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GEN: What do you consider the most significant innovation in vaccine development over the last 40 years?

Steve Hager, PhD
Steve Hager, PhD

Dr. Hager: The COVID-19 pandemic has accelerated significant innovation in vaccine development, most notably in the types of modalities that are being leveraged to quickly develop COVID-19 vaccines and make them available to the global population. The vaccines on the front lines in the fight against COVID-19 are nucleic acid based, specifically mRNA based and DNA based.

Historically, vaccines have been protein based or have consisted of attenuated or killed virus. However, these types of vaccines can take significant time to develop and bring to market. One of the benefits of nucleic acid–based vaccines is that they can be developed rapidly once the target antigen is identified. Additionally, nucleic acid–based vaccines can be quickly adjusted to address new variants as they arise in the population. The pandemic has led to the emergency use authorization of several nucleic acid–based vaccines, which suggests that these modalities can be part of the toolbox for development of new vaccines in the future.

GEN: What services does Catalent currently offer companies looking to develop new vaccines?

Dr. Hager: Catalent Biologics has the capabilities to support the development and manufacture of these new nucleic acid– based vaccines, but also more traditional protein-based and virus-based vaccines. Whether the vaccine program requires the expression and purification of proteins, nucleic acids, virus-like particles, polysaccharide-conjugated vaccines, recombinant viral vectors, or live attenuated pathogens (viruses/bacteria), Catalent can help with research and preclinical vaccine studies. As the project advances, we can also provide cGMP manufacturing services to bring vaccine candidates through clinical trials to the market. Catalent has expertise in developing and manufacturing vaccines to protect against a wide variety of infectious diseases and cancers, including working with multiple partners on all major classes of COVID-19 vaccines in development.

GEN: Where do you see next big breakthroughs in vaccine development coming from?

Dr. Hager: A logical next step in the evolution of vaccine development would be to look at nucleic acid–based vaccines for their ability to help address other infectious diseases. The ability to quickly adapt vaccines to new variants could make nucleic acid–based vaccines a good candidate to address fast-mutating viruses, such as influenza.

Another trend that we may see is drug developers looking to leverage these nucleic acid–based modalities to develop vaccines, not just for infectious diseases, but for other indications such as cancer.

For example, for patients with breast cancer, the genetic makeup of a tumor cell can vary from patient to patient and can even vary in the same patient over the course of their disease. It is not cost efficient to develop protein-based therapies against such a wide variety of tumor genetic “fingerprints.” Nucleic acid–based vaccines provide the opportunity to quickly design a cancer vaccine that can be tailored to the tumor’s genetic profile.

GEN: What lasting impact on the vaccine development process do you think the COVID-19 pandemic will have?

Dr. Hager: The pandemic has expanded our collective knowledge of how to develop, formulate, manufacture, and supply vaccines to the global population. We have seen that new modalities, such as nucleic acid–based vaccines, can be developed and quickly scaled to address a serious public health crisis. We have witnessed the improvement of cold-chain distribution to supply these novel vaccines across state lines and country borders. We have also seen unprecedented collaboration across pharma companies, regulatory agencies, suppliers, and other stakeholders. I hope that all of these advancements will be leveraged in the future as needed to address new and existing diseases.


For more information, visit biologics.catalent.com.

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