[BostonCard]

At around the time any drug enters phase 3 trials, the Sponsor will need to present a pediatric plan or request a waiver (this is a requirement) which would probably mean a separate pediatric study shortly after efficacy in adults is established. Particularly for COVID-19, where the risk of the disease in kids is very low, you will want to have shown benefit before you expose a pediatric population to risk.

Here’s the relevant excerpt from the FDA’s COVID vaccine guidance.

It is important for developers of COVID-19 vaccines to plan for pediatric assessments of safety and effectiveness, given the nature of the COVID-19 public health emergency, and to help ensure compliance with the Pediatric Research Equity Act (PREA) (section 505B of the FD&C Act (21 U.S.C. 355c)) (Ref. 18). The epidemiology and pathogenesis of COVID-19, and the safety and effectiveness of COVID-19 vaccines, may be different in children compared with adults. In order to ensure compliance with 21 CFR Part 50 Subpart D (Additional safeguards for children in clinical investigations), considerations on the prospect of direct benefit and acceptable risk to support initiation of pediatric studies, and the appropriate design and endpoints for pediatric studies, should be discussed in the context of specific vaccine development programs

BC

[BostonCard]

At around the time any drug enters phase 3 trials, the Sponsor will need to present a pediatric plan or request a waiver (this is a requirement) which would probably mean a separate pediatric study shortly after efficacy in adults is established. Particularly for COVID-19, where the risk of the disease in kids is very low, you will want to have shown benefit before you expose a pediatric population to risk.

Here’s the relevant excerpt from the FDA’s COVID vaccine guidance.

It is important for developers of COVID-19 vaccines to plan for pediatric assessments of safety and effectiveness, given the nature of the COVID-19 public health emergency, and to help ensure compliance with the Pediatric Research Equity Act (PREA) (section 505B of the FD&C Act (21 U.S.C. 355c)) (Ref. 18). The epidemiology and pathogenesis of COVID-19, and the safety and effectiveness of COVID-19 vaccines, may be different in children compared with adults. In order to ensure compliance with 21 CFR Part 50 Subpart D (Additional safeguards for children in clinical investigations), considerations on the prospect of direct benefit and acceptable risk to support initiation of pediatric studies, and the appropriate design and endpoints for pediatric studies, should be discussed in the context of specific vaccine development programs

BC