Perspectives on the Vaccine Industry

Merck recently conducted a study on the future of vaccine manufacturing in the Asia-Pacific region. Nearly 40 executives from the biopharmaceutical industry, CDMOs, and research institutes across ten countries were interviewed on topics ranging from vaccine modalities to technology adoption and the facility of the future.

Here are some key findings, from our perspective, on the study.

Key finding #1: mRNA is a key focus of vaccine manufacturers and is expected to be the dominant modality in the future.

While traditional vaccine modalities continue to play an important role, 87% of the respondents intend to focus on mRNA and the majority believe this modality will dominate the future vaccine landscape. Most manufacturers stated an intent to establish capabilities in novel vaccine platforms and indicated that both traditional and modern cell-based vaccines remain important given their proven regulatory record, high efficacy, and generally fewer side effects.

Given the protection offered by the SARS-CoV-2 mRNA vaccines and the accelerated development timelines, it’s no surprise that this modality has gained significant traction and interest across the biopharmaceutical industry. When comparing the development times of different modalities, nucleic acid-based vaccines have the fastest development time, and as an established platform technology, mRNA enables a tremendous amount of manufacturing flexibility and production speed.

Key finding #2: Vaccine makers prefer to establish new facilities, especially for mRNA but face technical and regulatory barriers.

More than 60% of survey respondents indicated that they favor establishing new facilities or revamping existing facilities with expansion plans over the next few years. Preference for a new facility is driven by the fact that mRNA does not require an extensive setup or that there would be no excess capacity to convert. Other respondents would prefer to update and utilise existing facilities for the pilot phase of development and, in some cases, only establish new facilities after the approval of the vaccine. For mRNA vaccines, the barrier to adoption is the lack of experience with this modality, lack of access to technology and manufacturing expertise, and the evolving regulatory considerations.

The recent pandemic created a sense of urgency across the entire biopharmaceutical industry to develop new vaccines and therapeutics. Given the need to move quickly, revamping existing facilities made the most sense to enable a rapid response. With the pandemic behind us, companies now have time to consider and evaluate a range of options when it comes to vaccine production. With mRNA vaccine production requiring relatively less space than other approaches, new facilities may be more feasible and affordable.

Key finding #3: Key concerns for adoption of new technology are expertise, availability of skilled personnel, associated risks, and the need for a reliable supply chain.

Survey participants were asked to rank their main concerns and challenges when planning for the adoption of new technologies. Availability of expertise, skilled personnel, and the risk of novel technologies were cited as the top concerns. Factors such as the return on investment, anticipated future demand, and scale-up ranked lower on the list of concerns.

Ultimately, the selection of which vaccine modality to be produced requires cost considerations and an assessment of available resources. In addition, partnering with a technology provider with global experience in manufacturing all different types of vaccine modalities can further ensure a cost-effective, high-quality process. A strong partner with in-depth expertise and the ability to leverage novel technologies will also help reduce risk and shorten timelines.

Going Forward

The COVID-19 pandemic has helped usher in a new era of vaccines and expanded the roster of modalities that can be applied to address some of the most devastating infectious diseases. We believe that together with the biopharmaceutical community, we can impact life and health with science. Here is what we can anticipate:

1. Manufacturers will continue to leverage more modern, leading-edge technologies to develop more advanced vaccine modalities such as mRNA and viral vectors.
2. Traditional vaccine types such as inactivated viruses and recombinant protein/subunits will remain an important part of the landscape due to a strong history of investment, efficacy, and regulatory success.
3. Most vaccine producers prefer a manufacturing capability that uses multiple vaccine templates and produces different biologic modalities in parallel, even if cautiousness is required for entering a new field.
4. Vaccine manufacturers are actively planning for expansion and next-generation vaccine facilities will undoubtedly incorporate the concepts defined by bioprocessing 0 consisting of connected, or continuous processing, seamlessly coupled with data and analysis; a fully digitalised manufacturing process would be ideal as regulatory authorities rely on data recorded during production for verification and approval.