'If Trials Go According To Plan, We May Have A Viable Vaccine By Early-Mid 2021'

Neeraj Jain, Indian Country Director, PATH, in a conversation with Outlook’s Bhavna Vij-Aurora, tells how Covid-19 has changed the priorities of health systems around the world. Globally, PATH is part of COVAX, which is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. COVAX is a global effort to ensure equitable access to the COVID-19 vaccines once they are available.

Q) The world is waiting for the Coronavirus vaccine. By when do you think it will be available in India?

Currently, the world has 201 Covid-19 vaccine candidates in the research and development stage. Of this, 45 vaccine candidates are in a clinical trial phase with 10 of them in advanced Phase 3 stage and 156 candidates in preclinical evaluation. It is hoped that at least one or more of these vaccine candidates would prove safe and effective sooner than later due to fast track regulatory approval processes being adopted by many countries, including India. If the trials go according to plan, we may have a viable vaccine by early-mid 2021.

Q) What do you think should be the rollout programme in terms of prioritizing—as in which groups should get the vaccine before the others?

Covid-19 will remain a threat until everyone has access to an effective vaccine. The guiding principle for this decision should be the public good. We must make decisions that maximize the vaccine’s protective power—because this is ultimately the best way to protect everyone. The Indian government has constituted an expert group to study the best options for equitable distribution. The government has also asked states to prepare lists of priority population groups that need to receive the vaccine first.

Q) The equitable distribution and administration of the vaccine is going to be a big challenge. Is PATH working with the Government of India in this regard? In a massive task like this, the government needs all the help it can get from the private sector and NGOs working in the field.

Definitely, cooperation, collaboration and partnerships are key to tackle such an enormous health challenge. For our part, PATH’s aim has always been to ensure that all essential vaccines—including new Covid-19 vaccines—are affordable, available, and accessible to the most marginalized and underserved among us. In India, PATH, along with public health partners, is supporting the development of a strategic document for Covid vaccine roll out for the Immunization Technical Support Unit (ITSU) of the Ministry of Health and Family Welfare. We are ready to provide any necessary technical support to the government.

Globally, PATH is part of COVAX, which is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. COVAX is a global effort to ensure that people in all corners of the world will get access to Covid-19 vaccines once they are available, regardless of their wealth. CEPI’s strategic investments in vaccine manufacturing at facilities around the world will support the COVAX goal to produce 2 billion doses of a safe and effective vaccine by the end of 2021.

PATH is also supporting CEPI with creating a database of vaccine manufacturers with fill/finish capabilities. We also identified and built the capacity of a pool of clinical trial sites to be available to vaccine manufacturers for their Phase 3 studies.

Q) You have been working in this area for quite some time. What has been the experience regarding some other vaccines like the rotavirus and Japanese encephalitis?

The ROTAVAC and ROTASIIL vaccines for rotavirus were developed through unique social innovation partnerships that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors. PATH is also conducting studies on these vaccines to assess vaccine effectiveness, cost of delivery, and impact assessment to generate data for policymakers.

PATH has nearly two decades of experience in advancing Japanese encephalitis immunization services in India. The country’s strategy of conducting catch-up campaigns in high-burden, high-priority districts, followed by routine immunizations, was recommended by India’s Ministry of Health and Family Welfare and the World Health Organization. We are supporting the state government of Bihar to resume a wide-ranging JE vaccination campaign that was delayed by the Covid-19 outbreak.

For any disease or outbreak, a vaccine itself is only one piece of the puzzle. In order to mass-produce, distribute, and administer the vaccine to billions of people—a whole host of other challenges must be overcome including adequate production, supply, cold chain and last-mile delivery. The rollout of the vaccine for Covid-19 will be different from the rollout of other vaccines in the routine immunisation programs. Since it is meant for the entire population, countries will need to roll it out rapidly in stages, utilizing a mix of the campaign and routine immunisation approaches.

Q) There is a debate on whether the coronavirus vaccine should be given free to all the citizens of the country. In a country like India, with a population of over 1.3 billion, won't it put too much pressure on the exchequer, especially with the possibility that more than one dose may be required?

Innovative financing to support the rollout of the vaccine is key. Gavi, the Vaccine Alliance is a cornerstone of vaccine financing for low-income countries, and continued donor commitments to this fund are essential. Gavi has approved the proposal for vaccine cost-sharing up to $1.60-2.00 / dose for the 92 Gavi COVAX Advance Market Commitment-eligible countries and economies, including India, with a goal of mobilizing resources from multilateral development banks, to ensure that inability to meet cost-sharing will not prevent or delay the provision of vaccine doses.

But Gavi is just one of many mechanisms that will be necessary to achieve global coverage.
We all have a stake in ensuring that all countries have access to the forthcoming Covid-19 vaccine, because until that happens, no nation is safe.

Equitable access for all should be the guiding principle for any roll-out of the vaccine. Those who can afford to pay should pay and those who cannot should get it for free.

Q) PATH recently came up with a cost calculator for vaccines. Can you put it in perspective? From the India point of view, is there an estimate on how much each dose of Covid-19 vaccine is likely to cost?

For country decision-makers, the opportunity to introduce a new vaccine comes with many considerations. Is the vaccine needed? What are the benefits? Is there enough capacity in the cold chain system? Often most important—what will it cost, and can the country afford it?
PATH recently developed a set of Vaccine Cost Calculators. These Excel-based tools enable simple estimation and comparison of the costs of vaccination programs using different vaccine products available for one disease.

Currently, calculators are available for rotavirus vaccines and pneumococcal conjugate vaccines. Each of these vaccine markets has recently experienced an increase in product options with new, lower-priced vaccines becoming available for countries (including those eligible for support from Gavi, the Vaccine Alliance) to consider for introduction or product switch.

The tools — available in English, French, Russian, and Spanish — are designed to be useful to decision-makers, implementers, technical partners, and others in any country, regardless of eligibility for co-funding from Gavi. With only a limited number of data inputs required, the calculators allow users to compare different vaccine product options and produce cost estimates—both annually and over a period of 10 years.

Though the calculators are useful tools, they do not account for other dimensions in decision-making and are not a replacement for detailed budget planning once a vaccine product has been selected. When there is more clarity on the Covid-19 vaccine, we look forward to developing a Covid vaccine calculator.

Q) With the Covid-19 bringing health in the public discourse, do you think the sector will finally get the attention it deserves from governments across the world, including India?

Absolutely. Covid-19 has changed the priorities of health systems around the world. Countries are faced with the immense challenge of rapidly responding to the pandemic while continuing to make progress against other health goals. With limited time and resources, existing barriers to health services and inefficiencies in health systems appear magnified. But many countries—including India—are translating the urgency around Covid-19 into opportunities to create more resilient health systems. There is a greater understanding that without improving health, we cannot address poverty and development, which is leading to the greater political commitment to strengthening health systems. There is also an accelerated shift towards leveraging digital health and AI technologies and data for disease surveillance, planning and diagnostics.

PATH’s continued long-standing partnership with state governments in India allows us to think critically about how the Covid-19 response can be turned into long-term improvements in health systems across the country.

We also need enhanced investment in delivery systems, like health workers, cold chain equipment, and more. This is the only way we can ensure that once ready, an effective Covid-19 vaccine reaches everyone, everywhere—especially those facing barriers to accessing health care. These foundational investments will continue to pay dividends long after the current pandemic. The collateral advantage of the pandemic, if I can call it that, is that we are going to see health systems globally undergo a transformation and become better equipped and resourced to handle future health risks.