Sarah Bennett
The Pfizer-BioNTech and Moderna vaccines were approved by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) for children between six months and four years old. This made the U.S. the only country in the world to vaccinate children as young as six months old. The vaccines are being distributed to pediatricians, children's hospitals, local pharmacies, and local health clinics. CVS, for example, is offering vaccines for children 3 and older.
| Characteristics | Values |
|---|---|
| CVS approval for vaccines for children 5 and under | CVS is vaccinating children aged 3 to 5 |
| First doses of COVID-19 vaccines for children under 5 | Approved and administered in June 2022 |
| Vaccines approved | Pfizer-BioNTech and Moderna |
| Age group | Children between six months and four years old |
| Number of shots delivered to vaccine providers | 2.7 million |
| Number of shots to be delivered as part of the first batch | 10 million |
| Number of pre-ordered Moderna vaccines | 34% |
| Number of pre-ordered Pfizer vaccines | 58% |
| Demand for vaccines for children aged 5 to 11 | Low |
| Percentage of parents of children under 5 eager to vaccinate their children | 18% |
| Percentage of parents who plan to wait and see how the vaccine works | 38% |
| Percentage of parents who are reluctant to vaccinate their children | 40% |
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What You'll Learn
The U.S. is the only country vaccinating children under 5
In June 2022, the U.S. became the first and only country in the world to vaccinate children under the age of five against COVID-19. The Pfizer-BioNTech and Moderna vaccines were approved by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) for children between six months and four years old.
The FDA and CDC began reviewing the safety data for the vaccines for Emergency Use Authorization (EUA) with children under the age of five. While the active ingredients of the Pfizer and BioNTech COVID-19 vaccines are identical to the adult versions, the difference lies in the buffer called tromethamine (Tris) used. The dosage for children under five is also different at 3 µg administered in 3 doses, compared to 10 µg given twice to children aged 5 and older.
The Biden administration expected vaccinations of young children to start as early as June 21, 2022, with vaccines distributed to pediatricians, children's hospitals, local pharmacies, and health clinics. However, pre-orders of vaccines for children under five were initially slow, with 58% of the available 2.5 million Pfizer vaccines ordered and only 34% of Moderna vaccines.
The decision to vaccinate young children was met with criticism and skepticism. Dr. Vinay Prasad, an associate professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco, stated that there was little evidence to support the need for vaccinating children that young. He criticized officials and media figures for not being transparent about the lack of data and the potential risks involved. Dr. Marty Makary, a public health expert at Johns Hopkins University, echoed similar sentiments, noting that the approval was based on very limited data and that the study sample size was too small to draw conclusions about safety. Florida was the only state in America that did not pre-order COVID-19 vaccines for children under five, citing concerns that the risks outweighed the benefits.
As of August 2025, the FDA is considering revoking the authorization of Pfizer's COVID-19 vaccine for healthy children under five. This could leave many children in this age group without access to a safe and effective vaccine, as Moderna's vaccine is only approved for those with underlying health conditions that increase their risk of severe illness from COVID-19.
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Pfizer-BioNTech and Moderna vaccines approved by FDA and CDC
In June 2022, the Pfizer-BioNTech and Moderna vaccines were approved by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) for emergency use in children between six months and four years old. This made the United States the only country in the world to vaccinate children as young as six months old.
The active ingredients of the Pfizer-BioNTech COVID-19 vaccines are identical to the adult versions. However, the buffer solution used is tromethamine (Tris), which is also used in cosmetics, serums, and vaccines since 1978. The dosage for children under five is also different from older age groups. Children under five will receive three doses of 3 µg each, while children between five and eleven years old will receive two doses of 10 µg each. Children aged twelve and above will be administered three doses of 30 µg each.
The Moderna vaccine contains tromethamine and tromethamine HCl as stabilizers. The main active ingredient in both vaccines is 2-hydroxypropyl beta-cyclodextrin (HPBCD), a compound derived from beta-cyclodextrin (BCD), which occurs naturally from starch.
The decision to approve the vaccines for young children was met with criticism from some experts, who argued that there was little evidence to support the need for the shots in this age group. They also questioned the effectiveness of the vaccines, with Dr Marty Makary, a public health expert, noting that the sample size for safety studies was too low to draw conclusive results. Despite the criticism, the White House COVID-19 response coordinator, Ashish Jha, expressed confidence in the vaccines and encouraged parents to vaccinate their young children.
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Slow pre-orders of vaccines for children under 5
The Biden administration has reported a slow pace of pre-orders for COVID-19 vaccines for children under five. However, officials are not concerned and expect the pace to increase after federal approvals. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are expected to approve the vaccines as early as June 21, with vaccinations starting soon after. The administration has allowed pre-orders from an initial batch of 5 million Moderna and Pfizer vaccines, with 2.5 million doses each.
