Today, the Pfizer became the first Covid-19 vaccine to become fully approved by the Food and Drug Administration (FDA). “When a therapy or medication receives full FDA approval, then that means that it has satisfied the requirements of the 1962 Kefauver Harris Amendment which established scientific safeguards that the FDA still uses today to ensure that consumers will not be victims of unsafe and ineffective medication,” says Jamie Lane, a Pharmacist at Baptist Health Hardin.
Terrie Burgon of the Lincoln Trail Health Department stated the new approval brings about several new changes including a new name.
“If people hear the name Comirnaty, that is synonymous with the Pfizer vaccine that everyone has been receiving all along. What you may not be aware of is that the full FDA approval is in individuals 16 years of age and older. So those who are 12 to 15, the Pfizer vaccine still operates under the Emergency Authorization Use. I know that there were some individuals who were waiting because they wanted it to be fully approved. Now that time has come. Our Covid numbers are escalating. If you have not gotten your vaccine, now is the time to do it.”
The other vaccines are both approved under the Emergency Authorization Use, and are currently seeking full approval.