Study Shows Moderna’s Omicron Bivalent Booster Vaccine Is Safe And Induces Higher Antibody Responses Than Original COVID-19 Vaccine
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AT A GLANCE
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A bivalent mRNA booster vaccine targeting the Omicron BA.1 variant of COVID-19 produces a significantly higher antibody response compared to the original vaccine with no new safety concerns, according to research presented at IDWeek.
The data come from a phase 2/3 clinical trial evaluating the safety and immunogenicity of the bivalent mRNA vaccine in adults 18 and over. Data from this trial supported the emergency use authorization of Moderna’s bivalent boosters by the Food and Drug Administration, which are currently available to people 6 years and older who have completed a primary series or previous booster two months prior.
“The Omicron variants have key mutations when compared to the original virus and raised the question about the need to update COVID-19 vaccines by including Omicron sequences in the vaccine,” said Dr. Spyros Chalkias, senior medical director of clinical development at Moderna and presenting author. “Our results indicate that the Omicron-containing bivalent booster vaccine has a safety profile that is similar to the original vaccine, and it induces enhanced antibody responses against the variants, compared to the original vaccine.”
The bivalent booster vaccine produced the same level of immune response in older adults as in younger adults, indicating the jab provides protection for this population.
While the trial focused on adults, researchers say the results are also important in informing vaccine development for other groups, including children. The data were included in the emergency use authorization application for children ages 6-11 years and adolescents ages 12-17 years, and also provide a framework for scientists tackling future variants of the disease.
“Responding quickly and effectively to emerging COVID-19 variants is one of the largest challenges facing the global community,” said Dr. Rituparna Das, vice president of clinical development of COVID-19 vaccines at Moderna. “This bivalent model provides a framework that may allow scientists to develop safe, effective and tailored vaccines more efficiently.”
In addition to Drs. Chalkias and Das, study authors include: Charles Harper, MD; Keith Vrbicky, MD; Stephen R. Walsh, MD; Brandon Essink, MD; Adam Brosz, MD; Nichole McGhee, BS; Joanne E. Tomassini, PhD; Xing Chen, ScD; Ying Chang, MS; Andrea Sutherland, MD; David C. Montefiori, PhD; Bethany Girard, PhD; Darin K. Edwards, PhD; Jing Feng, MS; Honghong Zhou, PhD; Lindsey R. Baden, MD; and Jacqueline M. Miller, MD.
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