![A nurse holds a phial of the Pfizer-BioNTech COVID-19 vaccine at Guy's Hospital in London, Tuesday, Dec. 8, 2020. U.K. health authorities rolled out the first doses of a widely tested and independently reviewed COVID-19 vaccine Tuesday, starting a global immunization program that is expected to gain momentum as more serums win approval. (AP Photo/Frank Augstein, Pool) [Dec-08-2020]](https://img.ksl.com/slc/2803/280316/28031601.jpg?filter=kslv2/responsive_top_sm)
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SALT LAKE CITY — The Food and Drug Administration will vote Thursday on whether to approve emergency authorization that will allow the Pfizer-BioNTech COVID-19 vaccine to be administered to patients.
According to Reuters, the FDA appears all but certain to approve authorization after finding no major safety concerns or issues with its efficacy. Once passed, it's expected that Utah's frontline medical professionals could start to get the vaccine as early as next week. That's when the state health department anticipates receiving its first round of vaccine doses.
The fact that there is already a vaccine available for review is unprecedented. It often takes years for a vaccine to be produced, the Mayo Clinic notes. "This is especially true when the vaccines involve new technologies that haven't been tested for safety or adapted to allow for mass production," the renowned medical research center points out about vaccines.
The COVID-19 vaccine to be voted on this week was produced a little over a year after COVID-19 was first discovered by any scientist.
The record project speed has caused some concern about the safety of the vaccine, and now we have a better idea of the adverse effects, or side effects, documented during Pfizer's trial studies. In addition to signaling support of the vaccine, the FDA posted a 53-page report of the Pfizer vaccine study on its website Tuesday. It details everything learned from the trial, including side effects, from the 38,000 people who participated.
Most of the effects were common with other vaccines. The report found that a vast majority — some 84% — suffered injection-site reactions, or inflammation where they were injected. About 63% reported fatigue, while 55% reported experiencing headaches.
About 38% reported muscle pain; a little under one-third reported chills; nearly one-quarter reported joint pain, while 14.2% reported fever. All of these reactions were considered mild.
The vaccine is to be administered in two doses. The report found that "severe adverse reactions" were a slight percentage and more frequent after the second dose with the rate of "non-fatal serious adverse events" listed as less than 0.5%. These included eight cases of appendicitis in the vaccine group compared to four in the control group.
Four participants in the vaccine group reported Bell's palsy, which is a sudden weakness or paralysis of the muscles in the face that could be very temporary or last for weeks. The cases were reported three, nine, 37 and 48 days after the vaccine was administered.
Other serious effects reported were acute myocardial infarction, pneumonia and cerebrovascular accident, which were anywhere from 0.02% to 0.04% higher than the placebo group. That said, the paper noted that none of the serious effects represented "a frequency above that expected in the general population."
"Otherwise, there were no notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic, neuroinflammatory, and thrombotic events) that would suggest a causal relationship to (Pfizer) vaccine," the report stated.
Six people in the study died; of those, only two were given the vaccine. One individual had "baseline obesity and pre-existing atherosclerosis" and died three days after receiving the first dose of the vaccine. The other suffered a heart attack 60 days after the second dose and died a few days later.
The reactions to the vaccine were "generally similar across age groups, genders, ethnic and racial groups, participants with or without medical comorbidities, and participants with or without evidence of prior SARS-CoV-2 infection at enrollment," the paper noted.
The Centers for Disease Control and Prevention points out all vaccines carry the potential for side effects. Previously approved vaccines typically result in symptoms mentioned in the Pfizer vaccine report, such as a sore arm or a low-grade fever. The agency said those symptoms typically end "within a few days."
During a press conference last week, Dr. Andrew Pavia, an infectious disease specialist for University of Utah Health, explained that the studies from both Pfizer and Moderna indicated a low risk of severe adverse effects.
"Both of these vaccines are as safe as most vaccines we have out there," he said.
Pavia's remarks came as officials for Intermountain Healthcare and University of Utah Health revealed their distribution plans for the COVID-19 vaccine when it arrives at their hospitals. Frontline medical workers — like doctors, nurses and technicians — will receive the first doses in the state.
Utah Department of Health officials announced their first purchase of the vaccine hours after that Thursday press conference. It's expected to arrive by Dec. 15 and will be distributed to five hospitals around the state.
