Manila to sue Sanofi over dengue vaccine


Last week, the Department of Health in the Philippines suspended the use of Dengvaxia produced by French drug giant Sanofi.

"This shall guide the Department of Health in responding to the safety concerns relevant to the use of this vaccine and how to proceed with the dengue program to ensure safeguards and prevent similar incidents in the future", Duque said.

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 USA dollars).

A draft report by House of Representatives committee on health, which conducted hearings on the efficacy of the vaccine, reported that "there were 997 adverse events following immunization, 30 of which were considered serious cases that needed hospitalization" between March 18, 2016 and August 20 a year ago.

The DDC is implementing a surveillance programme on possible dengue vaccine side effects and discussing and developing guideline on administering the jab, said the minister.

However, Sanofi Pasteur on November 29 issued an advisory warning of the risk posed by the vaccine to those without prior infection.

"We have to be very careful with vaccine because we are giving it to children who are healthy", she said.

"The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had a prior infection". Health officials earlier said the number of children vaccinated with Dengvaxia could be more, as the Health Department waits for its other regional offices to report.

WHO has also explained, "The WHO position paper did not include a recommendation to countries to introduce the dengue vaccine into their national immunization programs, 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".

"And as always, we stand ready to work with the DOH to provide information to affected families, and to support the DOH's deliberations on the future of the dengue vaccination program", World Health Organization said.

The Philippines has halted the distribution of the vaccine and ordered an investigation into the immunisation of more than 730,000 children who received the jab following an announcement by Sanofi that it could worsen the disease in some cases if given to those not previously infected by the dengue virus, according to news agencies. The government bought P3.5 million in Dengvaxia from Sanofi for a vaccination program that targeted about 1 million public school students.

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