Strategies for Effective Vaccine Development for Emerging Diseases

Dr. Maithal, a distinguished expert in Vaccines & Biologicals R&D, leads with a proven track record. Notably, he spearheaded the development of ZyCoV-D, the world's first human DNA Vaccine against COVID-19. His expertise spans product development, project management, and strategic alliances. In a recent interaction with Thiruamuthan (Correspondent, Industry Outlook), he shared his insights on various aspects pertaining to the vaccine development process and how the industry has evolved post the COVID-19 pandemic.

Tell us about how vaccines have improved public health in recent times.

Vaccines are one of the most important interventions in the history of mankind, as they not only help in eradicating diseases - but also significantly influence socio-economic balance across countries by improving global health. As per UN data vaccination has led to a decline in the global mortality rate among children aged less than five years from over 12 million to five million per year in the last three decades. Almost 90 countries around the world have contributed to the reduction of this mortality rate by at least 2/3rd in the same period. India has been able to do better than the average, reducing the mortality rate by 75 percent. Additionally, we have been able to eradicate polio and maternal & neonatal tetanus due to successful vaccination drives in our country. Due to successful vaccination drives, the quantum of funds saved in terms of fewer medical tests, medical interventions, medication, and less time off work by both patients and their caretakers helps in the economic growth of a country, besides making societies happier, more productive, and more vibrant. Although we have made big strides in this area, globally over one million children aged less than five years still succumb to vaccine-preventable diseases annually, which is worrisome and demands continued focus and effort by all stakeholders.

Tell us about the key considerations for developing vaccines for new diseases worldwide.

The primary consideration for vaccine development and introduction hinges on four main factors which are integrated and not in any sequence of priority. The first consideration is the epidemiological and surveillance data, which tells about the disease incidence, mortality & morbidity rates, pathogen diversity, anti-microbial resistance, pathogen escape mutants, and strain replacement that help in predicting the healthcare impact of the vaccine to be developed and its potential demand. The second consideration deals with programmatic implementation and is based on the economic burden of the disease, availability of alternative treatment tools or medicines, desired vaccine coverage, vaccine regimen, cold chain requirements, ease of distribution, and transportation. 

The third consideration is based on clinical aspects related to vaccine efficacy, its safety, assessment of risk vs. benefit of the vaccine, longevity of protective immune response, vaccine non-interference with other vaccines, and target cohort. The final consideration deals with understanding the competitive landscape, product commercialization timelines, cost of development, availability of both external & internal sources of funds for development, probability of technical & regulatory success (PTRS), and availability of manufacturing infrastructure. 

Besides these, there are several other factors that play an important role in deciding the development of a new vaccine like expected net present value, productivity index, existing vaccine pipeline, etc. 

How can companies, governments, and regulatory bodies work together to speed up the vaccine development and approval process?

For a successful and rapid vaccine development, I feel academia, industry, policymakers, regulators, and funding organizations have to work hand-in-hand. This was quite evident during the pandemic when the vaccine development and commercialization happened at an astonishing pace. 

During the pandemic, various multilateral organizations and Government agencies not only provided both financial and technical support but also shared the risk of failure during vaccine development, which increased the appetite for innovation in the country. The lessons learned during the pandemic need to be replicated well now, and there needs to be stronger public-private partnerships (PPPs) with clear deliverables and milestones to have a successful outcome. These PPPs also need to be supported based on priority vaccines by both push and pull funding. Also, the role of regulatory agencies becomes vital in terms of expediting product licensure based on CMC, preclinical, and clinical data. In fact, there have been significant efforts in streamlining this and digitalization in recent times, which will help in building robust processes, review mechanisms, and timely decision-making. Another important learning during the pandemic was the continuous guidance being provided by policymakers and regulators for COVID vaccine development, which helped vaccine developers to be the right first time and avoided unnecessary repetitions or ambiguity in the requirement of data for vaccine approvals and needs implemented for at least our country-specific vaccine programs. 

Explain the impact of new technologies like mRNA on the vaccine development process for new diseases.

Although messenger RNA (mRNA) was discovered in the early 1960s and technology to deliver it into cells was available in the 1970s, the major challenge was the rapid degradation of the mRNA in the body which often led to vaccine failure. But this issue is resolved with advancements in nanotechnology and today, lipid nanoparticle formulations have led to first-generation mRNA-based COVID vaccines, which were successfully used in many countries. Besides the mRNA platform, there has also been major progress in DNA and live viral vector-based vaccines during the pandemic. Both DNA and mRNA-based vaccines have significant advantages related to rapid vaccine development, ease of manufacturing, and safety. Additionally, they also reduce the risk of causing disease in immunosuppressed patients as there is no live virus. But unlike mRNA-based vaccines, DNA-based vaccines also have additional advantages in terms of low cold chain requirements. These new platforms have now become the norm for vaccine developers and are also being used for the development of bio-therapeutics and vaccines for non-communicable diseases including cancer, autoimmune disorders, and metabolic diseases.

                                      ***********

(The views expressed here are the individual’s own and does not necessarily reflect those of the organisation)