A study of COVID-19 on the pediatric population reaffirms the low risk of vaccines
A new study on COVID-19 vaccines looks at surveillance systems and critical clinical trials among the pediatric population. The conclusions of the study validate these vaccines for the pediatric population and show that adverse reactions to the administration of the vaccine are, for the most part, common.
The study "Safety of COVID-19 vaccines among the pediatric population: analysis of European surveillance systems and fundamental clinical trials" includes the participation of the researcher from the IDIAPJGol Scientific Area, Felipe Villalobos, plus some fifteen other authors from all over Europe. and the collaboration of the ilmiovaccinoCOVID19 group. The project has been carried out through a prospective cohort of vaccinated with ages between 5 and 17 years. This large-scale investigation was carried out through the COVID19-Vaccine Monitor (CVM) and Eudravigilance surveillance systems, and the frequency of serious adverse events (ADRs) and the most common adverse events after the first and second dose of the vaccine against Coronavirus. In the pediatric population the use of Comirnaty, Spikevax and Nuvaxovid was administered.
The cohort carried out through CVM enrolled 658 vaccinated with the first dose (children 5 to 11 years old; n = 250 and adolescents 12 to 17 years old; n = 408). Solicited local/systemic ADRs were common, while serious ADRs were rare. Among those who received the first and second doses of Comirnaty, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were ADRs most frequent local and systemic The results were consistent but slightly lower than the pivotal clinical trials.
Thus, the results of the study reinforce the low risk profile of these vaccines for the pediatric population. They have a high frequency of local adverse events, very common in the population, but hardly any serious. Those who have suffered these common reactions such as pain at the injection site, tiredness or headache have felt it more on the first injection than on the second.
In the future, we can benefit from these structured, organized and validated data collection systems beyond the COVID-19 pandemic emergency, as they can be easily adapted to other specific needs.
Referencia a l'article:
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials: Fariba Ahmadizar, Nicoletta Luxi, Monika Raethke, Sandor Schmikli, Fabio Riefolo, Putri Widi Saraswati, Camelia Bucsa, Alhadi Osman, Megan Liddiard, Francisco Batel Maques, Giuliana Petrelli, Simona Sonderlichová, Nicolas H. Thurin, Felipe Villalobos, Gianluca Trifirò, Miriam Sturkenboom & ilmiovaccinoCOVID19 collaborating group.
