COVID-19 vaccine update: What we know so far
While clinical trials are still ongoing, much is happening at UI Health Care to prepare for the eventual approval of COVID vaccines.
A multi-disciplinary committee, led by Mike Brownlee, PharmD, MS, chief pharmacy officer, and Jennifer Miller, MPH, MHA, assistant director for Support Services, has been meeting for months to make sure UI Health Care is ready.
Being ready for a vaccine includes everything from storage preparations and the purchase of special, ultra-low temperature freezers, to distribution logistics and tracking, as well as evaluating a prioritization to help determine who is first eligible for the vaccine. The committee also works alongside Johnson County Public Health and the Iowa Department of Public Health (IDPH) to help make some of these decisions.
We’re relying on the guidance of our experts and putting safety first.
Like other drugs and biologics, vaccines released in the U.S. must go through multiple phases of rigorous testing, analysis, and review as they are developed. The U.S. Food and Drug Administration (FDA) closely monitors the vaccine development process and testing results for efficacy and safety.
As part of the FDA’s formal process to determine if the vaccine is approved for public use, it also seeks a recommendation from a multidisciplinary team of experts consisting of independent medical officers, microbiologists, chemists, biostatisticians, and other health experts, known as the Advisory Committee on Immunization Practices (ACIP).
If approved, the FDA continues to oversee the vaccine and its manufacturing to ensure ongoing safety.
The speed at which the COVID vaccine might become available is not a concern. COVID vaccines are still required to go through the proper testing and analysis to make sure they are safe—no step in the process has been skipped.
However, because COVID-19 continues to disrupt society, the FDA under Emergency Use Authorization has the option to shorten the follow-up period for clinical trials to help speed the introduction of vaccine into the population. This is different from standard timelines for other vaccine approvals but takes advantage of the fact that most reactions from vaccines are seen within two months following vaccination.
To further the speed of vaccine delivery, the federal government is funding advanced production of some of the more promising vaccines so at least a limited supply would be available quickly after FDA Emergency Use Approval. So, steps that would have happened one after another in non-pandemic times have been done on a parallel track to be able to act quickly once a vaccine is approved or authorized by the FDA.
One of these promising vaccines is from Pfizer. The company reported that initial results indicate their vaccine to be about 95% effective, and on Friday, Nov. 20, Pfizer announced they would submit for emergency use authorization.
When a vaccine completes a clinical trial, the FDA may grant the manufacturing company an Emergency Use Authorization or full approval.
In certain types of emergencies, the FDA can issue an emergency use authorization (EUA) to provide more timely access to drugs, diagnostic tests, or other critical medical products that may help during an emergency, like the COVID pandemic.
Learn more about EUAs
University of Iowa coronavirus expert Stanley Perlman, MD, PhD, is among the national experts advising the federal government on that decision, as well as how to prioritize distribution of the first doses of an approved vaccine.