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Dr. Kapil Maithal, President – Vaccines and Diagnostics, Zydus Lifesciences, in an exclusive interview with Indranil Chakraborty, Assistant Editor, Industry Outlook, shares his insights on the Indian vaccine industry, scaling up vaccine manufacturing, the road ahead for vaccine development and more.

THE GLOBAL VACCINES MARKET is projected to reach $125.49 billion by 2028. How is the vaccine industry developing in India? What are factors affecting the growth?

India is one of the major vaccine manufacturing hubs in the world as we cater to almost 60 percent of the global vaccine demand. The major drivers of this has been the world class manufacturing infrastructure, available talent pool, and highly efficient cost of manufacturing which are prerequisites for providing high quality and low cost vaccines especially to low and middle income countries (LMIC) where the disease burden of vaccine preventable diseases is the highest.

After the onset of Covid-19 pandemic, we shed our image of just being a manufacturing power to now also an innovation driven industry. The major drivers of this inflection has been the significant push-and-pull funding by the government and support from regulatory agencies, which helped in fast-tracking research, development and subsequent commercialization of these vaccines which in turn has helped the vaccine industry to grow.

Moving forward, this momentum in growth can be further accelerated by continued risk sharing by the government in terms of providing funding and incentives to the industry and encouraging more investment in new vaccines where the risk of failure is high. Another important area to be prioritized is in setting up national centers for specialized testing and for providing curated, well-characterized bacterial and viral seeds for vaccine manufacturing.

Inconsistencies in the supply chain often imposts a great threat to the visibility and data centralization of the entire supply chain network. How can end-to-end supply visibility be attained?

Vaccine supply chain has greatly evolved over the years. One of the primary reasons behind this has been the continued emphasis on it by various regulatory and procurement agencies. In fact, UNICEF,one of the major vaccine procurement agency spends significant amount of resources in procurement of affordable and efficient cold chain equipment (CCE) for storage, handling, stock management and delivery of vaccines to the remotest locations. Similarly, GAVI, the major funding agency for vaccine supplies to LMIC across the world also helps in distribution, installation, commissioning, as well as on-site training on cold chain equipments to the countries under its Cold Chain Equipment Optimization Platform (CCEOP).

As vaccines are usually supplied in very large volumes, the packaging configuration for vaccines meant for most institutional supplies is usually defined. Over the years, there have also been myriad of technological advancements when it comes to vaccine supply chain including track and trace systems for real-time on-route dynamic logistics planning and monitoring and management of any In-Transit Cold Chain excursions. In most of the institutional supplies, vaccine vial monitors (VVM) are used, which will change color if there is any temperature excursion. That said, there is a need for consistent improvement in this segment as about 20 million children still remain at risk from vaccine preventable diseases in the world due to under or no vaccination.

Manufacturing process complexity arises from the need for rapid production and the prompt resolution of technical issues. Whilst traditional manufacturing processes are well established, these require time to scale up. How can vaccine manufacturing be scaled up?

Rapid scaling-up of vaccine production can be a challenge. This can be primarily attributed to the fact that vaccines can be developed using different platforms like whole virion vaccines, subunit vaccines or viral vectored vaccines and now we even have nucleic acid based vaccines, which may require very different type of manufacturing units.
The major factors, which need to be considered for scaling up are process and utility optimization as well as the availability of raw material and consumables besides numerous factors related to facility design, man-material movement and other resources. When it comes to process optimization, one would need to continue improving in the area of biochemical engineering and process quality controls, which can be integrated with computational sciences to develop mathematical models and predictive tools to identify critical process parameters or indicators, which can help to have a better design of experiments. Such an approach drastically narrows down the options as long as the critical process equipments are scaled up linearly to avoid more variables. In fact, many leading industries are already using these methodologies very successfully for traditional platforms and as more data related to newer vaccine platforms emerges, these tools will become even more powerful for scaling up these platforms.

