By Dr. Henning Ansorg, M.D., FACP, Health Officer County of Santa Barbara, Department of Public Health
Some have asked: how did the vaccines get developed so quickly and did the vaccine developers cut corners? The fact is that a true global emergency paired with early application of substantial resources made the rapid development of COVID-19 vaccines possible.
It is important to note that scientists had studied other coronaviruses for 50 years. They already knew the spike protein could be targeted by a vaccine, which gave them a goal to work toward immediately.
Researchers have been developing and researching an mRNA vaccine platform for more than 10 years. After the complete SARS-CoV-2 Genome was sequenced and shared with the international scientists in January 2020, the process to utilize the already existing mRNA technique to create a potential vaccine was performed in a matter of days in several different Bio-medical research labs.
Large scale vaccine clinical trials were organized quickly using previously established networks to be used in the development of an HIV vaccine. People enrolled quickly due to widespread public interest. Due to international emergency declarations, regulators were authorized to fast track approvals for the necessary trial phases.
The U.S. Federal government and others financed pre-built manufacturing facilities for the production of vaccines even without the assurance that the new vaccines would get approved. The financing by the government made the speedy production ramp up possible.
Regulators at the Food and Drug Administration and the developing Bio-medical research facilities had already confirmed mRNA vaccine platform. Therefore, researchers could dive into animal models and early human trials immediately.
No necessary study phase was eliminated, however certain study phases were allowed to overlap which helped in getting through the Phases 1-3 more expediently.
Following the trial results, the FDA re-analyzed the data in record time by compressing the review timeline to weeks instead of many months.
COVID-19 vaccines that are authorized for emergency use by the FDA have proven to be safe and effective. COVID-19 vaccines were evaluated in tens of thousands of participants in clinical trials. The vaccines met the Food and Drug Administration’s (FDA) rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization (EUA). Learn more about EUAs in this video.
Millions of people in the United States have received COVID-19 vaccines since they were authorized for emergency use by FDA. These vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history. This monitoring includes using both established and new safety monitoring systems to make sure that COVID-19 vaccines are safe.
Reported adverse events are immediately captured through an early warning system VAERS. Through this system 6 cases of a potentially vaccine-linked adverse events were quickly identified after 6.85 Million doses of the Janssen vaccine had been given. It resulted in a pause of the vaccine’s use to provide time to study and thoroughly evaluate the correlation between the vaccine and the adverse events by the FDA and the Safety Committees. It was subsequently cleared for ongoing use by these agencies. The incident was an excellent example in demonstrating how efficient the safety protocols are.