Sanofi seeks dialogue with FDA amid Dengvaxia controversy
French pharmaceutical firm Sanofi Pasteur on Tuesday said it is seeking dialogue with the Philippine Food and Drug Administration (FDA) following the suspension of sale, distribution and marketing of controversial dengue vaccine Dengvaxia.
In a statement, the firm also vowed to work with the FDA in reviewing the implementation of the order.
"We were informed of the position of the Philippine Food and Drug Administration which was published on December 4, 2017 and will work with them to review the implementation of their direction," Sanofi said.
"We will continue to seek constructive and transparent dialogue with them."
Aside from the withdrawal from the market, the FDA also ordered Sanofi to conduct an information dissemination campaign with advisories, letters, and forums with patients.
In FDA Advisory 2017-318 dated Dec. 4, 2017, Nela Charade Puno, FDA director general, said the order was done to protect the general public after Sanofi admitted that Dengvaxia poses potential risk to those who have never had dengue but were vaccinated.
Sanofi, meanwhile, reiterated its proposal to regulatory authorities to upate the product label of the dengue vaccine in order to reflect the new information as the vaccine's performance "differs according to prior dengue infection status."
"The proposed label update suggested to include the new data findings and instructions to ensure that physicians can make appropriate vaccination decisions with their parents," Sanofi said.
Last week, Sanofi advised against prescribing Dengvaxia to patients who are yet to have dengue as it could cause severe diseases in the long run.
After six years of studying clinical data, Sanofi on Wednesday said it has found that Dengvaxia was only beneficial in the prevention of dengue fever to those who have already suffered from the other serotypes of the virus.
The firm also clarified once again that Dengvaxia "does not contain any viruses that can make people ill with dengue or severe dengue."
"If you have had no previous dengue infection before vaccination, the vaccine does not give you dengue," it said.
"It is estimated that only 1 in 800 of all dengue infections (including symptomless infections) could lead to a severe infection, and the increased risk identified from the new analysis translated to 2 additional cases of 'severe dengue' out of 1000 previously dengue-uninfected people vaccinated over 5 years of follow-up. In this group, all fully recovered with proper medical treatment," Sanofi added.
Justice Secretary Vitaliano Aguirre II has ordered the National Bureau of Investigation (NBI) to investigate the P3.5-billion dengue vaccination program of the Department of Health that put the lives of more than 733,000 public school children at risk.
The NBI will determine whether Sanofi has communicated with the DOH the proper warning that the vaccine should not be given to somebody who has not contracted dengue before.
The DOH has already put on hold the government's vaccination program after Sanofi raised health concerns on the vaccine.
In December 2015, the Philippines was the first Asian country to clear the dengue vaccine and approve its distribution within a month of clearing its use. —KBK, GMA News