If Moderna Inc’s COVID-19 vaccine proves to be at least 70% effective, the company plans to seek emergency authorization for use in high-risk groups, the company’s chief executive told Reuters.
Moderna’s vaccine candidate, mRNA-1273, is nearing the finish line in its effort to enroll 30,000 people in an advanced-stage trial of a new coronavirus vaccine. But the company can declare victory early if it can show that the people who received the vaccine did much better in its trial than those who did not.
Vaccines must show that they are at least 50% more effective than a placebo to be considered for approval. To prove that, government officials have said, at least 150 COVID-19 infections must be recorded among trial participants and at least twice as many as occur in the placebo group.
If a vaccine is especially effective, companies might have their answer sooner.
An independent safety board will examine Moderna’s data for the first time as soon as a total of 53 people in the test become infected with COVID-19. Moderna projects that the interim analysis will take place in November, but could arrive in early October.
If the majority of the people who became ill received the placebo injection, that would indicate that the vaccine was protecting those inoculated and could be sufficient evidence to seek US regulatory approval. For Emergency Use Authorization (US) ).
“If the independent safety committee considers the intermediate reading to be positive with an efficacy of 70, 80 or 90%, we will actually consider its approval,” said Stephane Bancel, Moderna’s CEO, in a telephone interview.
“With such a level of effectiveness, if we get there, we can protect many lives of the people most at risk, so we will consider applying for an EUA for a very limited population,” Bancel said.
In a statement ahead of an investor meeting the company will hold on Thursday, Moderna said the trial has now enrolled 25,296 of the 30,000 expected volunteers and more than 10,000 have received two doses of the vaccine.
Moderna decided to publish its full trial plan to build public confidence that it is doing everything it can to ensure a vaccine is safe and effective, said CEO Stephane Bancel.
“We have been working nine months to try to stop this virus by bringing a vaccine to market,” Bancel said. “We want to make sure vaccines are trusted by the general public by being transparent.”
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