Philippines ‘defied experts’ advice in pursuing dengue immunisation programme’
MANILA: As she announced in January 2016 that the Philippines would immunise one million children with a new dengue vaccine, the nation’s then health secretary Janette Garin boasted it was a world-first and a tribute to her country’s ‘expertise’ in research.
At the time, it seemed the Philippines could be on the cusp of a breakthrough to combat a potentially lethal tropical virus that had been endemic in large parts of the Southeast Asian nation for decades.
Almost two years later, the programme lies in tatters and has been suspended after Sanofi Pasteur, a division of French drug firm Sanofi, said at the end of last month the vaccine itself may in some cases increase the risk of severe dengue in recipients not previously infected by the virus.
Documents reviewed by Reuters that have not been disclosed until now, as well as interviews with local experts, show that key recommendations made by a Philippines Department of Health (DOH) advisory body of doctors and pharmacologists were not heeded before the programme was rolled out to 830,000 children.
After Garin’s announcement, the Formulary Executive Council (FEC) of advisers urged caution over the vaccine because it said its safety and cost-effectiveness had not been established.
After twice meeting in January, the panel approved the state’s purchase of the vaccine on Feb 1, 2016 but recommended stringent conditions, minutes of all three meetings show.
“Based on the available scientific evidence presented to the Council, there is still a need to establish long-term safety, effectiveness and cost-effectiveness,” the FEC told Garin in a letter on that day.
The letter was reviewed by Reuters.
The FEC said Dengvaxia should be introduced through small-scale pilot tests and phased implementation rather than across three regions in the country at the same time, and only after a detailed ‘baseline’ study of the prevalence and strains of dengue in the targeted area, the FEC letter and minutes of the meetings said.
The experts also recommended that Dengvaxia be bought in small batches so the price could be negotiated down. An economic evaluation report commissioned by Garin’s own department had found the proposed cost of 1,000 pesos (US$21.29) per dose was ‘not cost-effective’ from a public payer perspective, the minutes from the meetings reveal.
For reasons unknown, these recommendations were ignored.
Over 1,000 people died of the disease in the country last year.
Two months after the FEC wrote to the health secretary, the DOH began immunising one million students around the age of 10 in all three target areas in April 2016, in accordance with its original plan but at odds with the FEC’s recommendations to conduct a slow roll-out of the vaccine.
“The usual process for the DOH that has protected our children for so many decades was not followed. That’s a fact,” said Susan Mercado, a former Philippines health department undersecretary and former senior official at the World Health Organisation (WHO).
WHO said in April 2016 that the Philippines’ campaign appeared to meet its criteria for using Dengvaxia because the targeted regions had high levels of dengue exposure; the vaccine would be provided to children 9 years and older; and they would each receive three doses.
WHO was not involved in the deliberations of the FEC, according to the minutes. It said in a statement last week that a position paper on the dengue vaccine it published in July 2016 did not include a recommendation for countries to introduce it.
Now, after Sanofi’s warnings, WHO has said it agrees with the government’s decision to suspend the immunisation programme. Until now, one child out of the 830,000 vaccinated, a girl who was hospitalised with severe dengue, has been linked definitively by the DOH to the campaign.
But the department of health says it still does not have complete data on those who fell ill after taking Dengvaxia. — Reuters