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More than a year and a half after older Americans gained access to coronavirus vaccines, the country’s youngest citizens are about to start vaccinating next week, a move that was possible. when federal regulators authorized vaccinations for children as young as 6 months old on Friday.
For many parents and pediatricians, the cleanup of two vaccines from the Food and Drug Administration, one from Moderna and the other from Pfizer and its German partner, BioNTech, is a great relief. Authorizations on Friday came two days after a group of outside advisers unanimously recommended that the green light vaccine agency be the last age group eligible for a vaccine to protect against the virus.
“Many parents, caregivers and doctors have been waiting for a vaccine for younger children and this action will help protect children under 6 months,” FDA Commissioner Robert M. Califf said in a statement. “As we have seen with older age groups, we expect vaccines for younger children to provide protection against the most serious outcomes of COVID-19, such as hospitalization and death.”
Vaccines for young children come at a critical time in the nation’s quest to beat the virus, with overall vaccination levels scoring even when covid-19 hospitalizations reach the highest average level in more than three months. . And they arrive a few months before the fall, which, along with the winter, could present another deadly increase in covid cases.
Many parents with infants and young children see that traits are critical to resuming their lives before the pandemic, with no frequent interruptions in daycare schedules or family celebrations. Some parents said they intend to vaccinate their children as soon as possible.
His first chance, if all goes as expected, will be early next week, following what are expected to be favorable recommendations from the Centers for Disease Control and Prevention on Saturday.
“This is a very important time,” said Sallie Permar, a pediatric vaccine expert at Weill Cornell Medicine in New York City. “Children and their parents have been waiting since the pandemic began to have a tool to prevent disease.”
However, there are indications that the initial absorption of vaccines will be low. In a recent Kaiser Family Foundation survey, only 18 percent said they plan to vaccinate their children immediately, while 27 percent said they will “definitely not” vaccinate their child.
Experts said it is not uncommon for parents to be hesitant when childhood vaccines are started, as was the case with polio and pneumococcal vaccines. But it means pediatricians and family doctors, in whom surveys show that parents are more confident, they will need to work diligently in the coming months to alleviate parents ’anxiety about their child’s vaccination.
“There’s a lot of information and confidence building that needs to happen,” said Tom Inglesby, director of the Johns Hopkins Center for Health Safety at Bloomberg School of Public Health. “It will take time to reach out to other parents, and they will need to develop a real trust in the vaccine and hear it from their most trusted local health care providers.” it is effective and safe “.
Other experts advise setting realistic expectations about what shots can do against a pathogen that can evolve rapidly. Neither vaccine has been tested against the rapidly spreading omicron subvariants, called BA.4 and BA.5, which are circulating and have an exceptional ability to evade immune protection.
Vaccines tested against previous coronavirus lineages “will not hold up as well in protection against infection by the new subvariants,” said Peter Hotez, a molecular virologist and dean of the National Tropical School of Medicine at Baylor College of Medicine in Houston. “But they will still be very effective in preventing children from going to the hospital or intensive care unit.”
The Modern vaccine is for children from 6 months to 5 years old. It consists of two doses of 25 micrograms each, a quarter of the adult dose, given four weeks apart. In studies, it was shown to be 51% effective in preventing disease in children 6 months to 2 years of age and 37% effective in children 2 to 5 years of age.
The Pfizer-BioNTech vaccine, which is for children 6 months to 4 years old, is three injections of 3 micrograms each, one tenth of the dose for adults. The first two injections are given three weeks apart, and the third at least two months later. Preliminary data suggest that the effectiveness of the symptomatic disease vaccine is 80 percent, but FDA officials said that figure was based on so few cases that it is likely to change and could decrease. The vaccine is now licensed for older children and adolescents.
As information about the two vaccines emerges, doctors are sure to discuss which is preferable. But many say it will require additional data accumulated during the use of both brands in the real world to determine which is more effective and other factors such as side effects need to be considered. In many cases, parents will have no choice because pediatricians can store only one of the vaccines, although large hospital practices can offer both.
Some parents may prefer Moderna’s two-dose regimen, which can be completed more quickly than Pfizer-BioNTech’s three-dose regimen. The Pfizer-BioNTech vaccine produces fewer fevers. This vaccine, with its lowest doses, had a low efficacy after two injections, but could ultimately provide more protection after three shots, given omicron and its subvariants. Modern is testing a third dose and says it will work over the summer.
In the coming days, however, the administration of Biden and others do not plan to emphasize the most subtle points of each vaccine regimen, but rather emphasize the importance of vaccinating children, regardless of which vaccine is used.
The FDA also approved the Moderna vaccine for children and adolescents ages 6 to 17 on Friday, providing another option for youth in this age group, who already have access to a Pfizer-BioNTech vaccine.
Assuming the CDC recommends vaccinations for young children, Richard E. Besser, president and CEO of the Robert Wood Johnson Foundation and former acting director of the CDC, said he will be a strong advocate.
“As a pediatrician, this is a tool I was looking forward to,” Besser said.
Although most children do not get seriously ill with covid, a small number develop a serious illness even if they do not have underlying medical conditions. More than 400 children under the age of 5 have died of covid, the FDA said this week. Others who are infected are at risk of developing long covid, a constellation of symptoms that can spread for months or years with long-term effects, including brain development, which are still being studied. Also, Besser said, vaccines will relieve the stress of caring parents: “What if my child has this bad result?”
Some parents are expected to choose to immunize their children, saying that they have some natural immunity because they had covid. According to a new study, 75 percent of children have been infected since the beginning of the pandemic, many during the recent rise in omicron infections.
But Besser said it would be a mistake to skip the vaccination because of a previous infection.
“Being infected doesn’t change the equation,” Besser said. “We’ve seen people get infected again, and those who have the best protection are those who have had covid and been vaccinated.”
Studies have shown that the immunity to omicron infection does not last long, and the rate at which omicron subvariants have evolved means that new strains can infect people who have recently had a covid infection. The Secretary of Health and Human Services, Xavier Becerra, announced this week that he had contracted covid for the second time in less than a month.
Health groups are preparing to promote vaccinations. The American Academy of Pediatrics is coordinating with another major medical group and the Biden administration to create a doctor’s office for speakers who can answer parents’ usual questions about the vaccine.
“When it comes to education, it will really take an effort at the federal level as well as at the state and local level,” said Lisa Costello, a member of the pediatric organization’s state government affairs committee. “We know that pediatricians and health care providers are reliable sources of information.”
Julia Skapik, director of medical information for the National Association of Community Health Centers, said many health professionals intend to hold vaccine talks with parents during regular office visits, because many parents do not plan to vaccinate their child. The time is coming when schoolchildren need their annual physical exams and “this is a real opportunity to vaccinate children.”
Some parents have wondered if babies under 6 months of age will be eligible for coronavirus vaccines at some point. Experts said some studies are underway, but no data are yet available on whether a vaccine for this age group would be feasible or beneficial.
Some vaccines are not given to babies because they have immature immune systems and therefore cannot generate a good immune response to a vaccine, Inglesby of Hopkins said. Babies also usually have their mother’s antibodies to protect them, Inglesby said.
Baylor’s Hotez said the immunization schedule for babies is already full and that studies are needed to show that any additional injections will not diminish the effectiveness of a previous vaccine.
“Don’t take a vaccine added lightly for less than 6 months”, Hotez …