Sunday, September 24, 2023
Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™
Nurses - 0.25 ANCC Contact Hour(s) (0 contact hours are in the area of pharmacology)
Pharmacists - 0.25 Knowledge-based ACPE (0.025 CEUs)
Physician Assistant - 0.25 AAPA hour(s) of Category I credit
IPCE - 0.25 Interprofessional Continuing Education (IPCE) credit
This activity is intended for primary care clinicians, pediatricians, nurses, pharmacists, nurse practitioners and other clinicians who treat and manage young children.
The goal of this activity is for members of the healthcare team to be better able to analyze the safety of mRNA-based COVID-19 vaccines among young children < 5 years.
Upon completion of this activity, participants will:
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Awarded 0.25 contact hour(s) of nursing continuing professional development for RNs and APNs; 0.00 contact hours are in the area of pharmacology.
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CME / CE Released: 7/28/2023
Valid for credit through: 7/28/2024, 11:59 PM EST
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Note: The information on the coronavirus outbreak is continually evolving. The content within this activity serves as a historical reference to the information that was available at the time of this publication. We continue to add to the collection of activities on this subject as new information becomes available. It is the policy of Medscape Education to avoid the mention of brand names or specific manufacturers in accredited educational activities. However, manufacturer names related to the approved COVID-19 vaccines are provided in this activity in an effort to promote clarity. The use of manufacturer names should not be viewed as an endorsement by Medscape of any specific product or manufacturer.
The latest guidelines from the Centers for Disease Control and Prevention (CDC) call for the application of COVID-19 vaccine for all individuals older than 6 months. The vaccine series for children aged between 6 months and 4 years should consist of 2 vaccine doses of the Moderna vaccine or a series of 3 doses of the Pfizer/BioNTech vaccine. The bivalent vaccines can be used for the primary series across all ages. The recommendations also call for a bivalent booster dose at least 8 weeks after the receipt of a monovalent vaccine.
However, despite these recommendations, COVID-19 vaccination rates are lowest for children younger than 5 years when compared with those of other age groups.
One limiting factor regarding application of the COVID-19 vaccine among young children is concern regarding the safety of the vaccine. The current study addresses this issue by using a large vaccine database.
TOPLINE:
COVID-19 vaccines from Moderna and Pfizer-BioNTech are safe for children younger than 5 years, according to findings from a study funded by the CDC.
METHODOLOGY:
The current study employed a rapid cycle analysis (RCA) to report safety surveillance in children under 5 years of age. Data came from the Vaccine Safety Datalink (VSD), which is a collaboration between the CDC and 8 health systems in the United States. Data was extracted from participating sites using sequential analysis to evaluate prespecified outcome indicators including myocarditis, pericarditis, and seizures. Outcomes were compared between those receiving a primary vaccination at 1-21 days postvaccination to comparators at 22-42 days postvaccination (control). Data from 135,005 doses given to children aged 4 years and younger who received the Pfizer-BioNTech mRNA vaccine, and 112,006 doses given to children aged 5 years and younger who received the Moderna version.
TAKEAWAY:
None of the prespecified outcome indicators, including myocarditis or pericarditis, was detected among the children in the 21 days after receipt of either vaccine. It was noted that one case of hemorrhagic stroke and one case of pulmonary embolism occurred after vaccination, but these were linked to preexisting congenital abnormalities. Descriptive analysis revealed that one case of anaphylaxis was found and associated with a food allergy and thus, unrelated to the vaccine. One case of multisystem inflammatory syndrome in children (MIS-C) was identified in the postvaccination period but the child acquired COVID-19 after the infection and before the diagnosis of MIS-C.
IN PRACTICE:
These results are consistent with other vaccine safety monitoring systems and phase 3 clinical trials. The data revealed in this study “can provide reassurance to clinicians, parents, and policymakers alike,” the authors write.
STRENGTHS AND LIMITATIONS:
The study included a large, diverse population with routine data analysis and a robust data capture. Limitations included a low statistical power for early analysis, especially for rare outcomes. In addition, fewer than 25% of children in the database had received a vaccine at the time of analysis.
STUDY DETAILS:
The study was led by Kristin Goddard, MPH, a researcher at the Kaiser Permanente Vaccine Study Center in Oakland, California, and was funded by the CDC.
DISCLOSURES:
Donahue reports receiving funding from Janssen Vaccines and Prevention for a study unrelated to COVID-19 vaccines. One coauthor reports receiving grants from Pfizer in 2019 for clinical trials for coronavirus vaccines and from Merck, GSK, and Sanofi Pasteur for unrelated research.
Pediatrics. Published online June 6, 2023.[1]
