Moderna has received emergency use authorisation from the US Food and Drug Administration (FDA) for its updated version of the COVID-19 vaccine.
The mRNA vaccine's 2024–2025 formulation, named Spikevax, has been developed to target the KP.2 variant of SARA-CoV-2.
The vaccine is suitable for those above 6 months of age, and will assist in reducing the prevalence of local outbreaks associated with the virus.
The update vaccine is scheduled to be available in the country within the coming days.
The FDA's verdict was based on a combination of manufacturing and preclinical data, with previous real-world and clinical evidence also influencing the decision.
Moderna is also manufacturing an updated COVID-19 mRNA vaccine that targets the JN.1 variant of SARS-CoV-2, which will allow the company to offer a more comprehensive range of vaccinations to support public health.
"COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalisation, regardless of age or health condition. In the 2023-24 season, we saw more than 600,000 hospitalisations due to COVID in the US. Staying up to date with your COVID-19 vaccine remains one of the best ways for people to be protected and prevent severe illness," said Stéphane Bancel, CEO of Moderna.
"We appreciate the US FDA's timely review and encourage individuals to speak to their healthcare providers about receiving their updated COVID-19 vaccine alongside their flu shot this Autumn."