A federal advisory committee unanimously recommended Tuesday that kids ages 5 to 11 receive Pfizer-BioNTech’s COVID-19 vaccine, setting the stage for mass vaccination of America’s elementary school children.
The director of the Centers for Disease Control and Prevention could sign off and allow children in this age bracket to begin receiving shots within a week.
Presidential adviser Jeffrey Zients said Monday that the Biden administration ordered enough vaccine to cover all 28 million American children in the age group. The administration’s distribution program will be “running at full strength” the week of Nov. 8, he said.
Though the vaccines carry some risk for children, their benefits are greater, concluded the CDC’s Advisory Committee on Immunization Practices, made up of vaccine and immune system experts from universities and medical schools across the country.
Children’s hospitals and temporary clinics within the community, schools, pharmacies, and doctors’ offices will all have vaccines. Shots will be available for free at one-third the dose of the adult vaccine and will be delivered in two shots at least three weeks apart.
Several professional groups added their support Tuesday for childhood vaccination, including the American Academy of Pediatrics, the American Academy of Family Physicians, the National Association of Pediatric Nurse Practitioners and the Pediatric Infectious Disease Society.
Pfizer BioNTech (the vaccine manufacturer) did not experience any serious side effects from the shots in several smaller trials.
Members of the committee acknowledged that it is possible for side effects to become more apparent after shots have been administered to millions upon millions of children. These side effects are not common in adult clinical trials, but were discovered with large-scale vaccinations.
“We need to acknowledge the unknown,” said Dr. Matthew Daley, a committee member and senior investigator at the Institute for Health Research at Kaiser Permanente Colorado in Aurora.
Daley stated that he is more worried about the risks of waiting for vaccines to be administered. We cannot prevent COVID-19 cases in this age group if we delay, which can lead to some serious cases.”
Data from the CDC suggests that nine children would have needed to be vaccinated to protect one of them from contracting COVID-19 in September during the peak of the last wave, and about 26 today when rates are lower. Six weeks ago, about 2,200 children would need protection to avoid one hospitalization. There are approximately 8,200 additional kids who have required vaccinations in the past six weeks.
Fully vaccinating 1 million children in this age group would prevent about 57,000 cases of COVID-19 and about 200 hospitalizations, the CDC said.
“The data that was presented really speaks volumes in terms of the safety and effectiveness of the vaccine,” said Dr. Pablo Sánchez, a professor of pediatrics at Nationwide Children’s Hospital in Columbus, Ohio.
“Children are dying, and we can reduce hospitalization and death with this safe and effective vaccine that will benefit the community,” said Dr. Oliver Brooks, chief medical officer for the Watts HealthCare Corporation in Los Angeles.
Concerned parents should talk to their doctor, CDC or committee member if they have any questions.
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The potential vaccine side effect of biggest concern is a swelling of the heart muscle, known as myocarditis, which has been seen particularly among young men who received vaccine.
According to government statistics, only 69 of the 1,000,000 16- and 17 year-old boys who were vaccinated have contracted the disease, as opposed to two of every one million 40-year-old men. None has died, and most cases appear to be mild without long-term consequences.
Matthew Oster, a pediatric cardiologist at Children’s Healthcare of Atlanta, said he expects the side effect will be even rarer in children.
Before COVID-19, myocarditis was most common among adolescents and young men probably because of their relatively high levels of the hormone testosterone, Oster told the committee. Low testosterone levels are more common among children under 12 years of age.
He said that myocarditis can be caused by COVID-19 infection. This is more severe than the swelling associated with vaccination.
Side effects can occur within 48 hours for many children, just as they do in adults. Side effects that were most commonly reported in trials included fatigue, headaches and joint pain.
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Last week, the Food and Drug Administration authorized vaccines for use in this age group after a signoff by an independent group of vaccine experts who determined that the benefits outweighed the risks.
Only Pfizer BioNTech, out of the three available vaccines for adults in the USA has conducted studies on minors. Moderna said Sunday that the FDA asked for more information about its shots in adolescents, which probably will defer its authorization until January.
Johnson & Johnson is further behind in its trials in adolescents and children.
Typically, companies test vaccines in adults, then move down in age as the shots are proved safe. Even younger children are being studied by Pfizer BioNTech, which is currently at 6 months.
The Pfizer BioNTech vaccine has been approved to be used in adult and older adolescents, but it is only authorized for immediate use in younger children. After they obtain more information about manufacturing, the collaborating companies may request full authorization next year.
Because children are less susceptible to severe COVID-19 infection, vaccines for children can be more controversial than those for adolescents or adults.
Still, 94 American children ages 5-11 have died from COVID-19 since the pandemic began – the eighth leading cause of death in this age group – and about 8,300 have been hospitalized.
Although at lower rates than adults, children ages 5 to 11 can suffer from lingering symptoms of COVID-19 infections, so-called long COVID – including months-long fatigue, pain, headaches, insomnia and trouble concentrating.
All children, regardless of age, can catch and pass on COVID-19, one study confirmed.
Pfizer-BioNTech’s COVID-19 vaccine is clearly effective in children 5-11, preventing more than 90% of infections, according to a company-run study in about 2,500 children.
Questions remain about the effectiveness and safety of the shots because of the relatively small number of children who received them – fewer than 3,500 across three company-run studies. The duration of the protection from COVID-19 and whether or not booster shots are required is unknown.
The risk of serious COVID-19-related infections is higher in children with compromised immune systems or who suffer from health problems such as diabetes and obesity. According to the CDC, two-thirds (33%) of COVID-19 children admitted were already suffering from preexisting conditions.
Childhood vaccinations will help families in which parents are fighting cancer, said Dr. Gwen Nichols, chief medical officer of the Leukemia & Lymphoma Society. “Vaccination will give children more freedom to communicate with their families, grandparents, and parents,” she stated. “This is particularly important for immunosuppressed patients, including those with blood cancers who have been in an impossible situation with their younger children returning to school in-person.”
According to data, children from color were hospitalized three times as often as whites.
As many as 42% of American children have been infected with COVID-19, according to a study presented to a different advisory committee last week. Although a previous infection may provide some protection from severe diseases, it is not known how strong. A very mild, or even non-symptomatic infection is more common in children than it is for adults.
An FDA analysis of infections found that the benefits of vaccination generally outweigh risks among children. If COVID-19 cases are extremely low – less than 10% of the rates seen in mid-September – the benefits of vaccination are less clear, the report concluded.
It takes five weeks for vaccines to reach full effectiveness. This is two weeks after they have been administered the second time.
Contact Karen Weintraub at [email protected]
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