The school year is fast approaching amid an increase in Covid pediatric hospitalizations. Parents desperately want to know: when can young children get the Covid vaccine?
This week, these parents have come significantly closer to the answer. On Monday, the U.S. Food and Drug Administration fully approved Pfizer and BioNTech’s Covid-19 vaccine for people 16 and older. The move does not particularly affect children ages 12 to 15, who have been eligible for the vaccine under an emergency use permit since May, but could have important implications for children in the age group 5 to 15. 11 years.
Legally, full approval opens the door for doctors to administer the Pfizer vaccine for off-label use, where approved medications or vaccines are prescribed for unapproved uses. In general, the tactic is common – drugs are often prescribed for off-label uses, especially for children and – and could theoretically be used now to vaccinate young children against Covid-19. The national daily average of new admissions to pediatric hospitalization rose to 309 the week ending Aug. 23, according to data from the Centers for Disease Control and Prevention, the highest number since the agency began. to follow up on pediatric Covid cases last year.
However, medical organizations and experts still recommend that parents and their children wait. The American Academy of Pediatrics on Monday issued a statement discouraging doctors from giving off-label vaccines to children under 12, citing the lack of sufficient data on the appropriate dose for the age group. The FDA also said that this approach “is not appropriate.”
If you are clamoring for an off-label vaccine for your child under the age of 12, here’s why it’s worth leaving and when you can expect children to get the Covid vaccines:
Why administering an adult vaccine to a child can be problematic
Adult medications are often prescribed off-label at lower doses for children, says Dr. Carl Fichtenbaum, a professor of infectious diseases at the University of Cincinnati and UC Health. Vaccines, however, are a “different animal.”
The reason: a child’s immune system responds completely differently to vaccines than an adult’s immune system. As it grows, the body develops a greater ability to respond to its environment, a process that is not fully utilized, at least when it comes to vaccinations, until shortly after puberty. “Children are not small adults,” Fichtenbaum says.
This means that the crucial question is not whether a child should be vaccinated or not. Rather, it is determining the right dose size, says Dr. Pedro Piedra, a professor of molecular virology and microbiology and pediatrics at Baylor College of Medicine in Houston.
Typically, the dose of vaccine is based on factors such as the weight, age, and movement of that particular vaccine throughout the body. If a dose is too low, you run the risk of being ineffective. If it’s too high, Piedra says, the injection can cause particularly severe fevers and headaches as short-term side effects.
A dose of vaccine for adults could also increase a child’s chances of developing myocarditis, a rare side effect of mRNA vaccines that causes inflammation of the heart and is usually more common in young people. In late July, the FDA asked Pfizer and Moderna to enroll more children in clinical trials to look for myocarditis. In severe cases, myocarditis can cause permanent damage to the heart muscle, which can lead to heart failure, heart attack or stroke and irregular heart rhythms.
Fichtenbaum also says children are more likely to have unforeseen reactions to vaccines. “Kids are always different,” he says. “And no one ever knows.”
At the same time, Fichtenbaum points out, he understands the concerns of parents. “It’s really frustrating and hard to watch the grass grow,” he says. “So one gets very impatient.”
The current vaccination schedule for children under 12
Clinical trials are currently being conducted for the 5 to 11 age group, which means these children are likely to be eligible for the vaccine in late fall or early winter, he said Tuesday. on the white-collar NBC television network Dr. Anthony Fauci, Senior Medical Advisor. There will be an independent assessment for children aged 2 to 5 years, with babies aged six months to 2 years in the final group.
Leana Wen, an emergency physician and public health professor at George Washington University, says some parents will look for vaccines for their children before they are officially fit for the vaccine. The FDA clearly discourages this practice, he says, and doctors should follow these federal recommendations.
“I can’t imagine there will be many pediatricians clamoring to take that risk,” Fichtenbaum adds. “Vaccinate someone with an unknown dose and an unknown side effect profile.”
The clearest sign that it is safe for parents to get vaccines for their children will be when the vaccines are authorized for emergency use between the ages of 5 and 11 by the FDA, Piedra says. The emergency use authorization means that the federal agency has rigorously reviewed the data and determined the optimal dose for the age group. “Do your best to try to wait for science to catch up with everything,” advises Fichtenbaum.
Meanwhile, Wen says, the FDA could be more transparent with the public about where it stands in the authorization process for younger age groups. Once Pfizer and Moderna have enough data to send them to the FDA, the agency will “move quickly” to evaluate them, Dr. Peter Marks, director of the Center for Biological Assessment and Research, said Monday. FDA.
Pfizer expects to send data by the end of September to apply for emergency use authorization. Modern aims for late fall and early winter. Johnson & Johnson plans to start a trial on children up to 12 this fall.
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