Children ages 5 to 11 are now eligible for the Pfizer-BioNTech COVID-19 vaccine, after the director of the Centers for Disease Control and Prevention signed off Tuesday night on an expert panel's recommendation.
Children in this age group could begin getting shots as soon as this week, as health providers can start vaccinating them "as soon as possible," the CDC said in a release.
Last week the Food and Drug Administration authorized Pfizer-BioNTech's vaccine for children 5 to 11, and the CDC's recommendation now clears the vaccine for those ages.
President Joe Biden called the news "a turning point in our battle against COVID-19," in a written statement Tuesday night.
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.
"We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine," a Tuesday release quotes CDC Director Dr. Rochelle Walensky. "As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated."
Vaccines will be available at 100 children's hospitals, temporary clinics in the community and at schools, as well as pharmacies and pediatricians' offices. Shots will be free, at one-third the dose of the adult vaccine and will be delivered in two shots at least three weeks apart.
A number of professional groups added their support Tuesday for childhood vaccination, including the American Academy of Pediatrics, the American Medical Association, the American Academy of Family Physicians, the National Association of Pediatric Nurse Practitioners and the Pediatric Infectious Disease Society.
In several small trials, Pfizer-BioNTech, which makes the vaccine, saw no serious side effects connected with the shots.
It is likely, committee members acknowledged, that some potentially dangerous side effects will become apparent once the shots are delivered to millions of children, just as rare side effects not seen in clinical trials of adults turned up with widespread 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 said he was more concerned about the risk of waiting to vaccinate kids. "If we wait, we miss the chance to prevent many cases of COVID-19 in this age group, and that includes some very severe cases."
Data from the CDC suggests that vaccinations can prevent 600,000 infections in the age group by March, including a number of hospitalizations and a few deaths.
Fully vaccinating 1 million children in the 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.
Parents who have concerns about the shots should speak with their pediatrician, CDC and committee members said.
Kid shots Q and A: Everything to know about COVID-19 vaccine and children
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.
Out of every one million 16- and 17-year-old boys vaccinated, 69 have developed the condition, compared with two out of every million men in their 40s, government statistics show. 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. Children younger than 12 typically have low levels.
Infection with COVID-19 can cause myocarditis that appears to be more serious than swelling seen with vaccination, he said.
Many children who receive the shots will, like adults and teens, feel side effects in the first 48 hours or so. The most common side effects in the trials were fatigue, headaches, joint pain, pain at the injection site and vomiting, nausea or diarrhea.
The CDC monitors vaccine recipients, including children, for serious vaccine reactions through several different systems. One involves self-reporting of symptoms, another is reported mainly by doctors and two others collect data from hospitals, the CDC's Dr. Tom Shimabukuro told the committee.
The Food and Drug Administration has a separate vaccine surveillance system, as does the Department of Defense, which first identified myocarditis as a risk among service members.
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.
Of the three vaccines available to adults in the USA, only Pfizer-BioNTech has completed studies in 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. Pfizer-BioNTech continues to study even younger children, down to 6 months of age.
Though fully approved for use in adults and older teens, the Pfizer-BioNTech vaccine is authorized only for emergency use in children and younger adolescents. The collaborating companies will probably request full authorization for these age groups next year, once they have longer-term data and more details on manufacturing.
Vaccines are somewhat more controversial in children than adolescents and adults, because children are less likely to suffer severe COVID-19 infections.
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 have received them so far – fewer than 3,500 across three company-run studies. It is not clear how long this protection against COVID-19 will last or whether booster shots will be needed.
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. About 2,200 kids would have needed protection six weeks ago to prevent one hospitalization and about 8,200 more recently.
Children who are immunocompromised or have health issues such as obesity and metabolic disease are at higher risk for serious COVID-19 infections. Two-thirds of children hospitalized for COVID-19 had preexisting health conditions, while one-third were previously healthy according to the CDC.
The CDC's recommendation for vaccination includes all children, regardless of their underlying medical 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 allow "children to interact with more freedom, including with their parents and grandparents," she said. "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.”
Children of color have been hospitalized at three times the rate of white children, data shows.
About 38% of American children have been infected with COVID-19, according to data presented to the committee.
Children who have already had COVID-19 will get some protection against severe disease but should still get vaccinated, according to the recommendation, because the shots provide more consistent protection than infection.
An FDA analysis of infections presented to a different advisory committee last week 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.
Vaccines take about five weeks to come to full effectiveness, two weeks after the second shot, so parents will not have time to provide vaccine protection in the face of a sudden outbreak or a fast-spreading new variant.
COVID-19 has already caused substantially more misery than other childhood diseases, CDC data showed. COVID-19 led to at least three times more hospitalizations and deaths than hepatitis A, meningococcal disease, varicella, rubella and rotavirus did before vaccines were introduced against those diseases.
Dr. Katherine Poehling, a professor of pediatrics at the Wake Forest School of Medicine in Winston-Salem, North Carolina, said that information helped convince her to strongly support COVID-19 vaccines for elementary school children.
"We can now make these COVID-19 hospitalizations and deaths vaccine preventable," she said.
Contact Karen Weintraub at firstname.lastname@example.org.
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This article originally appeared on USA TODAY: CDC recommends coronavirus vaccine for kids 5-11; shots set to begin