Moderna vaccine reports 100% efficacy against severe COVID-19

Primary efficacy analysis of the Phase 3 study of Moderna’s COVID-19 vaccine candidate, mRNA-1273, has confirmed a vaccine efficacy of 94.1% — just slightly lower than the 94.5% reported in the first interim analysis last month.

The primary endpoint of the Phase 3 COVE study of more than 30,000 participants is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. Vaccine efficacy was demonstrated at the first interim analysis with a total of 95 cases based on the pre-specified success criterion on efficacy. Primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. Efficacy was consistent across age, race and ethnicity, and gender demographics.

A secondary endpoint analysed severe cases of COVID-19 and included 30 severe cases, all of which occurred in the placebo group. There has been one COVID-19-related death in the study to date, which occurred in the placebo group.

Safety data continue to accrue and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB). A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and, importantly, the ability to prevent severe COVID-19 disease,” said Moderna CEO Stéphane Bancel. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death.”

Moderna has since filed for emergency use authorisation (EUA) with the US Food and Drug Administration (FDA) and for conditional marketing authorisation (CMA) with the European Medicines Agency (EMA); shipping of mRNA-1273 to designated distribution points throughout the US will occur shortly after an EUA is granted. The company has already initiated the rolling review process with the EMA, Health Canada, Swissmedic, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Ministry of Health in Israel and the Health Sciences Authority in Singapore, and intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO).

Moderna is working with the US Centers for Disease Control and Prevention, Operation Warp Speed and McKesson, a COVID-19 vaccine distributor contracted by the US Government, as well as global stakeholders, to be prepared for distribution of mRNA-1273 in the event that it receives an EUA and similar global authorisations and approvals. The company expects to have approximately 20 million doses of mRNA-1273 available in the US by the end of 2020 and remains on track to manufacture 500 million to 1 billion doses globally in 2021.

Image credit: ©stock.adobe.com/au/hedgehog94

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