US FDA Detailed Standards Required for "Emergency Use" of New Corona Vaccine Published October 7, 8:23
Regarding the new coronavirus vaccine under development, the US FDA (Food and Drug Administration) released detailed standards such as safety data necessary for pharmaceutical companies to obtain permission for emergency use on the 6th.
The FDA, a U.S. government agency that regulates and approves medicines, will allow limited use of the new coronavirus vaccine after clinical trials by pharmaceutical companies before the formal approval process. We have published detailed criteria for the data required to obtain "emergency use" permission.
According to it, participants who received the vaccine at the final stage of the clinical trial will be observed for at least 2 months, data such as antibodies will be collected, and data for more than 3000 people who investigated the effect on health will be required. is.
Opposition / Democratic parties and medical experts have criticized President Trump for rushing to put it into practical use before the presidential election next month and putting pressure on the FDA over the vaccine for the new coronavirus.
However, due to the strict standards released this time, it is highly unlikely that an emergency use of the vaccine will be granted before the election, and the US media reports that the administration has refused to approve the standards.
While experts have welcomed a certain level of safety, some have suggested that stricter standards should be applied, and the debate over the emergency use of vaccines is intensifying.