17 Nov

US pharmaceutical firm Moderna says its coronavirus vaccine candidate was found to be 94.5 percent effective in an interim analysis.

The company on Monday released the first interim analysis of the Phase 3 study of the vaccine candidate.

Moderna is conducting the study in collaboration with institutions including the National Institutes of Health.

The study enrolled more than 30,000 people in the United States, and 95 cases of COVID-19 were confirmed.

Of the 95 cases, 90 cases were observed in the placebo group, and five in the vaccinated group. The firm said this led to an estimate of vaccine efficacy of 94.5 percent.

There were 11 severe cases in the first interim analysis. The company said all of them occurred in the placebo group and none in the vaccinated group.

Moderna said no significant safety concerns were reported.

It said the majority of adverse events were mild or moderate in severity. After the second dose, 9.7 percent of participants experienced fatigue; 8.9 percent had myalgia; 5.2 percent suffered arthralgia; and 4.5 percent experienced headache.

The company said these data are subject to change based on ongoing analysis of the Phase 3 study data and final analysis.

Moderna plans to submit data from the full Phase 3 study to a peer-reviewed publication.

The firm says it will apply for an emergency use authorization with the US Food and Drug Administration in the coming weeks.

It expects to have about 20 million doses ready to ship in the US by the end of 2020. 

The company says it remains on track to manufacture between 500 million doses and one billion doses globally in 2021.

The Japanese government has a contract with Moderna to provide the country with doses of the vaccine for 25 million people, with four-fifths expected to be shipped between January of next year and June.

NHK