1. Incentivise a Made-in-India Zika vaccine

Incentivise a Made-in-India Zika vaccine

Actual drug-discovery costs are prohibitively high for an Indian firm in bringing a product to the market.

By: | Updated: February 13, 2016 8:10 AM
zika 1 The virus is yet to touch the Indian shores, but nevertheless, is predicted to make strides towards Africa and Asia, which are home to its natural vector—the Aedes mosquito. (Reuters)

Unless an individual is pregnant or planning on getting pregnant, Zika virus—a member of the family of viruses that cause dengue, yellow fever and chikungunya (all carried by Aedes mosquito)—may not be considered particularly harmful. Symptoms develop only in one out of five among those who are infected. These include mild fever, rash, joint pain, headaches and conjunctivitis (red eyes) that usually last a week. But, the virus’ recent outbreak in Latin America has got global public health agencies thinking again before they even emerged out from the Ebola outbreak. The outbreak in Brazil led to reports of Guillain-Barré syndrome (rapid onset of muscle weakness) and pregnant women giving birth to babies with birth defects, including microcephaly—a potentially fatal condition with reduced head circumferences and underdeveloped brains in babies.

The virus is yet to touch the Indian shores, but nevertheless, is predicted to make strides towards Africa and Asia, which are home to its natural vector—the Aedes mosquito. Zika is not a new virus and was discovered in the late 1940s in monkeys in the forest of Zika in Uganda. However, its outbreaks remained sporadic and the disease seemed to do little harm. But this time around, the World Health Organisation has sounded the war bugle and declared Zika a public health emergency on February 1.

Currently, there is no vaccine or cure for Zika. From this point onwards, developing a vaccine against Zika would be at the heart and forefront of any preventive strategy that the world can look up to. Indian vaccine manufacturers have time and again proven their mettle to the world while dealing with public health emergencies emanating from vaccine-preventable diseases. The meningitis vaccine project is one of the many successful examples where the manufacturing prowess of Indian firms was coupled with technologies developed in the West via the licensing agreements and an overarching technology transfer platform facilitated by select global


The WHO has called for researchers to develop a vaccine for Zika as well as better diagnostic tests to detect the virus. This, however, is likely to take a few years more. The latest development on this front is by Bharat Biotech, an Indian vaccine manufacturer, a firm that declared the availability of two potential vaccine candidates against Zika up its arsenal. Bharat Biotech began research on its vaccines nine months ago, when it legally imported a live Zika virus to India. Besides the claim that one of them is an inactivated vaccine, the exact mechanism of action of the other vaccine candidate has not yet been released. Some media reports claim that the same can be rolled out in as little as four to eight months if required. Before Bharat Biotech came out with the news, the best estimate that the WHO gave the world was that of a two-year time period when a commercially available vaccine could be rolled out and manufactured on a large scale. Deploying an indigenously developed vaccine in less than a year from now would be a great feat for any Indian firm. But before one rides on the train of optimism, one should remember that it is just a potential vaccine candidate and not a vaccine itself. There are key potential hurdles before the actual vaccine can be launched.

The vaccine candidates under question are in preclinical development phase and yet to even undergo animal trials. With a near broken clinical research milieu, unless India declares Zika a public health emergency, clinical trials on humans are unlikely to be fast-tracked. Moreover, similar vaccine candidates (for dengue) have been languishing in drug/vaccine pipelines of various firms in various phases of clinical development for years now, without any tangible success on this front.

Many of the successful vaccines that have been launched in the past have been a result of Advanced Purchase Commitments (APCs) by multilateral bodies or global alliances, which have incentivised Indian vaccine manufacturers to target process innovations related to manufacturing. The absence of such an incentive and the current estimated costs for novel drug discovery (that runs into a few billion US dollars) makes it prohibitively expensive for an Indian firm to bring the product into the market.

In the past, most product/process patents and the know-how behind vaccines of such public importance have been largely licensed to multiple vaccine manufacturers by the likes of the Netherlands Vaccine Institute and others based on a hub-and-spoke model or otherwise. The lack of such know-how would be a potential hurdle in the development of such a vaccine.

There is a grave need for reorienting drug/vaccine discovery strategies for public emergencies in the tropical and less developed countries. France’s Sanofi has announced an initiative to develop a vaccine against Zika. Following the league is Japanese drug maker Takeda Pharmaceuticals who announced a similar initiative. It is time that such privately funded initiatives join hands with the vaccine manufacturers in India to bring potential vaccine candidates to the fore and help stymie such outbreaks.

The author is a researcher at ICRIER and a doctoral candidate at the Centre for Studies in Science Policy, JNU.E-mail: rahulmongia@gmail.com

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