ISSUE1638
- Mark Abramowicz, M.D., President: no disclosure or potential conflict of interest to report
- Jean-Marie Pflomm, Pharm.D., Editor in Chief: no disclosure or potential conflict of interest to report
- Brinda M. Shah, Pharm.D., Consulting Editor: no disclosure or potential conflict of interest to report
- Michael Viscusi, Pharm.D., Associate Editor: no disclosure or potential conflict of interest to report
- Discuss the evidence supporting the FDA Emergency Use Authorization of the Pfi zer/BioNTech COVID-19 vaccine (Comirnaty) in children 5-11 years old.
The FDA has issued an Emergency Use Authorization (EUA) for a lower-strength (10 mcg/0.2 mL) formulation of the mRNA-based COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) for use in children 5-11 years old.1 The original formulation of Comirnaty (30 mcg/0.3 mL) is FDA-licensed for use in persons ≥16 years old and available under an EUA for use in adolescents 12-15 years old.2,3
CLINICAL STUDIES — A study compared the immunogenicity of a 10-mcg dose of Comirnaty in 264 children 5-11 years old with that of a 30-mcg dose in 253 persons 16-25 years old. Geometric mean titer levels of anti-SARS-CoV-2 neutralizing antibodies 1 month after the second dose in the two groups were similar (1197.6 vs 1146.5), and 99.2% of persons in each group experienced a seroresponse.4
In an observer-blind efficacy trial, 1968 children 5-11 years old with no evidence of prior SARS-CoV-2 infection were randomized 2:1 to receive Comirnaty 10 mcg or placebo at 0 and 3 weeks. There were 3 cases of COVID-19 with onset ≥7 days after the second dose in children who received the vaccine and 16 cases in those who received placebo; the vaccine efficacy rate was 90.7%. No cases of severe COVID-19 or hospitalizations due to COVID-19 occurred in either group.4
ADVERSE EFFECTS — The 10-mcg dose of Comirnaty appears to be better tolerated in children 5-11 years old than the 30-mcg dose is in adolescents 12-15 years old. In the efficacy trial, fatigue, headache, muscle pain, and injection-site pain and redness were common following administration of the vaccine. Most adverse effects were mild or moderate in severity and occurred at a higher frequency after the second dose. No serious adverse effects related to vaccination, including myocarditis/pericarditis and anaphylaxis, were reported.4-6
DOSAGE AND ADMINISTRATION — The new Comirnaty formulation is supplied in vials with orange rather than purple caps. After the contents are diluted with 1.3 mL of normal saline, each vial provides ten 10 mcg/0.2 mL doses of the vaccine. Children 5-11 years old should receive two 10-mcg primary doses of the vaccine intramuscularly 3 weeks apart.7 Booster doses of Comirnaty have not been authorized for use in children to date.
Additional Content Available Online
COVID-19 Vaccine Dosing Recommendations
COVID-19 Vaccine Comparison Chart
- FDA News Release. FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age. October 29, 2021. Available at: https://bit.ly/3waEUDC. Accessed November 10, 2021.
- FDA authorizes Pfizer-BioNTech COVID-19 vaccine. Med Lett Drugs Ther 2021; 63:1.
- In brief: Pfizer/BioNTech COVID-19 vaccine authorized for adolescents 12-15 years old. Med Lett Drugs Ther 2021; 63:81.
- EB Walter et al. Evaluation of the BNT162b2 Covid-19 vaccine in children 5 to 11 years of age. N Engl J Med 2021 November 9 (epub).
- FDA. Fact sheet for health care providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). For 5-11 years of age. October 29, 2021. Available at: https://bit.ly/3jX9xri. Accessed November 10, 2021.
- FDA. Fact sheet for health care providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). For 12 years of age and older. October 29, 2021. Available at: https://bit.ly/3bBH5GV. Accessed November 10, 2021.
- CDC News Release. CDC recommends pediatric COVID-19 vaccine for children 5-11 years. November 2, 2021. Available at: https://bit.ly/3k1TI2T. Accessed November 10, 2021.
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