The White House has blocked FDA guidelines for a coronavirus vaccine that are put in place to ensure the treatment is safe and effective because they would push the vaccine’s release past election day.
The NYT reports: “A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for a median of two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity. Given where the clinical trials stand, that two-month follow-up period would all but preclude any emergency clearance before Election Day.”
Said Michelle McMurry-Heath, the president and chief executive officer of the trade group BIO in a letter to HHS secretary Alex Azar: “We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic.”