Abstract
BackgroundThe immune system matures throughout childhood; therefore, evidence about the safety and efficacy of vaccines for the prevention of COVID-19 in the paediatric population is important. Efficacy and safety have not been established for COVID-19 vaccines in a large part of the paediatric population at the time of the initial approval for use in adults. This study aims to provide an overview of planned and ongoing paediatric clinical trials investigating the safety and/or efficacy of COVID-19.MethodsWe identified all paediatric clinical trials investigating the safety and/or efficacy of COVID-19 vaccines in clinicaltrials.gov and clinicaltrialregister.eu, as well as all clinical trials planned in agreed PIPs (Paediatric Investigational Plans) as of 11 June 2021. Information about the study design, the paediatric age groups that they included, and the primary and secondary safety and efficacy outcomes were collected, together with expected timelines for the studies.Results21 clinical trials were identified through the clinical trial registries and 19 clinical trials were specified in 6 agreed PIPs, 5 of these trials were also in the trial registers. All PIPs stipulated development of the COVID-19 vaccines for the full paediatric population, with a deferral. The earliest expected completion date of a PIPs is March 2024. The majority (14/21) of registered trials are randomised double-blinded studies. All investigated safety, 20 have a surrogate efficacy outcome (immunogenicity), of these 7 also measure clinical efficacy (COVID-19 infections). 18 studies were initiated, of these, all but one is still ongoing and one in adolescents has been finalised.ConclusionEven though several trials have been planned in agreed PIPs, the registered paediatric clinical trials identified are most often not part of a PIP.
Highlights
The rapid development and implementation of vaccines against COVID-19 are society’s best weapon against the social, economic and human devastation brought about by the COVID-19 pandemic
This study aims to provide insight into the timely drug development of COVID-19 vaccines for the paediatric population by investigating registered clinical trials on the safety and the efficacy of COVID-19 vaccines along with the planned clinical trials agreed in a PIP and the expected timelines for completion
The EU approval status and approval date for each active substance targeted by a PIP were retrieved by matching the Paediatric Committee (PDCO) decision number from the European Public Assessment Reports (EPARs) of an approved COVID-19 vaccine at the time of the MA with those of the PIP
Summary
The rapid development and implementation of vaccines against COVID-19 are society’s best weapon against the social, economic and human devastation brought about by the COVID-19 pandemic. Safety and efficacy in a large proportion of the paediatric population have not been established for COVID-19 vaccines at the time of initial approval for use in adults [4]. In the EU (European Union), four COVID-19 vaccines have currently been granted a CMA (Conditional Marketing Approval) [5,6,7,8] They are manufactured by PfizerBioNTech, Moderna, AstraZeneca and Janssen. Efficacy and safety have not been established for COVID-19 vaccines in a large part of the paediatric population at the time of the initial approval for use in adults. Methods We identified all paediatric clinical trials investigating the safety and/or efficacy of COVID-19 vaccines in clinicaltrials.gov and clinicaltrialregister.eu, as well as all clinical trials planned in agreed PIPs (Paediatric Investigational Plans) as of 11 June 2021. Conclusion Even though several trials have been planned in agreed PIPs, the registered paediatric clinical trials identified are most often not part of a PIP
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