Recently, the possibility of a 'multi-demic' is increasing as various respiratory infections, including influenza (flu), novel coronavirus infection (COVID-19), respiratory syncytial virus (RSV), and human metapneumovirus (HMPV) from China, are occurring simultaneously. In response, global pharmaceutical companies have begun developing combination vaccines that prevent multiple viruses with a single injection. It is expected that these 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 surged recently, indicating that this winter's outbreak will continue. Additionally, the number of hospitalized patients with RSV infections is continuing to rise primarily among infants and young children (0-6 years old). The agency is actively recommending vaccination to prevent respiratory diseases. Currently, COVID-19 and influenza vaccines can be administered simultaneously, but they must be given at separate sites.
Amid this situation, global pharmaceutical companies are accelerating their efforts to develop combination vaccines that prevent more than two viruses with a single injection.
Moderna, a U.S. pharmaceutical company that developed an mRNA-based COVID-19 vaccine, is representative of this trend. It is completing phase 3 clinical trials for its combination vaccine 'mRNA-1083,' which responds to COVID-19 and the flu, and plans to submit its product license application to the U.S. Food and Drug Administration (FDA) within this year. So far, Moderna is the only company to have completed the development of a combination vaccine.
mRNA-1083 is a vaccine that combines the flu vaccine candidate mRNA-1010 and the COVID-19 vaccine candidate mRNA-1283. In the results of phase 3 clinical trials conducted by Moderna last July, involving 4,000 participants aged 50-64 and over 65, it was revealed that the vaccine was more effective than when the COVID-19 and influenza vaccines were administered separately against three types of viruses (H1N1, H3N2, B/Victoria).
Stéphane Bancel, CEO of Moderna, emphasized, "mRNA-1083 can not only reduce the burden of respiratory viruses on the healthcare system but also provide a more convenient vaccination option for people," adding that it is "a vaccine that offers stronger protection against seasonal diseases."
According to Moderna, mRNA-1083 is expected to begin bridging clinical trials in the country starting in March to request approval from the Korean Ministry of Food and Drug Safety. Bridging clinical trials are additional trials conducted to verify any racial differences among domestic participants for drugs that have already been approved overseas. These trials have a shorter duration than general clinical trials, so the company estimates that it will take about 2 to 3 years for practical introduction.
Following the mRNA-1083 vaccine, Moderna plans to develop a vaccine that simultaneously prevents COVID-19, influenza, and RSV.
Novavax in the United States is also in the process of developing a combination vaccine for COVID-19 and influenza. A serious adverse event (SAE) related to motor neuropathy was reported in one of the phase 2 trial participants, leading the FDA to temporarily withhold approval for phase 3 trial plans, which was recently re-approved.
Pfizer is also developing candidates for a combination vaccine for COVID-19 and influenza, as well as a combination vaccine to prevent COVID-19, influenza, and RSV. In addition, Pfizer is developing vaccine candidates for more than 10 viruses, including tuberculosis and malaria, all built on the mRNA platform, with plans to create a multi-vaccine that can respond to more viruses simultaneously.
Among domestic companies, SK bioscience is also working on a combination vaccine. However, it is still in the very early stages of candidate substance discovery, so it is expected to take a long time before entering clinical trials.