FDA stops sale of Dengvaxia, orders withdrawal from market

MANILA, Philippines — The Food and Drug Administration has ordered a stop to the sale and distribution of dengue vaccine Dengvaxia and the withdrawal of stocks over potential risks to patients.

 

In an advisory released on Monday, FDA said it has ordered pharmaceutical firm Sanofi Pasteur to suspend the sale, distribution and marketing of the vaccine and to withdraw it from the local market "pending compliance with the directives of the FDA."

 

The Department of Health unit also said that "Sanofi was further directed to conduct an information dissemination campaign through Advisories, Dear Doctor Letters and Patient fora."

 

The FDA order comes after a November 29 disclosure by Sanofi that post-clinical trial study of Dengue Tetravalent Vaccine (Live, Attenuated) indicated an increased risk of hospitalization for dengue and "severe" dengue, "predominantly Grade I or II Dengue Hemorrhagic Fever", for patients not previously infected by the virus, which is spread through mosquito bites.

 

The World Health Organization classifies the severity of dengue fever into four grades.

 

Grade I is characterized by "fever accompanied by non-specific symptoms" although patients will show hemorrhaging through a tourniquet test or through being easily bruised.

 

Grade II is characterized by spontaneous bleeding aside from the fever and easy bruising. 

In a press conference Monday, Sanofi clarified that the vaccine itself will not cause a patient to contract dengue but that they can get sick from subsequent exposure to the dengue virus.

 

The FDA said in its advisory that it is in close coordination with the DOH to monitor for adverse events and reactions in relation to immunization with Dengvaxia "and will immediately take appropriate measures to protect the public."

 

The Department of Justice on Monday announced it has ordered a probe into possible criminal liability over the scandal while non-government group Volunteers Against Crime and Corruptions has claimed that at least three have died because of the vaccine. Their claims have yet to be verified.

 

Department of Health spokesperson Lyndon Lee Suy clarified Monday that only 10 percent of the more than 700,000 children vaccinated by Dengvaxia run the risk of developing "severe" dengue.

 

Presidential spokesperson Harry Roque also said there is no reason to panic.

 

"It is understandable to be a little worried because we thought that vaccination would mean complete immunity from dengue," Roque said in a press briefing Monday.

 

Roque explained that the "severe" dengue classification that Sanofi mentioned involves symptoms such as fever and hemophilia, which are not deadly.

 

"But there will be nine out of ten who will be protected from acquiring what could be not just serious but possibly a deadly stage of dengue," Roque said in Filipino and English. — Jonathan de Santos