The Philippine Food and Drug Administration (FDA) has permanently revoked the certificate of product registration (CPR) of controversial anti-dengue vaccine Dengvaxia, which has been blamed for the plummet in immunization rates.
The FDA said in a statement released earlier today that it will revoke the CPR due to the continued failure of the vaccine’s manufacturer French pharmaceutical company Sanofi Pasteur to submit post-approval commitment documents.
This means it would be illegal to import, sell, or distribute Dengvaxia in the Philippines. “The FDA also reminded Sanofi that pursuant to the revocation of the CPRs, it is unlawful to import, sell, or distribute the said products,” the statement reads.
FDA Director General Nela Charade G. Puno said the pharmaceutical company has shown complete disregard of FDA rules and regulations.
“Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” Puno said.
In an order issued on Dec. 21, the FDA told Sanofi Pasteur to surrender the original CPRs it received for the Dengvaxia products.
The previous administration led by former President Noynoy Aquino launched an immunization drive using Dengvaxia in 2016. More than 830,000 adults and children in Central Luzon, Calabarzon, Metro Manila, and Cebu were inoculated with Dengvaxia.
In November 2017, however, Sanofi Pasteur revealed that the vaccine could trigger more severe symptoms for those who have not yet had dengue. This prompted the government to stop the sale of the vaccine and the state immunization drive in December 2017.
The government then investigated Dengvaxia’s alleged role in the deaths of at least 14 children. Many were alarmed by the news and the fiasco eroded the public’s trust in the government’s other vaccination and health programs.
Immunization rates in the country plunged to 40 percent last year from the average 70 percent in recent years, which many credited to the Dengavia scare.
This has led to the current outbreak of vaccine-preventable measles in Metro Manila and in other regions of the country.
The FDA’s statement also says that its task force for Dengvaxia and the Center for Drug Regulation and Research (CDRR) have confirmed that Sanofi also failed to submit and comply with its post-marketing authorization requirements.
The CDRR will also defer the processing of any submission and application by Sanofi Pasteur regarding Dengvaxia and Dengvaxia-MD.
