Every year, millions of people safely receive vaccinations. All FDA-approved vaccines undergo comprehensive and laborious trials prior to being given to the public. Testing during the development process includes screenings to analyze which antigen should be utilized to solicit a response from our immune systems.
The stage that precedes clinical testing is conducted without testing on humans. An exploratory vaccine is initially used in animals to gauge its efficacy and ability to prevent illness. If the vaccine sparks a response from the immune system, then it can be investigated in human clinical trials; this typically takes place over three phases.
Phase #1
During the first phase, a limited number of healthy young adults are given the vaccine to test for safety. Physicians will evaluate if an immune response is provoked and find the correct dosage to distribute.
Phase #2
During the second phase, the vaccine is administered to hundreds of volunteers over multiple clinical trials. The goal is to examine the effectiveness, efficacy, and capability to precipitate an immune response. People who participate in the second phase will represent the population intended to receive the vaccine.
Additionally, a placebo group that does not receive the vaccine is incorporated into this phase. The placebo group helps compare outcomes and understand the changes credited with receiving the vaccine.
Phase #3
During the third phase, the vaccine is dispensed to thousands of subjects across multiple countries. Results are compared to a group of volunteers that received a comparator product. This step decides if the vaccine is beneficial to resist the disease and the use of a broader group.
The Importance of “Blinding”
During the second and third phases of trials, all participants do not know who received the testing vaccine vs. the comparator product. This strategy is referred to as “blinding.” It is critical to guarantee that both the trial participants and the clinical experts are swayed in their evaluations. Once the trial is completed, all results are collected and distributed among everyone.
Consequently, the clinical trial data is reviewed through stringent regulatory and public health approvals. Ongoing observations continue to persist after the vaccine is launched. The consistent observations allow researchers to monitor a large sample over an extended time period and provide data for adjustments.
COVID-19 Vaccines
All vaccines are varied to provide protection, but the common denominator in all of them is a supply of T-lymphocytes and B-lymphocytes. These elements give our bodies the power to fight against a virus upon exposure.
COVID-19 vaccines enable the ability to create an immunity to the virus, without having to actually acquire the illness. This process usually takes several weeks.
Eradicating a global pandemic requires a large number of people to work together in the safest way possible. Additional protocols such as wearing face masks and staying at least 6 feet apart in social situations further help lower the risk of being exposed to the virus.
In our next Auxo Medical blog post, we will cover the Commonwealth of Virginia’s plan to distribute the COVID-19 vaccine to its residents.