Keeping safety at the forefront of the race for a COVID-19 vaccine
On Monday, Nov. 9, Pfizer pharmaceutical company announced promising preliminary results from clinical trials of its COVID-19 vaccine candidate. This was welcome news, as we have all been eagerly awaiting a vaccine and this particular candidate has an apparent efficacy of 90%—well above the 50-60% that was initially hoped for.
However, Pfizer’s announcement also raises important questions as we begin shifting our thinking from the “what-ifs” to far more concrete “what nows” of a potential vaccine.
At University of Iowa (UI) Carver College of Medicine, I am fortunate to lead the team responsible for running the UI study site of the Pfizer vaccine trial. We have been directly involved in collecting some of the data that went into the recent announcement, having enrolled about 270 diverse individuals in the trial. Because of that, I want to provide additional insight that I hope will offer clarity and reassurance about how we reached this point—and what comes next.
Throughout my career I have helped run numerous vaccine trials and while the speed of the COVID-19 vaccine program has been remarkable, the safety measures put in place match those applied to any other vaccine candidate. Each step of the process is active and careful. We follow each participant—who all deserve our gratitude—very closely. While we typically wait for six months of safety data before approving most vaccines, the pandemic requires that we make some decisions earlier than usual. Fortunately, most severe adverse events that occur following a vaccine occur within the first two months after receiving the vaccine and the U.S. Food and Drug Administration (FDA) has required a two-month follow-up before considering an emergency use authorization.
The study as a whole has included more volunteers than normal for a clinical trial of this type. This has been done so that we can go above and beyond in demonstrating its safety and effectiveness. In the event an emergency use authorization is granted for the Pfizer vaccine, we will continue following the health of every volunteer for safety purposes.
The next step in this process will be to manage the logistical challenges involved once we have emergency use authorization for a vaccine. Fortunately, at UI Health Care, we have been looking ahead to these questions for months, and our participation in the trial has given us a jump start.
The storage and distribution of any vaccine is critical and requires technical and logistical expertise. Seemingly simple things like the temperature at which a vaccine is stored can make all the difference. For the Pfizer vaccine candidate, we purchased new equipment, including special freezers, to make plenty of room for a substantial amount of vaccine.
We are working with the Iowa Department of Public Health to apply guidance from the federal Centers for Disease Control and Prevention to the specific needs and realities here in our community. That partnership is also helping us begin prioritizing who will be first in line to receive an approved vaccine. It’s an important process to undertake now, as doses of any vaccine will be limited in the early stages while production ramps up. Rest assured that health care providers and state and local health departments are working hard to have an effective, efficient plan for administering the vaccine to those who need it most.
A vaccine clearly offers us hope. The early data from Pfizer should give reason for cautious optimism, and those of us on the UI site study team are excited about the initial results. But, it is critical to point out that while a safe, effective vaccine is very important – whether from Pfizer or any other company – it is just one piece of a larger solution to COVID-19. A vaccine should not be considered a light switch that will turn the pandemic from on to off overnight.
As we move into winter and closer to an approved vaccine, we must remain careful and vigilant. Please continue to protect yourself, your loved ones and the most vulnerable within our community. Wear a mask, maintain social distance, avoid gatherings, and wash your hands frequently. And yes, be hopeful. We’re not there yet, but we are getting closer.
Pat Winokur, MD is Executive Dean of the University of Iowa Carver College of Medicine and principal investigator for the UI trial.
This editorial was published in the The Cedar Rapids Gazette on Nov. 13, 2020.