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Emergency Use Authorization

The CDC now recommends the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) for children ages 5-11 years after the FDA’s EUA approval and support from the Advisory Committee on Immunization Practices (ACIP). The authorization is based on data from the ongoing clinical trial C4591007 that found the vaccine to be 90.7% effective in preventing COVID-19 among children ages 5 through 11.

The Clinical Trial

The ongoing randomized, double-blinded, placebo-controlled clinical trial C4591007 includes 4,700 children aged 5-11 in the United States, Finland, Poland, and Spain. 3,100 received two child-sized doses of the Pfizer-BioNTech COVID-19 vaccine (10 micrograms rather than 30 micrograms of messenger RNA) three weeks apart. 1,538 received the placebo. Of the 3100 children who received the vaccine, no serious side effects were reported.

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The FDA did a preliminary analysis of COVID-10 cases seven days after the second dose. Their analysis found that among participants without evidence of prior infection with SARS-CoV-2 (COVID-19), 3 cases of COVID-19 occurred out of the 1,305 vaccine recipients, compared to 16 COVID-19 cases among 663 placebo recipients, showing the vaccine was 90.4% effective in preventing COVID-19.

The side effects that were reported were mild-moderate in severity, occurring about 2 days after receiving the vaccine, usually the second. The majority of these side effects went away within one to two days. These symptoms included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea, and decreased appetite.

Benefit-risk Assessment

Myocarditis and pericarditis in children ages 5-11 vs. unvaccinated school aged children

Cases of myocarditis (inflammation of the heart) and pericarditis (inflammation of the lining around the heart) have been reported (especially in male adolescents) following the second dose of mRNA vaccines. The majority of these cases responded well to treatment and returned to their normal daily activities after symptoms improved.

COVID-19 Prevalence Among 5-11 Year Old Children

There have been over 1.9 million reported cases of COVID-19 in this demographc. About 8,300 hospitalizations dure to COVID-19 have been reported through mid-October. There have been at least 94 COVID-19-associated deaths in this age group. The emergence of the Delta variant played a major role in infecting adolescence. The CDC reports a 10 fold increase among unvaccinated adolescents since the rise of the Delta variant.

Multisystem Inflammatory Syndrome in Children (MIS-C) Post Vaccination

Children in this age group have a higher chance of developing multisystem inflammatory syndrome in children (MIS-C) 2-6 weeks after COVID-19 infection. Although this occurrence is rare, it can be very dangerous.

There is an estimated incidence of 1 MIS-C case in approximately 3,200 SARS-CoV-2 infections. 60-70% of patients with MIS-C are admitted to intensive care, and 1-2% die. Out of the 5,217 MIS-C cases reported nationally from February 2020 to September 2021, the median age was 9 years old, 2,316 of those cases were children aged 5-11 and 9 died.

The FDA conducted a benefit-risk assessment using modeling to predict the number of potential myocarditis cases, hospitalizations, intensive care unit (ICU) admissions, and deaths that the vaccine might cause vs the number of symptomatic COVID-19 cases, hospitalizations, ICU admissions, and deaths. They concluded the benefit outweighed the risk.

Will Parents Vaccinate their 5-11 Year Old?

Parent Sentiment & First Week Vaccination Numbers

In the CDC’s parental survey of 1000 U.S. parents of children aged 5-11, 35% would “definitely” vaccine their child, and 22% would “probably” get their child vaccinated. Long-term side effects and short-term side effects were the top concerns of parents who did not indicate they would get their child vaccinated.

CDC modeling predicts if this age group is vaccinated, some 600,000 cases of COVID-19 could be prevented through March 2022. Their modeling suggests that vaccinating 5-11-year-old children could accelerate the decline in cases by about 8%.

28 million children 5 through 11 years old in the United States are eligible to receive the Pfizer COVID-19 vaccine. In the first week, a White House official said nearly 1 million children have already received their first dose.

References

BNT162B2 (COVID-19 vaccine, mrna) vaccine in … – cdc.gov. (n.d.). Retrieved November 12, 2021, from https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/02-COVID-Gurtman-508.pdf.

Centers for Disease Control and Prevention. (2021, November 2). CDC recommends pediatric COVID-19 vaccine for children 5 to 11 years. Centers for Disease Control and Prevention. Retrieved November 12, 2021, from https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html.

Centers for Disease Control and Prevention. (2021, September 9). Hospitalizations associated with covid-19 among children and adolescents – covid-net, 14 states, March 1, 2020–August 14, 2021. Centers for Disease Control and Prevention. Retrieved November 12, 2021, from https://www.cdc.gov/mmwr/volumes/70/wr/mm7036e2.htm.

Centers for Disease Control and Prevention. (n.d.). Myocarditis and pericarditis after mrna COVID-19 vaccination. Centers for Disease Control and Prevention. Retrieved November 12, 2021, from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html.

Commissioner, O. of the. (n.d.). FDA authorizes pfizer-biontech COVID-19 vaccine for emergency use in children 5 through 11 years of age. U.S. Food and Drug Administration. Retrieved November 12, 2021, from https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age.

Keith, T. (2021, November 10). Nearly 1 million kids ages 5-11 will have their first COVID shots by the end of today. NPR. Retrieved November 12, 2021, from https://www.npr.org/2021/11/10/1054137225/nearly-1-million-kids-ages-5-11-will-have-their-first-covid-shots-by-the-end-of-.

A phase 1/2/3 study to evaluate the safety, tolerability, and immunogenicity of an RNA vaccine candidate against COVID-19 in healthy children and young adults – full text view. Full Text View – ClinicalTrials.gov. (n.d.). Retrieved November 12, 2021, from https://clinicaltrials.gov/ct2/show/NCT04816643.