Moderna COVID-19 vaccine 94.5 per cent effective

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Moderna has announced it will seek emergency authorisation in the US for its mRNA COVID-19 vaccine "in the coming weeks" after an interim analysis from a late-stage trial showed it was 94.5 per cent effective against the virus.

The company has become the second to report a strong efficacy readout from a late-stage trial, following Pfizer and its partner BioNTech reported similar results for their mRNA vaccine.

Moderna has advance supply agreements with multiple countries, including the US, Japan, the European Union and Switzerland, Canada and the global COVAX facility. It has also expanded its global manufacturing capacity through a deal with the Serum Institute of India.

Australia does have yet have an agreement with Moderna but has agreed to procure 10 million doses of the Pfizer-BioNTech candidate.

Moderna said it expects to have approximately 20 million doses of the vaccine ready to ship in the US by the end of 2020 and that it remains on track to manufacture 500 million to one billion doses globally in 2021. 

In a statement, the company said, "...the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.

"This study, known as the COVE study, enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services."

The study involved 30,000 participants aged 18 and older, including people aged over 65.

The company also announced the vaccine, which is administered in two doses, can be stored at 0-7 degrees (celsius) for up to 30 days and it stable for 12 hours at room temperature.

The study's primary endpoint of efficacy was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the vaccine group.

A secondary endpoint analysed severe cases of COVID-19. It included 11 severe cases in this first interim analysis. All 11 cases occurred in the placebo group and none in the vaccinated group.

"The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns," said the company, adding the majority of adverse events were mild or moderate in severity. 

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, CEO of Moderna.