Local doctors say COVID-19 vaccines may utilize some new technologies, but overall, they're looking to achieve the same end goal of any other immunization. (IMAGE: KSL Newsradio)
EDITORIAL NOTE: ‘Are the Covid-19 vaccines safe?’ is the second part of our four-part series, ‘The Vaccines: Hope on the Horizon.’ Each day, KSL will break down a different aspect of COVID-19 vaccine development and distribution. Listen to Utah’s Morning News at 7:45 a.m. and to Jeff Caplan’s Afternoon News at 4:45 p.m. every day this week for the latest.
SALT LAKE CITY — We’re getting closer to having an approved Covid-19 vaccine but can we trust that it’s safe to take? While full safety data isn’t released until a vaccine has been approved by the U.S. Food and Drug Administration, one of Utah’s top doctors said there are many safeguards in place and that she is “cautiously optimistic.”
Who approves a vaccine?
It’s the FDA that will determine if a vaccine is safe. More specifically, it comes from their third party group of experts known as the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, who are studying the data and will make a recommendation to the FDA.
“The FDA approves the vaccine, the Centers for Disease Control and Prevention (CDC) creates the clinical recommendations for the vaccine,” Dr. Tamera Sheffield, Intermountain Healthcare’s Medical Director of Community Health and Prevention told KSL.
“So [they tell] us, the providers, how to best provide it for best safety and best efficacy,” she said.
Dr. Sheffield is also a former liaison to the Advisory Committee on Immunization Practices, or ACIP, which is the name of that independent group of medical professionals creating those clinical recommendations for the CDC.
Two vaccines are currently waiting for emergency approval from the FDA, one from Pfizer and one from Moderna.
“Everything we’ve seen on preliminary data looks very promising.” Dr. Sheffied said. “So we are cautiously optimistic that these are good vaccines that are having the desired effect and their safety profile appears to be good in preliminary information that we got.”
The FDA’s committee is slated to meet about the Pfizer vaccine on December 10th in a public meeting, and again on December 17th to discuss Moderna’s data. A thumbs up on approvals could come shortly after those meetings.
Have the vaccines been rushed?
Dr. Sheffield said the vaccines haven’t been rushed in terms of safety steps.
“The trial production and production of the vaccines, many of those things were put into parallel so they are going faster, but in terms of meeting all the steps and going through the appropriate process, the same steps that we take for other vaccines are being taken on the Covid vaccine,” she said.
Researchers also weren’t starting from scratch. They had already been at work creating vaccines for other coronaviruses like SARS-CoV 1 and MERS-CoV. When the Covid-19 outbreak hit, resources and researchers shifted their focus. Dr. Sheffield said financial resources given to the vaccine manufacturers helped expedite things.
“To be able to both create large based studies quickly, and to be able to make the vaccine, those financial resources from our federal government are the thing that made and facilitated, this quick production,” Sheffield said.
Are the side effects worse than the virus?
Dr. Sheffield said it remains to be seen exactly how our bodies will react to the new way both the Pfizer and Moderna vaccines work, which is called mRNA. Simply put, a piece of genetic code is injected into your arm, which goes into your cells in the immune system and gives them instructions to create a “spike protein” which is found on the surface of the virus.
“And this genetic code tells those cells – make this protein, which is the spike protein from the virus. And that becomes the antigen that your body learns how to protect itself against.” Dr. Sheffield said.
However, there will likely be some side effects.
“We are seeing the same kind of responses we do with every vaccine where when our immune systems turn on, we may get a bit of a fever, we may feel some aches and chills, we may get a headache. This is our body doing exactly what it’s supposed to be doing,” she said.
And while that may be really uncomfortable for a few days Dr. Sheffield said it should be weighed against what you’re trying to protect yourself from.
Are the vaccines going to stop Covid-19 from spreading?
Dr. Sheffield is concerned that some people might get a false sense of security by taking the vaccine. Meaning, they’ll take it, think they’re protected, and still spread the virus.
“What we need to be aware of is that vaccine is probably our strongest tool in preventing spread of infection by creating immunity so individuals can’t pass disease from one person to another, but it’s not the only tool in the toolbox.” Dr. Sheffield said.
She urged that masking, distancing, and hand washing will need to continue in concert with the vaccine.
How long will immunity last?
Her other concern, she said, is that we don’t have data yet on how long vaccine immunity will last.
“So we are going to have to be watching disease rates in vaccinated and unvaccinated individuals over time, and there will post-licensure survey’s to allow us to do that, and that will tell us if we do need to have some type of a booster vaccine,” she said.
She said a Covid-19 booster is a “very possible likelihood.”
The vaccines are untested in two big populations
The vaccines haven’t been widely tested in children or pregnant women. Pfizer has started trials in kids as young as 12. Dr. Sheffield said they will progressively move down through the adolescent years. The FDA committee plans to discuss approving the vaccine for individuals age 16 and up. But there’s no timeline yet for studies on pregnant women.
This is the second part of our four-part series ‘‘The Vaccines: Hope on the Horizon.’ You can read part one‘Utahns describe COVID-19 vaccines symptoms, feel confident it’s safe’ by clicking here.
COVID-19 coronaviruses transmitted from person to person. It is a virus that is similar to the common cold and the flu. So, to prevent it from spreading:
Utah’s Coronavirus Information
The Church of Jesus Christ of Latter-day Saints
Utah Coronavirus Information Line – 1-800-456-7707
Centers for Disease Control and Prevention
Commonly asked questions, World Health Organization