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Moderna’s Covid-19 vaccine meets primary efficacy endpoint in Phase III trial

Moderna has announced that its Phase III clinical trial of the investigational next-generation Covid-19 vaccine, mRNA-1283, met its primary efficacy endpoint.

The vaccine demonstrated non-inferior efficacy against Covid-19 compared to Spikevax (mRNA-1273).

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Notably, the trial observed higher efficacy in adults aged 18 years and above, with a consistent trend reported in those aged 65 years and older.

The observer-blind, randomised, active-controlled study involved approximately 11,400 participants aged 12 and above.

Participants were administered either a 10μg dose of mRNA-1283 or a 50μg dose of Spikevax.

In March this year, the company reported positive interim immunogenicity data from the vaccine trial.

The latest efficacy data align with the immunogenicity results, indicating that mRNA-1283 elicits stronger neutralising antibody responses against both the Omicron BA.4/5 variant and the original SARS-CoV-2 strain.

In terms of safety, mRNA-1283 was found to have a profile similar to that of Spikevax, with the most common side effects being pain at the injection site, headache, fatigue, and myalgia.

The vaccine is also a component of the company’s combination vaccine candidate, mRNA-1083, which targets both influenza and Covid-19.

The company recently reported positive data from the Phase III combination vaccine trial.

Furthermore, Moderna plans to discuss the next steps for the mRNA-1283 programme with regulatory authorities.

Moderna CEO Stéphane Bancel said: “We are very pleased that mRNA-1283 has now met its primary vaccine efficacy endpoint in Phase III, and showed higher efficacy in adults compared to Spikevax.

“With five vaccine programmes that have achieved positive Phase III results, Moderna’s platform is consistently demonstrating its ability to address significant unmet needs in public health.”

mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena)  is supported by Trilink. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

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