COVID-19 Vaccines for Ages 5–11: Process of Vaccine Approval

Written on 16 November 2021.

Widespread vaccination against COVID-19 is paramount in preventing the continued spread of the novel coronavirus. Up until now, some 28 million Americans were ineligible for vaccination—specifically, elementary school-aged children.

Now, kids between the ages of 5 and 11 can receive an emergency child-appropriate dose of the COVID-19 vaccine to protect them from SARS-CoV-2 infection and help reduce community transmission.

Recommendations for Pediatric Populations

In a critical effort to ensure access to safe vaccines for pediatric populations, the Food and Drug Administration (FDA) recently approved the Pfizer-BioNTech COVID-19 vaccine for emergency use in elementary school-aged children. The CDC Advisory Committee on Immunization Practices, the central authority on vaccine recommendations, subsequently endorsed Pfizer’s pediatric COVID-19 vaccine on November 2, 2021.

The formal recommendation states that children aged 5 through 11 years can receive a separate vaccine formulation that is one-third the dosage received by adults and adolescents. The pediatric vaccine will be administered as two doses given three weeks apart. In addition, the vaccine will be injected using a smaller needle. This recommendation comes following a systematic review of data produced by clinical research teams and ensuing clinical trials.

The Process of Developing Pediatric Vaccines

Research is the first step in vaccine development. In the case of COVID-19, development dovetails years of past research and lab efforts to produce vaccines targeting related coronaviruses, like those behind Severe Acute Respiratory Syndrome (SARS) and the Middle East Respiratory Syndrome (MERS). The ability to utilize accepted knowledge has helped speed up the development of current COVID-19 vaccines.

For pediatric vaccines, scientists must scale down the dosage appropriately. This is done according to age rather than weight as vaccines work by introducing antigens (benign bits of virus) that allow a memory immune response to form. Children’s developing immune systems are more robust than adults, and lower vaccine doses are effective in mounting an immune response against a specific virus.

Clinical Trial Data Supporting the Recommendation

Vaccine approvals do not move forward without assurances that it is safe and effective. After initial development, vaccines undergo a series of clinical trials in which the vaccine formulation is tested among a group of patients. These studies are used to produce data in support of the safety and efficacy of a vaccine, to compare outcomes with non-vaccinated populations, and to gain insight into possible adverse effects.

In a large-scale phase II/III clinical trial, FDA scientists found that Pfizer’s pediatric vaccine was effective against COVID-19 in more than 90 percent of children aged 5 through 11 years. The study also found the pediatric vaccine very safe: side-effects were mild to moderate and most commonly included fatigue, headache, fever, or injection site pain—all of which resolved in a day or two. Serious events were uncommon (and occurred with the same frequency as in the unvaccinated group).

National Rollout of Pediatric Vaccination

Parents can expect the national approach to vaccinating 5- to 11-year-olds to shift from prior vaccination efforts. Rather than roll out vaccines across a range of public locations, vaccine efforts will concentrate on pediatric offices, hospitals, and community health centers.

This is based on data showing parental preferences to have their children vaccinated by trusted care providers whom they are familiar with and who are trusted messengers of vaccine information. In fact, your child can get the pediatric COVID-19 vaccine at the same time as other vaccines, like the flu shot.

How to Talk to Your Children About the Vaccine

Children are typically scared of getting shots, and information surrounding COVID-19 vaccines can be complicated and often misinformed. Don’t be afraid to talk to kids about the COVID-19 vaccine—start by asking them what they’ve heard and take their fears seriously. Answer questions as honestly as possible and enlist a trusted adult like a teacher or pediatrician to help explain how the vaccine offers protection.

It is important to engage with children on their level, and UNICEF provides useful tips on how to talk about the vaccine with elementary school-aged children. For the youngest patients, Sesame Street (in close partnership with the CDC) recently launched several public service announcements to spotlight the benefits associated with getting a COVID-19 vaccine, building hope for sunny days ahead.

Research and materials for this article were compiled, written, and distributed on behalf of the National Public Health Information Coalition. The views and opinions expressed in this blog are those of the various authors and do not necessarily reflect the official policy or position of the National Public Health Information Coalition or its members.

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