The U.S. Food and Drug Administration (FDA) on Tuesday issued official guidelines for the new crown vaccine,media BGR reported. The FDA provided guidance outlining the data it needs to receive to approve the COVID-19 vaccine. THE FDA-APPROVED COVID-19 VACCINE REQUIRES “PREVENTING DISEASE OR REDUCING THE SEVERITY OF AT LEAST 50 PERCENT OF PEOPLE VACCINATED.”
“We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19 and continue to work with industry, researchers, and federal, domestic and international partners to accelerate these efforts,” FDA Director Stephen M. Hahn, M.D., said in a press release. He said the FDA would not cut jobs and that the agency would maintain its regulatory independence, which has been under threat in recent times.
“Right now, neither the FDA nor the scientific community can predict the rate at which vaccine clinical trial data will occur,” added Peter Marks of the agency. “Once the data is available, the agency is committed to evaluating all data thoroughly and quickly. But make no mistake: the FDA will only approve or supply the COVID-19 vaccine if we are certain that it meets the high standards of the agency. “
In the document released Tuesday, the FDA recommends that the different populations most affected by COVID-19 be included in every stage of clinical development, including minorities, as well as the elderly and people with pre-existing conditions. Vaccine manufacturers are also encouraged to “provide data to support use during pregnancy and to plan a pediatric assessment of safety and effectiveness.”
The FDA wants clinical trials that could lead to the vaccine being approved large enough to demonstrate safety and efficacy, and it wants to see the COVID-19 candidate vaccine “prevent disease or reduce its severity in at least 50 percent of vaccinated people.”
Once the COVID-19 vaccine is finally approved, the FDA will continue to monitor the safety of the vaccine through various monitoring systems. The FDA may also require post-marketing research. Whether or not the vaccine is fully approved by the FDA or authorized for emergency use, the data must indicate that it is effective.