Sanofi hoping for restoration of Dengvaxia registration

MANILA, Philippines — Pharmaceutical firm Sanofi Pasteur is hopeful that the Food and Drug Administration (FDA) will restore the registration of Dengvaxia, the company’s dengue vaccine, saying it can prevent future epidemics.

According to Sanofi Pasteur general manager Jean-Antoine Zinsou, Dengvaxia may not help curb the current rapid spread of dengue in the country, but it can prevent future infections.

“The vaccine is not a solution or a silver bullet for the ongoing outbreaks. If you think about the vaccine, it has to be on the forthcoming outbreaks and how we can optimize the usage of this vaccine based on the current indication,” he told reporters.

Last February, the FDA had permanently revoked the Certificate of Product Registration (CPR) of Dengvaxia, after Sanofi Pasteur failed to submit its post-marketing surveillance on the vaccine.

Sanofi  had appealed the ruling which the FDA eventually denied.  Two weeks ago, the company had filed an appeal with the office of Health Secretary Francisco Duque III to reconsider the decision.

Zinsou noted that through the appeal, they hope to open a discussion with the FDA and “see how the revocation can be re-evaluated.”

“We want to turn to the future, for the benefits of the Filipinos. Dengvaxia vaccination issue has had an impact on many things here in the Philippines so we definitely need to settle this issue,” he added.

He clarified that the CPR was cancelled not because of safety and efficacy issues, but because of some “administrative consideration, or what we call the post-marketing requirement.”

Zinsou underscored that Dengvaxia has been proven “safe and efficacious” in 20 countries where it has already been approved and registered.

“The vaccine has been proven safe and efficacious... We comply with all the requirement in term of safety and efficacy data and also we have this post-marketing plan that we can share with all reguatory authorities,” he maintained.

Doing its part to combat dengue outbreaks across the country is the Philippine Red Cross (PRC), which is employing a three-point strategy to address the crisis.

According to PRC chairman Sen. Richard Gordon, the agency is treating the dengue crisis as a “national emergency” that requires concerted efforts to address.

The three-point strategy pertains to the deployment of medical tents, maintenance of adequate blood supply, and mobilization of PRC’s 143 volunteers to conduct clean-up activities. 

Under the program, the PRC is maximizing its network of community volunteers, through Red Cross 143 and Red Cross Youth programs, to track down dengue and conduct clean-up efforts within a 400-meter radius of vulnerable areas.

The agency had also installed medical tents in most-crowded hospitals in epidemic-affected areas, like the Balasan District Hospital, Sara District Hospital and Guimbal District Hospital in Iloilo; Tapaz District Hospital and Bailan District Hospital in Capiz; and Aklan Provincial Hospital.

It also opened a 60-bed medical tent at the Pagamutang Bayan ng Dasmariñas in Cavite, where 3,277 dengue cases have been recorded.

“All hands are on deck to address this deadly epidemic,” Gordon noted.

He added that PRC remains on full alert to supply the blood needs of dengue patients amid the declaration of a national epidemic.

Answering the call, some 270 soldiers voluntarily donated blood at a bloodletting activity held in Fort Bonifacio on Tuesday in support of the national campaign against dengue.

The Armed Forces of the Philippines Medical Center, Army General Hospital, the Office of the Army Chief Surgeon, and the Philippine Blood Center partnered to support the call of the Department of Health in coordination with the National Disaster Risk Reduction and Management Council to act on the dengue epidemic the country is now facing.

Army Commanding General, Lt. Gen. Macairog Alberto, directed all Army personnel not involved in combat operations to participate in bloodletting activities to be conducted in all the Army’s Infantry Divisions nationwide.

“This is a time to live up to our pledge of service, with the life-saving blood that could make a difference for many of our fellow Filipinos,” he stressed. – With Mary Grace Padin, Michael Punongbayan