FDA approval has been a buzzword since the COVID vaccines were developed. But what does FDA approval really mean? And why is a full approval of the COVID vaccine so important?
In short, the Food and Drug Administration (FDA) regulates and approves substances like dietary supplements, food, and drugs like vaccines. They review the medicine that drug companies create to ensure it is safe for the population to use.
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What is FDA Approval?
What is FDA Approval? According to the FDA website, “FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.”
CDER stands for the FDA’s Center for Drug Evaluation and Research. This branch focuses solely on evaluating new drugs.
The Approval Process
There are three steps to the FDA approval process. The Pfizer BioNTech COVID-19 vaccine just finished this process so let’s go through what exactly the FDA did:
The Target Condition and Available Treatments
FDA reviewers evaluate the target condition to determine how dangerous the disease is, and they weigh that against the risk/reward of the proposed drug.
The FDA says, “For example, a drug intended to treat patients with a life-threatening disease for which no other therapy exists may be considered to have benefits that outweigh the risks even if those risks would be considered unacceptable for a condition that is not life-threatening.”
Benefits and Risks of the Proposed Medication
So, after the reviewers look at the overall situation, it is now time to assess the benefit and risk information sent by the drugmaker. It is the drug maker’s responsibility to submit two well-designed clinical trials, “to be sure that the findings from the first trial are not the result of chance or bias.”
There are certain situations where the disease is too rare or two clinical trials aren’t feasible. In those cases, the FDA may accept convincing evidence from one clinical trial. These benefits need to outweigh any possible risks or side effects.
Risk Management Strategies
Finally, the FDA devises strategies for managing the risks of the proposed drug. Every drug on the market has some level of risk, and it is up to the FDA to determine those. In some cases, it is up to the manufacturers to create a Rish Management and Mitigation Strategy (REMS).
Approved COVID-19 Vaccine
The first fully approved COVID-19 vaccine is the Pfizer-BioNTech COVID-19 Vaccine. This vaccine has been approved under Emergency Use Authorization since December 11th of 2020, just like the other versions of the vaccine. According to the FDA, “the vaccine was 91% effective in preventing COVID-19 disease.”
As time goes on, the FDA will continue to monitor the safety of each COVID-19 vaccine.
Get Vaccinated At PHC
FDA approval means that the drug or vaccine in question has been extensively tested and approved by the Food and Drug Administration. There is a thorough process that each FDA-approved item has to go through.
Contact us for more information about the vaccine!
