FDA: Sanofi knew of Dengvaxia risks in 2015

RG Cruz, ABS-CBN News

Posted at Feb 26 2018 06:20 PM | Updated as of Dec 12 2019 05:03 PM

A worker shows used anti-dengue vaccine Dengvaxia inside a vaccine storage room in Sta. Cruz, Metro Manila. Reuters

Vaccine maker Sanofi knew as early as December 2015 that Dengvaxia should not have been given to patients who have not had dengue fever, the head of the Philippine Food and Drug Administration said Monday. 

Testifying at a joint committee investigation of the House, FDA Director Nela Charade Puno revealed that during their investigation, it was revealed that Sanofi already knew about the vaccine's risks when it applied for a Certificate of Product Registration (CPR) in Singapore.

"We visited some of the documents of Singapore. If you will check under publication, they approved Dengvaxia CPR September 2016. But with their publication they already announced that it is not to be used for patients who had not had dengue," Puno told lawmakers.

"Ibig sabihin, alam na nila December 22, 2015, alam na nila at dapat sinabi na nila sa Pilipinas na 'di ito pwede sa mga batang 'di pa nagkakaroon ng dengue," she added.

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The FDA head noted there were accommodations made to Sanofi in their compliance with the requirement to submit a Risk Management Plan (RMP). 

"The failure of Sanofi to their commitment of not changing the RMP, the Risk Management Plan, it is part of their post-marketing commitment. It is a mortal sin when you keep changing your risk management plan. Most of the time, in other countries, they cancel the distribution or selling of this medicine. We had to investigate, we found out several issues wherein there's doubt in terms of submissions or entertaining or accommodating Sanofi. Yes, it's true, risk management plan, they kept on changing," she said. 

"Hindi nila sinubmit. Tapos binago nila ang schedule kung kailan isa-submit." 

"They have indicated there the accommodation being given to Sanofi, the non- compliance to standard requirements like bawal magsubmit to FDA direct yung stakeholder to the evaluator or to the director. With Sanofi, it happened. All stakeholders or clients should go through FDA action center. With Sanofi they were able to give USB to [former Center for Drug Regulation and Research director] Benjamin Co] directly," she said.

Good Government Committee Chair Johnny Pimentel remarked: "In short, you're insinuating that Sanofi was given special treatment."

Puno also noted that "there was leniency" on the part of Director Co to stop the vaccination program in early 2017 after Sanofi failed to submit its risk management plan. 

She noted that in April 2017, Director Co issued a memo that reported a violation "of the subject marketing authorization regarding the post approval commitment for dengue tetravalent vaccine for the following reasons: failure to timely submit post approval commitment documents and provide complete accurate data."

"The issuance of incomplete as well as inaccurate data. The recommendation here was April 2017 and based on the studies here based on Dr. Dan's testimony in Senate that only the phase 3 was over in September, October, that triggered November 27 product label change that it could potentially cause dengue in seronegative patients," Puno added.

Health advocate Tony Leachon said the memo did not come out until 8 months later. 

"This document, somebody sat on this, this particular risk management plan on the safety data. If this had been acted upon, the expansion to the Region 7 and all the deaths related to this could have been averted," he said. 

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"They fined Sanofi P100,000 plus suspension of one year because of non-compliance to safety data that they promised in the CPR December 22. What's repulsive is they concealed the 4 identified risks. It should be written in the informed consent so that the mothers the victims are aware of the dangers."

"You have here a problem of concealment of data, particularly safety. There was hasty mass vaccination… you have here a classic regulatory capture in which the companies would influence the FDA and the Formulary Executive Council. You have here concealment of data on safety."

The FDA earlier ordered the suspension of the sale of Dengvaxia after Sanofi admitted that the vaccine could cause more severe symptoms of dengue if administered on those who have not had the mosquito-borne illness before.

Sanofi's admission prompted the government to suspend its nationwide dengue immunization program, under which some 830,000 children have been injected with the drug.