Recently, the possibility of a 'multi-demic' with multiple respiratory infections, including influenza, COVID-19, respiratory syncytial virus (RSV), and human metapneumovirus (HMPV) from China, is increasing. In response, global pharmaceutical companies have begun developing combination vaccines that prevent multiple viruses with a single shot. It is expected that these vaccines will be introduced in the country within the next two years.
According to the Korea Disease Control and Prevention Agency on the 10th, the number of patients with influenza and COVID-19 has recently surged, and this trend is expected to continue throughout the winter season. Additionally, the number of hospitalized patients with RSV infections is continuing to rise, mainly among infants and young children (ages 0-6). The agency is actively recommending vaccinations to prevent respiratory diseases. Currently, vaccinations for COVID-19 and influenza can be administered concurrently, but they must be given in different areas.
Amid these circumstances, global pharmaceutical companies are accelerating their efforts to develop combination vaccines that prevent two or more viruses with a single injection.
Moderna, a U.S. pharmaceutical company that developed the messenger RNA (mRNA) based COVID-19 vaccine, is a notable example. The company has completed Phase 3 trials for its combination vaccine 'mRNA-1083,' which targets both COVID-19 and influenza, and plans to submit a product approval application to the U.S. Food and Drug Administration (FDA) by the end of this year. To date, Moderna is the only company to have completed the development of a combination vaccine.
mRNA-1083 is a vaccine that mixes the influenza vaccine candidate mRNA-1010 and the COVID-19 vaccine candidate mRNA-1283. In the results of the Phase 3 trial conducted last July, involving 4,000 participants aged 50-64 and over 65, Moderna reported that the effectiveness was superior compared to receiving separate vaccinations for the coronavirus and three types of influenza viruses (H1N1, H3N2, B/Victoria).
Stéphane Bancel, CEO of Moderna, said, "mRNA-1083 can reduce the burden of respiratory viruses on the healthcare system and provide people with a more convenient vaccination option," adding that it is "a vaccine that offers stronger protection against seasonal diseases."
According to Moderna, mRNA-1083 is set to begin its bridging clinical trials in the country in March to request approval from the Korea Food and Drug Administration. Bridging clinical trials are additional studies to confirm whether there are racial differences in domestic populations for drugs approved abroad. These trials are typically shorter in duration compared to general clinical trials, and the company anticipates that actual implementation will take 2 to 3 years.
Following the mRNA-1083 vaccine, Moderna plans to develop a vaccine that simultaneously prevents COVID-19, influenza, and RSV.
Novavax, based in the U.S., is also developing a COVID-19 and influenza combination vaccine. A serious adverse event (SAE) involving a patient in Phase 2 trials was reported concerning a neuromuscular disease, leading the FDA to temporarily place the Phase 3 trial plan on hold before recently reapproving it.
Pfizer is also developing candidates for a COVID-19 and influenza combination vaccine and a combination vaccine that prevents COVID-19, influenza, and RSV. In addition, Pfizer plans to create candidates for vaccines against more than ten other viruses, including tuberculosis and malaria, using the mRNA platform, aiming to develop a multi-vaccine that can simultaneously tackle more viruses.
Among domestic companies, SK bioscience is developing a combination vaccine in collaboration with the French pharmaceutical company Sanofi. However, as this is still in the very early stages of candidate substance discovery, it is expected to take a long time before entering clinical trials.