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Moderna begins COVID-19 vaccine trial in adolescents

Posted at 6:00 AM, Dec 11, 2020
and last updated 2020-12-11 09:00:43-05

SAN DIEGO (KGTV) – Drug maker Moderna announced it had started the process of testing its COVID-19 vaccine on children ages 12 to 17. The company dosed the first adolescents Thursday.

“I think all of us are interested in getting control of this pandemic, and I think one of the opportunities here is to be able to immunize children also,” said Dr. Stephen Spector. He leads Moderna’s Phase 3 clinical trial on adults at UC San Diego. “We’re interested in participating; we haven’t heard yet from the sponsor.”

Spector is also a pediatrician and said generally, children tolerate viral vaccines better than adults. This study will answer many important questions.

“Are there possible adverse effects in children that weren’t seen in adults, and will they be more severe?” he said.

“The primary concerns now are whether or not the vaccine will be safe in children, and whether it will provide the same immune response in children as was seen in adults.”

Spector said once those factors have been determined, the vaccine can likely be approved to be used on children.

“Because we already know the vaccine works in adults, given the immune response will be a determinant of vaccine efficacy, you see that in children, then the vaccine can be approved for them as well,” he explained.

Data released by Moderna showed the vaccine efficacy against COVID-19 was 94 percent in adult participants, and the company has requested emergency use authorization from the FDA.

“I’m not going to minimize that there have been some side effects, but they’re usually short-lasting, maybe a day or two of three days at most,” he said. “The fact that the vaccine is over 90 percent effective really puts it in the same realm as measles, rubella, and other kinds of vaccines that have been tremendously successful in containing viral infections.”

Moderna will split the participants into two separate groups, half getting the placebo and the other half getting two vaccine shots 28 days apart.

The company hopes to enroll 3,000 young people in the study, with a goal of generating data in the spring of 2021 and potentially vaccinating kids shortly after, in time for the next school year.

“At this point, there are convincing data that the vaccine works, the FDA will review that data next week, and the expectation is there will be an emergency use approval by the end of next week for the vaccine,” said Spector.