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Moderna to seek limited emergency use of COVID-19 vaccine if data shows high efficacy | Reuters
CHICAGO (Reuters) - If Moderna Inc's MRNA.O COVID-19 vaccine proves to be at least 70% effective, the company plans to seek emergency authorization for its 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 push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. As of Wednesday night, Moderna had enrolled 25,296 participants.
But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who did not.
Vaccines must demonstrate 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 with at least twice as many occurring among the placebo group.
If a vaccine is especially effective, companies could have their answer sooner.
An independent safety board will take a first look at Moderna’s data as soon as a total of 53 people in the trial become infected with COVID-19. Moderna is projecting the interim analysis will occur in November, but it could come as early as October.
If most of the people who got sick got the placebo shot, that would indicate the vaccine was protecting those inoculated and could be enough evidence to seek U.S. regulatory approval for Emergency Use Authorization (EUA).
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With only 70% efficacy, it's still a gamble. Two shots, a couple of weeks apart, are needed. And it takes about a month for the vaccine to generate maximum immunity. And if you get infected before the full immunity is reached, this virus has a way of shutting down your immune system by stopping the production of antibodies.
CHICAGO (Reuters) - If Moderna Inc's MRNA.O COVID-19 vaccine proves to be at least 70% effective, the company plans to seek emergency authorization for its 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 push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. As of Wednesday night, Moderna had enrolled 25,296 participants.
But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who did not.
Vaccines must demonstrate 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 with at least twice as many occurring among the placebo group.
If a vaccine is especially effective, companies could have their answer sooner.
An independent safety board will take a first look at Moderna’s data as soon as a total of 53 people in the trial become infected with COVID-19. Moderna is projecting the interim analysis will occur in November, but it could come as early as October.
If most of the people who got sick got the placebo shot, that would indicate the vaccine was protecting those inoculated and could be enough evidence to seek U.S. regulatory approval for Emergency Use Authorization (EUA).
===================================================================
With only 70% efficacy, it's still a gamble. Two shots, a couple of weeks apart, are needed. And it takes about a month for the vaccine to generate maximum immunity. And if you get infected before the full immunity is reached, this virus has a way of shutting down your immune system by stopping the production of antibodies.