The Process of Vaccine Development
Discovering the Need for a Vaccine
Vaccine development typically starts when the need for a vaccine has been discovered. New viruses and bacteria are a common occurrence, so scientists determine the severity and need for a vaccine on a case-to-case basis. Vaccines are developed in laboratories and medical centers that receiving funding for the vaccination through government grants or private institutions.
Scientists begin vaccination testing on small animals that have been infected with the virus or infection. Several scientists will monitor progress of vaccination immunity and will evaluate the work of their fellow scientists simultaneously. If the vaccination, at any point, seems like it could be effective on a large scale for the general public the focus switches to research and product development via science.
Phase I Trials
Phase I vaccination trials are done on fewer than 100 healthy adults in a placebo-controlled study. Phase I aims to discover if the vaccine generates the expected immune response and if the vaccine safe.
During Phase I trials, scientists finalize the components of the vaccine, show that the intended results are consistently achieved, and apply to inform the Food and Drug Administration.
Phase II Trials
Phase II trials involve several hundred people, comparing those who did and did not receive vaccine to determine the amount vaccine that is appropriate, ways to manufacture the vaccine, vaccination safety, packaging, and continued efficacy consistency. The FDA can stop production at any time during this phase.
Phase III Trials
This is the final stage of development before a company requests product licensing, and involves thousands of participants receiving the vaccine versus placebo participants. Scientists gather the data, monitor efficacy and safety, and compile results.
The FDA and the CDC will review the science, have their scientists conduct studies, and monitor development.
Phase IV (after licensure)
Once the vaccine begins to be distributed, additional studies occur, and the CDC, FDA, and health departments monitor the vaccination in all aspects.
The Difference in the Quickness for Covid-19
The reason that the Covid-19 vaccination is occurring so rapidly is that the scientists and organizations working to create it have very large government grant funding, an unprecedented demand for quick vaccination options, and very little concern for separating the trial phases to allow time for adjustments after data collection from participants between each phase clinical trial. The developers must adhere to rigorous standards of clinical trials, as the CDC has set guidelines for this particular vaccine development. Read here. These condensed trials will not allow for ample time to completely understand efficacy of the vaccine down the road, meaning the first vaccination released will most likely not be the last. The phase III trials will involve tens of thousands of participants providing a large amount of data when it comes to adverse effects. The safety standards have been set, and the vaccine concern may not be with safety at this point, but rather, how it could potentially provide only partial immunity.
We will keep you posted on updates.
Reference: Children’s Hospital of Philadelphia