Philippines halts sale of dengue vaccine as Sanofi downplays risk

WHO denies recommending Dengvaxia for nat'l immunization programs

Singapore issues advisory on Dengvaxia dengue vaccine

The Philippine Department of Health put on hold its 3.5 billion peso ($69.5 million) public dengue immunisation drive launched a year ago - the world's first such public programme - after the study was released last week.

The World Health Organization (WHO) had apparently already flagged the risks of the vaccine in 2016 in a report, in which it recommended that the vaccine only be used in people who have had a prior dengue infection.

Sanofi is also working with the Philippine Food and Drugs Administration to update product labels to reflect the new information, she added.

"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", the WHO Country Office said in a statement.

On Nov. 29, the company disclosed that it would ask global health regulators to restrict use of its much-touted dengue vaccine to only people who have previously been infected by the virus.

"Like many others in the Philippines, WHO is awaiting the expert analysis of new data and advice about its implications for use of the vaccine". No cases in the most severe level were recorded, and all those stricken with dengue in the study have fully recovered, she said.

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Dengvaxia is the first approved dengue vaccine, and generates approximately $1 billion in sales every year for Sanofi.

De Guzman said the PHO is "strengthening the campaign for the 4S program of the government" and urges the public to do so.

One 12-year old girl in Tarlac province, north of the capital Manila, who completed the three-dose vaccine treatment, showed symptoms of severe dengue, Health Undersecretary Gerardo Bayugo told Reuters by phone.

The recent findings outline that sales forecasts may not be reached over the safety issues and clinical proofs that show unequal protection against various strains of dengue.

De Guzman also confirmed "there were no recipients of the Dengvaxia vaccine in Pangasinan" because of lower dengue cases a year ago compared with other places in the country.

It was a damaging admission from the company, which had secured approval of the shot in 19 countries - several of which had run public immunization drives.

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