Moderna Inc company plans to seek emergency authorization for its use if the COVID-19 vaccine proves to be at least 70 percent effective, 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. 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 didn't.
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-19infections 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).
"If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90% efficacy, we will indeed consider approval," Stephane Bancel, Moderna's chief executive officer, said in a telephone interview.
"At such a level of efficacy, if we get there, we can protect a lot of lives in the people at the highest risk, and so, we will consider filing for a EUA for a very limited population," Bancel said.
He said the FDA will determine whether the benefit of the vaccine to a small group of high-risk individuals outweighs the risk of not having a full readout of safety data from all 30,000 study participants.
The two groups of high-risk individuals who might be covered in such a EUA would be healthcare workers and the elderly, Bancel said.
Bancel said the company wants to gather more data on the safety of the vaccine in the study population over a period of several months before seeking full FDA approval.
Moderna which has never brought a vaccine to market has received nearly $1 billion from the U.S. government under its operation Warp Speed program. It has also struck a $1.5 billion supply agreement with the United States.
Source: Reuters
