‘Biotech R&D makes India hub of quality drugs, vaccines’: Trevor Mundel of Gates foundation
Trevor Mundel says India is not just making vaccines but making them within a quality system, has not been accomplished, broadly, and that is the unique aspect India has brought to the game.Updated: Jul 30, 2019 11:40 IST
Trevor Mundel is the president of Global Health at the Bill & Melinda Gates Foundation and leads the Foundation’s efforts to develop high-impact interventions against the leading causes of death and disability in low- and middle-income countries. He also manages cross-cutting product development programmes, including discovery & translational sciences, innovative technology solutions, and vaccine development in close collaboration with an international network of grantees, partners and governments.
In India to deliver a talk on Innovating for impact: How India can solve some of the world’s toughest health challenges at the All-India Institute of Medical Sciences on Monday, he speaks to Sanchita Sharma on India’s leadership in developing high quality, safe and effective vaccines and drugs and its potential to offer digital global health solutions.
What are two biggest high-impact global public-health interventions? What has been India’s role?
The most impactful intervention in public health has been GAVI, the Vaccine Alliance, which is an organisation that provides cost-effective vaccines to countries and populations. Over the years, I have been tremendously impressed by the pivotal role India has played and the quality of affordable vaccine industry that has evolved over here, uniquely actually. India is now the biggest volume supplier to the public market of vaccines.
Then there’s its contribution on the drugs front, of the quality generic drugs that come out of India. We want to replicate this and build for further progress on health in India with implications for global health community. This range of interventions can be made available globally given the bulk of scientific research and development and the regulatory environment that exists in India.
A couple of days ago, I got my typhoid injection that offers protection for two to three years. The Bharat Biotech’s new conjugate form of the typhoid vaccine lasts a decade, maybe a lifetime. It is not available in US and Europe, but it available in India and Bharat (Biotech) is providing it to GAVI for global use.
Can India’s success be replicated in other countries?
There is a proliferation of manufacturing, in China, Indonesia… but vaccines are very complex, multi-step products with lots of quality issues, with the end result that the vaccine may not be effective or may even be dangerous. India is not just making vaccines but making them within a quality system, has not been accomplished, broadly, and that is the unique aspect India has brought to the game.
Vaccine denial is increasing, in India and around the world. There have been measles outbreaks in United States. How can fake news about vaccines be stopped?
The people who understand the value of vaccine became somewhat complacent because of, in some ways, the success of vaccines. Take the measles vaccination, which eliminated measles in the US, and made people forgot the disabling consequences of measles. That allows the anti-vaccine movement to flourish. In eliminating the problem, the vaccine became the problem. We now know what happens when there is a relaxation (in vaccination coverage) and measles resurges – it is really deadly in children who have low resistance and are malnourished. So I think policymakers, governments and funders like ourselves cannot be complacent on the gains we have made on the vaccine front just because we got too successful.
India and the world have halved maternal and under-5 deaths. How can progress be accelerated to meet SDGs?
Sometimes, the last mile is the most difficult because now you’re left with more complicated circumstances, such as maternal issues that can’t easily be dealt with at a primary health clinic and need to be dealt in a district or secondary hospitals.
Most of the changes have to be on the systems side. I know that there’s been a tremendous amount of thought and interventions around wellness clinics, auxiliary nurse midwife (ANM) and Asha (community health worker), and the system can be enhanced in terms of workflows with new options within the digital framework. Much like they have been rolled out in financial services for the entire population, in the health area we are now seeing the opportunity for the digital services to provide an upgrade, I wouldn’t say for free, but with the same people who are in the system. It provides a real upgrade so the people can be more effective. And that will make the last mile more achievable.
How will machine learning and artificial intelligence (AI) improve delivery?
On this trip, I’m visiting some people who are working in the AI space, like the Wadhwani AI group in Mumbai that is developing pioneering mobile phone-based tools to diagnose the 1 million tuberculosis cases that go unidentified in India each year.
There are two stages of this evolution. The first is the actual digital implementation of tools that were implemented by hand. ICMR (Indian Council of Medical Research) has this wonderful integration of care pathways that have been distilled on one page.
Is it like a checklist?
It’s like a checklist. It’s a tremendous distillation. Stage one is we take that tremendous set of pathways and make it digital, working through cellphones so that the ANM in the field has it available as a guide.
