Moderna Hits Enrollment Target In Late-Stage Coronavirus Vaccine Study

Nearly three months after commencing the late-stage study of its coronavirus vaccine candidate — mRNA-1273 — and a scare over a slowing enrollment rate, Moderna Inc MRNA said it has completed enrollment in its COVE study. 

What Happened: The Cambridge, Massachusetts-based biotech said the 30,000th participant has been enrolled in the COVE study of mRNA-1273, which is being conducted in collaboration with the NIAID and the BARDA.

Of these, about 85.5% of the participants have received the second shot, the company said.

Moderna also said it has shared its statement at the FDA's Vaccines and Related Biological Products Advisory Committee meeting.

The company acknowledged the role of its CDMO partner PPD Inc PPD in assisting in the successful execution of the COVE study to date. 

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Highlighting the diversity in the study population, Moderna said more than 7,000 participants were above 65 years of age, and about 5,000 were under 65 and have high-risk chronic diseases such as diabetes, severe obesity and cardiac disease.


Source: Moderna

What's Next: Moderna said it will determine whether to submit a dossier to FDA requesting emergency use authorization based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks once the two months of median safety follow-up have accrued.

Data from the study will be reviewed by an independent Data Safety Monitoring Board chartered by NIH, Moderna said. Formal study efficacy analysis will be triggered at 151 cases, with two earlier, interim analyses after 53 and 106 cases, it added.

MRNA Price Action: Moderna shares gained 3.61% in Thursday's session, closing at $70.84. 

Related Link: FDA's COVID-19 Vaccine Guidance Shows 'Substantial' Obligations For Developers: Analyst

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