hoops still to be overcome.

Jean-Pierrre Baylet, Country Head, Sanofi Pasteur India, Mumbai says, “There are at least 5 good reasons to believe in our dengue vaccines: 20 years of research including India, recommendation from the World Health Organization, 10 countries have already adopted the vaccines, high against severe dengue and 5 lakh people globally have already been vaccinated so far.