Safety of the TAK-003 dengue vaccine

Extract from report of GACVS meeting of 15-16 May 2023, published in the WHO Weekly Epidemiological Record on 11 August 2023

SAGE requested GACVS to review the clinical trial safety data for the TAK-003 live attenuated dengue vaccine, manufactured by Takeda Pharmaceuticals. SAGE provided the context of known complexities in dengue vaccine safety, as observed with the CYD-TDV vaccine (Dengvaxia). The TAK-003 vaccine, like CYD-TDV, is based on chimeric constructs though with different backgrounds, YF 17D virus in the case of CYD-TDV versus an attenuated dengue 2 virus in the case of TAK-003. While it was considered biologically plausible that similar safety concerns could be observed, it was also noted that dengue 2 backbone of TAK-003 induces a broader range of dengue specific responses than seen with CYD-TDV. 

Representatives from Takeda Pharmaceuticals were invited to present data from pre-licensure trials, followed by confidential presentations from 2 independent experts on B-cell and T-cell immune responses to the dengue virus and vaccines. 

The Committee conveyed to SAGE its views on the TAK-003 vaccine and the current information gaps relating to vaccine safety. The Committee expressed interest in continuing to review any additional emerging data. The SAGE recommendations and deliberations concerning the TAK-003 vaccine will be published when available.

Safety in Philippines

20 July 2018 – Safety of dengue vaccine in the Philippines (from meeting of 6-7 June 2018)

Safety update

19 January 2018 - Dengue vaccine safety update (from meeting of 6-7 December 2017)15 July 2016 - Dengue vaccine update (from meeting of 15-16 June 2016)

CYD-TDV

21 August 2015 - Safety of CYD-TDV dengue vaccine (from meeting of 10-11 June 2015)

Introduction of the vaccine

23 January 2015 - Preparing for dengue vaccine introduction (from meeting of 3-4 December 2014)

Live attenuated vaccine

8 February 2013 - Live attenuated dengue vaccines (from meeting of 5-6 December 2012)