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COVID vaccine for children under 5 gets green light from regulatory agencies

Children under the age of 5 were the last age group to be eligible for the COVID vaccine in the United States.

The Food and Drug Administration’s advisory board approves the Pfizer-BioNTech vaccine for children aged 6 months to 4 years and the Moderna vaccine for children aged 6 months to 5 years 21-0. I voted in. The FDA’s Vaccine and Related Biopharmaceutical Advisory Board’s decision reflects consensus among the panel’s health professionals that the benefits of vaccines outweigh the risks of the youngest children.

The FDA is based on its own analysis, both Modana When Pfizer’s The vaccine was safe for these age groups and met the criteria for efficacy based on the immune response. These children may be readily available if the agency follows the advisory board recommendations as usual and the US Centers for Disease Control and Prevention recommends shots.

“Today was a breakthrough day for parents who wanted to know that there were other ways to protect their children,” said a member of the FDA Vaccine Advisory Board, director of the Vaccine Education Center and the attending physician of the infectious disease department. Paul Offit says. Illness in Philadelphia Children’s Hospital.He likens young children waiting for a vaccine to a movie scene JawsThe character describes a group of Navy sailors stuck in a shark-infested area and waiting to be rescued by a helicopter. “The most difficult time was, The helicopter saved people and was waiting for your turn, “Offit paraphrases. line..

“As a pediatrician, being able to provide patients with this life-saving innovation was a top priority,” said Sallie Permar, pediatrician at Weill Cornell Medicine and pediatrician at New York Elders Komanski Children’s Hospital. .. “You not only protect yourself from the rare possibility that your child will get a serious illness, but also help you achieve the normality of life that we all want and interrupt all current activities. I will continue without any problems. “

For many parents, this news has been a welcome relief. “I’ve been waiting for this day for years, and I’m very grateful to all who have made a tireless effort to make the world a little safer for these children. “Masu,” says Maegan Morris, the parent of a two-year-old boy in Brooklyn. , NY She knows that the vaccine is unlikely to completely prevent his son’s COVID infection, but “it gives him some protection and begins to live the childhood I wanted him to have. I hope that. “

The first COVID vaccine was granted an Emergency Use Authorization (EUA) for adults in December 2020, and the EUA for Pfizer’s vaccine was later modified to include 16 years and older.Pfizer’s vaccine Now available to people aged 12 to 15 years May 2021 5-11 years old Last October. The youngest children had to wait the longest.

COVID is less likely to cause serious illness in children than adults, but as of June 2, that fact remains the same. 442 children under 5 years old He died of this disease in the United States (by comparison) Influenza killed 87 children in this age group From 2019 to 2020 season. And more children were hospitalized with COVID, especially during the recent surge in Omicron.The child can develop a condition known as Pediatric multisystem inflammatory syndrome (MIS-C) causes inflammation of organs such as the heart, lungs, kidneys and brain. And like adults, children can suffer from long COVIDs.

Testing new vaccines in children is always challenging: the required safety threshold is higher in a population of individuals who are still developing and generally healthy. In addition, the elderly face the greatest risk of serious illness and death from COVID. Therefore, when vaccines are developed, it makes sense to start testing them first in the latter age group.

“We went down our way,” says Offit. Since the majority of COVID deaths occur in the elderly, health experts wanted to make sure that people in that age group were vaccinated first. Then they were evaluated by young adults, then 5 to 11 years old, and finally people under 5 years old. “Parents can at least quite reassure you that you have billions of doses out there,” he says. “Therefore, at this time, there is a lot of information about these vaccines.”

Manufacturers and regulatory agencies wanted to make sure that the vaccine did not cause more dangerous side effects than the disease itself, as infants have a relatively low risk of being aggravated by COVID. Pfizer first tested two child-specific vaccines in children under the age of five. Each was one-tenth that of an adult, but did not get a sufficient immune response, so a third vaccine was added. Moderna has tested two doses of vaccine in children under the age of six. Each is a quarter of the adult dose.

safety

Children in both Pfizer and Moderna vaccine trials experienced mild to moderate side effects. The most common are pain and redness at the injection site, headache, malaise, irritability and fever. Fever can cause seizures, so all were milder and less frequent than older children and adults, except for fever, which is of particular concern in infants. Very few study participants had seizures or other adverse events, most of which were considered vaccine-independent.

There was no case Myocarditis or pericarditis (Inflammation of the myocardium or its inner layer) Children from 6 months to 4 or 5 years in any test. Rare cases of vaccine-induced myocarditis or pericarditis occurred in older adolescents and young adults, primarily male individuals, but these cases were generally self-solving. COVID and other infections can also cause such inflammation and are usually more severe than those associated with vaccines. There were no deaths among the children at the trial.

