On Dec. 10, the Food and Drug Administration gave the green light to a COVID-19 vaccine. After nearly a year of scary statistics, economic downturn, isolation, separation and, worst of all, heart-wrenching loss, this is great news.
Not so fast. Emergency Use Authorization, or EUA, from the FDA is not the same as full approval. An EUA allows products to be used under special circumstances before all the evidence is available for evaluation. For an EUA, the agency considers whether a product’s “known and potential benefits outweigh its known and potential risks.”
The use of the new COVID-19 vaccines might seem like a Fast Drug Approval but to be clear, the FDA continues to evaluate the vaccine once launched. Your experience matters. If there are adverse events from the vaccine, your information can help determine if it is a trend and if further testing or labeling changes are needed.
Right now, the existing data for the EUA approval shows a 90 percent or better efficacy and minimal side effects. Your experience with the COVID-19 vaccine should be part of that data and can help validate these numbers.
I am not a doctor. I am a mother whose son underwent multiple operations for Crohn’s disease. During his illness I discovered that our health care system needed an overhaul. On my quest to impact the health care system, I became the consumer representative on the FDA’s Pediatric Advisory Committee. This position taught me the steps, timing and testing size required for FDA approval. It is part of the process to continue evaluation once a product is launched.
In 1990, the FDA incorporated a process to capture adverse events for vaccines, known as the Vaccine Adverse Event Reporting System, or VAERS. Many people are unaware of its existence. But with COVID-19 we can use the system to ensure that the data used to receive EUA approval is being replicated by consumers. VAERS is an online tool that allows patients and doctors to submit their experience: https://secure.vaers.org.
Even if you are not sure that the vaccine caused an adverse event, the FDA asks you to report:
1. If you are hospitalized
2. Any disabilities that may be a result
3. If a loved-one died after taking the vaccine
4. Any adverse event that happens after getting the vaccine
If you are not sure that a certain type of adverse event should be reported to VAERS, talk with your health care provider.
The good news is “all hands are on deck” to combat this pandemic. The good news is scientists and doctors are discovering ways to keep us safe. The good news is we have existing platforms to capture the information needed to determine if new vaccines work effectively. The good news is you are not alone. Your experience counts and can make a difference.
For more information, visit: Your experience matters at https://youtu.be/VyVUgUsc9BU.
Randi Oster, a resident of Fairfield, is the author of “ Questioning Protocol ,” and is the FDA’s Pediatric Advisory Consumer Representative as well as a founding member of the Patient Safety Action Network.
"Opinion" - Google News
December 18, 2020 at 11:17PM
https://ift.tt/3p5iFuh
Opinion: Your role in promoting vaccine safety - CT Post
"Opinion" - Google News
https://ift.tt/2FkSo6m
Shoes Man Tutorial
Pos News Update
Meme Update
Korean Entertainment News
Japan News Update
No comments:
Post a Comment