The US Food and Drug Administration is to announce stricter standards for any emergency authorization of a SARS-CoV-2 vaccine, the Washington Post reports.
It adds that the pending announcement, which is expected as early as this week, would make it difficult for any candidate vaccine to receive authorization by November 3, Election Day in the US. According to the Post, the new standards would require vaccine makers to follow trial volunteers for a median two months after they received their last dose before seeking authorization. CNN reports that Pfizer and Moderna, which started their trials in late July, have given their second dose to less than half their trial participants, making it unlikely they'd be able to seek authorization early November.
As the Post notes, this announcement aims to quell concerns among the public that the vaccine development process is being rushed and politicized. It adds, however, that efforts by FDA to boost confidence in the process — such as by highlighting career officials like FDA's Peter Marks who has said any approval decision will be science-based — are often undermined by President Donald Trump's repeated statements that a vaccine would be ready by the election and by revelations that other officials have sought to interfere with government scientists.