Younger children could soon receive their first dose of Pfizer's COVID-19 vaccine after the CDC officially endorsed the shot for this age group on Tuesday evening.
CDC Director Rochelle Walensky, MD, signed off on the recommendation, which she was expected to do, meaning Pfizer's vaccine could be available to kids within this age range as soon as Wednesday.
The move comes just hours after members of a panel that advises the CDC on vaccination strongly endorsed the shot for this age group. Earlier Tuesday, the 14 members of the CDC's Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend two doses of Pfizer's lower-dose mRNA vaccine for children ages 5 to 11 years old.
There are an estimated 28 million children in the U.S. in this age group.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence that 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 followed the FDA'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 well-being,” said Grace Lee, MD, a pediatrician at Stanford University who chairs the CDC's Advisory Committee on Immunization Practices.
Although masks are available to reduce the risk of the virus for kids, they aren't perfect and transmission still occurs, Lee noted.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The Pfizer vaccine for children is 2 doses that are 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. The same method will be used for the COVID-19 vaccine, experts said.
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.
The news comes as COVID-19 cases in this age group have climbed sharply over the summer and into the fall as school have fully reopened, sometimes without the use of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the U.S. 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 8,300 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.
Benefits vs. Risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. Side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes also occurred in some cases. 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.
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 1 million people over the course of a week. The risk of myocarditis jumps up to about 11 cases for every 1 million doses of mRNA vaccine given to men ages 25 to 30. It's between 37 and 69 cases per 1 million doses in boys between the ages of 12 and 24.
But experts say the possibility of this rare risk shouldn't deter parents from vaccinating younger children. Here's why: The risk of myocarditis is higher after COVID-19 infection than after vaccination. Younger children also have a lower risk of myocarditis compared to teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
The smaller dose authorized for children is also expected to minimize the risk of 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.
A Drop in Cases?
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 -- albeit not stop -- the emergence of new variants.
For every 1 million doses, the CDC's modeling predicts 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 (MIS-C).
CDC experts also estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
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, the CDC said.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccine 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.