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COVID-19 vaccines for children get the green light

It has been nearly a year since the U.S. Food & Drug Administration (FDA) issued its first Emergency Use Authorization (EUA) for a COVID-19 vaccine. Since December 2020, an increasing number of Americans have become eligible for their shots based on factors such as age, comorbidities and place of employment. Now COVID-19 vaccines for children ages five through under 12 are newly available.

Vaccination remains one of the best preventative measures against COVID-19. Here’s what we know about COVID-19 in children, vaccines for children and what to expect for the rollout:

How COVID-19 has impacted children

While COVID-19 tends to be less severe in children, more than 2.1 million cases and 191 related deaths in the five to under 12 age group have been reported to the Centers for Disease Control & Prevention (CDC) as of as of Nov. 15, 2021. More than 5,200 hospitals reporting to the CDC say that approximately 66,730 patients up to age 17 with confirmed cases of COVID-19 have been hospitalized since August 2020, and the CDC also reports more than 5,500 cases of a rare but serious condition known as multisystem inflammatory syndrome in children (MIS-C) have been recorded. Additionally, though “long COVID” appears to be less common in younger people, the American Academy of Pediatrics (AAP) reports that between 13% and 52% of children and adolescents experience lingering effects of COVID-19 weeks after their initial diagnoses.

Getting across the finish line for younger children

The COVID-19 vaccine for children is from Pfizer and BioNTech. The Pfizer vaccine has full FDA approval for those over 16, and it is currently authorized for those ages 12 to 15. Recently an FDA advisory panel voted to authorize this vaccine for children ages five to under 12, and an independent CDC advisory panel recommended the shot for this age group soon after. CDC Director Dr. Rochelle Walensky then quickly endorsed the CDC panel’s recommendation, enabling vaccinations to begin.

In Pfizer and BioNTech’s clinical trial, children five to 11 years of age received a two-dose regimen of the vaccine, given 21 days apart. The vaccine is 10 micrograms, one-third of the dosage adolescents and adults receive, and the two organizations report it is 90.7% effective against symptomatic COVID-19 for children ages five to 11. Participants in this study also developed coronavirus antibodies at similar levels to adolescents and teens.

Similar to adolescents and young adults, participants reported side effects like headache, fever and injection site pain, though generally at lower rates than older age groups. No severe illnesses were reported, and there was no statistically significant difference in the frequency of severe adverse events between vaccine and placebo recipients (0.07% versus 0.10%).

Myocarditis, or inflammation of the heart muscle, is a rare adverse event that has been reported among recipients of mRNA vaccines like the Pfizer-BioNTech vaccine outside of clinical trials. (In adolescents 12 to 15 years of age, about 40 males and 4 females per million second doses of the vaccine have experienced myocarditis.) The baseline (or pre-pandemic) risk of myocarditis among children ages five to 11 years is much lower than the risk in older adolescents.

As with any vaccination or treatment, clinicians should offer insight to patients on the possibility of side effects or adverse reactions. While there were no myocarditis cases reported among the clinical trial’s participants within at least seven days of follow-up after their second dose, the clinical trial was not conducted with enough patients to assess rare adverse events like myocarditis, so the CDC recommends clinicians counsel parents on this possibility following receipt of mRNA COVID-19 vaccines. In addition, it is important for clinicians to report any cases to the Vaccine Adverse Event Reporting System (VAERS) to facilitate safety surveillance of potential adverse events in this age group.

All approved drugs and vaccines come with some risk of side effects, and the CDC advisory committee determined the benefits of the vaccine outweigh the known and potential risks.

In addition to Pfizer, Moderna recently announced results from its development of a COVID-19 vaccine for children. In a clinical trial, participants received two 50-microgram doses in a 28-day span. Moderna plans to submit the study to a peer-reviewed publication as well as to regulators.

The rollout plan for children (and families)

The federal government announced it secured 28 million doses of the Pfizer–BioNTech vaccine—enough for every child from five to under 12 years old—and the rollout plan has been developed to meet the unique needs of this age group. For example, the vaccine is available at locations familiar to children, including 25,000 pediatricians’ offices and primary care sites, 100 children’s hospital systems, as well as pharmacies, schools and community health centers. In addition to the vaccine, these sites are receiving essential, ancillary supplies needed to administer the shots, such as smaller needles for children.

To support these vaccination efforts, the U.S. Department of Health and Human Services (HHS) is launching a national public education campaign to give families the information they need and answer questions about the vaccine, its effectiveness and risks. As part of this campaign, the federal government will also work with trusted entities like schools and faith-based organizations to share messages that will instill vaccine confidence in their communities.

As with adult vaccinations, parents hold a variety of attitudes around vaccinating their children. Research conducted in September 2021 by the Kaiser Family Foundation found that 34% of parents with a child five to 11 years old would get their child vaccinated “right away” once a COVID-19 vaccine is authorized for that age group, and 32% of parents would “wait and see.” About a quarter of parents said they will “definitely not” get their child vaccinated and 7% would only do so if required. Time will tell if these sentiments change as vaccinations continue for these children.

Understanding COVID-19 in children

As the pandemic continues, Allscripts is contributing to ongoing efforts to better understand COVID-19 and long COVID in children (and other patient populations). The Veradigm® business unit is a founding member of the COVID-19 Research Database, a consortium providing government and academic researchers rapid access to real-world data (RWD). Veradigm is also analyzing electronic health record data as a research partner for the COVID-19 Patient Recovery Alliance, a collaborative effort to study long COVID and advocate for impacted patients.

Visit the COVID-19 Research Database and COVID-19 Patient Recovery Alliance websites to learn more about these initiatives.

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