Respiratory Virus Vaccines on Deck for 2024

Public attitudes toward vaccination have become increasingly complex in recent years. Factors such as vaccine fatigue and misinformation—which began circulating during the COVID-19 pandemic and have persisted—have eroded trust in vaccination, making some individuals hesitant to roll up their sleeves. Some who had previously relied on vaccine regimens began to question their value, increasing skepticism and causing a dip in vaccine uptake.

Amid these challenges, 2024 offers hope: Pharmaceutical research and development teams are pioneering new vaccines that leverage messenger RNA (mRNA) technology, expand protection to vulnerable populations, and streamline the vaccination process—efforts that may help mend ongoing divides. Here is a look at some of the most anticipated vaccine developments in 2024

Merck: 21-Valent Pneumococcal Conjugate

After its biologics license application was accepted for priority review by the FDA late last year,⁵ Merck is anticipating the 2024 launch of V116, its 21-valent pneumococcal conjugate vaccine—a first-of-its-kind immunization designed to protect adults against invasive pneumococcal disease and pneumococcal pneumonia. Merck’s vaccine represents a potential breakthrough in the pneumococcal space, as it would be the first designed for adults to target disease-specific serotypes not covered by currently licensed pneumococcal vaccines. By accepting the immunization for priority review, the FDA acknowledged the urgency and impact of this vaccine for safeguarding adults from serious illness.

The protection offered by V116 spans 8 unique serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31, 35B) which, according to the CDC, are responsible for roughly 30% of invasive pneumococcal disease in patients 65 years and older.5 Key data supporting the application for V116 were elicited, in part, from the STRIDE-3 clinical trial (NCT05425732). The phase 3 study measured the immunogenicity, tolerability, and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults 50 years and older who had not received a pneumococcal vaccine. Strikingly, the study found that V116 produced superior immune responses for 10 of 11 unique serotypes compared with PCV20.6 Results also showed the safety profile of V116 to be comparable to PCV20.

“Invasive forms of pneumococcal disease can cause serious and sometimes life-threatening complications, such as pneumococcal pneumonia, pneumococcal meningitis, and bacteremia, especially for older or immunocompromised adults,” said Sady Alpizar, MD, principal investigator/internal medicine at Clinical Research Trials of Florida, Inc, and a lead study author. “These encouraging results demonstrate that V116 has the potential to help prevent invasive pneumococcal disease among vulnerable populations."6

Merck awaits the FDA’s decision on its pneumococcal vaccine with a PDUFA date of June 17, 2024.

Moderna: mRNA-1010 for Influenza

Capitalizing on the success of its pivotal mRNA COVID-19 vaccine (Spikevax), Moderna has resolved to build its respiratory portfolio of immunizations. Among its promising candidates, the company’s mRNA-1010 vaccine—a seasonal quadrivalent flu vaccine for adults—has taken center stage.

Whereas traditional vaccines prime immune systems to fight viruses by injecting weakened or inactivated pathogens into the body, mRNA vaccines deliver genetic instructions to cells, teaching them to build proteins that mimic viruses and trigger immune responses. In 2020, Moderna developed one of the first FDA-approved mRNA vaccines for COVID-19 and aims to “[deliver] on the promise of mRNA science to create a new generation of transformative medicines”1 with the development of further immunizations like mRNA-1010.

In June 2022, Moderna announced that the first participants of its phase 3 study (NCT05827978) for mRNA-1010—the first of any seasonal influenza candidate from the company to advance to that stage of testing2—had been dosed. Following a reformulation of the vaccine in response to setbacks measured in early trials, Moderna announced in September 2023 that mRNA-1010 had met all efficacy and safety targets.

Compared with GSK’s Fluarix quadrivalent vaccine, Moderna’s shot demonstrated higher antibody levels for all 4 World Health Organization– recommended influenza strains. These included influenza A strains H1N1 and H3N2, which the company noted account for most morbidity and mortality in older adults,2 and influenza B strains Victoria and Yamagata. The vaccine also produced superior seroconversion rates, described as the rates at which virus-specific antibodies are developed, and hemagglutination inhibition assay geometric mean titers than the licensed comparator. Results from the trial further revealed that mRNA-1010 elicited strong immune responses across all age groups, including older adults,3 a population more susceptible to complications from the illness.

