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Author: Anika Kaushik;
With the emergence of COVID-19, there have been many proposed ideas and developments in the creation of a vaccine. We receive updates on a vaccine quite often, yet there isn’t an approved and distributed one yet. To clarify the reasonings as to why, and the updates opened to the public, one has to understand the process by which a vaccine is developed and deemed safe for the general public.
The Exploration Stage
This stage is coined for what one thinks is happening in the development of a functioning vaccine. It’s research-oriented and is often where scientists try to identify “natural or synthetic antigens that might help prevent or treat a disease” (Vaccine Development, Testing, and Regulation). Proposed COVID-19 vaccines have passed this phase.
The Preclinical Stage
Once an antigen is successfully identified a candidate vaccine is proposed. This vaccine is then tested on “tissue-culture or cell-culture systems,” hoping to elicit an immune response; the effect is called its immunogenicity. If it fails to do so, the vaccine is either discarded or taken back to the previous stage to alter and magnify results. The effects are analyzed and its ethicality to be administered to humans is determined. Proposed COVID-19 vaccines have passed this phase.
The Clinical Development Stage
Phase I – The first human trials begin here. With an immune response present in smaller subjects, they can declare the vaccine qualified for clinical trials. The first trials begin with “a small group of adults, usually between 20-80 subjects” (Vaccine Development, Testing, and Regulation). Depending on the audience of the vaccine, for example, newborns are given Hib (https://www.cdc.gov/vaccines/vpd/vaccines-age.html), the vaccine is tested at younger ages if successful and safe in the adult group. Determining safety and the extremities of immune responses is the main goal in this phase.
Phase II – This phase has more than 100 subjects. A placebo is introduced and the subjects often contain those who have higher risks of contracting the given illness. This process is randomized. The same criteria in Phase I are further explored in Phase II, along with “proposed doses, schedule of immunizations, and method of delivery” (Vaccine Development, Testing, and Regulation).
Phase III – This phase includes thousands of subjects. The large subject group allows adverse effects to be followed that may not have been evident in smaller test groups (Producing Prevention). The experiment randomized and doubleblind, or in other words, neither the researcher nor the subject are aware whether they’re given a placebo or the candidate vaccine.
The furthest developed COVID-19 vaccine lies in between phases II-III. This is the Bacillus Calmette-Guerin (BCG) live-attenuated vaccine sponsored by University of Melbourne and Murdoch Children’s Research Institute, Radboud University Medical Center, and Faustman Lab at Massachusetts General Hospital (Craven). According to the NCBI, it’s the “live attenuated vaccine form of Mycobacterium bovis.” This vaccine is used to protect from severe cases of tuberculosis (Bacille Calmette-Guérin). To find other candidate vaccines in previous stages, click on this link.
Post Clinical Development
After the clinical development phases are over, the vaccine is essentially done. There are legal guidelines and processes necessary before the vaccine is given to the general public in order to avoid liability costs and protect citizens. For example, the vaccine goes through a process deemed “Regulatory review and approval” (Producing Prevention). It passes when the developer sends in a Biologics License Application to the FDA. Then follows manufacturing and quality control to ensure the best quality product is released to serve citizens.
With the environment right now, it’s easy to get frustrated with the lack of social exposure. As shown through the process above, there’s nuances to an applicable vaccine that takes hard work and dedication from researchers and scientists. However, during a time of crisis, developers are incentivized to speed up the process, and A vaccine has the ability to deplete the existence of a disease to almost zero, as shown through smallpox and polio. Although the wait seems long, it will be worthwhile. Stay safe until then!
Works Cited
“Vaccine Development, Testing, and Regulation.” History of Vaccines,
“Recommended Vaccines by Age.” Centers for Disease Control and Prevention, Centers for
Disease Control and Prevention, 22 Nov. 2016, www.cdc.gov/vaccines/vpd/vaccines-
“Producing Prevention: The Complex Development of Vaccines.” Blog, 6 Mar. 2019,
“Bacille Calmette-Guérin (BCG) Vaccination and COVID-19.” World Health Organization,
World Health Organization, 12 Apr. 2020, www.who.int/newsroom/commentaries/detail
/bacille-calmette-gu%C3%A9rin-%28bcg%29-vaccination-and-covid-19.