In virology, novel means new. The term refers to a new virus strain that was previously not known. For example, the virus that causes COVID-19 is a novel viral strain because it was known in the past. SARS-CoV-2 was not identified in human beings in the past (Mohammadi et al., 2020). Since human beings have not been exposed to the virus in the past, their bodies are not prepared to fight the infection. This is why researchers are working day and night to develop a vaccine to enable the human body to build immunity to the virus, preventing and stopping the infection. The vaccine development and approval process is not easy and may take years before a vaccine is made available in the market (Gruber & Marshall, 2018). The FDA is in charge of approving the use of new vaccines.
Vaccine development goes through several stages, including exploration, pre-clinical, clinical, and regulatory and approval, manufacturing, and quality control stages (CDC, 2019). Researchers study the sugars and proteins on a virus or an infected cell in the exploratory phase to determine if the proteins can generate an immune reaction. The pre-clinical step is the first safety testing stage on animals to explain the likely reaction in human bodies. The clinical development step includes three stages involving testing on a dozen, numerous hundreds, and several thousands of individuals. The vaccine is then reviewed by regulators for approval and produced and subjected to quality control.
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The FDA requires sponsors to follow an approval process that includes an application for investigation, clinical trials for the vaccine before licensing, a BLA, an inspection of the factory where the vaccines are manufactured, presenting findings, and usability testing of the vaccine's labeling (CDC, 2019). Even after approval, the FDA keeps monitoring to ensure the vaccine's safety. Vaccines are preventive hence different from antiviral drugs. A vaccine is administered before an individual becomes infected, while antivirals are prescribed when a person is already infected to stop the virus' activity.
References
CDC. (2019, April 5). Vaccine testing and approval process | CDC . Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/basics/test-approve.html
Gruber, M. F., & Marshall, V. B. (2018). Regulation and testing of vaccines. Plotkin's Vaccines , 1547-1565.e2. https://doi.org/10.1016/b978-0-323-35761-6.00079-1
Mohammadi, M., Meskini, M., & Do Nascimento Pinto, A. L. (2020). 2019 novel coronavirus (COVID-19) overview. Journal of Public Health . https://doi.org/10.1007/s10389-020-01258-3
