The Food Drug Administration announced new guidelines for researchers developing a coronavirus vaccine. Researchers will need to conduct two months of follow-up data on volunteers in phase 3 trials before Emergency Use Authorization will be up for consideration.
Researchers are also required to include information on a minimum of five volunteers with serious cases of COVID-19 who were given a placebo before the vaccine can be presented for approval.
The additional time needed to fulfill the FDA’s new guidelines decreases the chances of a vaccine being approved at a quick rate.
The changes were made to ensure a vaccine would be safe for Americans. Many Americans have expressed hesitation in response to the vaccine, afraid to take one so soon after getting news of a coronavirus outbreak.
FDA officials are hoping to address the concerns of Americans, put their fears at ease, and use the time to research potential side effects of the virus.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said a statement from Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research.
The Trump Administration has communicated its support of a vaccine. More often, their support of its approval before Election Day.
Trump conveyed his disappointment towards the agency and its latest requirement via a post on Twitter.
“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day,” he wrote. “Just another political hit job!”
The administration favored an urgent distribution of the vaccine, before approving the new guidelines.
For more information on the new guidelines, click here.