The development of the Covid-19 vaccines has brought relief to a lot of people, but has left others wondering about the safety of an inoculation which surfaced much faster than we’ve seen in the past. Previously, the fastest vaccine to be created was the mumps vaccine -- taking four years. So, how were researchers able to create the Covid-19 vaccine in under a year and still have it be safe to use?
Today, we’ll take a look at the clinical protocol that goes into vaccine development, and examine why the Covid-19 vaccines were able to develop so quickly, without compromising safety.
In the United States as in many other countries, vaccine development follows a rigorous schedule of research and testing to determine the safety and efficacy of the product, well before it ever reaches wider society. This process can best be understood when broken down into stages, beginning with those that are exploratory in nature.
Exploratory and Pre-clinical Stages
In the exploratory stage, federally funded scientists research possible antigens to prevent and treat diseases. This can include synthetic as well as natural sources, and is typically derived from parts of a weakened virus, or virus-like pathogens. This stage takes several years to complete.
This is where the Covid-19 vaccine development benefitted from previous years of research, given that it is a variant of an already well-studied virus type belonging to the broader coronavirus family. This meant researchers had already completed about 50 years worth of exploratory work on this type of virus. They had already made the important identification of the S proteins as a target for the development of antibody therapies and vaccines.
What would normally follow the exploratory stage is the pre-clinical stage, wherein researchers use tissue-cultures (and typically animal testing) to determine the safety of the vaccine. In the case of Covid-19, researchers including those at Janssen, had already developed the “viral vector” method of transporting part of a pathogen to our immune systems in order to build immunity to it that is used in the Covid-19 vaccine.
Worldwide collaboration also enabled researchers to share their discoveries with as much urgency as the global pandemic, a feat which hadn’t been accomplished to this degree until the outbreak. Because scientists weren’t starting from scratch, and had access to other researcher’s data from around the world, they could move onto further development much faster.
Phase I Clinical Trials
At this stage, human trials can begin in very small groups (around 20 to 80 people is typical), in order to determine the safety of the vaccine. This is also when researchers have the ability to determine the type and extent of the immune response people have to the vaccine.
These were begun rapidly, as the emergency of the pandemic resulted in significantly more funding toward vaccine development than had been seen in the past. In the US, Operation Warp Speed (OWS) partnered the CDC with the NIH in order to bolster funding for the rapid development, production, and distribution of the vaccine.
Phase II Clinical Trials
These clinical studies involve a much larger group of several hundred people, some of which may be at risk for getting the disease and developing serious complications. These trials are randomized and utilize control groups. Their purpose is to hash out the exact immune response of the vaccine, and to determine the most effective dose and delivery method. Researchers watch for mild, anticipated symptoms such as low-grade fevers, soreness at the injection site, and headaches, as well as any severe reactions that should be rare. Continuing with Janssen as an example, the researchers for the Covid-19 vaccine combined this stage with the first phase of clinical trials in order to answer a lot of questions about the vaccine in a shorter time (essentially running both trials side-by-side to ascertain results faster without compromising on safety.)
Phase III Clinical Trials
Phase III tests the largest group of people, administering the safe doses established in Phase II to thousand and sometimes hundreds of thousands of people. The Pfizer vaccine involved over 44,000 participants in their Phase III trial from July to November of 2020.
Here, it is hoped that any rare side effects that did not show up in smaller samples will become evident and can be studied so that necessary adjustments can be made before the vaccine becomes available to the public.
After reaching the public
After the vaccine has started to be distributed to the public, data is still recorded and studied carefully to ensure any issues that arise are dealt with immediately. Organizations like the Vaccine Adverse Event Reporting system allow anyone to report negative side effects that might be related to the vaccine. If side effects are severe, even those that are rare and occur in only a small fraction of the population, sometimes the vaccine can be “paused”, or temporarily be removed from circulation while researchers investigate the anomaly and make the necessary adjustments.
This has happened recently with the aforementioned Janssen vaccine, after a series of blood clots were found in seven of the seven million people who have received the vaccine. Despite the small number of those impacted, the vaccine has halted rollout and investigations are underway to determine the extent of the vaccine’s impact on the incidences of blood clots.
These kinds of pauses are very common, and despite how scary it may seem to those who have already received the vaccine, it is a sign that the clinical process is working as intended, and that people are continually paying attention to the safety of vaccines after their rollout. During the investigation, if the cause of the side effects is determined to be the vaccine, new guidance may be administered as to who should or should not receive the vaccine in the future. The pause also provides doctors with a chance to familiarize themselves with recognizing and treating the condition, and lets people who have received the vaccine know what to be on the lookout for.
Why the Covid-19 Vaccine wasn’t “rushed”
Through established research on mRNA vaccine techniques, well developed technology, global cooperation and a surplus of funding, the Covid-19 vaccine was able to come together much faster than inoculations of the past. This is due to the worldwide urgency of the situation, which has not been seen to this extent in generations. Since past pandemics, we have had a chance to develop technology and clinical trial strategies that weren’t available before. This, combined with the communal efforts of researchers across the globe to cooperate on this one undertaking, resulted in safe, effective vaccines being developed in under a year.
Simply put, this feat of science was able to come together so quickly while attending strictly to all of the necessary stages because we put a lot of minds and money to the task -- a luxury of necessity that few medical developments of the past have had.
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