Sanofi stands by claim that WHO backed dengue vaccination program

The manufacturer of Dengvaxia on Friday stood by its earlier statement that the World Health Organization backed the controversial dengue vaccine's use in "highly-endemic" countries.

In a statement, Sanofi-Pasteur said on Friday that the WHO based on findings by the Strategic Advisory Group of Experts in Immunology (SAGE) found the value of the vaccine in dengue prevention.

The firm said clinical data available on the vaccine up to April 2016 provided the basis for the individual assessment conducted by SAGE on their dengue vaccine Dengvaxia or CYD-TDV and their recommendation to the WHO.

"The SAGE recommendation served as the basis of the WHO position paper on the vaccine issued in July 2016 that recommends its use in highly-endemic countries as part of integrated dengue prevention efforts," Sanofi said.

Sanofi issued the statement after WHO denied recommending the introduction of Dengvaxia in national immunization programs.

Only in areas with 70 percent seroprevalence

WHO issued a preliminary position paper on the dengue vaccine after the SAGE on immunization met on April 12 to 14, 2016 in Geneva, a week after the Philippine immunization program kicked off on April 4, 2016.

In the paper, SAGE "recommended countries consider introduction of CYD-­TDV only in geographic settings (national or subnational) with high endemicity" or areas with 70 percent seroprevalence or population previously infected by dengue.

Dengue immunization was primarily recommended in "highly endemic settings" where 90 percent of persons aged 9 and above were already seroprevalent; for areas with below 90 percent seroprevalence to 50 percent seroprevalence, it recommended vaccination at ages 11 to 14.

The WHO amended the percentage to 70 percent in their formal position paper on the dengue vaccine on July, but retained the SAGE recommendation against introducing Dengvaxia "where seroprevalence is below 50 percent."

Countries were also advised to consider "local priorities, national and subnational dengue epidemiology, predicted impact and cost-effectiveness with country-specific hospitalization rates and costs, affordability and budget impact" in introducing the dengue vaccine.

"Dengue vaccine introduction should be a part of a comprehensive dengue control strategy together with a communication strategy, well-executed and sustained vector control, the best evidence-based clinical care for all patients with dengue, and robust dengue surveillance," the WHO wrote.

The Department of Health (DOH) stated in April that it restricted the introduction of Dengvaxia in the National Capital Region (NCR), CALABARZON, and Central Luzon to conform with the WHO's recommendation to restrict dengue immunization to dengue hotspots in the country.

"Mas makakabuting i-introduce nila 'yun sa lugar kung saan dati nang mataas ang dengue. Desisyon ng Kagawaran ng Kalusugan na dun sa tatlong yon ay base yun sa report namin for the past three years," then-DOH spokesperson Dr. Eric Tayag said.

Dengue vaccination was also restricted to public schools to help the DOH monitor the efficacy of the vaccine.

Without approval

It was announced a month prior to the beginning of the dengue immunization program that the government will push through with vaccination in public school students even without recommendation from the WHO.

While Sanofi was given a license to sell Dengvaxia from the Food and Drug Administration in December 2015, former Health Undersecretary Susan Mercado said the DOH's National Formulary Executive Council did not give the government the go-signal to purchase P3.5 billion-worth of the vaccine.

Mercado also said that once the council gave its approval, the program introduced the vaccine on a larger scale than recommended and failed to inform the schoolchildren's parents and health workers proper information on Dengvaxia.

The former health undersecretary also claimed that the P3.5 billion Dengvaxia deal and dengue immunization program did not go through the required government processes. —NB, GMA News