Even though COVID-19 has been around for close to a year, the scientific community is still developing and applying innovative ways to combat this virus. The fate of humanity depends on a vaccine, as this virus is highly transmissible. This means that a vaccine for COVID-19 should be the number one global priority at this time.
What is a vaccine?
Vaccines contain the same germs that cause disease. For example, the measles vaccine contains a modified version of the measles virus. When creating a vaccine, scientists have either killed or weakened the virus to the point that they don’t make you sick when administered (e.g. by injection, or spray, or ingestion). Some vaccines contain only a part of the disease germ rather than the entire virus. A vaccine stimulates your immune system to produce antibodies, just as if you were exposed to the disease as a whole. After injection, your immune system develops immunity to the specific disease without being infected first.
For a vaccine to be approved for use, much data has to be collected by scientists. After a company or country develops its own vaccine, it must undergo the entire clinical trial process, which consists of several phases, to ensure that the product is safe and effective.
The phases in the development of the COVID-19 vaccine
The Preclinical phase: Once a vaccine candidate is identified, scientists have to select the proper antigen to invoke an immune response. Preclinical phases are typically done as animal trials. The preclinical stages are also necessary to determine the appropriate dose and drug formulations (ex: tablet, injection). After the vaccine in this phase is considered safe and effective, it needs to undergo 3 stages of human clinical trials that are run consecutively.
Phase 1: This phase involves human volunteers (typically 10 to 100 healthy adults). According to the U.S. Centers for Disease Control, scientists want to find out the following: is the vaccine safe? Does it work? Are there any serious side effects? How is the size of the dose of the vaccine related to the side effects? These volunteers are then monitored for 6 to 12 months, but Phase 2 trials can begin before Phase 1 is complete if the vaccine seems safe.
Phase 2: The transition from Phase 1 to Phase 2 relies on the success and results of Phase 1 in a small cohort of healthy volunteers. Phase 2 requires more healthy volunteers (typically several hundreds) to analyze the vaccine reactions in a more diverse set of people to test different schedules.
Phase 3: This phase involves testing the vaccine on an increased number of human volunteers (typically 30,000). The vaccine must be proven to be safe and effective in natural disease conditions before being submitted for approval and then general production.
Phase 4: In this phase, trials ensure the safety and efficacy of the vaccine and include the release of the vaccine to the public.
Phases 1 through 4 can take anywhere from years to decades—all depending on the accessibility of the antibodies. Even with a successful vaccine developed, regulatory bodies such as Health Canada would have to approve its use, which adds more months of waiting; however, the world can’t wait that long; death rates continue to rise and suffering in many domains weighs on countless people. The U.S. government is investing billions of dollars to fast-track the development of promising vaccine candidates with the federal government’s Operation Warp Speed program. Scientific teams around the world are aiming to develop the new vaccine in just 12 to 18 months. With such a short time frame, some people may mistrust the new COVID-19 vaccine as they may be concerned that scientists are “cutting corners.”
As previously mentioned, a vaccine normally must go through the 4 phases of clinical trials that are run consecutively; unfortunately, that process can take years to complete. However, there are strategies to decrease the time needed to get a new vaccine out without skipping any steps in the process or compromising safety. For example, with COVID-19, vaccine developers were given the permission to run trials in “parallel”—this is critical to understanding how the COVID-19 vaccine can be expedited. This allows Phase 2 to begin once the results from Phase 1 are promising - this process can speed up the creation of the vaccine by years.
In addition to running trials in parallel, vaccine developers are allowed to do what’s called adaptive design in order to further speed up the process. The developers can create a plan to adjust their trials depending on the preceding results. A fitting example of this would be if volunteers aren’t responding well to a low dose of the vaccine. In this case, the team would be allowed to alter the dose or even add a second dose without starting from the beginning. Finally, advanced manufacturing is a process that will allow for early access to vaccines. In this strategy, manufacturers can start production in advance if approved during early phase clinical trials, even though there would be no guarantee that the new vaccine would ever make it through the other phases and get approved. Governments around the world are providing financial aid in unprecedented ways to support vaccine trials and advanced manufacturing with the hope of making a new vaccine faster.
In conclusion, COVID-19 has brought upon terrible consequences to our world and civilization; the only solution to return to normal is to create a vaccine.Scientists are sharing information and are dedicated to working around the clock to make this happen while respecting the procedures necessary to ensure that the vaccine is safe and effective. Governments and vaccine manufacturers have forged new alliances to support accelerating vaccine fabrication. COVID-19 has opened up a new era of vaccine development that is hoped to benefit millions of people. This is truly amazing.
Author: Lucas X. Perri, Level II