By Caroline Seydel, GEN News, March 3, 2025

The extraordinary success of mRNA vaccines in the rapid response to the COVID-19 pandemic has precipitated a monumental shift in the landscape of vaccine development. Companies worldwide are now strategically leveraging the remarkable versatility and adaptability of mRNA technology to address a broader spectrum of infectious diseases, extending beyond traditional viral targets to encompass formidable bacterial pathogens. This revolutionary approach promises to redefine disease prevention strategies, offering enhanced efficacy, rapid adaptability to emerging threats, and the potential to mitigate the escalating crisis of antibiotic resistance.

 

Confronting the Silent Pandemic: mRNA Vaccines Battle Antibiotic Resistance

CureVac, a vanguard in mRNA technology with over two decades of experience, is spearheading the development of a groundbreaking vaccine against uropathogenic E. coli (UPEC), the predominant cause of recurrent urinary tract infections (UTIs). This mRNA vaccine targets the highly conserved fimH antigen, a critical adhesive surface protein that facilitates bacterial colonization of the urinary tract. By orchestrating both robust antibody and potent T-cell responses, this vaccine aims to provide comprehensive and durable immune protection, significantly reducing the reliance on repeated and often prolonged antibiotic treatments.

“The true brilliance of mRNA technology lies in its capacity to elicit a multifaceted immune response,” elucidates Alexander Zehnder, MD, CEO of CureVac. “Beyond inducing the production of neutralizing antibodies to prevent initial infection, it empowers the immune system to mobilize cytotoxic T cells, which actively seek out and eliminate already infected cells. This dual mechanism offers a more robust and sustained defense against recurrent infections, addressing both the prevention and resolution of the disease.”

Preclinical studies have demonstrated the superior immunogenicity and T-cell activation elicited by CureVac’s mRNA vaccine compared to traditional protein-based comparators, showcasing its potential to surpass conventional vaccine approaches. With plans to file an Investigational New Drug (IND) application in the second half of 2025 and initiate Phase I clinical trials in early 2026, CureVac is poised to translate these promising preclinical findings into tangible clinical benefits for patients.

Afrigen Biologics, in collaboration with Evaxion, is tackling the increasingly urgent challenge of antibiotic-resistant gonorrhea with an innovative mRNA vaccine. Leveraging Evaxion’s proprietary AI-Immunology™ platform, they have meticulously identified and validated key antigens for their vaccine candidate, EVX-B2. Preclinical data have demonstrated that the mRNA version of these antigens elicits comparable immunogenicity to protein-based versions, demonstrating the platform’s capacity to induce a robust and protective immune response.

“The COVID-19 pandemic has unequivocally demonstrated that mRNA is a safe, versatile, and highly effective platform for vaccine development,” emphasizes Petro Terblanche, PhD, CEO of Afrigen. “By extending this technology to combat antibiotic-resistant infections, we are addressing a critical global health challenge that threatens to undermine decades of progress in infectious disease control.”

This vaccine holds particular significance given the Centers for Disease Control and Prevention’s (CDC) designation of gonorrhea as an urgent antibiotic-resistant threat, underscoring the pressing need for alternative preventive measures to curb the spread of this increasingly intractable infection.

 

mRNA Vaccines: A New Arsenal Against Common Viral Infections and Beyond

Moderna has initiated a pivotal Phase III clinical trial to evaluate the safety and efficacy of its mRNA norovirus vaccine, with a primary focus on the elderly population, which is disproportionately affected by severe gastroenteritis and its associated complications. The vaccine’s inherent adaptability to emerging norovirus genotypes represents a significant advantage, allowing for rapid updates to vaccine composition to ensure effectiveness against circulating strains.

“The ability to swiftly adapt to new norovirus genotypes is a key strength of our mRNA platform,” explains Doran Fink, MD, PhD, of Moderna. “This flexibility ensures that the vaccine remains effective against circulating strains, providing optimal protection to vulnerable populations and mitigating the burden of norovirus-related morbidity and mortality.”

The trivalent vaccine, targeting three prevalent norovirus genotypes, utilizes the same mRNA and lipid nanoparticle (LNP) technology that underpinned the success of Moderna’s COVID-19 vaccine, demonstrating the platform’s versatility and applicability across a range of viral targets.

Pfizer and BioNTech have reported promising results from a Phase III clinical trial of their combination COVID-19 and influenza mRNA vaccine, aiming to simplify immunization logistics by providing simultaneous protection against both respiratory viruses in a single injection. While demonstrating robust immunogenicity against influenza A, the companies are evaluating adjustments to enhance responses against influenza B, ensuring comprehensive protection against both influenza subtypes.

Pfizer also announced compelling Phase II data for its second-generation trivalent influenza vaccine, showcasing robust immunogenicity against all tested strains. These findings underscore the potential of mRNA technology to deliver next-generation influenza vaccines with improved efficacy, breadth of protection, and adaptability to evolving viral strains.

 

The Dawn of a New Era in Vaccine Development and Global Health Security

These groundbreaking developments underscore the transformative potential of mRNA technology to revolutionize vaccine development and redefine global health security. As research progresses and clinical trials advance, mRNA vaccines are poised to play a pivotal role in preventing a wide range of infectious diseases, offering enhanced efficacy, rapid adaptability to emerging threats, and the potential to mitigate the escalating crisis of antibiotic resistance. This technology represents a significant leap forward in global health, offering hope for more effective, accessible, and adaptable preventive measures against a diverse array of pathogens, and ushering in a new era of proactive and responsive public health interventions.

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