Marketing Program Manager, CISCRP
Researchers are testing a number of approaches in clinical trials that involve introducing a weakened or inactive form of the virus into the body to prompt an immune response without causing harmful disease. If the body reacts as desired by creating antibodies to attack the virus, then it may build protection against future infection.
Vaccines like this have been successfully developed to prevent many diseases like measles, mumps, rubella, smallpox and chickenpox. Other vaccines under investigation, such as genetically-engineered DNA or mRNA vaccines, try to trick the coronavirus into mutating into a form that the body can more easily and effectively attack. Another category of vaccines are those intended to block the virus from attaching to healthy cells in the body and reproducing to cause widespread infection.
As researchers work to uncover an effective vaccine for prevention, they are also testing treatments in specific patient populations that are already infected with COVID-19. These treatments look to lessen the severity of symptoms and shorten recovery times. Some treatments currently in development seek to moderate the body’s own immune response to the virus.
The necessary steps
Vaccines and treatments for infectious diseases usually take nine or 10 years to develop, and most will fail to complete the process or obtain regulatory approval. This seems like a long time, but it is necessary for understanding the real effects of a new therapy and determining whether it is safe and effective at specific dosage levels.
Clinical trials follow a set progression: They begin with a small number of people to assess whether a treatment is safe, then grow to further evaluate safety and efficacy. At each stage of this progression, researchers review the results of clinical trials and get approval to move on to a subsequent stage.
Accelerating the process
The clinical trial process for COVID-19 treatments and vaccines is moving at a faster pace and may produce promising therapies within a few years. The pandemic has mobilized much higher levels of coordination between companies and government agencies. Some treatments and vaccines have a head start because they are based on research that was conducted for viruses that are similar to COVID-19.
Fast-tracked treatments and vaccines in clinical trials have received a lot of attention in the news. They include Moderna’s vaccine (mRNA-1273), Gilead Sciences’ treatment (remdesivir), Regeneron and Sanofi’s Kevzara treatment (sarilumab), and the antimalarial drugs hydroxychloroquine and chloroquine.
In some instances, for the most promising treatments and vaccine candidates, the Food and Drug Administration (FDA) may issue an emergency-use provision so patients, doctors, nurses, and other essential workers can begin using it. Under emergency-use conditions, even more information about a new vaccine or treatment will be used to inform researchers and the FDA about safety and efficacy.
There are many useful resources that provide real-time information about COVID-19 vaccines and treatments. To learn more, please visit https://www.nih.gov/health-information/coronavirus. If you would like to learn more about the clinical trial process and the phases of clinical research, please visit www.ciscrp.org.