- The Food and Drug Administration (FDA) issued guidance on Tuesday for a coronavirus vaccine.
- In order for a COVID-19 vaccine to be approved by the FDA, it needs to “prevent disease or decrease its severity in at least 50% of people who are vaccinated.”
- The FDA knows that there are plenty of people who are concerned about taking a vaccine, but promises not to cut corners when it comes to ensuring safety.
Many countries around the world have managed to get a handle on the novel coronavirus pandemic, but until we have a safe and effective vaccine, we’re going to have to continue to take drastic measures to protect ourselves and our neighbors. The good news is that Dr. Anthony Fauci, the country’s leading infectious disease expert, is convinced that a vaccine will be ready by early 2021, and in preparation, the U.S. Food and Drug Administration (FDA) provided guidance on Tuesday outlining the data it would need to receive in order to approve a COVID-19 vaccine.
“We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19 and continue to work collaboratively with industry, researchers, as well as federal, domestic, and international partners to accelerate these efforts,” said FDA Commissioner Stephen M. Hahn, M.D in a press release. He said that the FDA will not cut corners, and that the agency will maintain its regulatory independence, which has been threatened lately.
“Right now, neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials,” added the agency’s Peter Marks. “Once data are generated, the agency is committed to thoroughly and expeditiously evaluating it all. But make no mistake: the FDA will only approve or make available a COVID-19 vaccine if we determine that it meets the high standards that people have come to expect of the agency.”
Within the document published on Tuesday, the FDA recommends that diverse populations most affected by COVID-19 are included in every phase of clinical development, including racial and ethnic minorities as well as elderly people and people with pre-existing conditions. Vaccine makers are also encouraged to “provide data to support use during pregnancy, as well as plan for pediatric assessments of safety and effectiveness.”
The FDA expects the size of the clinical trials leading up to the potential approval of a vaccine to be large enough to demonstrate safety and effectiveness, and it also wants to see that the COVID-19 vaccine candidate “would prevent disease or decrease its severity in at least 50% of people who are vaccinated.”
Once a COVID-19 vaccine is finally approved, the safety of the vaccine will continue to be monitored by the FDA with a variety of surveillance systems. The FDA may also ask for post-marketing studies. Whether a vaccine receives full FDA approval or Emergency Use Authorization, the data has to show that it works.
