What will be India’s role as a leader of this coalition?

When disease outbreaks occur, depending on the mode of transmission they can spread very rapidly to affect people very far from where the outbreak starts. In India, we recognise that preparedness to handle outbreaks also includes strategies for prevention.

For known and as yet unknown diseases, vaccines offer the potential to be deployed rapidly and on scale to prevent both disease and its further transmission. India, represented by the Ministries of Science and Technologies and Health and Family Welfare, intends to stand shoulder-to-shoulder with governments and agencies, such as the World Health Organization, the Wellcome Trust and others to develop the strategies for partnerships, technical development, regulatory and ethical approaches and find the resources and commitments needed for the coalition.

Indians have developed effective vaccines that are yet to be utilised – will these feature prominently?

The term ‘effective’ in science and in common use reflect different levels of rigour. There are actually relatively few ‘effectiveness’ or efficacy studies of vaccines developed in India. The last vaccine developed in India which underwent an efficacy study was the rotavirus vaccine made by Bharat Biotech with the support of the Department of Biotechnology, and this is now being used by the MOHFW in four States, with plans to expand nationally in the near future.

The coalition will not focus on common diseases like rotavirus, but will focus on diseases that have the potential for causing outbreaks. Among the known diseases that may be targeted is Chikungunya, for which a vaccine has been developed in India, but its effectiveness in preventing the disease needs to be evaluated. It is possible that support for such studies for existing, partially tested vaccine may be available.

In addition, we will be looking at new targets, as well as establishing platform technologies that will allow us to rapidly address the currently unknown diseases which may cause outbreaks in the future.

How are the human trials planned to be carried out?

For testing any new vaccine, safety is paramount and the vaccine is first tested in a small number of healthy people in phase 1 studies. Only then does the study move to a slightly larger number of people in phase 2 to figure out what dose is best to produce the best immune response. After that, come the larger scale phase 3 efficacy studies to test whether the vaccine can prevent disease in its target populations. While the phase 1 and 2 studies can be done anywhere, phase 3 studies require a population where the disease is reasonably likely to occur, so phase 3 would have to be where the outbreak is happening.

Under this coalition, the plan is to develop vaccines through phase 1 and 2, and we will apply the highest standards for safety in these studies. In more industrialised countries, many vaccines are now being tested in a unique form of volunteer studies, where disease is actually induced in people in a tightly controlled setting — the controlled human infection model or CHIM and the ability of the vaccine to prevent disease is characterised, so that fewer people are put at risk when testing vaccines. This requires volunteers who are altruistic and have great understanding of the risks of the experiments. There are currently no plans to do such studies in India, but may be, in a few years, we will feel ready to think about such approaches.

Which are the diseases being actively targeted? What is the strategy?

The targets will largely reflect the WHO R & D blueprint which has been evolved over the past couple of years. The goal of the coalition is to focus on diseases which do not have a large market in global terms; therefore, targets have been identified through a careful process of considering candidates that have been through some pre-clinical testing, but might not proceed to further testing because vaccine manufacturers do not consider the returns to be sufficient for the investment they need to make.

As you can see from the CEPI website, much progress has been made on Zika , and for dengue, there is already one licensed vaccine available and at least three other candidates are in late phases of development, so it is unlikely to be considered. Swine flu and other influenza viruses cause diseases with the potential to result in pandemics, and for such diseases, there will be big markets and the bigger vaccine manufacturers will be developing vaccines in any case.

There is a perception that India will be the pharmaceutical hub of the world and also the laboratory for the world… How does this new role ensure our global leadership, especially in having a say on ethical practices in these sectors?

Ethical practices relate to both the development of drugs, vaccines and other products which is the domain of academia and regulatory authorities as much as manufacturers and to their marketing and use, where manufacturers have the greatest role.

In development and testing, we will adhere to the highest ethical standards, ensuring that participants in studies completely understand the purpose as well as the risks and benefits of their participation. This will require strong credible academic partners and regulations, and the Drugs Controller General of India has already taken the lead in improving the standards of clinical testing in India.

How much money is needed to be raised, and will India have a part in raising funds as well?

The anticipated requirements for funding is about 200 million US dollars per year, which is relatively modest. Yes, India will have a role in contributing, but the scale of contribution is not yet defined.

CEPI has announced a plan of getting more people on board – What is likely to be India’s role in this ?

India is home to one sixth of the world’s people. Our people live and travel everywhere. This is important for us, but we must also bring other partners on board. India will play a role in working not only with industrialised countries, but also with less resourced settings, particularly in Asia and Africa. The India-Africa Health Summit, organised by the ICMR and supported by four Indian ministries is an example of the kind of engagement where we could work with African countries likely to be affected by outbreaks that need to build capacity in science, medicine and manufacturing.