By Karen L. Kier RPh,
on behalf of the ONU HealthWise Team
Many news reports are focusing on vaccines and the ONU HealthWise Pharmacy is receiving questions related to vaccine development. Here's a detailed vaccine explanation from Karen Kier.
All vaccines have to follow the same steps from concept to availability for the public. Each vaccine takes a different amount of time to get to market based on how quickly manufacturers provide information on each step.
Since 1902, all vaccines in the United States require government oversight. This legislation resulted in the creation of the Hygienic Laboratory of the U.S. Public Health Service and they were charged with overseeing manufacturers. The Hygienic Laboratory ultimately became known as the National Institutes of Health (NIH), which still exists today.
In 1944, the U.S. Public Service Act mandated that the federal government issue licenses for vaccines. Eventually, this approval and regulation including vaccine safety was moved to the Center for Biologics Evaluation and Research within the Food and Drug Administration (FDA).
Outside of the United States, the European Medicines Agency regulates vaccines and the World Health Organization has committees that provide recommendations.
How does a vaccine get to market and available for the public?
There are more steps then one might realize. All steps require regulation by the FDA and oversite through the development process.
The first step is an Exploratory Stage involving laboratory investigation to determine if researchers can develop a substance that has the ability to fight the infection. Once a substance is found, then the Pre-Clinical Stage starts.
This stage takes the future vaccine and determines its safety and ability to protect the body in tissue or cell cultures. Scientists will then make modifications as they explore the safest way to give the vaccine and the best way to protect the body.
Researchers at this stage may do animal studies to see if they can give the vaccine and protect the group. If all goes well with this stage, then the company will apply for an Investigational New Drug approval by the FDA and the FDA has 30 days to provide an answer.
If the answer is yes, then the investigational vaccine is available for further research in clinical studies with human subjects.
Three distinctive phases
There are three distinctive phases for vaccine human trials that must be completed with all data going to the FDA at each stage before the vaccine can be approved for the public.
The first step is referred to as Stage I and involves a small group of adults. Usually between 20-80 people are involved in this phase. All participants are carefully monitored during this stage with information going back to the FDA.
If the vaccine has been successful, then it is on to Phase II of human studies. This is a much larger study phase involving usually around 100-200 people. Again, the companies are looking at effectiveness and safety.
With successful completion of this phase, the company will move on to Phase III human studies.
Phase III trials involve thousands of patients and are very well controlled. This phase is looking at how well it works as well as how safe is the vaccine in more people.
The study data are submitted to the FDA for approval or licensing of the vaccine. This is the stage where the company submits all data and the FDA Advisory Committee is looking at the results for potential approval.
The Vaccines and Related Biological Products Advisory Committee is the group responsible for looking at the study information and provides a recommendation to the FDA. It is important to note that these advisory groups are not FDA employees but rather experts in the field of infectious disease.
The committee members are mostly physicians, but public health professionals and health administrators are also involved. The committee discussions and recommendations are public record. Once the advisory committee makes a recommendation, then the FDA makes the final determination to approve the vaccine.
Once the FDA approves and provides a license, the company may start to provide the vaccine to the public. However, the company is still required to provide information to the FDA.
The last step
This is the last step known as Phase IV or postmarketing (after the drug is available). The FDA will examine all data after the vaccine is approved. The FDA and the Centers for Disease Control and Prevention (CDC) has a program that was started in 1990 that allows anyone to report an issue with a vaccine.
The program is called The Vaccine Adverse Event Reporting System (VAERS). https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index....
Vaccines are processed though all of these stages and steps. The time to get a vaccine to market can differ substantially depending on how rapidly a stage is completed.
If you have questions about vaccines or the vaccine development process, please feel free to contact one of the ONU HealthWise immunizing pharmacists.
