Sanofi Taking $118.5M Charge, Seeks Restrictive Label for Dengue Vaccine

Frederick Owens
December 2, 2017

THE Department of Health (DoH) said on Friday that it would suspend its dengue immunization program after its supplier revealed that its vaccine may cause a more severe case of dengue fever.

This follows new analysis from six years of clinical data showing that Dengvaxia vaccine provides persistent protective benefit against dengue fever in those who had prior infection.

Health Secretary Francisco Duque III said further recommendation will be released on December 12 or 13 by the Strategic Advisory Group of Experts on immunization, an advisory body of the World Health Organization. Sanofi's revised label will no longer recommend vaccination in patients who were previously uninfected by dengue virus-but will instead limit its recommendation of the vaccine to patients in countries with high burden of dengue disease where potential benefits outweigh the potential risks.

Philippine health officials began vaccinating over a million children in April a year ago (2016) with Dengvaxia, the world's first dengue vaccine, amid safety concerns expressed by public health advocates.

Health spokesperson Lyndon Lee Suy said "It's totally different from the current guidelines of the WHO".

He said there were no reported case of severe infection from those who received the vaccination.

More than 730,000 Filipino children have received at least one dose of Dengvaxia, the first licensed vaccine for the virus, since the Department of Health launched the 3.5 billion peso (£51.5bn) immunisation drive in schools previous year.

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"The latest medical report issued by Sanofi is deeply shocking and disturbing especially to any parent whose children have received the vaccine", she said. "The value of that has to be preserved, and our vaccination programme has to be enhanced and strengthened, and we are committed to do exactly that", he said.

Meanwhile, Senator Joel Villanueva called for accountability in the vaccine mess that could have a long-term effect to more than 733,000 children who had undergone the government's vaccination program.

Dengvaxia was developed by Sanofi after 25 clinical studies in 15 countries over 20 years.

"They immunized nearly the same number as the ones vaccinated here".

The company said it expected the new findings to cost it £88m.

The Food and Drug Administration will also halt the commercial sale of Dengvaxia in the country until Sanofi replaces its packaging with one that states a new warning.

Other reports by Free-Prsite

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