Ethics of a partially effective dengue vaccine: Lessons from the Philippines

Halstead, Scott B.; Katzelnick, Leah C.; Russell, Philip K.; Markoff, Lewis; Aguiar, Maíra; Dans, Leonila R.; Dans, Antonio L.

doi:10.1016/j.vaccine.2020.06.079

Cited by 53 publications

(42 citation statements)

References 28 publications

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“…Even though the above-mentioned manuscript ( 2 ) mentions an unjustified optimistic statement about this issue, this may be among the biggest long-term concerns, especially if patients in the future get infected with mutated strains of the virus. It took another company close to 10 years to research the safety of Dengvaxia, a dengue vaccine, but it took only a very short time after mass vaccination for disaster to strike in the Philippines, with children experiencing increased disease severity after receiving Dengvaxia ( 3 ). Vaccine-associated enhanced disease was first described more than 50 years ago, when a vaccine against respiratory syncytial virus (RSV) was tested.…”

Section: Potential Concernsmentioning

confidence: 99%

Primum Non Nocere

Rostenberghe

2021

MJMS

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The coronavirus disease 2019 (COVID-19) pandemic is severe and has not shown any signs of warning up to today. Biotech companies around the world have raced to come up with an acceptable vaccine and recently two mRNA vaccines have received emergency usage authorisation from regulatory bodies in several countries. mRNA vaccines, which consist of a new and revolutionary technology have not been previously tested widely on humans. Medium- and long-term safety data are not available. While many experts seem to support the start of a mass vaccination campaign, others feel there are too many unknowns to embark on a mass vaccination campaign. Concerns include uncertainties about the long-term effects of foreign mRNA on human cellular physiology and the possibility of vaccine-enhanced disease severity, which may not be unlikely with the current disease presentation of COVID-19.

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Section: Potential Concernsmentioning

confidence: 99%

Primum Non Nocere

Rostenberghe

2021

MJMS

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“…Unsurprisingly then, it has taken several decades to develop a vaccine. The first licensed dengue vaccine led to considerable controversy [ 4 ], and to date, no dengue vaccine is in widespread use.…”

Section: Introduction To Dengue Vaccine Developmentmentioning

confidence: 99%

Dengue vaccine development by the year 2020: challenges and prospects

Wilder‐Smith

2020

Current Opinion in Virology

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Highlights As a tetravalent immune response is desired, each component would need to independently result in four different monotypic immune responses that are solid to each serotype. Plaque reduction neutralization assays do not reliably differentiate between serotype-specific versus heterotypic antibodies; hence identifying immune correlates remains elusive. All three leading dengue vaccine candidates are live-attenuated vaccines, with the main difference between them being the type of backbone and the extent of chimerization. Sequential immunization or heterologous prime-boost strategies should be considered to improve a balanced protection against all four serotypes.

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“…Reviews in 2016–2017 identified individual serostatus prior to vaccination as determinants of Dengvaxia efficacy and adverse events [ 16 , 17 ], anticipating Sanofi Pasteur’s retest of the entire phase 3 serum collection announced in November 2017 [ 18 , 19 ]. Dengvaxia is licensed in more than 20 countries, although mass vaccination programs, initiated in the Philippines [ 20 ] and in the South of Brazil, are now suspended.…”

Section: Introductionmentioning

confidence: 99%

“…Vaccine efficacy data have now been extended to 18 months of surveillance [ 10 ] indicating that similarly to Dengvaxia, individual serostatus prior to vaccination is determinant of vaccine efficacy. Vaccine efficacy estimations for 12 and 18 months show that DENVax efficacy is decreasing over time and therefore, long-term surveillance consisting of prudent and careful observation of vaccine phase 3 recipients is required [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

The Impact of Serotype Cross-Protection on Vaccine Trials: DENVax as a Case Study

Aguiar

Stollenwerk

2020

Vaccines

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There is a growing public health need for effective preventive interventions against dengue, and a safe, effective and affordable dengue vaccine against the four serotypes would be a significant achievement for disease prevention and control. Two tetravalent dengue vaccines, Dengvaxia (CYD-TDV—Sanofi Pasteur) and DENVax (TAK 003—Takeda Pharmaceutical Company), have now completed phase 3 clinical trials. Although Dengvaxia resulted in serious adverse events and had to be restricted to individuals with prior dengue infections, DENVax has shown, at first glance, some encouraging results. Using the available data for the TAK 003 trial, we estimate, via the Bayesian approach, vaccine efficacy (VE) of the post-vaccination surveillance periods of 12 and 18 months. Although better measurement over a long time was expected for the second part of the post-vaccination surveillance, variation in serotype-specific efficacy needs careful consideration. Besides observing that individual serostatus prior to vaccination is determinant of DENVax vaccine efficacy, such as for Dengvaxia, we also noted, after comparing the VE estimations for 12- and 18-month periods, that vaccine efficacy is decreasing over time. The comparison of efficacies over time is informative and very important, and brings up the discussion of the role of temporary cross-immunity in dengue vaccine trials and the impact of serostatus prior to vaccination in the context of dengue fever epidemiology.

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Ethics of a partially effective dengue vaccine: Lessons from the Philippines

Cited by 53 publications

References 28 publications

Primum Non Nocere

Primum Non Nocere

Dengue vaccine development by the year 2020: challenges and prospects

The Impact of Serotype Cross-Protection on Vaccine Trials: DENVax as a Case Study

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