Everyone these days is thinking about why the vaccine for COVID-19 is not developing what the researchers are doing. The answer is that it is not as easy as we think to develop a vaccine against this novel virus. So the question arises, what makes it tricky?
COVID- 19 virus mutates (changing shape) very rapidly. The genetic material is single-stranded Ribonucleic Acid (RNA) it easily gets cut up and remixed once broken so vaccines made for a specific RNA may become quickly obsolete.
Vaccine development begins in a laboratory. If tests show that a vaccine has potential, it is tested in experimental animals like mice, rabbits, or guinea pigs. If a vaccine is found safe in animals, clinical trials are done with human volunteers.
According to the Centers for Disease Control and Prevention (CDC), there are three main phases of clinical trials. The Food and Drug Administration (FDA) sets guidelines for the three stages of clinical trials to ensure the safety of the volunteers.
Phase 1, Clinical trials focus on safety and include healthy volunteers. In Phase 1, the size of the dose is related to the side effects of the vaccine. At this early phase, scientists learn the efficacy of the vaccine. If no severe side effects are found in the vaccine, then it goes on Phase 2 trials, which involves several hundred volunteers. This phase includes studies that may provide additional information on common short-term side effects and how the size of the dose is allied to immune response.
In Phase 3 studies, thousands of volunteers participate. Vaccinated people are correlated with people who have received a placebo or another vaccine so scientists can learn more about the test vaccine's safety and effectiveness and identify common side effects.
Clinical trials are conducted by the Food and Drug Administration (FDA) to ensure the highest scientific and ethical standards. In addition to examining the results of the clinical trials, FDA scientists also evaluate a wide range of information regarding the vaccine's physical, chemical, and biological properties carefully to ensure that it can be made consistently safe, pure, and potent. The trials and all other data must unveil that the vaccine's benefits supersede the side effects for people who will be recommended to receive the vaccine only if a vaccine's benefits are found to outweigh its potential risks then its granted license and allowing to be used for the public. After vaccines are licensed, they are monitored minutely as people begin using them. The purpose of monitoring is to watch for adverse events.
So it is a lengthy and time-consuming procedure; it may not be developed overnight; it may take years to bring a vaccine in the market; we have to keep patience amid current turmoil and follow the guidelines of world health organization (WHO), i.e., maintaining social distance, wearing face masks, and frequent hand washing. We have to live with this virus for some more. Don't try to fool this novel virus; this one is smarter than you. Biut don't worry, this virus should also have antidote.
Gowhar Rashid, PhD Researcher, Clinical Biochemistry SKIMS, Srinagar