Sanofi Pasteur knew of Dengvaxia risks as early as 2015, FDAP exec says

The Food and Drug Administration Philippines (FDAP) on Monday said French pharmaceutical company Sanofi Pasteur already knew about the risks of the controversial Dengvaxia vaccine as early as 2015, but belatedly informed the Philippine government only last year.

At the joint inquiry of House committees on good government and public accountability and health, FDAP Director General Nela Charade Puno said they were informed "very late" that Dengvaxia could pose danger to patients who have not acquired the dengue virus.

"We visited some of the documents of Singapore recently and if you will check on their publication, they approved the Dengvaxia certificate of product registration in October 2016. But in their publication, they already announced that it is not to be used for patients who hadn't had dengue," Puno said.

"So ibig sabihin, alam na nila dapat December 22, 2015. Alam na nila at dapat sinabi na nila sa Pilipinas na hindi ito puwede sa mga batang hindi pa nagkakaroon ng dengue," she added.

In December 2015, the Philippines became the first Asian country to approve the sale of Dengvaxia, the world's first dengue vaccine. It entered the Philippine market in January 2016.

Sanofi issued an advisory in November 2017 on the possible risks of giving Dengvaxia to patients who have not had dengue.

The advisory prompted the Department of Health (DOH) to stop the implementation of the dengue vaccination program in December 2017, but it had already been administered to at least 800,000 people, mostly children.

Dr. Anthony Leachon, an independent health advocate, presented a document during the hearing stating that as early as December 2015, Sanofi Pasteur has already identified four risks that come with the vaccine.

These, he said, include anaphylactic reaction (severe allergy), viscerotropism (acute muscular vital organ dysfunction after vaccination), neurotropism, increase in severity of dengue disease, and occurrence of dengue overtime.

"When we heard the [implementation] of the mass vaccination in January 2016, one week before the vaccination we wrote a position paper which was presented in Congress, but we were not allowed to present on the first day," Leachon said.

Leachon accused Sanofi Pasteur of concealing the four identified risks.

"It should be written in informed consent so that the mothers of the victims are aware of the dangers, the last one is severe dengue which has been proven already in the global advisory of November 29 of Sanofi, that is actually the admission of Sanofi that severe dengue can actually, potentially be present," he said.

"You have concealment of data on safety which actually for public interest dated April 2017 acted upon only on December 2017. And to me, this is a grave sin to the Filipino nation considering this was a program of the government," he added.

Special treatment?

Puno also claimed that there may be a special treatment given to Sanofi Pasteur.

Citing the findings of the FDAP Dengvaxia Task Force, Puno said there is an accommodation being given to the French company.

"The non-compliance to requirements like bawal mag-submit sa FDA nang direct yung stakeholder to the evaluator or the director. With Sanofi, it happened," she said.

Puno said she had released a circular prohibiting all clients to enter the FDAP headquarters, and that all stakeholders or clients should strictly go through the FDAP transactions center.

"But with Sanofi, they were able to give the USB (which contains the requirements) to Director [Benjamin] Co directly," she said.

Co is the director of the FDAP's Center for Drug Regulation and Research.

Puno was asked if she was insinuating that Sanofi was given special treatment.

"Yes, looking at all the circumstances, definitely that's the conclusion," she replied.

The Public Attorney's Office has been conducting autopsies on the bodies of children out of suspicion that they died due to Dengvaxia vaccination.  —ALG, GMA News