How are new vaccines developed?
So vaccines normally require years of testing and more time to produce at a large scale, but -as we know- scientists are hoping to develop a covid-19 vaccine ASAP. But how are these vaccines tested? I got you.
Stage 1 Exploratory stage
The exploratory stage involves basic lab research and often lasts between 2-4 years. I can get into the whole scienc-y stuff but… none of us understand anyway.
Stage 2- Pre-clinical stage
At this point researchers give the vaccine to animals to test its safety and see if it triggers an immune response. This gives researchers an idea of the cellular responses they might expect in humans. They may also suggest a safe starting dose for the next phase of research as well as a safe method of administering the vaccine.
Stage 3- Clinical development
This stage has 3 phases.
Phase 1: During phase 1 the vaccine is given to a small group of people to determine whether it is safe and to learn more about the immune response it provokes.
Phase 2: In phase 2, the vaccine is given to hundreds of people so scientists can learn more about its safety and correct dosage. The vaccines are given to people who have characteristics -like age, physical health etc.- similar to those for whom the new vaccine is intended.
Phase 3: In phase 3, the vaccine is given to thousands of people to confirm its safety – including rare side effects – and effectiveness. These trials involve a control group which is given a placebo.
Stage 4- Regulatory review and approval
After a successful Phase 3 trial, the vaccine developer will submit a Biologics License Application to the FDA. Then the FDA will inspect the factory where the vaccine will be made and approve the labeling of the vaccine.
Stage 5- Manufacturing
Stage 6- Quality control