Moderna’s coronavirus vaccine elicits a strong immune response in children aged 6 to 11 yearsResearchers reported Wednesday – another road sign in what has become a long and winding road to protect young children from the virus, though cases are on the rise again.
Modern Monday requested clearance from the Food and Drug Administration for the use of the vaccine in this age group. But the permission, if granted, is unlikely to increase the low immunization rates among children of a lot.
The Pfizer-BioNTech vaccine is available for children aged 5 to 11 from November, but from Wednesday only 28.7 percent had received two doses. There is no coronavirus vaccine available for children under the age of 5, forcing parents to rely on less reliable protective measures.
last month, asked Moderna the FDA to authorize its vaccine for use in children between the ages of 6 months and 6 years. The agency is already reviewing the company’s data on teens and should decide on the use of the Moderna vaccine in children of all ages in June.
In February, Pfizer and BioNTech also asked for their vaccine to be authorized for use in younger children, but withdrew the application after data suggested that two doses did not produce adequate protection against the Omicron variant.
The companies are targeting a third dose to boost immunity in children, and the FDA is also expected to review this data in June.
“We can’t really do it this way in the future, we can’t leave the children to the last,” said Dr. Sallie Permar, pediatric vaccine expert at Weill Cornell Medicine in New York.
The process has been particularly confusing and unfair for parents of younger children who have not yet had access to a vaccine for more than two years in the onset of the pandemic, he said.
It’s been nearly a year since Moderna applied for FDA clearance to use its vaccine in teens ages 12 to 17. While the agency gave the green light to the Pfizer-BioNTech vaccine for use in that age group in just three weeks, the agency’s review of Moderna’s vaccine had stalled.
The delay in authorization was longer in the United States. The drug regulatory authorities in Europe Moderna’s vaccine approved for teens ages 12 to 17 last summer, and has approval recommended for children aged 6 to 11.
In the United States, just over one in four of the 28 million children between the ages of 5 and 11 have been vaccinated against the coronavirus. Parental reluctance appears to stem in part from the fact that the infection is known to be less risky for children.
“The risk of a child becoming severe Covid is much, much, much lower – let’s be honest,” said Dr. Ofer Levy, director of the precision vaccine program at Boston Children’s Hospital and a consultant to the FDA
However, he said he had just treated a child with leukemia who had been hospitalized for Covid. “Some children get severe Covid, others end up in hospital,” she said, adding that more than 1,500 children children under 18 have died so far in the pandemic.
“I don’t like mandates, but I think families should have the ability to protect their little ones,” said Dr. Levy said.
In his study, published in the New England Journal of Medicine, Moderna first tested several doses of his vaccine and chose a dose of 50 micrograms – half the adult dose – for children between the ages of 6 and 11. The researchers then randomly assigned more than 4,000 babies to receive two shots 28 days apart.
Three-quarters of the children received the vaccine and the rest received placebo injections of salt water. Roughly helped, the children came from communities of color. To assess the potency of the vaccine, the researchers measured the antibodies produced after immunization. (Pfizer’s vaccine studies relied on this same approach, called immunobridging.)
Children who received the vaccine produced slightly higher levels of antibodies than those seen in young adults, a promising sign. The studies were not large enough to evaluate the vaccine’s ability to prevent serious illness or death.
But based on a small number of Delta variant infections among the participants, the researchers estimated the vaccine to be 88 percent effective against infections.
“Immunobridging is basically a plausible hypothesis we take – that the same level of immunity will be just as protective in a younger age group as it was in an older age group,” said Dr. Permar said. “So it’s nice when you can also follow it effectively.”
The strokes appeared to produce only minor side effects, including injection site pain, headache, and fatigue, and less often than in adults. Those who helped the children also had a fever for about a day.
This side effect can become a problem in children under the age of 5, because high fever in very young children requires invasive testing to rule out dangerous bacterial infections, said Dr. Permar said.
The study wasn’t large enough to detect rarer side effects, such as heart problems that were seen in other age groups. The Pfizer-BioNTech vaccine appears to cause fewer cases of so-called myocarditis among young children than 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 were found to be less effective, in all age groups, against the Omicron variant.
Independent scientists have reported that the Moderna vaccine provokes a strong immune response children aged 7 to 11and in adolescents, against the Omicron variant and other versions of the coronavirus.
But these antibodies seem to want over time, as they do in adults. “Vaccine performance, in terms of vaccine efficacy, is likely not going to be as high in real-world data,” said Dr. Levy said.
Dr Permar said he hopes the pandemic will bring about a change in how vaccines are evaluated during an emergency.
“We need to think of a different way of approaching children and pregnant women in earlier trials,” she said. “And we have to do it now, because the next pandemic will be upon us before we want it to be.”