FDA suspends sale, distribution of dengue vaccine Dengvaxia

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Metro Manila (CNN Philippines, December 5) — The Food and Drug Administration (FDA) suspended on Tuesday the sale and distribution of the dengue vaccine Dengvaxia amid safety concerns.

The order came after pharmaceutical company Sanofi Pasteur said on November 30 that the vaccine may cause "severe disease" for people who have not yet had dengue, prompting the Department of Health to suspend the vaccination program.

Read: Drug firm warns of 'severe disease' from dengue vaccine for people with no prior infection

"In order to protect the general public, the Food and Drug Administration (FDA) immediately directed Sanofi to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA," the agency said.

The FDA added it is coordinating with the Department of Health (DOH) for any adverse reactions from those who were immunized with Dengvaxia.

"All drug establishments, including consumers and non-consumer user (e.g. healthcare professionals) are enjoined to take part in the post marketing surveillance of Dengvaxia, by reporting to FDA any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person," it said.

Sanofi officials on Monday said the release of the new study is only a preventive measure.

Sanofi further claimed there are no deaths related to the vaccine, but there is a higher chance of hospitalization for those who will be infected with dengue virus for the first time since getting vaccinated with Dengvaxia.

"All data we've seen has seen the completion of all three doses," Sanofi Pasteur Global Medical Head Dr. Ng Su Peing said.

Vaccinated Filipinos have so far received at least 2 doses of Dengvaxia.

Sanofi officials also said the vaccine offers more benefits than risks.

"In dengue-endemic countries, the potential benefits of vaccination outweigh the potential risks in individuals….The majority of people are going to benefit from the vaccine," Ng Su Peing said.

The Department of Health (DOH) had been using Dengvaxia for its P3.5-billion dengue vaccination campaign from April 2016 until December 1, 2017, when it suspended the program.

DOH said 733,713 children from Central Luzon, the region of Cavite, Laguna, Batangas, Rizal, and Quezon and Metro Manila were administered Dengvaxia. Among them, around 70,000 had not yet contracted dengue when they received the drug, the DOH added.

Read: Gov't halts dengue vaccination program due to health risk

WHO suggests vaccinating patients with prior dengue infection

The World Health Organization (WHO) has suggested administering the Dengvaxia vaccine only to those with prior dengue infection.

The WHO said its suggestion is a "precautionary and interim measure."

"The subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age," the WHO said in a statement on November 30.

The WHO said it will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and Strategic Advisory Group of Experts (SAGE) on immunization for revised guidance of the use of Dengvaxia.

In July 2016, the world health body issued its first position paper on the vaccine. It recommended Dengvaxia be administered among children nine years old and up, in three doses and within a six-month interval.

It advised against using the vaccine among children aged 2-5 as this posed an increased risk of hospitalization.

Read: DOJ orders probe of dengue vaccine program

CNN Philippines' VJ Bacungan contributed to this stoy.