As the largest vaccination campaign in U.S. history begins this week, we all may want to take at least a few minutes to simply marvel at the astonishing achievements of scientists, physicians, chemists, microbiologists, pharmacologists and other experts who developed and documented the safety and effectiveness of the COVID-19 vaccine in less than nine months.
It is a process that normally takes years, sometimes more than a decade to complete, but Monday, the vaccine they first imagined just last March went into the arms of thousands of medical and health care professionals — the heroes who continue the battle every day on the front lines of the COVID-19 pandemic.
Just a glance at the most basic outline for the FDA’s vaccine approval process casts the deployment of the COVID-19 vaccine in less than one year as nothing short of amazing.
As the FDA outlines, it all starts in the laboratory, where research and discovery stage scientists begin their initial work. This is considered the research and discovery stage. Once a scientific finding is thought to have practical applications, the research moves forward into the pre-clinical phase.
Here, the researcher may conduct tests with animals to determine if there is even a possibility that the theory might work in humans.
When a researcher is ready to begin studies in humans, they compile their laboratory results and submit it to the FDA in the form of an Investigational New Drug application (IND). The FDA evaluates the work to determine if it’s reasonably safe for testing in people before allowing it to move forward to clinical trials.
Clinical trials occur in three phases. In Phase 1, the emphasis is on safety and generally includes 20 to 100 volunteers who have not been exposed to the disease being studied and are otherwise healthy. In the absence of safety concerns from Phase 1, research moves on to Phase 2 with studies that include hundreds of people. Various dosages are administered to different demographic groups in randomized-controlled studies.
If all goes well, research advances to Phase 3 where the vaccine is administered to thousands of people, with an emphasis on safety and identification of side effects.
It is only after these three phases of clinical trials that a company can seek approval from the FDA to distribute and market the vaccine.
During its approval phase, the FDA assembles a team of experts, and sometimes, as in this case, an additional panel of outside independent, technical professionals, who look carefully at the benefits and risks of the vaccine. They all work together to evaluate all of the scientific data and determine if it should and will be approved.
That approval came Friday evening for Pfizer’s COVID-19 vaccine. Tuesday, the FDA said Moderna’s vaccine was safe.
As the COVID-19 vaccines are administered, first to health care professionals and to people who live in nursing homes, it is appropriate to pause, appreciate and give thanks for this historic achievement.
NOTE: Opinions expressed in The Daily Item’s editorials are the consensus of the publisher, top newsroom executives and community members of the editorial board. Today’s was written by Digital Editor Dave Hilliard.