Sanofi knew about Dengvaxia risks in 2015, FDA says

The Food and Drug Administration (FDA) recently revealed that Sanofi Pasteur was well-aware of the risks of its Dengvaxia vaccine months before the launch of the mass immunization program but refused to inform the Philippine government.

FDA director-general Nela Charade Puno presented documents from Singapore to support the agency’s claims against the pharmaceutical company during the House panels’ probe on the now-suspended dengue immunization program.

“We visited some of the documents of Singapore recently. If you will check on their publication, they approved the Dengvaxia CPR (Certificate of Product Registration) October 2016,” said Puno. “With their publication, they announced that it is not to be used for patients who hadn’t had dengue,” she added.

The said documents urged the FDA to believe that Sanofi already knew about the vaccine’s risk for people without prior dengue infection even dating back to December 22, 2015 and should have told the Philippine government about it.

December 22, 2015 was the day when the FDA allowed Sanofi to make Dengvaxia commercially-available.

It was only on November 29, 2017 that Sanofi announced a caveat on the vaccine stating that it should not be used for people who were not previously infected by dengue as they could contract “severe disease.”

Former Health Secretary Janette Garin launched the immunization program in February 2016 and in December 2017, FDA suspended Dengvaxia’s sale for a year.

Aside from Puno’s finding, health advocate Dr. Anthony Leachon pointed to a document Sanofi submitted to FDA in 2015, which reveals the company already identified four risks of Dengvaxia.

“Four important identified risks have been established for CYD dengue vaccine: allergy/anaphylactic reaction, viscerotropism and neurotropism, increase in severity of dengue disease from the start of vaccination, and warning protection against dengue disease over time,” said Sanofi in the document.

These risks, however, were not indicated on the vaccine’s package insert nor the consent form signed by the parents before their children were given a shot of the dengue vaccine.

In his defense, Sanofi Asia Pacific head Thomas Triomphe asserted it is “factually wrong” to claim they concealed information about Dengvaxia.

He explained that the risks Sanofi was referring to in the document were theoretical risks to look for.

“What was communicated before – and I think that’s important because there is a misunderstanding about this – the information identified before referring to 2015 and 2016 are talking about potential risks to look for or are talking about theoretical risks to look for,” said Triomphe.

He added that Sanofi immediately took action and warned the public about Dengvaxia’s adverse effect on a person without prior dengue infection as soon as the information was available to them. Lyka Mae P. Chiang

Rate this post