New COVID-19 clinical studies on Pfizer vaccine booster will start soon on participants between the ages of 12 and 17 and 18 and 30 at Upstate's Institute for Global Health.
One study is looking to investigate the trend of myocarditis in people between the ages of 18 and 30.
“We want to do very intensive investigations to see how frequently it’s happening, what’s actually happening when it does happen, to look at even very mild cases,” Upstate Global Health Director Dr. Stephen Thomas said.
The very rare heart inflammation side effect appears to impact males. According to Centers for Disease Control and Prevention data, it’s been reported in just over 24 per 1,000,000 people between 18 and 39 years old and almost 47 per 1,000,000 males between the same ages.
What You Need To Know
- Upstate’s Institute for Global Health seeks COVID-19 booster dose study participants
- The study will if a booster dose of the Pfizer vaccine is needed, and how well a booster dose of works in people 12-30 who have already had two vaccinations of at least six months ago
- Participants will receive one vaccination and one placebo, and be compensated $119 for each in-person visit
- The duration of this study is two months
“You’ll be randomized to two different groups," Thomas said. "At some point, you will get a third dose. We will follow your symptoms, how you feel. We’ll take your blood and look at very specific things related to heart inflammation."
He said when conducting first in-human trials of any vaccine or medication, the groups are too small to identify trends in rare side effects.
The studies look for common side-effect trends.
He said the need for the study is not unusual, as information on medications and vaccines are always changing the more people use them.
“I think if people have the expectation that you’re going to study it, you’re going to get an answer and the answer is never going to change, or the information is never going to change, that’s just not an expectation people should have," Thomas said. "That’s just not how science works. That’s not how medicine works."
He said it certainly does not indicate that a Pfizer booster is dangerous.
“My son falls into that high-risk demographic, and we got him three doses because when I looked at the risks of having a side effect of vaccination, it was much lower than the risk of having the side of effect of natural infection," Thomas said. "For me it just made sense."
He said the clinical studies will not only serve COVID vaccines, but all MNRA vaccine technology. He also added that for the rare side effect myocarditis, more than 90% do very well with treatment.
To learn more about the study, its inclusion criteria and how to volunteer, email Trials@Upstate.edu or call (315) 464-9869.