Newsman: 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.
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.”
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.
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.
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.
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.
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.
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. 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.
In several small trials, Pfizer-BioNTech, which makes the vaccine, saw no serious side effects connected with the shots.
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.
Parents who have concerns about the shots should speak with their pediatrician, CDC and committee members said.
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.
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 according to experts.
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.
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.
Vaccines are somewhat more controversial in children than adolescents and adults, because children are less likely to suffer severe COVID-19 infections.
Still, 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.
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.
But the 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.
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.
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.
