By: Derek Martinez
You may have been hearing about a COVID-19 vaccine potentially being available soon, and with that information, there are bound to be rumors and uncertainties. Personally, I have been hearing some of my family members’ concerns that the vaccine will “backfire,” causing a person to contract COVID-19. Though nobody can say for sure how effective the vaccine will be, there is a lot of evidence that supports the fact that the vaccine will be very safe.
Side Effects?
First things first: the part of the vaccine that you are likely most worried about. As with any vaccine, you may feel some symptoms that are part of your body’s immune response to the COVID vaccine. If you get vaccinated frequently, you may be familiar with symptoms such as inflammation, fatigue, arm soreness, and even fevers, among other symptoms. These symptoms are actually expected when you get a vaccination, as they help the immune system’s defenses by making it harder for viruses and bacteria to spread. Swelling in particular attracts phagocytes, cells that consume foreign pathogens and damaged cells. I personally experience these symptoms often, since I get vaccinated every few weeks to grow immune to my grass allergy; these effects are not lethal at all.
What exactly are they injecting into me?
Vaccines are made of compounds that resemble pathogens (disease-causing microorganisms) that are used to “train” your immune system. Vaccines can contain either a weakened version of the pathogen, or antigens (surface proteins) that are found on the pathogen. The vaccines that are being used for COVID are a special type called “mRNA vaccines” which are new, but have been researched before. You may remember from biology class that mRNA stands for messenger RNA, which carries genetic code in a cell’s nucleus to ribosomes during protein synthesis; this is the same for the mRNA vaccine. The COVID mRNA vaccine specifically gives instructions to your cells for creating a spike protein, which is found on the surface of the virus that causes COVID-19. What’s important about this is that the vaccine cannot give you COVID nor can it alter your DNA. After the protein piece is made, the cell breaks down the instructions and gets rid of them. Once the immune system recognizes that the protein does not belong there, it develops a response and creates antibodies which target the protein. After the process is complete, the body learns how to fight against future infection.
How do researchers know it works?
Whenever a treatment is being developed, it goes through 3 phases for researchers to test its effectiveness. The phases are as followed:
Phase 1: Basic Research
The main question for the first phase of research is “How does it work?” The goal of this phase is to investigate the biological aspects behind what you are researching. Some things that researchers may examine are the biological processes behind viruses and bacteria, but the information they gain from these investigations may not immediately connect to human health.
Phase 2: Translational Research
In translational research, scientists are asking “Can it be applied to people?” or “What can be applied to people from basic research?” In this phase, researchers transition to a more human health focus with experiments in cells and petri dishes, as well as experiments involving research model organisms (zebrafish, mice, etc…). This phase is also called “bench to bedside,” and researchers can develop new therapies or treatments from research model organisms.
Phase 3: Clinical Research
In this last phase, scientists are asking, “What are the specific effects?” and “How well does it work in the real world?” As the name suggests, clinical research involves conducting clinical trials on real people to test the effectiveness of a treatment and refine the treatment. Since these trials are being conducted on humans, there is always risk involved, which is why there is a standardized process to conduct clinical trials in phase 3.
Clinical Research Phase 1:
The first phase of clinical trials is extremely small and is only testing if the treatment is
even safe for human use. It usually involves 20-80 participants and takes up to several
months. About 70% of drugs/treatments can move on into phase 2.
Clinical Research Phase 2:
The second phase is still small, and is testing the efficacy of a treatment. It typically has
around 100-300 participants and can take up to 2 years (of course, since the COVID
vaccine is being developed in a pandemic, this is much faster). Only about 33% of
treatments move on after phase 2.
Clinical Research Phase 3
Phase 3 moves on to a larger trial with about 1,000 - 3,000 participants and lasts 1-4
years. With clinical trials for COVID vaccines, there have even been trials with 30,000
participants. Phase 3 aims to refine the treatment much more and studies its efficacy,
short and long-term safety, and dosing. Only about 25-30% of treatments pass this
phase, and if it succeeds, the treatment also gets approved by the FDA (Food and Drug
Administration). Most COVID vaccine trials are currently in this phase.
Clinical Research Phase 4:
After phase 3, the treatment can be prescribed to the general population. “Phase 4” is
more of a monitoring phase which studies the long term effectiveness of a treatment
and its cost effectiveness. Phase 4 has a relatively high success rate of about 70-90%.
Concerns?
The phases involved with research are clearly very rigorous and focus heavily on safety. No vaccine or treatment will ever be perfect, but we can be very sure that America’s scientists and leading healthcare workers are doing their best to slow the pandemic. There is a concern that the vaccine may not be as effective as it should be since SARS-CoV-2 has mutated before, which changed the spike protein, and it could continue to change. However, the vaccine still is predicted to be completely safe and only beneficial. Even those who have been infected with COVID-19 before are encouraged to receive the vaccine. I hope that with this information, people will be encouraged to receive vaccinations to help not only themselves but also their communities.
Educational Content
Q: Can the COVID-19 vaccine cause a person to be infected with COVID?
A: No, the vaccine does not contain any form of the actual SARS-CoV-2 virus. Instead, the vaccine contains mRNA which gives instructions on how to create a spike protein, which is found on the surface of the virus. It cannot infect you with COVID and neither can it alter your DNA in any way.
Q: How many phases are there in developing a treatment?
A: There are 2 research phases and 1 clinical phase with humans that has 4 sub-phases to test safety and efficacy.
Sources:
Seattle Children’s Research Institute Science Education Website
Image:
https://pixabay.com/photos/syringe-injection-medical-needle-4544448/