The steps to developing a COVID-19 vaccine [Video] | hioscar Blog | Oscar
The steps to developing a COVID-19 vaccine [Video]
Oscar's Dr. Stephanie Reznick walks us through the process of developing a COVID-19 vaccine.
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Oscar board-certified virtual provider Dr. Stephanie Reznick walks us through the process, from the exploratory stage through quality control, and the time it takes to make sure any vaccines are safe for you and your loved ones.
"Hi everyone. For those who haven't met me virtually yet, I'm Dr. Stephanie Camaglia Reznick. I'm a board-certified internal medicine physician and I'm one of the Doctors on Call available through Oscar.
In today's segment on COVID-19 also known as the novel coronavirus, I'm going to explain a bit about the vaccine development process and how it applies to COVID-19. As you may have heard on the news or from various public health officials, we are really hoping for a vaccine to help control this pandemic but a vaccine is probably a good 12 to 18 months away. Why does it take so long?
Well, first let's take a step back and let me explain what a vaccine is. A vaccine is a way of tricking the body into thinking it's infected so that it mounts an immune response but you're not actually infected so you won't get that sick. Part of that immune response includes a memory component which means next time your body sees the infection in real life, the immune response will be immediate and it will kill the virus before you can get sick.
The first step in developing a vaccine is called the Developmental or Exploratory Stage. It's when researchers try to figure out what they can put in the vaccine to mimic the COVID-19 infection and have your body mount the correct immune response. This is also known as trying to find the correct antigen or the correct target and this could take years. The good news is scientists were already working on a vaccine for coronaviruses that are like COVID-19 although not identical such as the SARS virus or the MERS virus and some of this information has been applied to making the COVID-19 vaccine. The other good news is that early on, researchers were able to genetically sequence COVID-19. This was done back in January and this allows scientists to know a lot of details about the virus and to be more easily able to find a target or antigen for the vaccine to use.
Once scientists decide what target they're going to use, they move on to step two which is the Preclinical Stage. In the preclinical stage, the vaccine is used on animals to get a sense of how safe it is and also get a sense if it's going to be effective or not. For example, the vaccine that they're working on in Oxford, England has been tested in monkeys and so far it looks like it's effective. That's a good sign and perhaps that the vaccine will work in humans.
Once a vaccine has passed stage 2, it goes on to stage 3 which is the Clinical Stage. In the clinical stage, a vaccine goes through multiple phases of clinical trials. In phase 1 of a clinical trial, a few patients are given the vaccine to make sure it's safe. If it's safe in those few patients, the vaccine moves on to phase 2 trials in which more patients are given the vaccine. The phase 2 trial focuses more on whether or not the vaccine is going to be effective. If the data shows that it's probably effective, the vaccine then goes on to phase 3 studies which include thousands of people to further test the efficacy and safety of the vaccine.
Once phase 3 data looks promising as well, a lot of times, vaccines will go on to the fourth stage of development which is the Regulatory and Compliance Stage. This is a stage where organizations like the FDA look at the data from the phase 1, 2 & 3 trials and decide if it's safe and effective to be given to humans for the indications, in this case, the prevention of COVID-19.
Of note, in certain emergencies like this pandemic, the FDA might not offer full authorization which is a really thorough deep dive into the data but rather what they call an EUA, or or emergency use authorization, which means that the FDA has looked over the data somewhat briefly and believes it's adequate enough to start being given or administered to the public.
If a vaccine were to get to this point, the next step would be the Manufacturing step and this could also pose some hurdles to be overcome. There needs to be the proper equipment, personnel and the proper starting materials to make the vaccine. As you might have heard, there's been shortages of various other equipment, substances and whatnot, where there's actually medication services. These same kind of shortages and issues might come across when it comes to manufacturing millions if not billions of vaccines for all the humans who would need it. This doesn't mean that we need to be worried that it won't happen — it just might take some time.
Once the vaccine is passed that manufacturing stage, it goes into the final stage which is Quality Control. We want to make sure that every vaccine that is made is equal to the ones that were tested and proven to be working and safe. We also want to make sure that we are keeping an eye out for any adverse reactions or side effects that weren't noticed in trials but might be noticeable when given to millions or billions of people.
This is why it's important that any adverse effects be reported. In the United States, there is a vaccine adverse effects reporting mechanism that is run by the CDC and the FDA to monitor any bad side effects that might occur. After a vaccine has already been approved, hopefully there won't be that many bad side effects or any at all but, if there are, rest assured organizations are watching and the regulations will protect us. S
As you can see, developing a vaccine is a very involved and often long process so while 12 to 18 months might seem like a long time, it's actually very fast for the world of vaccines."
This content does not constitute medical advice and is not meant to be a substitute for professional medical advice, including diagnosis or treatment. Contact your physician with any questions you may have regarding COVID-19 or your personal health. If you are experiencing a medical emergency, dial 911 for immediate assistance.
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