The vaccine against COVID-19 has almost arrived for children under 5 years of age

The youngest children in the United States are almost finished waiting for the COVID-19 vaccine.

On June 17, the U.S. Food and Drug Administration granted emergency permits to Moderna and Pfizer-BioNTech mRNA vaccines for infants, toddlers, and preschoolers. Step – Relief for many families of young children who have experienced the rise of COVID-19, limited outings and daycare interruptions – It is now two and a half years since the adults were vaccinated against COVID-19 in December 2020 (SN: 20/12/18).

Two days earlier, an FDA advisory committee voted unanimously in favor of the move. “This recommendation meets the significant unmet need of a completely marginalized young population,” said FDA board member Michael Nelson, an allergist and immunologist at the University of Virginia School of Medicine in Charlottesville. “Families will have the opportunity now,” he said, adding that he hopes to “vaccinate all children in the United States in the near future.”

Pending a recommendation from the U.S. Centers for Disease Control and Prevention on June 17 and 18, which is holding its advisory committee meetings on June 17 and 18, close-ups for young children may be available on June 21. According to plans released by the road administration. , the initial 10 million doses for young children will come first, and millions more will arrive in the coming weeks. Families can pick them up at pediatric offices, community health centers, public health clinics, children’s hospitals, and pharmacies, among others.

The FDA Advisory Board meeting reminded that once again young people are not without the risk of COVID-19. Among children, children aged 0 to 4 have the highest number of deaths compared to the elderly: 481 children aged 0 to 4 have died, compared to 366, 382 and 310 reported between the ages of 5-11, 12-15 and 16. –17-year-old age groups, according to the CDC’s COVID Data Tracker, respectively, as of June 16.

“We need to be careful not to get bored with the number of child deaths due to the sheer number of deaths in the elderly,” said Peter Marks, director of the FDA’s Center for Biological Assessment and Research, which oversees vaccine review. meeting.

And the winter rise driven by the omicron variant of coronavirus did not favor the youngest children: they had a significant increase in cases and hospitalizations (SN: 22/03/01). For children under the age of 5, there were 14.5 hospitalizations per 100,000 children in the U.S. at the peak of the omicron, five times higher than that seen at the peak of the delta variant, the researchers reported in March. Illness and Mortality Weekly Report.

COVID-19 ends up in the intensive care unit of about 4 children under the age of 5 in hospital, said pediatrician Evan Anderson of the Emory University School of Medicine in Atlanta in a presentation at an FDA meeting. “After caring for many of the children who have been at the ICU fans in Covid and caring for several dead children of COVID-19, we need to be able to prevent COVID-19,” Anderson said.

The severity of the disease means “prevention is really the way to go,” said Hayley Gans, a board member of Stanford University School of Medicine and a specialist in pediatric infectious disease specialists. The COVID-19 vaccine “is a breakthrough that has allowed us to move forward from the pandemic … [with] less suffering and sickness. ‘

At a meeting of the FDA’s advisory board, members reviewed Moderna and Pfizer’s immunity and safety data for young children. Both vaccines come in different doses and times. Moderna’s COVID-19 mRNA vaccine is a two-dose series for children 6 months to 5 years of age, 25 micrograms per dose, spread over four weeks. (Adults receive two doses of 100 micrograms for the initial two doses in the series).

The Pfizer option, for children aged 6 months to 4 years, is a series of three doses of 3 micrograms per dose. The first two shots are given in three weeks, and a third dose at least eight weeks later. (The initial two-shot series for adults contains doses of 30 micrograms.) Young children tend to receive lower doses of vaccines because of the need to balance a strong response to shooting while maintaining the expected side effects, such as fever.SN: 21/2/25).

Determining how a vaccine will work in children is tested differently than in adults. In the adult COVID-19 vaccine trials, there were tens of thousands of people per trial, enough to determine the effectiveness of the vaccine (SN: 20/10/4). This is how the vaccine measures how well those in the vaccinated group are protected compared to those given the placebo, considering how many cases occur in each group. For children, even larger trials would be needed to read enough about the effectiveness of COVID-19 cases (because overall totals among children were lower than for adults).

Thus, as a proxy for efficacy, the trials compared the antibody response generated by children with shots with that measured for younger adults in efficacy sessions. In the case of modern, the comparison group is between 18 and 25 years old, while in the case of Pfizer, the answer is similar to those between 16 and 25 years old (Pfizer included older teenagers in the adult test).

Among more than 6,600 participants, Modern reported that the response to antibodies given to the two-dose series of young children matched that observed among adult comparison groups. Pfizer reported the same thing to more than 4,500 participants in its children’s test: the three-dose series created antibody levels seen between the 16- and 25-year-old comparison groups, who received two shots.

The advisory board has also looked at the safety of vaccines for children. There were no worrying allergic reactions to the shooting, no deaths, and no cases of heart inflammation, a very rare side effect of COVID-19 mRNA vaccines (SN: 21/6/23) COVID-19 carries a much higher risk during illness. Common side effects of both vaccines were arms, crying, irritability, drowsiness, and fever.

When vaccines are approved, 20 percent of very young parents plan to be online immediately, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. A survey conducted in mid-April said another 38 per cent want to wait and wait for the vaccine to be extended before deciding how things are going, while 11 per cent say they will only immunize the youngest if vaccines are needed. This leaves 27 percent in the “Definitely No” category, which is similar to the percentage of parents who say they will not vaccinate children over the age of 5.

One issue that remains is whether younger children will need a booster added to the initial shot series, just like adults and older children. And some members of the FDA’s advisory board also stressed the need for clear communication about shooting options and schedules, as Moderna and Pfizer are different jabs.

Security monitoring will also continue, through various U.S. surveillance systems, such as the Vaccine Incident Reporting System. To date, about 600 million doses of COVID-19 vaccine have been administered in the United States, and the proven safety is reassuring, said FDA board member Henry Bernstein, a pediatrician at Cohen Children’s Medical Center in New Hyde Park, NY. I think it’s very important to have a COVID vaccine available for this young population, given that there may be pediatric cases. [have] there may be problems in the future. ”

Leave a Comment