[Companies] Interview: Moderna’s Pioneering Vaccines - Adapting to evolving variants and enhancing influence in Korea

Interview with Patrick Bergstedt, Senior Vice President Commercial Vaccines at Moderna

Patrick Bergstedt, Senior Vice President Commercial Vaccines at Moderna is having an interview with Chosun Biz at Moderna’s Korea office in Gwanghwamun, Seoul, on Nov. 7

In the ongoing landscape of the endemic COVID-19, major vaccine developers such as Pfizer and Moderna remain steadfast in their commitment to addressing the continually evolving variants of the virus. Recently, they unveiled the XBB.1.5. vaccine, designed to protect against the EG and XBB variants. This groundbreaking development saw its distribution commence in Korea on Oct. 19, with a noteworthy increase in vaccination rates targeting high-risk individuals aged 65 and older.

During an interview with Chosun Biz at Moderna’s Korea office in Gwanghwamun, Seoul, on Nov. 7, Patrick Bergstedt, Senior Vice President Commercial Vaccines at Moderna, said, “Korea is a very vaccine conscious society, and people are relatively vaccine friendly.”

“The Korean government does a really good job of advocating vaccines, especially KDCA (Korea Disease Control and Prevention Agency) is doing an excellent job of effectively communicating and promoting vaccination efforts,” he said.

Having previously served as Head of Asia-Pacific and Head of Vaccine Marketing and Commercialization at Sanofi and MSD, He joined Moderna in June 2020 to lead the Emerging Markets division of the vaccines business. He visited Korea to assess the delivery system for the new vaccine and discuss collaboration with Korean stakeholders.

“I think there is a consciousness of parents vaccinating their children and adults vaccinating themselves,” Bergstedt said. “Even in this culture, adults vaccinate their parents or their grandparents which is a great case of giving back.”

Moderna established a branch in Korea in 2021 amidst the peak of he COVID-19 pandemic to expand the market. Beggstedt emphasized the strategic selection of Korea as a prime emerging market, considering factors such as the country’s economy, government support for innovation, a conducive ecosystem for clinical development, and public trust in vaccines.

“When we looked at the various criteria, Korea, Japan and Australia were the best places to expand, so Moderna was deliberate in choosing South Korea and we chose to go direct,” Bergstedt said. “The fact that the Korean government has declared the pharmaceutical and bio industry as the next growth sector was crucial.”

Currently, Moderna has 43 programs in development, with 34 entering clinical trials and accelerating development. Bergstedt outlined the company’s plan to launch up to 15 products across its main focus areas by 2028, with potential launches as early as 2025.

Bergstedt’s visit to Korea aimed to gather feedback on the recently launched vaccines, attend the Healthcare Innovation Forum 2023 organized by Chosun Biz, and explore opportunities to strengthen Moderna’s presence in Korea.

―As COVID-19 transitions into an endemic phase, is vaccination still necessary?

“I think everybody’s trying to move on. Everybody wants to forget about COVID-19 and move on and forget that the pandemic ever happened. I think while we may think so, unfortunately, the virus does not. Unfortunately, the SARS-CoV-2 continues to evolve, making it critical that we continue to keep the vaccine updated. It’s essential that we keep the vaccine relevant, and that we still offer the best protection for people.

This is especially important in a society like Korea, which faces the challenge of a rapidly aging population, making it one of the most aged populations in the world. The vulnerable populations remain at risk, and ensuring they are up to date on their vaccinations is of utmost importance.”

―What are the characteristics of the updated vaccine?

“The previous vaccine was a bivalent vaccine targeting the BA.4/5 variant. It contained the original prototype virus and the Omicron BA.4/5 variant. The latest vaccine is a monovalent vaccine targeting the XBB.1.5. The updated vaccine is no longer bivalent but offers broader protection against some of the EG variants as well as some of the other XBB variants.”

―Can you provide an update on Moderna’s progress with the influenza and COVID-19 combination vaccine?

“Moderna’s first combination vaccine candidate combines COVID-19 and the influenza. Moderna has recently announced that the first participant has been dosed in a Phase 3 study of mRNA-1083 in the U.S. The trial is expected to enroll approximately 8,000 adults in the Northern Hemisphere. We do not have the clinical data yet, but ensuring that the vaccines are safe, well tolerated and efficacious, but also bringing this convenience of only needing one shot is our first goal. We are planning to complete clinical trials and commercialize by 2025.

With combining vaccines, we will be offering you one shot that provides you with a broad, pan-respiratory protection against COVID-19, influenza and RSV. We fundamentally believe that the combination vaccines will help to improve vaccination coverage rates, which ultimately will help to improve the health of society in general.”

―When can we expect FDA approval and commercialization of the RSV vaccine?

“We have filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA), which is under review. We expect approval and commercialization in the first half of next year.

Moderna’s RSV vaccine is the only mRNA-based RSV vaccine in development approaching the market. Its RSV vaccine platform that we’ve used is the same one utilized for COVID-19 vaccine development. In addition, we plan to introduce this vaccine with a prefilled syringe. The form of vaccine will provide healthcare professionals with more convenience as the other vaccines will require multiple steps in terms of dilution.”

―Given the decline in COVID-19 product sales, how does Modena plan to navigate this situation?

“Moderna made hundreds or thousands of doses at a clinical scale to suddenly go into a situation of making a billion doses in 2021. The revenues came with that, because governments were so desperate that they were prepared to order vaccines before we even completed development.

Since the pandemic is coming to an end, that demand for COVID-19 vaccines is reducing and with that, so are the associated revenues. It’s good for the world. It’s not bad for us either. The technology was adaptable and Moderna was able to develop a very efficacious and safe vaccine. Moderna was not founded as a COVID-19 vaccine company. But now we’ve got to pivot back and get back to what we sought to do.”

―What were Moderna’s focus areas before the pendemic, and how have those pipelines progressed?

“In fact, the CMV vaccine program was our lead clinical program before COVID-19. Cytomegalovirus (CMV), is one of the greatest causes of birth defects in children. Moderna’s CMV program is far advanced. Moderna’s CMV vaccine (mRNA-1647) is in Phase 3 clinical trials for primary prevention to enable universal vaccination, in women over the age of 18. The trial is being enrolled in the U.S. and globally across 290 sites which should be completed this year.”

―Are there any collaborations with Korea in Moderna’s research efforts?

“Moderna conducted interesting R&D on a disease that is specifically problematic in Korea, which is a tick-borne disease called Severe fever with thrombocytopenia syndrome (SFTS). SFTS is debilitating for farmers as well as the military and Moderna is conducting that research program in collaboration with Korea’s National Institute of Infectious Diseases (KNIID). We will use this visit to discuss various mRNA vaccine collaborations in addition to the KCDC.”

―Beyond vaccines, what else is Moderna focusing on?

“We have a philosophy, a mindset, of digitizing everywhere, every day, everything that we can. We have Moderna University, which provides in-house training to all of our employees, helping them learn how to use AI and how to use ChatGPT in their day-to-day work. And it can be powerful. It helps us in terms of speed and efficiency. Our manufacturing and R&D processes are also powered by AI. Tracking COVID-19 variants also incorporates AI to predict how variants are evolving around the world.”

Ji Young-mi, Director of the KCDC, is discussing cooperation with Patrick Bergstedt, Senior Vice President Commercial Vaccines at Moderna on Nov. 8, on the development and supply of mRNA vaccines for emerging infectious diseases.

This article was originally published on Nov. 17, 2023.

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