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May 18, 2023

CDC Approves Pfizer COVID Vaccine for Kids as Young as 5

CDC Approves Pfizer COVID Vaccine for Kids as Young as 5

Children as young as 5-years old are now eligible for a COVID vaccine. Following the recommendation of its independent panel of advisers, the Centers for Disease Control and Prevention (CDC) approved the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11-years old. 

The CDC’s Advisory Committee on Immunization Practices (ACIP)—a group of medical and public health experts that develop recommendations on how to use vaccines in the United States—voted unanimously to recommend the vaccine for this younger age group following a review of all available evidence. The vaccine was authorized for emergency use by the U.S. Food and Drug Administration (FDA) on October 29.

On November 2, CDC director, Rochelle P. Walensky, MD, MPH, gave her final sign off, allowing kids to start receiving their shots. 

“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,” said Dr. Walensky in a November 2 statement.

Younger kids will get one-third of the dose that people ages 12 and older receive. In anticipation of the CDC's approval, the Biden administration began moving 15 million pediatric doses to facilities and distribution centers where they are already being packed and loaded into special containers, which will be shipped across the country.

Is the vaccine safe and effective for younger kids?

The latest data Pfizer submitted to the FDA showed its vaccine is safe and nearly 91 percent effective against symptomatic COVID-19 in children ages 5 to 11.

During the trial, which included around 2,000 children, researchers identified only three cases among the kids who got the vaccine. Meanwhile, there were 16 positive cases in the placebo group, which was about half the size of the vaccine group.

The Pfizer vaccine is already FDA-approved for use in people ages 16-years and older and is available under emergency use authorization (EUA) for kids and teens between 12 and 15-years old. The latest CDC data available on teens shows that among young people ages 12 to 18-years old, two doses of the Pfizer vaccine were 93 percent effective in preventing hospitalizations due to COVID-19.

Like teens and adults, these younger kids were given two doses of the vaccine 21 days apart. But they received a lower dose of 10-micrograms. People ages 12 and older get two 30-microgram doses. This lower dose was chosen carefully to ensure its safety and tolerability among younger people, while ensuring its effectiveness, according to Pfizer.

The trial also found the vaccine was safe and well-tolerated among younger children. Side effects were typically mild to moderate and resolved quickly. The most commonly reported issue include pain at the injection site, fatigue, headache, muscle pain and chills.

The CDC has cautioned about an association between the Pfizer and Moderna mRNA vaccines and reported cases of inflammation in the heart muscle (myocarditis) or in the outer lining of the heart (pericarditis).

So far, there are no reports of this side effect among children between 5 and 11-years old. Most cases have occurred in men younger than 30-years old.

The data Pfizer submitted to the FDA suggest this rare side effect peaks among young men between 16 and 19-years old and declines among younger teens between 12 and 15-years old. This downward trend and the fact that younger kids receive one-third of the dose given to older kids and teens suggests inflammation of the heart would be even more rare among younger age groups.

Overall, researchers conclude that the benefits of vaccination among children between 5 and 11 outweigh any possible risks.

Kids aren’t immune and cases are on the rise

The number of children getting COVID-19 has increased amid the rise of the more contagious Delta variant. The data Pfizer submitted to the FDA noted a 419 percent increase in cases among kids in August and September, compared to June and July 2021.

As of October 14, nearly 6.2 million children have tested positive for COVID-19 since the pandemic began. More than 1.1 million child cases were confirmed over the past six weeks, the American Academy of Pediatrics reports. Children account for 16.4 percent of all COVID cases in the U.S.—even though they make up around 22 percent of the total population.

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.

As of October 14, there have been roughly 1.8 million confirmed COVID-19 cases and 143 related deaths among children between 5 and 11-years old. Of children in this age group, there have also been more than 8,600 hospitalizations through mid-September, making COVID more worrisome for these younger kids than the flu.

Children are also at risk for certain COVID-related complications, including multisystem inflammatory syndrome, or MIS-C. Although still very rare, the CDC reports a roughly 15 percent increase in reports of MIS-C since late July. Half of children with MIS-C are between 5 and 13-years old. Researchers point out that myocarditis, which may be a concern among those who are hesitant to vaccinate, is actually more likely to develop due to MIS-C or COVID infection.

And while underlying health issues, such as diabetes and obesity, are tied to more severe COVID-19, about one-third of kids hospitalized due to COVID do not have a preexisting condition.

So, when could the vaccine be available?

Now that the FDA has authorized the emergency use of the Pfizer COVID vaccine for children ages 5 to 11-years old and it's been approved by the CDC, doses of the vaccine would be available to these children within a matter of days—in time for them to get at least one dose before Thanksgiving.

The Biden Administration says it is working with the public and private sector to ensure that all states have the supply and the support they need to effectively distribute an adequate supply of vaccines. This includes packaging in smaller configurations for easier storage, smaller needles and more than 25,000 vaccination sites at pediatric and primary care provider locations. Over the next couple of days, several million doses will be delivered to local pediatricians and family doctors’ offices, pharmacies, children’s hospitals, community health centers, rural health clinics, and other locations, according to a November 1 White House press briefing. Additional doses will be packed and shipped in the coming days.

What about even younger children?

Research on the safety and effectiveness of all COVID vaccines available in the United States is ongoing as the drug companies continue to compile the data needed for full approval in the United States.

Pfizer is currently evaluating the safety and effectiveness of its two-dose COVID-19 vaccine among children between 2 and 5-years old as well as babies and toddlers between 6-months and 2-years old. The company says initial results on the safety and efficacy of the vaccine among these younger age groups may be available before the end of the year.

All children and teens included in the Pfizer trial will continue to be monitored for two years after receiving their second dose of the vaccine. Researchers will not only be analyzing the long-term safety of the shots but also tracking immunity to COVID-19 over time.