On September 21, 2020, the Food and Drug Administration (FDA) submitted new guidelines for the emergency authorization of a coronavirus vaccine to the White House Office of Management and Budget (OMB). According to a report in the New York Times on October 5, 2020, OMB has refused to approve the guidelines for more than two weeks. The report indicates that White House chief of staff Mark Meadows objected to a provision in the guidelines requiring that, before any vaccine can be authorized, volunteers who have participated in vaccine clinical trials be monitored for two months after their final dose. Mr. Meadows reportedly questioned the need for two months of monitoring and suggested that FDA Commissioner Dr. Stephen Hahn had been "overly influenced by his agency's career scientists." In response, FDA officials provided additional justification for the two monitoring requiring, telling OMB it was necessary to ensure the vaccine's effectiveness and identify possible side-effects. However, as of October 5, OMB had still not approved the guidelines.
Update:
The vaccine guidelines were published in late October 2020. The guidelines included the provision recommending that participants in vaccine trials be monitored for two months after their final dose.