According to Elena Smolyarchuk, the Chief Researcher of the Center for Clinical Research on Medications, the Sechenov First Moscow State Medical University in Russia finally completed the clinical trials of the world’s first vaccine for COVID-19.
Smolyarchuk said that the research has been completed and the vaccine is safe.
Stages of the Research
The first stage of research started last June 18, 2020 at Sechenov First Moscow State Medical University and 18 volunteers were vaccinated.
On the second stage which was conducted last June 23, 2020, 20 volunteers were injected with the vaccine.
Furthermore, Chief Researcher Smolyarchuk said the volunteers will be discharged on July 15, and July 20, 2020, but they will remain under medical supervision on an out-patient basis after being discharged.
While this may be the case, the W.H.O. guidelines on clinical evaluation of vaccines as well as the CDC Stages in the Development of vaccines, suggest that the success of the clinical trials has only completed Phase 1.
Stages of the Development Cycle of Vaccine
Here is the following process on how a vaccine is developed.
- Exploratory stage
- Pre-clinical stage
- Clinical development
In the clinical development there is a three-phase process:
- Phase 1 – small groups of people receive the trial vaccine
- Phase 2 – clinical study is expanded and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended
- Phase 3 – the vaccine is given to thousands of people and tested for efficacy and safety.
Also, many vaccines undergo Phase IV formal which is the ongoing studies after the vaccine is approved and licensed.
- Regulatory review and approval
- Quality control
While it is not clear right now on which gold standard is being followed by the developers of the vaccine in Russia. To give us an idea of the processes on how a vaccine is approved for distribution to the public, we look into the Vaccine approval process of the US-FDA.
Vaccine Product Approval Process
The one responsible for regulating vaccines in the United States (US) is the U.S Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research External (CBER).
Multi-Step Approval Process
These are the following multi-step approval process to be followed by the sponsor of a new vaccine product.
- An Investigational New Drug application
- Pre-licensure vaccine clinical trials
- A Biologics License Application (BLA)
- Inspection of the manufacturing facility
- Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory CommitteeExternal (VRBPAC)
- Usability testing of product labeling
Here’s what’s going to happen after the vaccine is approved:
- FDA will continue to oversee its production to ensure continuing safety.
- Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.
- FDA can require a manufacturer to submit the results of their own tests for potency, safety, and purity for each vaccine lot.
- FDA can require each manufacturer to submit samples of each vaccine lot for testing.
Furthermore, once the Vaccine is administered Vaccine Adverse Event Reporting System (VAERS) will track the side effects of the vaccine.
VAERS is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). And it collects and analyzes information from reports of adverse events (side effects) that occur after the administration of US-licensed vaccines.
The following report can be submitted by all concerned individuals such as:
- Healthcare providers
- Vaccine manufacturers.