COVID-19 Vaccine for Children

FDA and CDC benefit-risk assessments raise questions

Photo by jacoblund

On October 26th, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA approved one third dose of Pfizer’s COVID-19 vaccine for emergency use in children five to 11. On November 2nd, the CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously approved the vaccine. Children could begin receiving vaccines by November 3rd.

At the FDA hearing on the vaccine, a benefit-risk assessment was presented by Hong Yang, PhD, Senior Advisor for Benefit-Risk Assessment Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research. Yang’s analysis is based on six possible scenarios for one million fully vaccinated five to 11 year olds over a six-month period. All scenarios assume that there will be incidences of vaccine-associated myocarditis.

Scenario 1

Scenario 1, the base, assumes that COVID-19 incidences remain the same as they were for the week of September 11, 2021 and assumes a vaccine efficacy of 70% against cases of COVID and 80% against hospitalization. This scenairo projects that the vaccine will prevent 45,773 COVID-19 cases among five to 11 year olds, 192 hospitalizations, and one death. However, it also projects that there will be 106 cases of…