Stephen Bancel, chief executive officer of the American company Moderna Inc, said today that the US government may approve its emergency use in December if a positive result of the third phase of human vaccine testing comes out in November. Bansel, while addressing the annual conference of a newspaper, said today that the vaccine is not expected to come until next year if there will be sufficient interim results for the Phase III trial.
Moderna started the third phase of human trials on 30,000 volunteers in July. During the test, 50 percent of the volunteers were given a vaccine dose and the remaining volunteers were given a placebo. The company’s CEO says that its first analysis report to examine the effects of the vaccine may come in November but it is not sure when it will come. In fact, the first interim analysis report is prepared on the basis of whether the corona with 53 volunteer symptoms was infected during the whole trial. If the number of people taking the vaccine in these 53 people decreased significantly from those taking placebo, then the company would then apply for vaccine approval.
The company’s CEO said that if the vaccine’s effect was not sufficient in the first interim analysis, it would do a second analysis when 106 volunteers showed signs of infection. This may take up to December and in such a situation, approval may be given by the end of January next year or in the beginning week of February. Bansal said that to find out if the vaccine is safe, she needs to monitor the safety of at least 50 percent of the volunteers involved in the test for two months and only then she can apply for emergency use. This work is also expected to be completed by the last week of November. If Mordana immediately applies after this, it will take a few weeks to check the application and then the decision will come out in December.