Never have we seen such rapid scientific progress as we have seen with the COVID-19 vaccine. Some might say that it was developed in “warp speed“. With this fast pace of development, you might be wondering how a vaccine could be developed this fast while still being safe. Rest assured, the COVID-19 vaccines have to go through the same safety measures as any other vaccine.
Research and Development/ Pre-Clinical Phase
Laboratory testing on the pathogen (in this case the COVID-19 virus) narrow down possible vaccine candidates. Once there is a scientific discovery that proves applicable, it will then be given to animal subjects. This is all done by the company or manufacturer producing the vaccine.
Clinical Trial Phases
This is the part where the Food and Drug Administration, or FDA, first comes into play. The FDA will evaluate the new vaccine for quality, safety, and production process. They also will evaluate the laboratory practices of the drug company to ensure that the scientific findings from the previous stage were sound. If the FDA approves, the vaccine will move onto clinical trials where it will be tested on voluntary human subjects. These phases vary in size and makeup of the subject pool.
- Phase 1: 20-100 healthy volunteers receive the vaccine. You might remember this happening back in March 2020 when news stories came out about the first 45 volunteers receiving the Moderna vaccine.
- Phase 2: Hundreds of volunteers of varying demographics and health statuses. This randomization ensures that the vaccine can be used in a broader population. It also contains a “control group”, which will receive a placebo for comparison.
- Phase 3: Thousands of volunteers participate in the trials. This phase emphasizes effectiveness of the vaccine and compares rates of the disease between vaccinated and unvaccinated individuals.
Emergency Use Authorization
Only after passing those previous phases can a drug manufacturer apply for Emergency Use Authorization (EUA). The EUA does not mean skipping any of the necessary safety trials, however it does mean that the FDA will review the data collected from the previous phases sooner than if it were a non-emergency. The FDA will make a decision for EUA approval based on the final analysis of Phase 3’s results, plus discussions with the Vaccines and Related Biological Products Advisory Committee. The FDA has a great write-up on their EUA process here.
If a vaccine gets approved for EUA through this process, the vaccine will still be closely monitored for safety standards. Adverse effects such as hospitalizations will be reported and the FDA will continue to evaluate risk verses benefit. Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), and the Biologics Effectiveness and Safety (BEST) Initiative are just some of the reporting systems in place for discovering safety issues post-approval.
Can the Vaccine Really be Produced That Fast AND Safe?
The leading American authority on drug safety, the FDA, says yes! Currently, the FDA is reporting minimal to no side effects in the vast majority of vaccinated individuals. Side effects that do occur are the mild reactions one might see in any other vaccine, such as day-of fatigue and soreness at the injection site.
In future posts we will uncover more about the science of mRNA and how scientists are using the latest in cytology to develop safe and innovate vaccine solutions.
Until next time, stay safe McDonough County!