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September 7, 2023

CDC Approves Pfizer COVID Booster For Kids Ages 5 to 11

CDC Approves Pfizer COVID Booster For Kids Ages 5 to 11

Booster shots are now available for children ages 5 to 11 who've already received two doses of the Pfizer COVID vaccine. The Centers for Disease Control and Prevention (CDC) approved the decision of the U.S. Food and Drug Administration (FDA) to authorize the additional dose for kids in this age range at least five months after their second shot. The CDC's approval aligned with the recommendation of its Advisory Committee on Immunization Practices (ACIP).

"Since the pandemic began, more than 4.8 million children ages 5 through 11 have been diagnosed with COVID-19, 15,000 have been hospitalized and, tragically, over 180 have died. As cases increase across the country, a booster dose will safely help restore and enhance protection against severe disease," the CDC said in a May 19 statement.

As of May 17, nearly 68 percent of Americans live in an area where community transmission of the virus is “substantial” or “high,” according to the CDC.

The agency cautions that a subvariant of Omicron, called BA.2.12.1, is quickly becoming dominant, now accounting for 42.6 percent of all new cases. Early evidence suggests this variant may be even more contagious than its predecessors and may be better able to evade immune defenses, including existing protections from vaccination and prior infection. 

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, MD in a May 17 news release.

"The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe,” Dr. Califf added.

Boosters can help bolster waning protection

The FDA authorized the first two doses of the Pfizer vaccine for children ages 5 to 11 last fall. Each dose is 10 micrograms, which is one-third the dose for people ages 12 and older. At the time, Pfzier said the dose for school-age children was “carefully selected based on safety, tolerability and immunogenicity data.”

The effectiveness of existing COVID vaccines, however, has declined as more time has passed since people got their shots and newer, highly contagious variants have emerged.

Health officials have already recommended booster shots for everyone 12 and older. The CDC has also approved a second booster for those age 50 and older, or those with weakened immune systems.

Preliminary research from the New York State Department of Health also suggests that immunity among school-aged kids has decline substantially. A late February study of some 1.2 million children and teens that has yet to be published and peer-reviewed found that the efficacy of the low dose Pfizer vaccine in preventing infection among kids ages 5 to 11 fell from 68 percent to 12 percent between December 2021 and January 2022. The researchers pointed out, however, the vaccine still provided strong protection against severe disease.

By comparison, the effectiveness of the vaccine among older kids ages 12 to 17 who received the larger 30-milligram dose did not have the same dramatic decline. It fell but only slightly—from 66 percent to 51 percent over the same time period.

About a month ago, Pfizer released newer trial data, which showed that its booster increased protection against Omicron among children ages 5 to 11. The kids received a third dose of the vaccine six months after their second shot. The trial found the kids’ antibody levels were six times higher, offering better protection against the Omicron variant. Pfizer noted some kids saw a 36-fold jump in neutralizing antibodies.

What happens now

Once the CDC weighs in on the FDA’s decision, it’ll be up to parents to get their children vaccinated—and boosted. As of May 11, 9.9 million U.S. children between the ages of 5 and 11-years old have received at least one dose of COVID vaccine—about 35 percent of kids in this age group, the CDC reports. And 8.1 million kids between 5 and 11 are fully vaccinated, which represents about 28 percent of this age group. This leaves about 18.5 million school-aged children unvaccinated, or without even one dose of the vaccine.

"Children 5 through 11 should receive a booster dose at least 5 months after their primary series. Vaccination with a primary series among this age group has lagged behind other age groups leaving them vulnerable to serious illness," said CDC director Rochelle Walensky, MD, MPH in a May 19 statement. "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. I encourage parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations."

New COVID cases among children have surged in 2022 amid the Omicron wave, peaking at 1,150,000 cases reported in one week, according to the American Academy of Pediatrics (AAP). For the week ending May 12, more than 93,000 new child cases were reported—a jump of about 76 percent from the two weeks prior, the AAP reports.

Since the start of the pandemic, more than 13 million children have tested positive for COVID. Children are much less likely to die from COVID than adults, but in the United States the coronavirus was among the top leading causes of death for kids between 5 and 14-years old between January and May 2021.

Children are also at risk for certain COVID-related complications, including multisystem inflammatory syndrome, or MIS-C. Although still very rare, the CDC is tracking a roughly 15 percent increase in reports of MIS-C since late July.

The CDC urges all those eligible to get fully vaccinated and boosted, advising this is the best way people can protect themselves from severe disease, hospitalization, and death; help slow the spread of COVID-19; and reduce the odds that new variants will emerge.