tetano
Editor, Senior Moderator
Vaccine. 2019 Mar 29. pii: S0264-410X(19)30390-1. doi: 10.1016/j.vaccine.2019.03.056. [Epub ahead of print]
[h=1]Modification of the vaccine manufacturing process improves the pyrogenicity profile of inactivated influenza vaccines in young children.[/h] Sawlwin DC[SUP]1[/SUP], Graves Jones A[SUP]2[/SUP], Albano FR[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] There were increased reports of fevers and febrile reactions in young children (particularly children aged <5 years) receiving the Seqirus/CSL Southern Hemisphere 2010 trivalent inactivated influenza vaccine (IIV3). Modifying the vaccine manufacturing process by increasing the minimum concentration of splitting agent (sodium taurodeoxycholate [TDOC]) from 0.5% w/v to 1.5% w/v for all strains resolved this issue. The current analysis compared fever rates in three pediatric studies of Seqirus IIV3 (S-IIV3) or quadrivalent inactivated influenza vaccine (S-IIV4), prepared using the modified manufacturing process, with fever rates in three pediatric studies of historical (pre-2010) IIV3 formulations. The historical IIV3 formulations, S-IIV3, and S-IIV4 had 0/3, 2/3, and 4/4 vaccine strains split at 1.5% TDOC, respectively.
[h=4]METHODS:[/h] For each study, fever rates (any grade and severe) were determined for the following age subgroups (as applicable), using the fever intensity grading system used in the S-IIV3/S-IIV4 studies: 6 months to <3 years; 3 to <5 years; 5 to <9 years; and 9 to <18 years.
[h=4]RESULTS:[/h] For each age subgroup, the any grade and severe fever rates were lower in the S-IIV3/S-IIV4 studies than in the historical IIV3 formulation studies, with the greatest differences in fever rates observed in the youngest age groups. In the 6 months to <3 years group, the any grade fever rate was 7.0% (severe fever: 2.5%) in one S-IIV4 study compared with 38.7% to 40.0% (severe fever: 9.6% to 17.8%) in the historical IIV3 formulation studies. In the 3 to <5 years subgroup, the any grade fever rate was 4.9% (severe fever: 1.2%) in one S-IIV4 study compared with 34.1% to 36.0% (severe fever: 6.3% to 16.5%) in the historical IIV3 formulation studies.
[h=4]CONCLUSION:[/h] This analysis provides clinical evidence that the modified manufacturing process improved the fever profile across all pediatric age groups, in particular, in children aged <5 years.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Febrile seizure; Fever; Inactivated influenza vaccines; Paediatrics; Quadrivalent influenza vaccine; Safety
PMID: 30935743 DOI: 10.1016/j.vaccine.2019.03.056
[h=1]Modification of the vaccine manufacturing process improves the pyrogenicity profile of inactivated influenza vaccines in young children.[/h] Sawlwin DC[SUP]1[/SUP], Graves Jones A[SUP]2[/SUP], Albano FR[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] There were increased reports of fevers and febrile reactions in young children (particularly children aged <5 years) receiving the Seqirus/CSL Southern Hemisphere 2010 trivalent inactivated influenza vaccine (IIV3). Modifying the vaccine manufacturing process by increasing the minimum concentration of splitting agent (sodium taurodeoxycholate [TDOC]) from 0.5% w/v to 1.5% w/v for all strains resolved this issue. The current analysis compared fever rates in three pediatric studies of Seqirus IIV3 (S-IIV3) or quadrivalent inactivated influenza vaccine (S-IIV4), prepared using the modified manufacturing process, with fever rates in three pediatric studies of historical (pre-2010) IIV3 formulations. The historical IIV3 formulations, S-IIV3, and S-IIV4 had 0/3, 2/3, and 4/4 vaccine strains split at 1.5% TDOC, respectively.
[h=4]METHODS:[/h] For each study, fever rates (any grade and severe) were determined for the following age subgroups (as applicable), using the fever intensity grading system used in the S-IIV3/S-IIV4 studies: 6 months to <3 years; 3 to <5 years; 5 to <9 years; and 9 to <18 years.
[h=4]RESULTS:[/h] For each age subgroup, the any grade and severe fever rates were lower in the S-IIV3/S-IIV4 studies than in the historical IIV3 formulation studies, with the greatest differences in fever rates observed in the youngest age groups. In the 6 months to <3 years group, the any grade fever rate was 7.0% (severe fever: 2.5%) in one S-IIV4 study compared with 38.7% to 40.0% (severe fever: 9.6% to 17.8%) in the historical IIV3 formulation studies. In the 3 to <5 years subgroup, the any grade fever rate was 4.9% (severe fever: 1.2%) in one S-IIV4 study compared with 34.1% to 36.0% (severe fever: 6.3% to 16.5%) in the historical IIV3 formulation studies.
[h=4]CONCLUSION:[/h] This analysis provides clinical evidence that the modified manufacturing process improved the fever profile across all pediatric age groups, in particular, in children aged <5 years.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Febrile seizure; Fever; Inactivated influenza vaccines; Paediatrics; Quadrivalent influenza vaccine; Safety
PMID: 30935743 DOI: 10.1016/j.vaccine.2019.03.056