Effectiveness

Both the Pfizer and Moderna vaccines produced an immune response that met the FDA’s criteria for infant approval. Their effectiveness was assessed by so-called immune cross-linking. Basically, the level of vaccine-induced antibody that neutralizes the virus that causes COVID in the youngest child is compared to that of a young adult.

A preliminary analysis of children under 5 years of age showed that three doses of Pfizer vaccine were 80.4% apparently effective in preventing confirmed COVID (75.6% at 6-23 months of age, 2- 82.4% at the age of 4) Old man). The apparent efficacy of the modelna double-dose vaccine was 50.6% in children 6-23 months and 36.8% in children 2-5 years. However, during Wednesday’s meeting, many members of the FDA Advisory Board said that the number of children in the trial was too small to reach a firm conclusion on their effectiveness.

These efficacy rates are lower than those found in older children and adults, but relatively recent Omicron variants known to partially avoid immunization from vaccination and previous infections. Please note that a vaccine test was conducted on infants when they were already circulating.

“The big difference here is that the virus has changed,” says Permar. “The virus currently prevalent is the Omicron variant, which is more infectious than any other mutant and has been shown to avoid vaccine immunity induced by the vaccine of the original strain.” Efficacy is consistent with actual data for adults with the Omicron variant, she says. “It’s like the game changed when the exam was done for the youngest kids,” she adds.

Kauser Talat, an associate professor of international health at the Johns Hopkins Bloomberg School of Public Health and a researcher in the study of Pfizer vaccines in children, agrees. “It’s probably unfair to compare this vaccine tested in small children during Omicron with the same vaccine tested in adults,” she says.

Vaccines continue to provide excellent protection against serious illness, hospitalization and death in adults and are expected to provide similar protection in children.

For young children, there are currently two vaccines available with very similar mechanisms, but with different doses, dosing intervals and efficacy. Talaat says he wants to know if the CDC recommends one vaccine over the other. “We want our children to have something more effective, even if it takes more time,” she says, “if we have a choice, people need to talk to a pediatrician.” There is, “she says.

Peace of mind and frustration

Many parents are very enthusiastic about getting their infants vaccinated. The overwhelming feelings of many people spoken by Scientific American were relief, followed by frustration that it took so long to get approval.

Fred Blau in Brooklyn has a 5-year-old daughter and a 3-year-old son. He and his wife “both are very preventative,” he says. “We wanted our children to be vaccinated in the fall or winter of 2021, or perhaps January,” but “we were waiting, waiting, waiting.” He. His son was infected with COVID, but Blau finds it worthwhile to vaccinate him. “Toddlers tend to be the least severe, but there are still risks. We want to reduce children as much as possible and return to normal life as comfortably as possible,” Blau said. increase.

Sarah Trist, Albany, California, has a 22-month-old daughter and a 5-year-old son. She works for the Headstart Program, an early childhood education program in Auckland, and has seen first-hand how COVID can pass through a day care center. “I’m waiting every day for a call from day care that my child will be quarantined,” she says. She was very hopeful when the vaccine was first launched. “But the finish line kept moving,” she delayed one after another. Now that day has finally come, it feels “really bittersweet,” says Trist.

“The main feeling is relief,” says Allison Moy, the parent of a 20-month-old boy in Pittsburgh. “Many people have returned to their normal lives with the launch of vaccines for adults and older children,” adds Moy, who works as a microbiologist. “But it wasn’t an option for us because it made the child think.” When her son’s pediatrician emailed her parents to schedule a vaccine appointment prior to announcing the approval, Moy immediately called and booked. When the staff chose either Pfizer or Moderna, she said to them, “I don’t care!”

However, not all parents are so enthusiastic. Less than 60% of US children and adolescents between the ages of 12 and 17 are fully vaccinated, and less than one-third of the ages of 5 to 11 are vaccinated. According to the Kaiser Family Foundation poll 1 in 5 parents of children under 5 years old They said they were eager to vaccinate their children “immediately” and two in five said they “want to wait” to see how the vaccine works. Almost 30% of parents with children of that age said they would not be vaccinated at all.

“Unless people recognize that this is a serious infection in children, especially infants, it is unlikely that they will be vaccinated,” says Talaat. Palmer agrees. “Inadvertently leaving the youngest children in court showed her parents that it wasn’t really necessary,” she says. Scientists need to rethink how to conduct clinical trials in children, Permar adds. She says it’s important to do the first research on a new medical product in an adult who agrees, but toddlers need to be included early in the process.

However, for parents like Trist, vaccine safety data is sufficient. The risk of vaccines is “lower than the risk of COVID,” she says, and “it’s a very clear choice,” she says.

https://www.scientificamerican.com/article/covid-vaccines-for-kids-younger-than-five-get-green-light-from-regulators/ COVID vaccine for children under 5 gets green light from regulatory agencies

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