BOSTON, Mass. -- By Lee Han-soo/Korea Biomedical Review correspondent -- The Covid-19 pandemic led to significant challenges worldwide, yet it spurred remarkable progress in the pharmaceutical industry. Moderna, a Cambridge-based biotech company, stood out as a trailblazer in developing and distributing Covid-19 vaccines.

Moderna's rapid production scalability and global supply chain played a vital role in its ascent. Through strategic alliances with governments, organizations, and manufacturers worldwide, Moderna achieved large-scale manufacturing and widespread distribution of the vaccine. The company's dedication to equitable access drove collaborations with COVAX, the initiative ensuring fair distribution of Covid-19 vaccines to low-income countries.

The success of Moderna's Covid-19 vaccine not only saved lives but also bolstered the company's reputation as an innovative force in the pharmaceutical sector.

Its mRNA technology, which had previously shown promise in preclinical and clinical trials for other diseases, is now being recognized as a transformative platform with vast potential.

Rituparna Das, Moderna's VP of Covid-19 vaccines clinical development, shared valuable insights on vaccine development challenges and future vaccination strategies in an exclusive interview with Korea Biomedical Review.

Das, who joined Moderna in 2021, has been instrumental in overseeing the entire Covid vaccine program, including initial vaccine development, approval of booster shots, and expansion of vaccinations to adolescents and young children.

Reflecting on her experience, Das expressed the fulfillment she felt in working on a vaccine that immediately impacted billions of people, emphasizing the significance of this achievement in her career.

Nevertheless, Das emphasized that the journey of developing the Covid-19 vaccine was not without difficulties.

She pointed out the initial challenges faced by the scientific community, as they had to swiftly adjust and react to emerging variants like Delta and Omicron. Despite these hurdles, Moderna successfully developed Omicron-targeted vaccines in a timely manner, which demonstrated their trust in their technology, manufacturing prowess, and ability to generate clinical data.

Covid-19 is here to stay

Considering the need for continuous response to Covid-19 due to ongoing mutations, Das emphasized Moderna's collaboration with partners worldwide, including the World Health Organization (WHO) and health ministries of various countries.

“By closely monitoring new variants and the diseases they cause, Moderna aims to stay ahead in vaccine development,” she said. “The company is currently focusing on targeting the XBB variants -- XBB.1.5 and XBB.1.16 -- which are particularly evasive, and Moderna has already manufactured candidate vaccines to tackle this variant.”

Moderna is gathering that data right now and has been sharing it confidentially with investigators.

“We'll share publicly next week at the U.S. Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting,” she said.

While the interview was held on June 8, Das recently commented on such data at the VRBPAC meeting on June 15.

The company had been evaluating shots targeting XBB.1.5 and XBB.1.16 and preclinical trial data on mice suggests that the vaccine targeting XBB.1.5 produces a more robust immune response against the XBB variants than the conventional bivalent shot for BA.4 and BA.5.

Das added that clinical trial data on more than 100 people also showed that the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants.

Discussing the future of the Covid-19 vaccine administration, Das mentioned the fact that governments worldwide have already announced that Covid-19 vaccination will be an annual occurrence.

She mentioned the conversion of primary vaccination against Covid-19 for children 12 and older to a bivalent vaccine and the streamlining of the vaccination process.

Additionally, she highlighted the significance of vaccinating high-risk groups, such as the immunocompromised, to prevent severe illness and death.

Moderna well prepared to keep up with demand

Scaling up mRNA production for large-scale vaccine distribution is another hot topic. Das praised Moderna's remarkable journey, evolving from a company with a single vaccine in phase 3 trials to a global distributor of over a billion Covid-19 vaccine doses.

“Having a comprehensive understanding of our technology and a dedicated infrastructure enables Moderna to respond rapidly to evolving demands,” she said. “Moreover, the ability to use the same structures for various vaccines, such as respiratory syncytial virus (RSV) and influenza, contributes to their manufacturing consistency and adaptability.”

She went on to explain Moderna's plans for combining multiple vaccines into a single, multifaceted solution.

“Moderna already has a Covid/flu vaccine in the pipeline and is studying the feasibility of a Covid/flu/RSV vaccine,” Das said. ”With a deep understanding of respiratory infections and their impact on various populations, Moderna believes its platform is well-suited to tackle this challenge effectively.”

She placed considerable emphasis on Moderna's ongoing trial for RSV.

Turning to Moderna's recent release of phase 2 clinical trial data for an RSV vaccine candidate, she stressed despite the focus on Covid-19 during the early stages of the pandemic, Moderna managed to progress with many of its phase 1 and 2 studies for other pathogens, including RSV.

“The large phase three study for RSV, with over 37,000 participants across 22 countries, yielded promising results,” she said. “With the RSV season gaining significance in 2022, Moderna was able to capture cases swiftly and release encouraging top-line data in January.”

The vaccine demonstrated positive efficacy, prompting further analysis and data gathering for upcoming regulatory submissions.

When asked about Moderna's advantages over competitors in the highly competitive field of RSV vaccine development, Das emphasized the non-adjuvanted nature of Moderna's vaccine.

“This characteristic addresses concerns about adjuvants in vulnerable populations,” she said. “Additionally, Moderna's mRNA technology, with its extensive safety data from mRNA vaccines administered globally, provides a strong foundation for the RSV vaccine's safety and efficacy.”