As of June 9, 58% of the available Pfizer vaccines have been ordered, while only 34% of the Moderna vaccines have been pre-ordered. This slow uptake could be due to several factors, including parental concerns about vaccine safety and effectiveness in young children. A Kaiser Family Foundation poll in April found that only 18% of parents with kids under 5 planned to get them vaccinated immediately, while 38% wanted to wait.
The FDA and CDC have been reviewing the safety data for the Pfizer and Moderna vaccines for Emergency Use Authorization (EUA) in children under 5. Understanding the ingredients and dosage amounts is crucial for parents making informed decisions. The vaccines will have different buffer ingredients and lower dosages than adult vaccines.
Despite the initial slow pre-orders, the Biden administration is prepared to distribute the vaccines through pediatricians, children's hospitals, local pharmacies, and community health centers. They anticipate that 85% of children under 5 live within 5 miles of a potential vaccination site, ensuring easy access.
Following the approval of the vaccines, the U.S. became the only country in the world to vaccinate children as young as six months old. While some experts criticized the decision, citing limited data and small study sample sizes, the Biden administration remains confident in the safety and effectiveness of the vaccines for young children.
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Low demand for vaccines in kids aged 5-11
In June 2022, the Pfizer-BioNTech and Moderna vaccines were approved by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) for emergency use in children between six months and four years old. However, there has been low demand for vaccines in kids aged 5 to 11.
While the Biden administration is not alarmed by the slow pre-orders for this age group, they expect the pace to pick up after federal approvals. The administration has learned from previous campaigns that individuals are influenced by those they trust, such as doctors and community leaders. As a result, they plan to work closely with community partners to ensure that community members receive information from familiar sources.
Despite the low demand, public health experts note that the coronavirus still poses a threat to healthy children under 2. Data from the CDC reveals that among children aged 6 months to 2 years who were hospitalized with Covid from October 2022 to April 2024, over half had no underlying health conditions. Additionally, the vaccines offer modest protection against long Covid in some children.
However, some critics argue that there is little evidence supporting the need for vaccines in young children. Dr Vinay Prasad, an associate professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco, has criticized officials and media figures for not being transparent about the shots. Similarly, Dr Marty Makary, a public health expert at Johns Hopkins University, questioned the approval of the vaccines based on limited data.
As of August 2025, the FDA is considering discontinuing the emergency use authorization for the Pfizer vaccine in children aged 6 months to 4 years. If the authorization is not renewed, healthy children in this age group will have no officially sanctioned vaccine options. However, Pfizer expects its vaccine for children aged 5 to 11 to be fully licensed in the fall of 2025.
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Safety data for vaccines for children under 5
In June 2022, the US became the first country in the world to approve and administer the COVID-19 vaccine to children under the age of five. The Pfizer-BioNTech and Moderna vaccines were approved by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) for children aged six months to four years.
The safety of the vaccines for this age group has been questioned by some experts, who claim that the studies underpinning the approval were based on very little data. Dr Marty Makary, a public health expert at Johns Hopkins University, commented that the sample size was too low to make a conclusion about safety. Dr Makary also noted that the studies were conducted on children who had not previously had COVID-19. Dr Eric Rubin, editor-in-chief of the New England Journal of Medicine, acknowledged the lack of data but asserted that safety can only be established through real-world use: "We're never going to learn about how safe this vaccine is unless we start giving it."
The risk of myocarditis and pericarditis, a rare vaccine side effect seen in adolescent males, is thought to be very low for children under five. There were no cases of these side effects in the trials, and experts will continue to monitor for these and other rare side effects as the vaccines are administered to more children.
The CDC has emphasised that the vaccines can be used safely and effectively in children under five, and that the benefits outweigh the risks. The FDA and CDC's approval was based on data from older children and adults, which showed that the vaccines were effective in preventing severe COVID-19 illness. There were no cases of severe illness in either the vaccine or placebo groups. The Pfizer vaccine was estimated to be 80% effective in preventing symptomatic COVID-19, based on a subset of children who received a third dose.
The vaccines will be distributed to pediatricians, children's hospitals, local pharmacies, and local health clinics, allowing parents to access the vaccines easily and make informed decisions about their children's health.
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Frequently asked questions
No, CVS did not approve the vaccines for children 5 and under. However, they are encouraging customers to visit their site for appointment availability.
The Pfizer-BioNTech and Moderna vaccines were approved by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) for children between six months and four years old.
The dosage for children under the age of 5 is 3 µg that will be administered in 3 doses.
