Sanofi: Dengvaxia suspension not linked to safety issues

MANILA, Philippines — The manufacturer of Dengvaxia clarified that the suspension of the sale of its controversial vaccine was due to an alleged failure to comply with post-marketing requirements.

In a statement, Sanofi Pasteur made it clear that the one-year suspension of Dengvaxia’s certificate of product registration imposed by the Food and Drug Administration is not connected to the safety and efficacy of the vaccine, which has triggered a panic last year.

Sanofi has also been fined P100,000 for violating the FDA law.

But the pharmaceutical giant stressed that it has complied with Philippine laws and regulations and would continue to do so.

“As part of our standard company practices, Sanofi routinely conducts post-approval commitments to continuously evaluate the safety and effectiveness of our vaccines in the countries where they are in use, and we have done so in the Philippines with Dengvaxia,” it said.

Sanofi added that it will continue to cooperate in full transparency with the FDA. 

Sanofi also said that periodic reports are submitted to the national regulatory authorities in the countries where the product has been approved.

“No other requests of market withdrawal or license suspension have been received from other NRAs where the vaccine is approved,” it said.

Earlier, the FDA ordered a stop to the sale and distribution of Dengvaxia and the withdrawal of stocks following the company’s disclosure that the anti-dengue vaccine poses threat to individuals vaccinated without prior infection.

According to the Department of Health, more than 860,000 people have been vaccinated with Dengvaxia since it was launched during the term of former DOH secretary Janette Garin.

READ: Garin: Decision on Dengvaxia based on 'data available at the time'