What Did the COVID-19 Vaccine Trials in Kids Show?

Dr. Paul Offit explains the results of the COVID-19 vaccine clinical trials in kids and why vaccination of the 5 to 11 age group is safe and important.


What did the COVID-19 vaccine clinical trials in kids show?

Paul Offit, MD: Hi, name is Paul Offit. I'm talking to you today from the Vaccine Education Center at the Children's Hospital of Philadelphia. It is Tuesday, November the 16th, 2021. So, I think parents can reasonably ask now, why does my child need a COVID vaccine? Isn't this really principally a disease of the adults. And it's true that when the virus SARS-CoV-2 first came into the United States early last year, early in 2020, about 93% of all the deaths from this virus were in people over 55 years of age. And at the time when the virus first came into the country, only about 3% of all cases were in children.

Well, today it's closer to 27%, and children can suffer this disease and can be hospitalized and can die from this. Actually, almost 700 children less than 18 years of age have died from this virus, thousands and thousands have been hospitalized. Thousands have been admitted to the intensive care unit, and only about a third of those who are admitted to the hospital have no other comorbidities. So, but that still means that about a third of those who are infected severely can have no other risk factors that puts them at high risk of having a serious COVID.

So, what do we know about the vaccines? We know that the vaccines have been tested now extensively in those between 12 and 15 years of age, and now most recently between 5 and 11 years of age. What we found out from the 12- to 15-year-old trial is that was roughly a 2,400-child trial, 1,200 got vaccine, 1,200 got placebo, and what you found when the trial was done that there were 18 cases of COVID, all in the placebo group. When the trial was done in 5- to 11-year-olds, again, roughly a 2,400-child study, this time 1,600 children got a vaccine, 800 got placebo. What you found in that study is that there were 16 cases of COVID in the placebo group and 3 in the vaccine group for a protective efficacy of 91%.

So, the vaccine works and works well. Is it going to be safe? There are now systems in place like the Vaccine Safety Datalink, which will see whether or not the vaccines are safe, but certainly now millions of 12- to 15-year-olds have been vaccinated safely, and there's every reason to believe that will also be true for the 5- to 11-year-old. Because remember, even just looking for the 5- to 11-year-old, there's been about 8,300 hospitalizations, among 200 million children have been infected, a third of those hospitalizations have resulted in ICU admissions, and there's been a 100 deaths just in that age group.

Also, the 5- to 11-year-old is the group that's at highest risk of this multisystem inflammatory syndrome of children, called MIS-C, where a child typically is fine, has a very mild infection or an asymptomatic infection, rids themselves of that infection, and then a month later comes back with high fever, lung involvement, liver involvement, heart involvement, and it can be quite severe. It can result in an intensive care unit admission and can result, occasionally, in death. And that's really a disease, that so-called multisystem inflammatory disease, is a disease of the 5- to 13-year-old, peaking at 9 years of age, making it all the more important to vaccinate the 5- to 11-year-old.

Thank you.

Related Centers and Programs: Vaccine Education Center

Last Reviewed on Dec 15, 2021