Philippines orders pull out of controversial dengue vaccine

MANILA, Dec. 5 (Xinhua) -- The Philippines has ordered French pharmaceutical company Sanofi Pasteur to pull out its Dengue vaccine from the market, pending the compliance with the directives of the Federal Drug Administration (FDA), said the government agency.

The FDA immediately directed the giant pharmaceutical company to suspend the sale, marketing, distribution of its Dengue vaccine, and to conduct an information dissemination campaign through advisories, dear doctor letters and patient fora, the FDA said in a statement issued on Monday night.

The regulatory agency also directed the French pharmaceutical company to withdrawal the Dengvaxia vaccine.

The FDA, a regulatory agency under the Department of Health, issued the statement hours after the Department of Justice of the Philippines ordered an investigation into the purchase of the vaccine that cost the government 3.5 billion pesos (69.1 million U.S. dollars).

"The FDA is closely coordinating with the DOH (Department of Health) for any adverse events or reaction that may be reported by the recipients following their immunization of the Dengvaxia, and will immediately take appropriate measures to protect the public," the FDA statement said.

The Department of Health said at least 733,000 children aged nine and above from public schools in Metro Manila, and nearby provinces south and north of Manila have been administered with the vaccine.

However, Sanofi Pasteur on Nov. 29 issued an advisory warning of the risk posed by the vaccine to those without prior infection. In the latest finding, it said Dengvaxia can cause a more severe dengue infection among individuals who had not been previously infected with the dengue virus.

"The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had a prior infection. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of the severe disease could occur following vaccination upon a subsequent dengue infection," Sanofi Pasteur said.

The warning has raised concerns to parents of students who have received the vaccination, prompting the Department of Health to suspend its dengue immunization program for public school students last Friday.

In a news conference on Monday, Sanofi Pasteur global medical head Ng Su Peing insisted that Dengvaxia is safe, saying that the vaccine still provides up to six years of protection against dengue to those with a history of dengue infection.

The Philippine Presidential spokesman Harry Roque assured the public on Monday that there is no reason to panic over the government's dengue vaccination program even as it announced the start of a probe into the governments' procurement of Dengvaxia vaccine.

To allay the fears of the public, Roque said the government will initiate a probe to see if there were irregularities in the government's dengue vaccination program.

[ Editor: meng ]


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