The agency issues guidelines to enhance transparency and public confidence as it moves closer to making a critical decision about whether a potential vaccine is safe and effective. Public health experts are increasingly concerned about that President TrumpRepeated predictions of a coronavirus vaccine by November 3, coupled with the administration’s intervention in federal science agencies, may prompt Americans to reject any hasty and potentially contaminated vaccine. …

The directive, which is much stricter than what was used for emergency disposal of hydroxychloroquine or convalescent plasma, is an attempt to bolster confidence in an agency that has made the wrong steps during the pandemic. With vaccines, the Food and Drug Administration is expected to require manufacturers seeking emergency clearance – a process that is much faster than formal approval – to follow late-stage clinical trial participants for at least two months, starting with receiving a second vaccine. In the shot, according to two people familiar with the situation who spoke on the condition of anonymity to discuss the information before it was made public.

As evidence of the vaccine’s success, the agency is also looking for at least five severe cases of Covid-19, the disease caused by the coronavirus, in the placebo group for each trial.And As well as some cases of disease in the elderly. These criteria, plus the time it will take companies to prepare their requests and the agency to review the data, make it extremely unlikely that any vaccine will be licensed before the election. The agency said earlier that any vaccine should be 50 percent more effective than a placebo.