Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has reported positive interim efficacy data of its COVID-19 vaccine candidate, mRNA-1273, from a Phase III study, which found the vaccine to be more than 94.5% effective in preventing COVID-19.

The data, which was reviewed by a data safety monitoring board appointed by the National Institutes of Health, was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus five cases observed in the vaccinated group, thereby resulting in a point estimate of vaccine efficacy of 94.5%. A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases in this first interim analysis. All 11 cases occurred in the placebo group and none in the vaccinated group. The Phase III study has enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the NIH, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Service.

Based on interim safety and efficacy data, Moderna intends to submit for an emergency use authorization (EUA) with the US Food and Drug Administration in the coming weeks (as reported on November 16, 2020) and anticipates having the EUA informed by final safety and efficacy data (using a median duration of at least two months). Moderna also plans to submit applications for authorizations to global regulatory agencies.

Rolling reviews with other regulatory agencies

Late last month (October 2020), Moderna received confirmation that the Medicines and Healthcare products Regulatory Agency, the UK pharmaceutical regulatory agency, started a rolling review of its COVID-19 vaccine. A rolling review process allows review of data from ongoing clinical trials as soon as it is available. This process can reduce time to authorization while maintaining standards of safety, efficacy, and quality.

In addition to the UK, other regulatory agencies have started rolling reviews of Moderna’s COVID-19 vaccine, mRNA-1273. Earlier this month (November 2020), the Committee for Medicinal Products for Human Use of the European Medicines Agency started a rolling review of Moderna’s COVID-19 vaccine. Swissmedic, the Swiss pharmaceutical regulatory agency, also started a rolling review of mRNA-1273 earlier this month (November 2020) following positive results from a preclinical viral challenge study and a positive interim analysis of a Phase I study of mRNA-1273 in adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.

Supply pact with the UK and global manufacturing update

In a separate development, Moderna has entered into a supply agreement with the UK government to supply its COVID-19 vaccine, mRNA-127, beginning in March 2021 if it is approved for use by UK regulatory authorities.

Moderna says it is scaling up global manufacturing to be able to deliver approximately 500 million doses per year of its vaccine and possibly up to 1 billion doses per year beginning in 2021. The company is working with its strategic manufacturing partners, Lonza and Laboratorios Farmacéuticos Rovi of Spain, a pan-European pharmaceutical company and CDMO, for manufacturing and fill-finish of its vaccine for a dedicated supply chain to support Europe and countries other than the US that enter into purchase agreements with Moderna. Separately, the US government earlier agreed to provide up to $1.525 billion to purchase supply of mRNA-1273.

Source: Moderna (interim results), Moderna (UK supply), Moderna (Swissmedic), and Moderna (European Medicines Agency)