Potential participants must:
-Be between 6 months and 11 years
-Be in good health
-Not currently take any investigational or approved treatments for COVID-19
-Not have received a vaccine for COVID-19
-Not taken part in a clinical trial in the past month
KidCove lists three study sites in our area: Houston, Tomball, and Port Lavaca.
Baylor College of Medicine is expected to be a study site.
"Really this is the last piece of the puzzle to get us back to normal," said Dr. Erin Nicholson, an expert in pediatric infectious disease with Baylor College of Medicine.
Because while children tend to not get as sick as adults, Dr. Nicholson says, they can spread it to others who are at-risk of severe COVID-19. She also notes the link between COVID-19 and multisystem inflammatory syndrome in children which can be deadly.
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The trial is in Phase 2/3.
"They are planning on looking at what specifically is going to be the best dose for each age group and they're going to work through that in the initial Phase 2 portion," Dr. Nicholson explained. "And, then the Phase 3 will be wider, kind of general trial."
The Phase 3 will compare the vaccine to a placebo in a randomized study. Moderna states the goal is to enroll 6,750 participants in the U.S. and Canada.
So, is it safe? mRNA vaccines have been studied for more than a decade including in young animals.
"They did look at different types of animals including non-human primates in young ages and they did find very nice safety and efficacy in animals," Dr. Nicholson added.
She adds, with any trial, doctors will discuss the risks in-depth with parents.
"Anaphylaxis is always on everybody's mind of course," she noted.
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She expects the trials will show mostly similar side effects in children as with adults like fever and soreness at the injection site. The side effects tend to be minor and may only last a few days.
"Taking part in a research trial is not for everyone and it's something that needs to be proceeded through thoughtfully," Dr. Nicholson concluded.