When can children under 5 receive a COVID-19 vaccine? – Community News
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When can children under 5 receive a COVID-19 vaccine?

Almost exactly a year ago, the first COVID-19 vaccines became available in the US. Today they are approved or authorized for almost every age group – except young children. But clinical trials on children as young as 6 months old are now underway, and some may have results by the end of the year.

At present, the Pfizer-BioNTech COVID-19 vaccine is the only one approved in the US for use in children under the age of 18. 16 years and older. The FDA then approved it for 12- to 15-year-olds in May and for 5- to 11-year-olds in early November.

Status of COVID-19 vaccines for children under 5 years old

The most recent estimates from Pfizer CEO Albert Bourla are that we could have data on the company’s vaccine in children under 5 years old by the end of the year, NBC News reported. And the vaccine may be available in early 2022 for children in that age group.

Moderna submitted data from clinical trials involving 12- to 17-year-olds, but in November the FDA said it needed more time to review those data. The company also recently released statements stating that the two-dose mRNA vaccine is safe and effective in 6- to 11-year-olds. And Moderna studies involving children 6 months and older are underway.

When it comes to the Johnson & Johnson single-dose vaccine, the company told TODAY in a statement that it has “initiated its Phase 2/3 HORIZON 2 clinical trial in healthy adolescents ages 12 to 17 with the goal of providing valuable insights in the safety and immune responses of our vaccine in this critical group.” The company did not share information about studies in younger age groups.

As exciting as that is, the reality is that many parents of young children are still anxiously waiting their turn to have their children vaccinated. Here’s the latest on the status of ongoing pediatric COVID-19 vaccine trials in the US and more on the careful work being done developing vaccines for young children.

Finding the perfect dose

In the first phase of the clinical trials of Pfizer’s COVID-19 vaccine in children, researchers were focused on finding the right dose, Dr. Simon Li, director of the pediatric critical care division at Rutgers Robert Wood Johnson School of Medicine, TODAY.

In that first trial, the researchers were looking for two things, said Li, who is leading the work at one of 81 sites working on a Pfizer Phase 2/3 clinical trial involving children 6 months to 11 years old. “One is how much of the vaccine you need to get a good immune response. And the second is how many side effects you have.” The right dose is one that provides adequate protection against COVID-19 with the fewest side effects.

In the trials for 5- to 11-year-olds, researchers tested three doses of the Pfizer vaccine: 10, 20 and 30 micrograms, with 30 being the same dose used in adults and 12- to 15-year-olds. They found that for this age group, a dose of 10 micrograms was enough to get a satisfactory immune response with far fewer side effects.

“We had more fever at the 30 microgram dose and the 10 microgram gave a really good immune response. We didn’t need to go any higher,” Dr. Kawsar Talaat, a vaccinologist at the Johns Hopkins Bloomberg School of Public Health who is involved with Pfizer’s pediatric vaccine trials, told TODAY.

And the same seems to be true for this younger group, Li said. Children under 5 are currently only getting 3 micrograms in each dose in the Pfizer studies, he explained, but they’re still investigating the efficacy of that dose.

For the Moderna COVID-19 vaccine, the appropriate dose in children under the age of 6 appears to be only 25% of the adult dose, Dr. Bill Hartman, principal investigator of UW Health’s KidCOVE Moderna vaccine study, TODAY. In children aged 6 to 11, the company found a dose of 50 micrograms effective, which is half the adult dose.

Hartman expects Moderna to begin interpreting data on its vaccine in younger children in mid-January and the company will decide whether or not to seek emergency use approval at that time. When emergency use approval comes through the FDA, children who received a placebo during the trial could switch to the actual vaccine or another vaccine approved for their age group, he explained.

What parents need to know

While parents wait, it’s important to remember that researchers move quickly but carefully. “There has been no cut in the development of this vaccine,” Talaat said. “The reason we were able to get vaccines so quickly is that there was an enormous amount of resources, in terms of financial resources, but also in terms of expertise, personnel and personnel.”

In addition, researchers working on pediatric vaccine trials have the advantage of building on the data we already have for the millions of COVID-19 vaccine doses given to adults, Talaat explained. And that’s usually not the case for pediatric vaccines.

To monitor potential side effects, parents are asked to follow their children for two years in the Pfizer study and 14 months in the Moderna study. Monitoring starts with daily assessments via an electronic diary system in the weeks after the children receive the vaccine and eventually slows down to weekly checkups, Li explained. But there are certain checkpoints that all parents and children should participate in, Hartman said.

When it comes to giving informed consent, Talaat explained that some older children may go through a modified process called consent. “They get an easier form to look at, whether that’s read or explained,” she said, noting that it’s usually illustrated with lots of pictures. But for the young children in these studies, it’s the parents who give their consent — and until now, they’ve been excited to do so.

“I’ve done a lot of vaccine trials over the past 15 years and this was the easiest trial to recruit for,” Talaat said. Hartman agreed, adding that after just one day, his group had a “huge waiting list” to enroll in the trial.

“We all want our kids to get back to normal lives than they’ve had for the past two years,” Hartman said. “The best way out of this pandemic is to vaccinate people and get our children involved. By vaccinating them, you protect them from all the bad things that can happen from COVID, but you also protect your family and your community.”

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