COVID-19 Vaccine for Children Ages 5-11 Receives Final Approval

Pediatricians can start vaccinating children ages 5-11 years against COVID-19.

Federal health officials gave final approval to using the Pfizer-BioNTech vaccine for about 28 million children in this age group Tuesday, and the AAP released a policy statement recommending all eligible children without contraindications get vaccinated.

“Sharing this life-saving vaccine with our children is a huge step forward and provides us all with more confidence and optimism about the future,” AAP President Lee Savio Beers, M.D., FAAP, said in a news release. “Pediatricians are eager to participate in the immunization process and talk with families about this vaccine. We want to ensure that access to this vaccine is equitable, and that every child is able to benefit.”

Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, M.D., M.P.H., signed off on using the COVID-19 vaccine in children Tuesday evening following a 14-0 vote in favor by the agency’s Advisory Committee on Immunization Practices (ACIP). The final approval comes four days after the Food and Drug Administration granted emergency use authorization of the Pfizer-BioNTech vaccine down to age 5 years.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19,” Dr. Walensky said in a news release. “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.”

Vaccine administration

The pediatric vaccine already is being shipped around the country. Vaccine providers must use the pediatric vaccine formulation with orange caps and labels. Children ages 5-11 years will be vaccinated with two 10-microgram doses administered 21 days apart. The dosage is one-third of the adolescent and adult dose.

Dosages are determined by age, not a child’s size or weight. Some children may be 11 years old when they get their first dose and 12 at the time of their second dose. They should receive a dose based on their age on the day of vaccination, according to the CDC. 

The COVID-19 vaccine can be given at the same times as other routine vaccines but should be done in a different injection site. The CDC and AAP also recommend children with prior COVID-19 infection get vaccinated. This includes children who have a history of multisystem inflammatory syndrome in children (MIS-C) if they meet several criteria including clinical recovery, at least 90 days have passed since their diagnosis, onset of MIS-C occurred before COVID-19 vaccination and they are in an area of high or substantial community transmission or otherwise have increased risk for exposure to the virus. Even if they don’t meet all the criteria post-MIS-C, the CDC said vaccination may be considered.

 Any adverse events after vaccination should be reported to the Vaccine Adverse Event Reporting System.

Under a plan released by the White House, pediatricians will be on the front lines of vaccinating children. The AAP has resources to help pediatricians sign up to be COVID-19 vaccinators and to prepare their practices. Pediatricians can reach out to their state immunization managers to request vaccines for their practices. They also are urged to contact their AAP chapters for assistance.

Vaccine trial data on efficacy, safety

Clinical trials in children ages 5-11 years found the vaccine to be 90.7% effective in preventing symptomatic COVID-19. The vaccine also met immunobridging success criteria for geometric mean neutralizing antibody titers and seroresponse rates.

Safety data from the trials, which included more than 3,000 children who received the vaccine, found the most common reactions were pain at the injection site, fatigue and headache. Reactions were mostly mild or moderate. There were no serious adverse events related to the vaccine, including anaphylaxis or myocarditis, although the latter likely was too rare for detection in a trial of that size.

The occasional cases of myocarditis that have been reported after an mRNA COVID-19 vaccine have been predominantly in males ages 12-29 years. The CDC noted baseline rates unrelated to vaccination are much lower in children ages 5-11 years than in older children, so the same may be true of vaccine-associated cases. Studies also have found the risk of myocarditis is greater from COVID-19 infection than from vaccination.

“I think the data supports that we have one more vaccine that saves the lives of children and that we should be very confident to employ it to the maximum to do what it is meant to do without significant concerns of serious adverse events,” said ACIP member Sarah S. Long, M.D., FAAP, professor of pediatrics at Drexel University College of Medicine.

Many members said their adolescent and adult family members have been vaccinated and if they had children or grandchildren in this age group, they would not hesitate to get them vaccinated.

“I have vaccinated my kids because I feel like it’s safe, and I would not recommend something if I did not feel that way,” said ACIP member Helen Keipp Talbot, M.D., associate professor of medicine at Vanderbilt University. “ … We are parents. We have given this to our children because we have seen the devastation of this disease and the disruption in our kids’ lives.”

COVID-19’s impact on children

Since the start of the pandemic, about 1.9 million children ages 5-11 years have been infected. More than 8,300 have been hospitalized and 94 have died, according to federal data. The death toll in the past year puts COVID in the top 10 causes of death for this age group.

Children also have experienced impacts on their education and have suffered the loss of parents. Last month, the AAP, American Academy of Child and Adolescent Psychiatry and Children’s Hospital Association declared a national emergency in children’s mental health due to the toll of the pandemic.

“I value preventing infection in children, and I think it can have a huge positive impact on their health, their social and emotional well-being, their educational outcomes and their long-term trajectory,” said ACIP Chair Grace M. Lee, M.D., M.P.H., associate chief medical officer for practice innovation at Stanford Children’s Health, who noted mask use has been variable. “… Vaccines are really the only consistent and reliable way that we can provide that protection other than cocooning them at home to minimize their risk but then that is depriving them of many other important aspects of their childhood.”

Resources

Read the AAP Statement on the approval: American Academy of Pediatrics Applauds CDC Advisory Committee's Approval of Safe, Effective COVID-19 Vaccine for Children Ages 5-11

###

AAP News

Original Posting