Philippines halts sale of Sanofi dengue vaccine

Philippines halts sale of Sanofi dengue vaccine

The safety fears involve possible increased risk to people who had not previously been exposed to the dengue virus prior to vaccination with Dengvaxia.

Ching Santos, general manager of Sanofi Pasteur in the Philippines, said the company has begun sharing the new data with all stakeholders, including private health care professionals, and will cooperate with Philippine health authorities in an ongoing review of the public vaccination programme.

When asked about the status of vaccine in India, the company said it had submitted the vaccine regulatory file to the Indian authorities in October 2015.Awaiting approval for its dengue vaccine in India, French drug major Sanofi today said it has shared data with authorities here about the risk of administering its vaccine to patients who have not been infected with the virus previously.

The Philippine Food and Drug Administration also directed Sanofi to conduct an information dissemination campaign and said all drug establishments should report any incidents if the vaccine was suspected to have caused any deaths or serious illnesses.

Sanofi officials said on Monday in Manila that there had been no reported deaths related to the vaccine which was used to immunize almost 734,000 children aged 9 and over in the Philippines. 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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However, Department of Health Undersecretary Gerardo Bayugo told Reuters the three referred to by the NGO died due to causes not related to the vaccine and Sanofi said no deaths had been reported as a result of the program.

Dengvaxia, the first approved Dengue vaccine, had been forecast by Sanofi to eventually bring in almost $1 billion in annual sales.

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.

Health Secretary Francisco Duque III said the Philippines will wait for a recommendation to be released on December 12 or 13 by the Strategic Advisory Group of Experts on immunisation, an advisory body of the World Health Organization (WHO).

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