Moderna Inc has concluded plans to seek for emergency authorization for the use of its Covid-19 vaccine on high-risk groups if it proves to be at least 70% effective.
This disclosure was made by the Chief Executive Officer of Moderna, Stephane Bancel, during a telephone interview with Reuters.
Bancel said, “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. 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 an EUA for a very limited population.”
He disclosed that the Food and Drug Administration (FDA) will determine whether the benefit of the vaccine to a small group of high-risk individuals is greater than the risk of not having a full readout of safety data from all 30,000 study participants.
Bancel noted that the 2 groups of high-risk individuals who might be covered in such Emergency Use Authorization (EUA) would be the healthcare workers and the elderly.
According to him, 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’s approval.
Moderna’s vaccine candidate, mRNA-1273, which is at the conclusion stage with its move to enrol 30,000 volunteers in a final stage trial of a novel coronavirus vaccine may be able to announce its success early if it is able to show that people who got doses of the vaccine fared much better in its trial than people who didn’t.
Vaccines must show they are at least 50% more effective than a placebo to be considered for approval. Government officials said that in order to show its effectiveness, at least 150 people with Covid-19 infections must be recorded as trial participants with at least twice as many occurring among the placebo group.
