It feels like we’ve been in quarantine for ages… and until a safe and effective vaccine is approved and released, life won’t be the same. The questions is, when we be able to get a vaccine? Weeks ago there were rumors that several possible vaccines, so does that mean we’re close? Most vaccines take years to develop, so does that mean that we’ll be in quarantine for years? So many questions but not many answers. To understand the time frame we need to understand the vaccine development and approval system.
But First… What Is A Vaccine And What Does It Do?
A vaccine is a type of treatment that stimulates the body’s own immune system to fight against infectious pathogens (a bacteria or virus that causes the disease). In simple terms, vaccines trick the body into thinking that it’s infected so it recognizes the virus when it actually does come into contact with it and quickly beats it before the body gets sick.
The most important ingredient in the vaccine is the antigen. The antigen is what the body recognizes as foreign. The antigen could be molecules from the virus or a weakened version of the virus. Researchers are primarily searching to find a suitable antigen that will trigger an immune system response to protect against COVID-19. An adjuvant can also be used to amplify the immune response, which could potentially prove helpful for the elderly, who don’t respond as effectively when vaccinated.
Stages of Vaccine Development and Testing
This is essentially the research stage. Scientists identity possible antigens that could prevent or treat a disease. This stage usually takes 2-4 years.
In this stage researches will test their hypothesis on animals like monkeys or mice. Through this testing process they will make sure there are no side effects, find a safe starting dosage, a safe method to inject the vaccine, and check to see if the vaccine actually does anything. This stage usually takes about 1-2 years.
If the vaccine continues to prove successful and safe, the producers of the vaccine will submit an IND (Investigational New Drug) application to the FDA (Food and Drug Administration). If the application has been approved, the vaccine will go through three phases of testing. This process can take up to a month.
Phase I Vaccine Trials:
This phase is the first time the vaccine will be used on humans, usually on a small group of adults between 20-80 subjects. In this phase, researchers are testing to check the safety of the candidate vaccine and determine it’s effectiveness. During these tests, some patients may even be purposefully infected with pathogen after they have been vaccinated and carefully monitored.
Phase II Vaccine Trials:
This phase will involve a large group of several hundred participants. This group may include individuals who are most at risk of acquiring the disease. These trials will well controlled and include a placebo group. The goals of this phase are to study the vaccine’s safety, effectiveness, proposed doses, schedule of immunizations, and method of delivery.
Phase III Vaccine Trials:
This phase will involve thousands to ten thousands of participants, also involving a placebo group. The goal of this phase is to study side effects that may be rare and will not show up in smaller test groups. This phase will also help understand if the candidacy vaccine prevents the disease, prevents infection with the pathogen, and if it leadds to production of antibodies or other types of immune responses related to the pathogen. If this trial is successful, the vaccine developer will submit a Biologics Licesnse Application to the FDA, and if everything looks good, they will approve the labeling of the vaccine.
How COVID-19 Vaccine Development Is Different
Usually, releasing a vaccine will take 10-15 years from start to finish. In this case, a vaccine is predicted to be released in about a year. It seems super far in the future, but the development and approval process has already been cut to 1/15th of it’s original speed. The Phase 1 clinical trial is set to begin no later than fall of 2020 and will hopefully be available for emergency use in the US in early 2021.
However, something else to consider is how differently various age groups are reacting the the virus. This means that this might not be a one kind of vaccine cures all kind of situation.
What Definitely Won’t Work
While researchers are scrambling to find an effective and safe vaccine, there are some things that definitely will not boost immunity, cure COVID-19, or prove that you are immune.
It’s a popular belief going around, but make sure not to fall into it. Antibiotics are medicine that are designed to fight bacteria, so it won’t work on COVID-19, because it is a virus.
2. Positive Antibody Test
The WHO (World Health Organization) recently said that “There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.” But how could this be? I was confused at first too, because I thought antibodies (molecules your immune system produces to fight the virus) would work to fight a second round of infection. Antibodies and Antibody tests are definitely useful, but they don’t necessarily mean permanant immunity (at least not that we know of). Yet at this point, we still don’t know how immunity to this virus works, so much more testing is required to definitively say that antibodies mean immunity to the virus. Furthermore, we don’t even know long that possible immunity could last. This might depend on the quality of the quality of the antibodies. All this research is still underway, which is why we can’t count on antibodies to solve all our problems right now. So don’t jump out there to get infected so you can fight it off and “get back to normal life.”
So… What Now Then?
Researching this definitely made me a little more concerned for the future. Will we have to spend another year in quarantine, living in fear and unable to see our friends? The future is uncertain for sure, but one thing is for sure, we can all do our part by staying home and preventing more people from getting infected. It’s really hard to stay optimistic when it feels like we don’t know anything about the virus or anything about what our future looks like, but staying hopeful is one of the most important things we can do right now. Keep doing what you’re doing and stay strong—whether you need to have a few more at home spa days to relax, learn how to massage your eyes to relieve screen stress, or just zoom with some friends, all of this wackiness will pass, it’s just a matter of when.
U.S. Department of Health & Human Services (HHS)