MANILA, Philippines – The World Health Organization (WHO) clarified it never made a recommendation to the Philippines and other countries to use the world’s first dengue vaccine in their national immunization programs.

The WHO issued a statement on Tuesday, December 5, amid the controversy surrounding the now-suspended school-based immunization program for Sanofi Pasteur’s Dengvaxia vaccine. 

The French pharmaceutical giant said last week that its vaccine may lead to “more severe” cases of dengue on individuals who had not been infected by the virus prior to immunization. (READ: TIMELINE: Dengue immunization program for public school students) 

“The WHO position paper did not include a recommendation to countries to introduce the dengue vaccine into their national immunization programs. Rather, WHO outlined a series of considerations national governments should take into account in deciding whether to introduce the vaccine, based on a review of available data at the time, along with possible risks,” said the WHO.

On April 4, 2016, Janette Garin, then chief of the Department of Health (DOH), launched the school-based dengue vaccination program in the National Capital Region, Central Luzon, and Calabarzon. Since then, more than 700,000 Filipino gradeschoolers have received the risky dengue vaccine. 

WHO’s Strategic Group of Experts (SAGE) on Immunization published its preliminary advice on Dengvaxia only 14 days after that. 

WHO said the vaccine should be used in areas where a high proportion, or at least 70%, of the population had been exposed to the virus. WHO also said Dengvaxia must only be given to people aged 9 and above, and those to be vaccinated must receive 3 doses. A full copy of its position paper on Dengvaxia was published by the WHO in July 2016.

WHO said it “acknowledged” that the Philippines had met all 3 conditions for the vaccination.

“WHO acknowledged mid-April 2016 that these conditions appeared to be met in the 3 regions of the Philippines in which the dengue vaccination effort was already ongoing at that time – noting that the decision to roll out the vaccine had been taken by the DOH before WHO’s advice became available,” said the WHO. 

Current DOH Secretary Francisco Duque III has suspended the program, pending consultations with various stakeholders, like the WHO’s SAGE, on how to proceed. They are set to meet next week.

WHO said it is supporting the vaccination program’s suspension.

“As always, we stand ready to work with the DOH to provide information to affected families, and to support the DOH’s deliberations on the future of the dengue vaccination program,” said the WHO. 

“WHO continues to advise anyone [vaccinated or not] with signs of dengue disease – high fever, severe headache, pain behind the eyes, muscle and joint pains, nausea, vomiting, swollen glands and/or rash – to seek medical care,” it added.

The Food and Drug Administration has recalled Dengvaxia off the shelves until Sanofi updates its packaging label to reflect the new warning. – Rappler.com