The manufacturer of the anti-dengue vaccine, Dengvaxia, on Thursday clarified that the suspension of the sale, distribution, and marketing was due to an alleged failure to comply with post-marketing requirements.
"On December 29th, the Philippines Food and Drug Administration (FDA) notified Sanofi Pasteur of a one-year suspension of Dengvaxia Marketing Authorization. According to the notification, this suspension is linked to an alleged failure to comply with post-marketing requirements and is not linked to the product profile," Sanofi Pasteur said in a statement.
The pharmaceutical giant also said it conducts a routine evaluation of the safety and effectiveness of all its vaccines, including Dengvaxia.
"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," the company said.
The company also said that periodic reports are submitted to national regulatory authorities (NRAs) and that these NRAs have not received other requests of market withdrawal or license suspension from countries where Dengvaxia was approved.
Sanofi vowed to continue to cooperate "in full transparency" with the FDA regarding the issue.
The FDA issued the one-year suspension and imposed a fine of P100,000 on the vaccine's manufacturer, citing violations on product registration and marketing, after Sanofi allegedly failed to submit post-marketing surveillance reports even prior to their controversial announcement in November last year.
It has earlier suspended the suspension of sale, distribution of Dengvaxia and its withdrawal from the market following Sanofi's announcement that the vaccine may pose risk to those who have not been infected with dengue prior to immunization.
Sanofi earlier advised against prescribing Dengvaxia to patients who have not been infected by the virus in the past, since it was found that it may cause severe dengue in the long run.
The Department of Health said more than 733,000 children aged nine and above from public schools in Metro Manila, Central Luzon, and Calabarzon have already received at least the first three doses of the vaccine. —With a report from Nicole-Anne C. Lagrimas/BAP/KG, GMA News