DOH likely to extend ban on Dengvaxia vaccine

December 11, 2018

Despite a one-year suspension of a marketing license by the Food and Drug Administration (FDA)  nearing its end, the Department of Health (DOH) does not see a return of the Dengvaxia anytime.

“The one-year suspension of the Dengvaxia CPR ( Certificate of Product Registration) is not yet lifted and I don’t see it being lifted anytime soon,” said Health Undersecretary Eric Domingo.

At this time, we do not see it being registered and allowed for marketing again in the Philippines,” he added.

Domingo cited several pending regulatory and legal issues that its manufacturer, Sanofi Pasteur is facing.

“We still have a lot of pending issues, both  regulatory issues and cases in court, with the vaccine,” he noted.

In December 29 2018, the FDA issued a one-year suspension of the Dengvaxia marketing authorization.

According to the FDA, the suspension is linked to the company’s supposed failure to comply with post-marketing requirements.

The suspension came after the Dengvaxia controversy was revealed by Sanofi itself.

Domingo said even if the suspension on use of Dengvaxia is lifted, “I doubt if Filipinos will still have themselves immunized.” DMS.