Moderna Initiates Phase III Clinical Trial for Combo Flu and COVID-19 Vaccine
ICARO Media Group
Moderna, a leading biopharmaceutical company, has announced the commencement of a phase III clinical trial for a combination influenza and COVID-19 vaccine. This significant development aims to evaluate the safety and efficacy of the combo vaccine in comparison to separate flu and COVID vaccines. The trial will be conducted on two groups of adults, one comprising 4,000 individuals aged 65 and older, and another involving 4,000 adults between the ages of 50 and 64.
Previous Phase I/II clinical trials conducted by Moderna have demonstrated promising results, indicating that the vaccine candidate generates antibody levels comparable to, if not higher than, those of licensed standalone influenza and COVID-19 vaccines. The combination vaccine is expected to provide simultaneous protection against flu and COVID-19 in a single dose, effectively reducing the overall burden of acute viral respiratory diseases.
By offering the convenience of receiving two shots at once, the combo vaccine has the potential to significantly increase vaccine coverage rates for both viruses. Moderna aims to obtain regulatory approval for the combination vaccine by the year 2025, emphasizing the public health benefits that combination vaccines can provide.
Modern CEO Stéphane Bancel highlighted the seasonal burden posed by both flu and COVID-19, affecting individuals, healthcare providers, systems, and economies alike. Bancel believes that combination vaccines offer a valuable opportunity to enhance consumer and provider experience, improve compliance with public health recommendations, and deliver value for healthcare systems.
Moderna estimates that between 50 and 100 million COVID-19 vaccine doses will be administered in the upcoming fall season, and over time, the COVID-19 market is expected to rival the influenza market in the United States. Currently, around the world, 500 to 600 million flu shot doses are administered annually, with 150 million in the U.S. alone, according to Moderna.
Notably, Moderna's efforts in developing a flu-COVID combination vaccine are not isolated, as other pharmaceutical companies are also exploring similar options. Pfizer-BioNTech launched phase I clinical trials for a flu-COVID combination vaccine in November 2022 and subsequently received Fast Track designation from the U.S. Food and Drug Administration to expedite development and review. Novavax is also in the process of conducting phase I/II clinical trials, with positive data indicating a robust immune response among participants.
As public health officials emphasize the importance of getting vaccinated against both the flu and COVID-19, anyone aged 6 months and older is encouraged to receive their annual flu and COVID-19 shots. The introduction of a combination vaccine holds immense potential for reducing the burden on individuals, healthcare systems, and economies, providing a convenient and effective means of protection against these viral respiratory diseases.
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