September 2016. Volume 12. Number 3

Without data on long term damage, vaccines with new adjuvants show a slight increase in short and medium term adverse effects

 
 
 
 
 
 
 
 
 
 
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AVC | Critically appraised articles

Stassijns J, Bollaerts K, Baay M, Verstraeten T. A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among children. Vaccine. 2016;34:714-22.

Reviewers: Albi Rodríguez MS1, Aparicio Rodrigo M2.
1Servicio de Neumología Pediátrica. Hospital Universitario 12 de Octubre. Madrid. España.
2Centro de Salud Entreví­as. Área 1. Madrid. España.
Correspondence: María Salomé Albi Rodríguez. Email: msalbir@gmail.com
Reception date: 04/07/2016
Acceptance date: 06/07/2016
Publication date: 13/07/2016

Abstract

Authors’ conclusions: there were no safety events of concern with the new adjuvanted vaccines in children under 10 years, although the unexplained increased of certain events, as meningitis or narcolepsy, in some of them makes it necessary to warrantee continued safety monitoring.

Reviewers’ commentary: the new adjuvanted-vaccines seem safe in short and medium term in children under 10 years. The shortcomings of the meta-analysis, the increase of certain serious adverse effects, and the lack of knowledge about long-term effects, make it advisable to maintain a high vigilance level

How to cite this article

Albi Rodríguez MS, Aparicio Rodrigo M. Sin datos a largo plazo, las vacunas con nuevos adyuvantes aumentan discretamente los efectos adversos a corto y medio plazo. Evid Pediatr. 2016;12:42.

AVC | Critically appraised articles

Stassijns J, Bollaerts K, Baay M, Verstraeten T. A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among children. Vaccine. 2016;34:714-22.

Reviewers: Albi Rodríguez MS1, Aparicio Rodrigo M2.
1Servicio de Neumología Pediátrica. Hospital Universitario 12 de Octubre. Madrid. España.
2Centro de Salud Entreví­as. Área 1. Madrid. España.
Correspondence: María Salomé Albi Rodríguez. Email: msalbir@gmail.com
Reception date: 04/07/2016
Acceptance date: 06/07/2016
Publication date: 13/07/2016

How to cite this article

Albi Rodríguez MS, Aparicio Rodrigo M. Sin datos a largo plazo, las vacunas con nuevos adyuvantes aumentan discretamente los efectos adversos a corto y medio plazo. Evid Pediatr. 2016;12:42.

References

  1. O’Hagan DT, Fox CB. New generation adjuvants-from empiricism to rational design. Vaccine. 2015;8:B14-20.
  2. RTS,S Clinical Trials Partnership. Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial. Lancet. 2015;386:31-45.
  3. Vaughn DW, Seifert H, Hepburn A, Dewe W, Li P, Drame M, et al. Safety of AS03-adjuvanted inactivated split virion A(H1N1)pdm09 and H5N1 influenza virus vaccines administered to adults: pooled analysis of 28 clinical trials. Hum Vaccin Immunother. 2014;10:2942-57.
  4. Pellegrini M, Nicolay U, Lindert K, Groth N, Della Cioppa G. MF59-adjuvanted versus non-adjuvanted influenza vaccines: integrated analysis from a large safety database. Vaccine. 2009;27:6959-65.
  5. Aparicio Rodrigo M, Esparza Olcina MJ. Existe evidencia de que Pandemrix® (vacuna contra la gripe A/H1N1 con ASO3) puede precipitar el desarrollo de narcolepsia. Evid Pediatr. 2013;9:67.

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García Sánchez N, Hernández Merino A, en representación del Comité Asesor de Vacunas de la Asociación Española de Pediatría. Seguridad de las vacunas utilizadas en niños. ¿Los nuevos adyuvantes pueden alterar el equilibrio entre eficacia y toxicidad? Evid Pediatr. 2016;12:39.

13/07/2016

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