WEBMD NEWS BRIEF By Ralph Ellis
Moderna probably will not have clinical trial results anytime soon on how its COVID-19 vaccine affects children and adolescents, according to the company CEO and a federal official.
The Moderna vaccine was authorized for use in December and is now being given to people 18 and over. But children would receive lower doses, so new clinical trials must be done, Moderna CEO Stephane Bancel said at the JPMorgan virtual Health Care Conference on Monday.
Clinical trials on children 11 and younger "will take much longer, because we have to age de-escalate and start at a lower dose. So we should not anticipate clinical data in 2021, but more in 2022," Bancel said, according to Business Insider.
Moderna’s clinical trials for 12- to 17-year-olds started 4 weeks ago, but the company is having trouble getting enough participants, said Moncef Slaoui, PhD, the scientific head of Operation Warp Speed, the U.S. government’s vaccine effort. That could delay FDA approval, he said.
"It's really very important for all of us, for all the population in America, to realize that we can't have that indication unless adolescents aged 12 to 18 decide to participate," Slaoui said, according to USA Today.
He said the adolescent trials are getting only about 800 volunteers a month, but need at least 3,000 volunteers to complete the study, USA Today reported. Parents interested in having their child participate can check eligibility and sign at this website.
The Pfizer/BioNTech vaccine won authorization for use in 16- to 17-year-olds as well as adults.
The coronavirus doesn’t appear to have as serious complications for children as for adults.
“At this time, it appears that severe illness due to COVID-19 is rare among children,” the American Association of Pediatrics says. “However, there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”
The association says 179 children had died of COVID-related reasons in 43 states and New York City as of Dec. 31. That’s about 0.06% of total COVID deaths, it says.
But children do get sick. As of Jan. 7, nearly 2.3 million children had tested positive for COVID-19 since the start of the pandemic, the association says.