The COVID-19 vaccine for children under 5 is almost here

The youngest children in the United States are almost ready to wait for the COVID-19 vaccine.

On June 17, the US Food and Drug Administration authorized the emergency use of Moderna and Pfizer-BioNTech mRNA vaccines for infants, young children and preschoolers. The move – relief for many families with young children who have suffered multiple increases in COVID-19, limited outings and interruptions in day care – comes two and a half years after adults were first vaccinated against COVID-19 in December 2020. (SN: 18/12/20).

Just two days earlier, an FDA advisory committee voted unanimously in favor of the move. “This recommendation does fill a significant unmet need for a truly ignored younger population,” said FDA Commissioner Michael Nelson, an allergist and immunologist at the University of Virginia School of Medicine in Charlottesville. “Families will now have a choice,” he said, adding that he hoped every child in the United States would be vaccinated in the near future.

Pending a recommendation from the Centers for Disease Control and Prevention in the United States, which meets on June 17 and 18, the first vaccines for young children may be available as early as June 21. According to plans released by the Biden administration, the initial 10 million doses for young children will come first, with millions more arriving in the coming weeks. Families will be able to receive photos in pediatric offices, public health centers, public health clinics, children’s hospitals and pharmacies, among other places.

The FDA Advisory Committee meeting reiterated that the youngest are not at risk from COVID-19. Children aged 0 to 4 have the highest number of deaths as older people: 481 children aged 0 to 4 have died, exceeding 366, 382 and 310, reported in 5– 11, 12-15 and 16, respectively, age groups of 17 years, according to the CDC’s COVID data as of 16 June.

“We must be careful not to remain insensitive to the number of pediatric deaths due to the huge number of older deaths,” said Peter Marx, director of the FDA’s Center for Biological Substance Evaluation and Research, which oversees vaccine reviews, at the meeting.

And the winter jump caused by the omicron variant of the coronavirus did not spare even the youngest children: they suffered a significant increase in cases and hospitalizations (SN: 3/1/22). For children under 5, there were 14.5 hospitalizations per 100,000 children in the United States during the peak of omicron, a rate five times higher than that observed during the peak of the delta variant, researchers said in March in Weekly report on morbidity and mortality.

Approximately 1 in 4 children under the age of 5 hospitalized with COVID-19 end up in the intensive care unit, said pediatrician Evan Anderson of Emory University School of Medicine in Atlanta during a presentation at the FDA meeting. “After caring for many children who have been in the intensive care unit for COVID … and caring for several children who have died from COVID, we need to be able to prevent COVID-19,” Anderson said.

The severity of the disease means that “prevention is really the way to go,” said Hailey Hans, a member of the FDA committee and a specialist in pediatric infectious diseases at Stanford University School of Medicine. The COVID-19 vaccine is a ‘breakthrough that allowed us to get through the pandemic’ [with] less suffering and disease. “

At the FDA Advisory Committee meeting, members reviewed the immunity and safety data of Moderna and Pfizer injections for young children. The two vaccines have different dosages and timing. Moderna’s COVID-19 RNA vaccine for children 6 months to 5 years of age is a series of two doses, 25 micrograms per dose, given at four-week intervals. (Adults received two doses of 100 micrograms for their initial two-dose series.)

The Pfizer option, for children 6 months to 4 years of age, is a three-dose series with 3 micrograms per dose. The first two injections are given three weeks apart, followed by a third dose at least eight weeks later. (The initial series of two injections for adults consists of doses of 30 micrograms.) Younger children tend to receive smaller doses of vaccine because of the need to balance their strong vaccine response by maintaining controlled expected side effects such as fever (SN: 25.02.21).

Determining how well a vaccine is expected to work in children is tested differently than in adults. Tests with COVID-19 vaccines for adults involve tens of thousands of people with enough experience to determine the effectiveness of vaccines (SN: 10/4/20). This is a measure of how well the injections protect those in the vaccinated group compared to those given a placebo, based on the number of cases in each group. For children, even larger studies would be needed to have enough cases of COVID-19 (as the total for children is lower than for adults) to read the efficacy carefully.

Thus, as a substitute for efficacy, the experiments compared the response of antibodies generated by children to vaccines with that measured for the youngest adults in efficacy studies. For Moderna, the comparison group was 18 to 25 years old, while for Pfizer the answer was compared with those aged 16 to 25 (Pfizer included older teenagers in its adult study).

Among more than 6,600 participants, Moderna reported that the response of young children’s antibodies to the two-dose series was similar to that observed in the comparison group of young adults. Pfizer reported the same for more than 4,500 participants in the study with young children: a series of three doses produced levels of antibodies that reached those observed in the 16- to 25-year-old comparison group that received two injections.

The Advisory Committee also reviewed the safety of vaccines for young children. There were no alarming allergic reactions to the injections, no deaths and no cases of heart inflammation, a very rare side effect of COVID-19 mRNA vaccines (SN: 23.06.21), which poses a much higher risk during disease than COVID-19. Common side effects for both vaccines include hand pain, crying, irritability, drowsiness and fever.

After the vaccines are given the green light, nearly 20 percent of the parents of very young people plan to be online immediately, according to the Kaiser Family Foundation’s monitoring of vaccines against COVID-19. The mid-April poll said another 38 percent plan to wait and see how things go with the vaccine before deciding, while 11 percent say they will only immunize their youngest if vaccines are needed. This leaves 27 percent in the “definitely not” category, which is similar to the percentage of parents who say they will not vaccinate children aged 5 and over.

The question remains whether the youngest children will need boosters added to the original series of photos, both adults and older children. And some members of the FDA’s advisory committee also stressed the need for clear communication about photo options and schedules, as Moderna’s and Pfizer’s strikes are different.

Safety monitoring will also continue through various surveillance systems in the United States, such as the vaccine adverse event reporting system. So far, about 600 million doses of COVID-19 vaccine have been given in the United States, and the safety demonstrated is reassuring, said FDA Commissioner Henry Bernstein, a pediatrician at Cohen Children’s Medical Center in New Hyde Park, New York. the availability of a COVID vaccine for this younger population is extremely important, given that pediatric cases can be, [have] has been and may be problematic in the future. “

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