Happy Nice Mall

Moderna’s coronavirus vaccine elicits a strong immune response in children aged 6 to 11Researchers reported Wednesday — another signpost on what’s become a long and winding road to protecting young children against the virus, even as cases rise again.

On Monday, Moderna sought approval from the Food and Drug Administration for the vaccine to be used in this age group. However, if authorized low immunization rates among very young children.

The Pfizer-BioNTech vaccine has been available for children ages 5 to 11 since November, but as of Wednesday, only 28.7 percent had received two doses. The lack of coronavirus vaccines for children younger than 5 is forcing parents to rely on less reliable preventative measures.

Last month, asked the modern The FDA has allowed the vaccine to be used in children 6 months to 6 years old. The agency is already examining the company’s data on adolescents and He is expected to decide on the use of the Moderna vaccine. In children of all ages in June.

In February, Pfizer and BioNTech also sought permission for their vaccine to be used in the youngest children, but withdrew the application after data suggested that the two doses did not provide adequate protection against the Omicron variant.

The companies are banking on a third dose to boost immunity in children, and the FDA is expected to review that data in June.

Pediatric vaccines specialist at Weill Cornell Medicine in New York City. “We really can’t do it this way in the future – we can’t leave the kids for last,” said Sallie Permar.

He said the process has been particularly confusing and unfair for parents of the youngest children who still do not have access to vaccines, more than two years after the pandemic.

It’s been nearly a year since Moderna sought FDA clearance for its vaccine for use in adolescents aged 12 to 17 years. While the agency allowed Pfizer-BioNTech’s vaccine to be used in this age group in just three weeks, the agency had stopped reviewing Moderna’s vaccine.

The delay in authorization is the longest in the United States. Europe’s drug regulators Moderna vaccine approved for adolescents aged 12 to 17 years last summer, and proposed approval For children aged 6 to 11 years.

regulatory bodies Canada and Australia It also allowed the Moderna vaccine for 6-11 year olds.

Just over a quarter of 28 million children ages 5 to 11 in the United States have been vaccinated against coronavirus. Parental reluctance seems to be due in part to knowing that the infection is less risky for children.

D., director of the precision vaccines program at Boston Children’s Hospital and FDA advisor. “A child’s risk of contracting severe Covid is much, much, much lower – let’s be honest about it,” Ofer Levy said.

Still, he said he was treating a child with leukemia who was hospitalized for Covid. “Some kids get severe Covid, some go to the hospital,” he said. more than 1500 children Under 18 years of age have died in the epidemic so far.

Dr. “I’m not in charge but I think families should have the option to protect the youngest,” Levy said.

In its trial, published in The New England Journal of Medicine, Moderna first tested different doses of its vaccine and chose a 50 microgram dose — half the adult dose — for children ages 6 to 11. The researchers then randomly assigned more than 4,000 children. To get two shots 28 days apart.

Three-quarters of the children were vaccinated and the rest received placebo saline injections. Roughly half of the children were from colored communities. To measure the potency of the vaccine, the researchers measured the antibodies produced after vaccination. (Pfizer’s vaccine trials relied on the same approach, called immune bridging.)

Children who received the vaccine produced slightly higher levels of antibodies than those seen in young adults, a promising sign. The trials were not large enough to assess the vaccine’s ability to prevent serious illness or death.

However, based on the small number of infections with the Delta variant among participants, the researchers estimated that the vaccine had an 88 percent efficacy against infection.

Dr. “Immune bridging is basically an educated guess we get — that the same level of immunity will be just as protective in a younger age group as it is in a larger age group,” Permar said. “So, it’s nice that you can track that effectively.”

The shots seemed to produce only minor side effects, including pain at the injection site, headache, and fatigue, and less frequently than in adults. About half of the children also had a fever for about a day.

Dr. This side effect can become a problem in children younger than 5 years old, Permar said, because high fever in very young children requires invasive testing to rule out dangerous bacterial infections.

The trial was not large enough to detect rarer side effects such as heart problems observed in other age groups. The Pfizer-BioNTech vaccine appears to cause fewer cases of so-called myocarditis in young children compared to adolescents or young adults.

Moderna’s trial measured the vaccine’s potency against the Delta variant, and researchers are still evaluating its performance against Omicron. All vaccines have proven to be less effective against the Omicron variant in all age groups.

Independent scientists report that the Moderna vaccine triggers a strong immune response. 7-11 years old childrenand in adolescents, Against the Omicron variant and other versions of the coronavirus.

But these antibodies seem to be decreasing Over time, as in adults, Dr. “Probably the performance of the vaccine won’t be that high in real-world data in terms of vaccine efficacy,” Levy said.

Dr. Permar said she hopes the pandemic will bring about a change in the evaluation of vaccines in an emergency.

“We need to consider a different approach to including children and pregnant women in trials before,” she said. “And we need to do this now, because the next pandemic will hit us before we want it to happen.”