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Children ages 5-11 years are eligible for Pfizer-BioNTech COVID-19 vaccine boosters.
The Centers for Disease Control and Prevention (CDC) signed off on boosters for this age group Thursday after its Advisory Committee on Immunization Practices (ACIP) recommended the boosters in an 11-1 vote with one abstention.
“With over 18 million doses administered in this age group, we know that these vaccines are safe, and we must continue to increase the number of children who are protected,” CDC Director Rochelle P. Walensky, M.D., M.P.H., said in a statement. “I encourage parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations.”
A 10-microgram booster dose for 5- to 11-year-olds can be given five months after the primary series to increase protection and comes as COVID cases are rising once again.
More than 93,000 pediatric COVID cases were reported during the week ending May 12, a 76% increase over two weeks prior, according to data from the AAP and Children’s Hospital Association.
This booster will be a third dose for children who are not immunocompromised and a fourth dose for those who are immunocompromised.
Children ages 5-11 years became eligible for COVID-19 vaccines in early November 2021, but only 29% are fully vaccinated, according to CDC data.
Immunogenicity of booster dose
Clinical trial data from Pfizer compared SARS-CoV-2 geometric mean titers (GMT) of children at several stages of vaccination. It showed a GMT level of 1,254 one month after dose two, which dropped to 271 just before dose 3 and then rose to 2,721 one month after dose three.
Safety of booster dose
Information on safety of a booster came from 401 children ages 5-11 years and found no serious adverse events, anaphylaxis, myocarditis or deaths. About 2.5% had lymphadenopathy after the booster, which was higher than after dose two but lower than what was seen after adult boosters.
Systemic and local reactions in children after dose three were similar to reactions after dose two. The most common systemic reactions after a third dose in children were fatigue, headache and muscle pain.
In other age groups, the risk of myocarditis has been lower after a booster than after a second dose. Instances of myocarditis after a primary series in children ages 5-11 years are lower than for teens. Experts also noted myocarditis is more common and more serious after SARS-CoV-2 infection than after vaccination.
COVID-19 among children ages 5-11 years
There have been more than 4.8 million cases of COVID-19 reported among children ages 5-11 years, and seroprevalence studies have found 77% of children in this age group have evidence of a prior SARS-CoV-2 infection.
During the omicron predominant period last winter, about 87% of those hospitalized were unvaccinated. One-third of hospitalized children did not have underlying medical conditions. Roughly 27% of hospitalized children in this age group required intensive care.
About 3,809 children ages 5-11 years have had multisystem inflammatory syndrome, 16 of whom died. Overall, 189 children in this age group have died of COVID, making it the 11th highest cause of death for them in 2020.
The pandemic also has affected their education and mental health, and some have had long-lasting physical impacts.
“We tend to focus and define severe disease by hospitalization and death, but the impact and the severity of long-haul COVID on kids is substantial,” said ACIP Chair Grace M. Lee, M.D., M.P.H., associate chief medical officer for practice innovation at Stanford Children’s Health. “And while we might not see it in the medical care setting, it is absolutely affecting the lives of individuals who are impacted. And I’m also concerned the disparities are worsening.”
ACIP discussion
Much of the debate among ACIP members Thursday focused on whether to say children in this age group “should” or “may” get a booster. The majority agreed with the stronger wording using “should,” staying consistent with other age groups.
“Children live in communal settings,” said ACIP member Katherine A. Poehling, M.D., M.P.H., FAAP, professor of pediatrics and epidemiology and prevention at the Wake Forest School of Medicine. “They live in families. There are people with high-risk conditions. And then they go to school, and … fewer masks are being worn in schools and there’s children with high-risk conditions.”
Several members, including ACIP COVID-19 Vaccines Work Group Chair Matthew F. Daley, M.D., FAAP, said they think the primary series should have been three doses all along and noted three doses are not uncommon for pediatric vaccines. Dr. Daley, senior investigator at the Institute for Health Research at Kaiser Permanente Colorado, also favored the stronger language to encourage boosters.
“We have seen presented today … that a booster dose of an mRNA vaccine when it’s given to adults during the period of omicron, provided measurable, detectable benefits across a wide range of health outcomes and that includes infection, emergency department visit, hospitalization, critical illness,” he said. “So that data poses to me the question why would we think the same would not be true for children 5-11 years of age when they receive a lower dose of vaccine?”
Yvonne “Bonnie” A. Maldonado, M.D., FAAP, chair of the AAP Committee on Infectious Diseases, was not eligible to vote but speaking for herself encouraged approval of boosters.
“I do think having some access is going to be important, and I would also urge equity issues and distribution issues be considered for this age group,” she said.
ACIP member Sarah S. Long, M.D., FAAP, professor of pediatrics at Drexel University College of Medicine, supported the recommendation but noted with so many recent infections, she thought boosters could wait several months.
The lone “no” vote came from ACIP member Helen Keipp Talbot, M.D., associate professor of medicine at Vanderbilt University. She too said additional doses may be able to wait until fall and it is more important to focus on the large percentage of children who haven’t been vaccinated.
With Thursday’s approval, everyone ages 5 years and older is eligible for one booster. Adults ages 50 and older, people ages 12 and older who are immunocompromised and people who got two doses of Johnson & Johnson’s vaccine can get a second booster. The CDC on Thursday strengthened its recommendation for second boosters for people 50 and older and those 12 and older who are immunocompromised.
Resources
- AAP COVID vaccination resources
- CDC clinical considerations for administering COVID-19 vaccines
- Information from the CDC on COVID-19 vaccine boosters
- Information from HealthyChildren.org on preparing children for a COVID-19 vaccine