Moderna hopes to launch mRNA-1010 in time for the 2024-2025 flu season and is already looking to expand its repertoire of respiratory immunizations. The company announced in a shareholder letter that enrollment has been completed for trials for combination mRNA flu/ COVID-19 and flu/COVID-19/respiratory syncytial virus vaccines “with the intention to have a combination vaccine available as early as 2025.”4

Pfizer-BioNTech: mRNA Combination Influenza/COVID-19

Pfizer and BioNTech—companies that became household names during the COVID-19 pandemic for their vaccine—are competing with companies like Moderna and Novavax to bring a combination mRNA flu/ COVID-19 vaccine to market as early as 2024. In late 2022, they announced that their vaccine had received fast track designation from the FDA, signaling its potential to address critical unmet medical need.7

By combining vaccines for the 2 respiratory diseases into a single, convenient injection, the companies hope to boost lagging COVID-19 vaccination uptake observed in recent years caused in part by pandemic fatigue, adverse effect concerns, and antivaccination sentiments. This single-dose approach offers a double benefit: It prevents severe illness among more individuals, thus easing the burden placed on health care systems.

In the most recent topline data released by Pfizer-BioNTech, the combination vaccine produced robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains in adults aged 18 to 64 years. Further, results deemed that the safety profiles of the combination vaccine were comparable to those associated with the companies’ own Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

Pfizer-BioNTech announced in October 2023 that they were anticipating the start of a pivotal phase 3 trial in coming months but have not released further information. In the future, the companies expect their combination vaccine to become a routine seasonal defense against COVID-19 and the flu.

(This article appeared originally on our partner website, Drug Topics)

References

1. The power of mRNA. Moderna. Accessed February 14, 2024. https://www.modernatx.com/en-US/power-of-mrna/science-of-mrna
2. Moderna announces first participants dosed in phase 3 study of seasonal influenza vaccine candidate (mRNA-1010). News release. Moderna. June 7, 2022. Accessed February 14, 2024. https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-First-Participants-Dosed-in-Phase-3-Study-of-Seasonal-Influenza-Vaccine-Candidate-mRNA-1010/default.aspx
3. Moderna expands the field of mRNA medicine with positive clinical results across cancer, rare disease, and infectious disease. News release. Moderna. September 13, 2023. Accessed February 14, 2024. https://investors.modernatx.com/news/news-details/2023/Moderna-Expands-the-Field-of-mRNA-Medicine-with-Positive-Clinical-Results-Across-Cancer-Rare-Disease-and-Infectious-Disease/default.aspx
4. Bancel S. Moderna 2023 shareholder letter. Moderna. January 2, 2024. Accessed February 14, 2024. https://www.modernatx.com/en-US/media-center/all-media/blogs/moderna-2023-shareholder-letter
5. FDA grants priority review to Merck’s new biologics license application for V116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults. News release. Merck. December 19, 2023. Accessed February 14, 2024. https://www.merck.com/news/fda-grants-priority-review-to-mercks-new-biologics-license-application-for-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults/
6. Merck’s V116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults, demonstrated superior immunogenicity for 10 of 11 unique serotypes compared to PCV20 in adults 50 years of age and older. News release. Merck. November 28, 2023. Accessed February 14, 2023. https://www.merck.com/news/mercks-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults-demonstrated-superior-immunogenicity-for-10-of-11-unique-serotypes-compared/
7. Pfizer and BioNTech receive US FDA fast track designation for single-dose mRNA-based vaccine candidate against COVID-19 and influenza. News release. Pfizer. December 9, 2022. Accessed February 14, 2024. https://www.pfizer.com/news/announcements/pfizer-and-biontech-receive-us-fda-fast-track-designation-single-dose-mrna-based