The Medical Letter on Drugs and Therapeutics
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ISSUE
1652
COVID-19 Update: Booster Dose of the Pfizer Vaccine for Children 5-11 Years Old
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Med Lett Drugs Ther. 2022 Jun 13;64(1652):94
Disclosures
Principal Faculty
  • 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
Additional Contributor(s)
  • Michael Viscusi, Pharm.D., Associate Editor: no disclosure or potential conflict of interest to report
Objective(s)
Upon completion of this activity, the participant will be able to:
  1. Discuss the recent updates in COVID-19 vaccination and treatment recommendations.
 Select a term to see related articles  Comirnaty   COVID-19   Spikevax   vaccines 

The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who completed a primary series of the Pfizer vaccine ≥5 months previously.1

IMMUNOGENICITY – Expansion of the EUA was based on the results of an immunogenicity trial (summarized in the FDA Fact Sheet) in 67 children 5-11 years old who received a booster dose of the Pfizer vaccine 7-9 months after completing a 2-dose primary series. Geometric mean neutralizing antibody titer (GMT) levels against an ancestral reference strain of SARS-CoV-2 were about 10-fold higher 1 month after the booster dose than they were before it. In a population subset, GMT levels against an Omicron variant of SARS-CoV-2 (B.1.1.529) were about 22-fold higher 1 month after the booster dose than they were 1 month after the second primary-series dose.2

SAFETY – In a safety trial in 371 children 5-11 years old (summarized in the FDA Fact Sheet), injection-site pain, swelling, and erythema, fatigue, headache, muscle pain, and chills were common following administration of a booster dose of the Pfizer vaccine. The rates of these adverse effects were similar to those with primary-series doses of the vaccine. Most adverse effects were mild to moderate in severity.2

DOSAGE AND ADMINISTRATION – In children 5-11 years old, the booster dose of the Pfizer vaccine is the same as the dose for primary immunization (10 mcg IM). A single booster dose may be given ≥5 months after completion of a 2-dose or, in moderately or severely immunocompromised children, a 3-dose primary series.2

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