COVID-19 was a novel virus. Novel means “new”. That means it was new to us and our immune system. Our body was not able to fight it off efficiently because our cells did not have memory of it. Once exposed, our immune system had to work from scratch to mount a defense against it. Having an intact, robust, well working immune system was the key to recovery. To fight the virus, scientists around the world worked together to develop a tool to give our immune system the abiltiy to fight off this virus. This tool is the vaccines.
Much has been printed/reported about the quick way the vaccines were developed. But remember this was a world wide effort. Typically pharmaceutical companies work alone on developing a new drug. This pandemic changed that dynamic and scientists worked together for the sake of the world.
Emergency Authorization Use has been if effect for many years. Many HIV/AIDS drugs were put on the market through this process as were other safe/effective drugs.
For this discussion I would like you to see the rigorous process of drug approval.
First read this article from the FDA:
Then go to the National Institute of Health’s clinical trials website: https://www.nih.gov/health-information/nih-clinical-research-trials-you
Click on “The Basics”
Click on the different links and read through the information
Please focus on the following three links:
“What are Clinical Trials and Why do People Participate”
“What are the Phases of Clinical Trials”.
“What Happens After a Clinical Trial is Complete”
Once you have read this information, for your discussion:
Describe the drug approval process in your own words
Explain how this information would be useful for you to use in your career of choice when discussing vaccine/medication hesitance with your patient.
REPLY ONLY to the two posts below. A minimum of 5 sentences each is needed.
When it comes to the drug approval process there are many steps taken to assure the safety and security of a drug. After the drug is created, it must go through and pass three phases in clinical trials to be approved for public use and even go through a phase after it is made available to the public. The first phase begins with administering the drug to a small group of people who are in good health. This phase allows researchers to look into the side effects and safety of the drug. If the drug was deemed not safe or had no effect at all in this phase then the researchers can not move onto the next phase. In the second phase, more people are brought into the trials and this group is more diverse in their health history and status as well as demographic. This phase also looking into the side effects of the drug but more focus is put on the short-term side of it and of course the safety and effectiveness of the drug. Usually, people in this group are given different dosages of the drug to see the effectiveness and safety of each dosage. Just like the first phase, if the drug is deemed not safe or effective in the second phase then it can not move onto the third phase. In the third phase, the trial group should now be in the thousands and it should be very diverse to represent the general population. This phase mostly helps researchers determine the effectiveness and safety of the drug as it gives crucial information into these areas. However, this phase also allows researchers to see any side effects and compare the drug to anything similar to it. After the three phases and analysis of all the phases are completed the drug then needs to be approved by the Food and Drug Administration (FDA). In the event of an Emergency Use Authorization (EUA), the FDA looks at the safety of the drug and makes sure the benefits outweigh the risks. However, this is only for all the known benefits and risks that were acquired from the trials. The scientists and physicians in the FDA’s staff are experts in the field of drug development and in determining the safety and effectiveness of a drug as well as people with good standing morals and ethics. Finally, after the approval of the vaccine from the FDA, the drug is made available to the public and researchers still keep an eye on the safety and the benefits and side effects the drug is having on the general public that was not seen in the clinical trials.
Having this information by my side would be extremely helpful if a patient had any hesitance when discussing a vaccine/medication. This would allow me to show the patient what each and every drug goes through to be made available to be used by the public as well as how much significance is put into the safety and effectiveness of a vaccine/medication. Showing this information would hopefully help the patient become more comfortable when making a decision on a certain vaccine/medication.
It all starts with research. They must complete a certain amount of research before even starting a clinical trial, the book refers to this stage as pre-clinical. Then we move to a clinical trial. There are multiple parts to a clinical trial: Phase I, II, and III. Phase I is when researchers test their new drug or treatment in a small controlled group of 20 to 80 people. They watch for saftey and to identify the side effects. In Phase II, researchers give the drug to a slightly larger group consisting of 100 to 300 people, they study the effectiveness. In Phase III, the drug is tested on a very large group of people to confirm the findings in Phases I and II, the group size is usually around 1000 to 3000 people. The the drug is submitted and reviewed. In this stage the drug is either denied or granted FDA approval. If approved, it is then released to the public where it is then continuosly researched and retested. As a nurse I would explain the pros and cons of each drug as well as things like cost, side-effects, and alternative treatments. Having extensive knowledge about the drug as a nurse would calm the patient and give them a clear understanding of the situation. I would let them know it has been approved by the FDA and had been tested on a large group of people with good results. To reduce hesitance, I would make sure they had all of the information needed, and provide them with the studies to prove the validity of the drug.