The World Health Organization (WHO) has already evaluated four vaccines against COVID-19, and they met the requirements in terms of safety and efficacy. The organization is also currently reviewing two other vaccines manufactured by two Chinese companies before they can be included in the COVAX facility of the organization. When a person gets vaccinated, he will have a reduced risk of getting the virus. To ensure these vaccines are safe to use, their development production process follows strict standards to prevent contamination.
Vaccines produced in the United States should get approval from the US Food and Drug Administration (FDA) before they are used. The FDA also set standards to ensure these vaccines are safe, potent, pure, and effective. Doctors and scientists also evaluate these vaccines before the FDA approves them for public use.
Additionally, the vaccine production facilities also go through FDA inspection to ensure they follow Current Good Manufacturing Practice (CGMP) regulations. This means the facility should be thoroughly clean and may require pharmaceutical flooring to ensure they are sterile.
Development of Vaccines
The development of vaccines starts in the laboratory before conducting tests on animals or humans. Scientists create a rationale for the vaccine using their knowledge of how viruses and other infectious organisms can cause diseases. These scientists conduct laboratory research and experiments to test theories for a vaccine candidate.
When the vaccine candidate shows potential based on research, the scientists may conduct tests on animals. These tests provide scientists with information on how the vaccine works. It also allows them to know if the vaccine is safe for humans.
After an organization is ready to start studies on humans, it compiles its research and tests before submitting it to the FDA. The information the organization submits also includes the manufacturing technology information and vaccine quality. The organization submits all the information as an Investigational New Drug (IND) application to the FDA.
Once the FDA determines that the tests followed Good Laboratory Practices and it is reasonably safe to conduct human testing, it moves forward to the clinical development stage under the FDA’s guidance.
Clinical Development of Vaccines
|The clinical development of vaccines goes through three phases. Phase I involves a small number of volunteers who will receive the vaccine to evaluate its safety ad check its immune response. It also determines the dosage.
Phase II involves hundreds of volunteers who will receive the vaccine. In this phase, the scientists monitor the volunteers for potential side effects and evaluate any immune response caused by the vaccine. Scientists also collect data on possible disease outcomes. Even as some volunteers receive the vaccine, others do not receive the vaccine to allow the scientists to know more about the vaccine. But the number is not large enough to have a better picture of the vaccine’s effect on the disease.
Phase III involves thousands of volunteers where some receive the vaccine, and others do not, which is similar to phase II of the trials. The scientists collect data from the two groups to check the safety and effectiveness of the vaccine. The scientists will collate the results along with the data on the efficacy and safety of the vaccine.
During a health emergency similar to the current pandemic, the organizations normally apply for an Emergency Use Authorization (EUA) at the FDA to facilitate its production, availability, and use of the vaccine.
Production of Vaccine
The FDA typically evaluates the production facility even as an organization conducts clinical trials. The government agency goes through the process and the facility itself. It requires the organization to submit information about the production process, product characterization, facilities, and a lot-to-lot demonstration of the consistency of the production process.
The FDA will also work with the organization in the development of the release protocol. The protocol involves testing each lot produced by the organization. Experienced evaluators normally assess the facility and its operation to ensure it follows the regulations of the FDA.
Continuous Monitoring
Since no vaccine is 100 percent effective, it is important for the FDA to continuously monitor it for any adverse effects on the general population. Many of the side effects are minor and do not last long. Some people may experience soreness on the injection site, while others may have a slight fever.
There are instances when serious side effects can happen. Currently, the authorities have not yet detected any pattern in deaths attributed to the Covid-19 vaccines. The US government has already administered more than 211 million doses of the vaccine, and deaths reported among people who received it was only 0.0016 percent.
With the current pandemic, the government needs to ensure the vaccines are safe and effective.
