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When can children under 5 get the COVID-19 vaccine?

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Almost exactly a year ago, the first COVID-19 vaccines became available in the United States today, they are approved or permitted for almost all age groups except young children. But clinical trials involving children as young as 6 months are underway and some could have results by the end of the year.

Currently, the Pfizer-BioNTech COVID-19 vaccine is the only one authorized in the United States for use in children under the age of 18. The original emergency use authorization – and, later, full approval – from the Food and Drug Administration covered people from the age of 16. The FDA then cleared it for 12-15 year olds in May and for 5-11 year olds in early November.

Status of COVID-19 vaccines for children under 5

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

Moderna submitted data from clinical trials involving 12 to 17 year olds, but in November the FDA said need more time to review this data. The company also released statements recently declared that its two-dose mRNA vaccine was safe and effective in children 6 to 11 years old. And Moderna trials involving children 6 months and older are ongoing.

Regarding the single-dose Johnson & Johnson vaccine, the company said TODAY in a statement that it “has launched its Phase 2/3 HORIZON 2 clinical trial in healthy adolescents 12 to 17 years of age. in an effort to gain valuable information about the safety and immune responses of our vaccine in this critical group. ”The company has not shared information about trials in younger age groups.

As exciting as it may be, the reality is that many parents of young children are still anxiously awaiting their turn to get their children immunized. Here is the latest information on the status of ongoing pediatric COVID-19 vaccine trials in the United States and more on the painstaking work going into vaccine development for young children.

Find the perfect dose

In the first phase of clinical trials for the Pfizer COVID-19 pediatric vaccine, researchers have focused on finding the right dose, said TODAY Dr Simon Li, director of the pediatric intensive care division at Rutgers Robert Wood Johnson School of Medicine.

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

In trials for children ages 5 to 11, 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 sufficient to achieve a satisfactory immune response with far fewer side effects.

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

And the same seems to be true for this younger group, Li said. Children under age 5 are currently only getting 3 micrograms in each dose in Pfizer trials, he explained, but they are still studying it. effectiveness of this dose.

For the Moderna COVID-19 vaccine, the correct dose in children under 6 appears to be only 25% of the adult dose, said TODAY Dr Bill Hartman, principal investigator of the pediatric vaccine trial KidCOVE Moderna from UW Health. In children aged 6 to 11, the company has found a dose of 50 micrograms to be effective, which is half the adult dose.

Hartman predicts that Moderna will be able to begin interpreting data on its vaccine in young children in mid-January and the company will decide whether or not to seek emergency use authorization at that time. When emergency use clearance is issued by the FDA, this is when children who received a placebo during the trial can switch to the actual vaccine or another vaccine approved for their group. of age, he explained.

What parents need to know

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

Additionally, researchers working on pediatric vaccine trials have the advantage of building on the data we already have for the millions of doses of COVID-19 vaccine given to adults, Talaat explained. And this is generally not the case with pediatric vaccines.

To keep an eye out for potential side effects, parents are advised to monitor their children for two years in the Pfizer trial and 14 months in the Moderna trial. Surveillance begins with daily assessments through an electronic diary system in the weeks after childhood immunizations and ends up slowing down to weekly checks, Li explained. But there are certain checkpoints that all parents and children should. participate, said Hartman.

When it comes to providing informed consent, Talaat explained that some older children may go through a modified process called assent. “They have a form that’s easier to look at, or read or explained to them,” she said, noting that it’s usually illustrated with lots of pictures. But for young children in these trials, it’s the parents who give their consent – and, so far, they’ve been delighted to do so.

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

“We all want our children to return to a more normal existence than they’ve had in the past two years,” Hartman said. “The best way out of this pandemic is to vaccinate the people and our children are included in it. By vaccinating them you are protecting them from all the bad things that can happen due to COVID, but you are also protecting your family and your community. . “