Virus Vaccine Research and Development- Accelerated Workflows

“This is not a race between manufacturers. It is us against the virus.”

There is a saying in science that “anything is possible.” The SARS-CoV-2 pandemic proved it. In the U.S., two messenger RNA (mRNA) vaccines went from bench to bedside in months, not years, with Food and Drug Administration (FDA) emergency use authorization (EUA) designations.

Virus vaccine research and development are being transformed in real-time. To protect the world from the threat of COVID-19, researchers are redefining vaccine development timelines, processes, and platforms.

Pre-COVID-19, vaccine development took 5-18 years. It was lengthy, complex, and daunting, with a high failure rate. How was this process seemingly upended overnight to develop the first human mRNA vaccines in less than a year? To find out, PerkinElmer spoke with vaccine expert Sanjay Garg, Ph.D., Platform Head, Vendor Management R&D Global Operations, Sanofi Pasteur. Dr. Garg has followed vaccine development for two decades with academic research training at Emory University, followed by experience at the Centers for Disease Control and Prevention.

“We are all collaborating to speed up the process,” said Dr. Garg. “This is not a race between manufacturers. It is us against the virus; we have a common enemy.”

Intersecting clinical and preclinical research

Instead of occurring in a sequence, clinical trials now overlap to compress time frames. Preclinical studies may occur in tandem with first-in-human studies. Phase 1 may intersect with Phase 2. And Phase 2 may crossover into Phase 3.

According to Dr. Garg, when initial results show promise, decisions are being made for mass distribution, manufacturing large quantities at risk in parallel with Phase 3 studies. He also emphasized the importance of conducting post-marketing Phase 4 studies to continue data gathering and analysis.

“To shorten the timelines of clinical research, we need to have a good science base for vaccines,” said Dr. Garg.

One of the most challenging aspects of virus vaccine development is understanding the pathogen.  Omics and artificial intelligence expedite this stage. Systems thinking can help researchers understand the mechanisms underlying pathogenesis and characterize the effect on the immune system (Dhillon, 2020).

“We used to study virology, viral pathogenesis, and immunology separately,” said Dr. Garg. “Now, it is all together.” He described an integrated system with a holistic perspective of immune response that integrates genomics, transcriptomics, and proteomics-backed up by artificial intelligence and bioinformatics.

Multiplex solutions for accelerated workflows

To characterize immune response and identify the mediators of efficacy, viral vaccine development teams need high-throughput, reliable workflows. Multiplex panels can show mechanisms of action and monitor treatment effects with speed and reliability.

“New technology with multiplexing infrastructure is needed to look into how the virus is tracking with the immune system at the cellular level,” said Dr. Garg.

To analyze the large data sets, Dr. Garg says bioinformatics experts need to be added to the team to visualize and interpret data. Simultaneously, artificial intelligence can develop models to analyze multi-assay data, predict immune response, and validate data.

Teamwork at every level

Collaboration is key, not only among interdisciplinary teams working in parallel, but also between industry, academia, and government. As evidenced by Pfizer’s collaboration with BioNTech on the first COVID-19 vaccine to receive an EUA, leading manufacturers can join hands with biotech companies to quickly scale up. When driven by the shared goal of protecting public health, these different-sized companies’ knowledge complements each other, according to Dr. Garg.

“Partnerships with government, industry, and academia are needed. We can’t do it alone. No one can claim it all. t is about collaboration,” said Dr. Garg.

It is a new way of thinking-different players coming to the table with a commitment to share knowledge, resources, and solutions. Everyone is aligned. In this shared space, industry, academia, and government form linkages to weave a more robust, more effective safety net to protect public health and create a new foundation for virus vaccine research and discovery.

References

Dhillon, B. M. (2020, July 30). Systems biology approaches to understanding the human immune system. Frontiers in Immunity, 11, 1683. Retrieved from https://www.frontiersin.org/articles/10.3389/fimmu.2020.01683/full

Disclaimer: The information in this blog post reflects Dr. Sanjay Garg’s view on the topic and should not be taken as representing Sanofi Pasteur.