Sanofi denies concealing info on Dengvaxia risks

French pharmaceutical company Sanofi Pasteur on Wednesday denied accusations it concealed from the government and the public the risks of using dengue vaccine Dengvaxia.

In a statement, the company lamented the "inaccurate information" that had come out on the transparency of data and findings related to Dengvaxia. 

"All our vaccines undergo extensive clinical investigations and their efficacy, safety and public health impact is continuously followed up post license," the firm said.

Sanofi said in the Dengvaxia's case, from the time of its sale until November 2017, they had no information or data on the "serostatus of the vaccinees showing a different product profile in the population of 9-years-old and above."

The company said it only learned about the different product profile of the dengue vaccine for those with or without a previous dengue infection in November 2017.

Since that time, Sanofi Pasteur claimed it had shared the new data in full transparency with national health authorities countries where the vaccine is approved or where it is being considered for regulatory approval.

Sanofi's statement came a day after Surigao del Sur Rep. Johnny Pimentel, chair of the House Committee on Good Government and Public Accountability, said the firm was the "Number 1" entity that will be held accountable for the Dengvaxia mess.

The lawmaker slammed the French company for committing dishonesty and misrepresentation when they failed to inform the previous administration about the risks of the vaccine.

"If they had informed the Philippine government beforehand, probably the former officials or former administration would not push through with the purchase of Dengvaxia," he said.

"So I believe Sanofi should be held accountable for this. And and of course, the past administration officials, they will also be held accountable," Pimentel added.

The Food and Drug Administration Philippines (FDAP) and Health reform advocate Dr. Anthony Leachon both said in a House hearing that Sanofi already knew about the risks of the controversial vaccine as early as 2015, but belatedly informed the Philippine government only last year.

“What is very repulsive is that they actually concealed the four identified risks. It should be written in the informed consent, so the mothers, the victims, are aware of the dangers,” Leachon was quoted in reports as saying.

Former President Benigno Aquino III, in the same hearing, had said he had no way of knowing in 2015 the risks posed by the vaccine on seronegative recipients or those who had no previous exposure to the dengue virus. — MDM, GMA News