Editor's note: This story has been updated to report the CDC director's endorsement of the vaccine for young children. Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.
The decision comes mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“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. 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. 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," Walensky said in a prepared statement.
President Joe Biden applauded Walensky's endorsement: "Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus," he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
"I feel like I have a responsibility to make this vaccine available to children and their parents," said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
"If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible," she said.
Their recommendations follow the US Food and Drug Administration's emergency authorization of Pfizer-BioNTech's vaccine for this same age group last week.
"I'm voting for this because I think it could have a huge positive impact on [kids'] health and their social and emotional wellbeing," said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC's ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren't perfect and transmission still occurs.
"Vaccines are really the only consistent and reliable way to provide that protection," Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that's almost certainly an undercount. More than 8300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing Benefits and Risks
In clinical trials that included more than 4600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis — swelling of the heart — were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they're watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It's between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn't deter parents from vaccinating younger children.
Here's why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What About Benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC's modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
CDC. Advisory Committee on Immunization Practices Meeting, November 2, 2021
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Cite this: CDC Endorses Pfizer’s COVID-19 Vaccine for Young Kids - Medscape - Nov 02, 2021.