Level two is where the AI and machine learning comes in as to how do we provide the element of context and background knowledge to that ANM as she is working with an issue that would help her know if that patient -- who has had two previous pregnancies, of which one was complicated, has hypertension in her second pregnancy is now at risk of recurrence. So it is providing integrated knowledge to the frontline worker to provide high level of care that would be available at a secondary or tertiary hospital.
What are the two biggest challenges in public health? Two decades ago, it was AIDS, malaria and TB.
Sadly, I can’t say that has changed at all, (though) the regions have changed. Let’s start with malaria. I would have hoped by now that at least in the control front, we will continue to see a decline but in the last two to three years, the decline has slowed, particularly in sub-Saharan Africa. Various reasons have been given, including pyrethroid resistance used in standard bednets. So, now we have a generation of new bednets to address that problem but unfortunately they cost a bit more than the old bednets.
Do you think global malaria elimination is possible by 2040?
Not unless we get some better tools, which means we get better vector control tools and also a new drug. It is a tricky parasite that has co-existed for millions of years and adapted well. We can never be completely sure about the next adaptation. But I think we are getting there with these new tools.
There is a vaccine that moderately effective, so I think the next generation of malaria vaccines could be much more effective, which will be a hugely helpful thing.
What’s the progress on tuberculosis?
Tuberculosis remains incredibly resistant. It is the quintessential disease of poverty and has now become the number one infectious disease killer in the world. We have the added difficulty of drug resistant TB. We have quite an exciting set of new drugs which we hope will be universal cures for TB, which means would get around the issue of resistance. We see line of sight to those.
On the vaccine front, if you asked me two years ago, I’d have said TB vaccine is a long way away. There have been some striking advances, one even on the old vaccine BCG. ICMR is in the process of working with Serum Institute of India around the development of a recombinant form of the BCG vaccine. We found in a study in southern Africa that BCG revaccination, which has always been controversial thing in teenagers, actually seems to be highly protective against TB. We are just launching a study to confirm that in southern Africa. I’m hoping we’ll have a study here in India, which would likely be performed by ICMR.
India has a goal to eliminate TB by 2025. The biggest challenge is India has one million missing cases of TB. Of the 3.4 million cases in the world, a third is in India. What I mean by “missing” is what we know about TB incidence, of the cases treated, and one million we don’t know about. So what happened to those people? Did they die, are they still infected, did they become chronic?
We need a shorter better tolerated treatment. The next regimen we want for TB is that is universal and acts on all forms of TB. There is a regimen that is coming out quite soon, which will be effective even on extremely drug resistant TB. But it is not a simple regimen to take and requires a lot of supervision. At least one of the drugs on the regimen has issues if used chronically. Blood tests are needed every week to monitor a patient’s response to the drug and it can be very difficult to do that in a community health setting.
How can the missing cases be traced?
We can actually make a big dent on TB just by better management of the disease. Once again, I think some of the digital options are going to help us.
Wadhwani AI is working on a set of digital tools apps that would help you identify patients, cohorts, contacts of patients, patients who are risk for defaulting or becoming non-compliant etc. This is where the AI will come in. It’s patient tracing with the added layer being if a patient comes with these characteristics – malnourished, certain age, male, high risk of being a defaulter, have missed a visit — their risk goes up and they are identified as somebody we should really track.
Why is HIV still a big public health threat?
One must not get complacent about basic behaviours that lead to the flourishing of HIV, but on education about prevention and paying attention to the needs of vulnerable communities, I think India has done a great job. HIV is declining and is stable (in India) at the moment. Those circumstances haven’t occurred in southern and parts of east Africa, in particular, where the epidemic is flourishing and projections are that by 2035, although incidence may be going down, we will see more people numerically with HIV than we have today. So it’s far from an epidemic contained.
Going by the expense of keeping people on lifelong treatment currently, to put all of the people (who have HIV) in 2025 on treatment indefinitely, there is no way such an enterprise will be funded. We need to have some really new thinking.
There are some hopeful new potential items on the list for HIV. We have two large vaccine studies underway in phase 2 and phase 3 right now, which will be completed in three to four years.
The drugs have become remarkably good, people on treatment have very good outcomes. There are still some health issues to be addressed, but generally the outcomes are excellent for people who are completely virus suppressed.
We can look forward to the next generation of very effective, tolerable long-active drugs. Can you imagine, a once-a-monthly oral drug, or a six-monthly injectible? That is something we can look forward to in three to five years. That will change the equation in terms of sustainability of the system of treatment.