Today, there is an increased need to ensure patient safety. How do you see the industry working to attain the same?

Vaccination is one of the most successful tools in reducing the burden of diseases and mortality in the world and WHO estimates that vaccination prevents around 3.5 to 5 million deaths every year. However, as vaccines are usually given to a healthy population, safety is definitely of paramount importance. In order to ensure safety, the vaccine developers undertake rigorous pre-clinical testing in both in vitro and in vivo models for vaccine potency and safety using sophisticated analytical tools before moving into toxicology study in animals. If the vaccine is found suitable in this stage, then it moves into different phases of clinical trials before being approved.
Vaccine introduction for public supplies is also examined by National Technical Advisory Group on Immunization (NTAGI) and based on risk to benefit ratio, which depends on disease burden, mortality, morbidity along with vaccine safety, efficacy and ease of delivery, appropriate recommendations are made.
Additionally, there are strong pharmacovigilance system in place, which helps in detection, assessment, understanding, prevention and communication of adverse events following immunization (AEFI) on periodic basis to regulatory agencies even after vaccine introduction and in case there are any alerts in safety signal the vaccine registration can be withheld or withdrawn completely.

With increased demand for vaccines, it is now imperative to reduce the time to market. How do you see the industry working to attain the same?

As vaccines are usually given to healthy individuals so its safety and efficacy especially of the new ones, need to be evaluated carefully before licensure and public use and this may take some time, which is essential for complete evaluation. Usually the time from initiation to commercialization of a vaccine ranges from 06 to 12 years depending on the complexity of the disease, disease burden, market demand and availability of clinical assays and correlate of protection etc.

One of the major breakthroughs which happened during Covid pandemic is licensure of DNA and mRNA based vaccines which are plug and play technologies and would help in expediting the delivery of vaccines in case of new wave of Covid or emergence of new pandemic.

Besides this, there are lessons learnt from Covid vaccine development and all critical stakeholders need to play a strong role in expediting the vaccine development. In this regard, there needs to be a greater emphasis on the ‘One Health’ concept as majority of diseases are of zoonotic origin. We also need to further strengthen disease surveillance and epidemiological centers for disease reporting and identification of related pathogen as new diseases emerge. At the same time we also need to set up specialized testing facilities for non-human primate and “Controlled human infection model” challenge studies to identify possible correlates of protection, which may reduce clinical trial timelines and help in our preparedness for next pandemic.

Besides this, there needs to be focus on various public private partnership programs to improve and develop next generation viral vectored vaccines and nucleic acid based vaccines.

How do you see the vaccine industry evolving in the future?

The vaccine industry has evolved a lot in the last three to four decades with many new vaccines being licensed. Further, we have learned a lot in the last two years because vaccines garnered global attention, which was a major turning point for the vaccine industry. Going forward, I believe that there will be major advancements in all aspects of vaccine research, development, manufacturing and delivery.

The next generation of vaccines would be universal vaccines targeting most of the strains and genotypes of a pathogen. We would also have therapeutic vaccines including those for non-communicable diseases. Newer vaccines are expected to be more thermostable and having better safety profile and providing longer duration of protection which can be done by advancements in protein engineering, our understanding of pathogen evolution and development of new class of adjuvants.

One would also expect better in vitro and in vivo disease models for potency and safety evaluation including challenge studies. There would be superior clinical trial designs with improved monitoring of disease prevalence, which will help in better cohort selection, establishment of safety biomarkers for quick evaluation of adverse events of special interests and high throughput assays to evaluate innate, humoral and cellular immune responses.
At the same time, vaccine delivery is expected to improve with use of needle free injection system, micro patches, implants and also non-invasive routes of delivery like oral and intranasal.

Already lot of work is going on these areas both in our country and globally and there are some reports emerging which suggest that in the next decade, we may have many such innovations and discoveries, which will revolutionize the field and vaccine industry, as we know today.

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