What does the FDA approval of the vaccine mean for me?
GEHA | September 1, 2021
Dr. Shusko, MD, MPH, FAAFP, FACOEM, FACPM, Medical Director, is a Family Medicine, Occupational Medicine and Preventive Medicine physician. He recently retired from the Navy after 35 years and is a Medical Director at GEHA, focusing on Prevention and Wellness.
A) The FDA has extremely high standards and thorough testing protocols. The approval of Pfizer’s COVID-19 vaccine included a review of outcomes 6 months after inoculation, visits to manufacturing facilities to ensure quality, and a review of the data to evaluate relative risk. Their formal approval of the COVID-19 vaccine should give you even more confidence in the safety, effectiveness and manufacturing quality of the vaccine.
The FDA’s Center for Drug Evaluation and Research (CDER) is made up of physicians, researchers, scientists, regulators and other professionals who analyze all the data on medications, drugs and vaccines to determine if their benefits outweigh the known and potential risks for the intended population to ensure that they are safe and effective.
FDA approval may also mean certain organizations will begin mandating the vaccine.