Just want the facts?
With such a controversial topic it is important to point to determine what is true and what isn't. Here we will outline some of the basic facts for all the vaccines being used in the United States under Emergency Use Authorization. The information presented here is meant for educational purposes only. We strongly advise you to write down your questions and the information you find so that you can ask any questions to your health provider.
We get a lot of questions if these products are vaccines. Generally speaking, these products are designed to create antibodies in effort to produce immunity and widely advertised as vaccines. We will use the word vaccine for simplicity.
We get a lot of questions if these products are vaccines. Generally speaking, these products are designed to create antibodies in effort to produce immunity and widely advertised as vaccines. We will use the word vaccine for simplicity.
What is Emergency Use Authorization?
In short, Emergency Use Authorization means that the FDA has permitted use of a vaccine, drug, or other treatment that is not licensed for use because:
So it is licensed by the FDA, right?
No, it is not. The FDA reviewed the data available, in this case a couple of months, and determined that the known risks of the vaccine were minimal compared to the benefit of using it in an emergency situation. Additional time and testing will be needed to be approved for full use. It is estimated that the earliest any of the vaccinations will be fully licensed is 2023, possibly 2024.
All the normal tests that vaccines go through have been done, right?
Kind of. I know that isn't the answer you wanted but let me explain. All the appropriate testing up to this point in time has been completed. However, because the vaccines are still so new there are tests that could not be completed due to data not being available. Further, animal testing was skipped for the vaccines. One of the benefits to completing animal testing is their shorter lifespan can reveal potential diseases or complications that might take several years or even decades appear in humans. This can help identify potential problems in a much shorter time frame.
- A health emergency has occurred.
- There are no current treatment options available.
- The known benefits out weigh the known risks.
So it is licensed by the FDA, right?
No, it is not. The FDA reviewed the data available, in this case a couple of months, and determined that the known risks of the vaccine were minimal compared to the benefit of using it in an emergency situation. Additional time and testing will be needed to be approved for full use. It is estimated that the earliest any of the vaccinations will be fully licensed is 2023, possibly 2024.
All the normal tests that vaccines go through have been done, right?
Kind of. I know that isn't the answer you wanted but let me explain. All the appropriate testing up to this point in time has been completed. However, because the vaccines are still so new there are tests that could not be completed due to data not being available. Further, animal testing was skipped for the vaccines. One of the benefits to completing animal testing is their shorter lifespan can reveal potential diseases or complications that might take several years or even decades appear in humans. This can help identify potential problems in a much shorter time frame.
You can watch the Emergency Use Authorization video prepared by the FDA here.
