WHO expected to issue guidelines on dengue vaccine use in April

MONTHS after the launch of the world's first dengue vaccine, the World Health Organization (WHO) is expected to issue its guidelines on the public health use of dengue vaccines next month.

According to WHO, the WHO Strategic Advisory Group of Experts (Sage) on Immunization is already reviewing the evidence on the recommended use of dengue vaccine.

"Sage will advise WHO likely in April 2016 on recommended use of a dengue vaccine," noted the WHO in its FAQ on dengue vaccines.

The SAGE study will tackle issues on vaccine safety, vaccine efficacy, disease burden, programmatic suitability, including dose scheduling and cost-effectiveness.

But according to the WHO, it has yet to issue an approval over the public health use of Dengvaxia® (CYD-TDV).

"CYD-TDV is currently not prequalified. Prequalification requires a National Regulatory Authority (NRA) of record, which is typically the NRA in the manufacturing country, which, in this case, the EMA (European Medicines Agency)," said the WHO.

The world health body said it is still waiting for the submission of an application from the manufacturer for prequalification of Dengvaxia®.

"Formal WHO guidance on public health use will only be issued following licensure of the vaccine by a functional NRA meeting certain criteria as assessed by WHO," it said.

Back in December 2015, Dengvaxia® was issued a license in Mexico, thereby becoming the first dengue vaccine to be licensed.

It is a live recombinant tetravalent dengue vaccine that was developed by Sanofi Pasteur and must be given in three doses.

Subsequently, the Philippines also granted marketing approval for Dengvaxia®.

On the other hand, the WHO related that there are approximately five additional dengue vaccine candidates that are already in clinical development.

Of the five, Instituto Butantan (Brazil) and Takeda Pharmaceutical Company (Japan) are already expected to begin the Phase III trials in early 2016.

"A safe, effective, and affordable dengue vaccine against the four strains would represent a major advance for the control of the disease and could be an important tool for reaching the WHO goal of reducing dengue morbidity and mortality by 2020," said the WHO.

To note, the Department of Health (DOH) is already set to begin the mass vaccination program on Monday for close to one million Grade 4 public school students, aged nine to 10, in the National Capital Region, Central Luzon, and Calabarzon. (HDT/Sunnex)
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