Philippines revokes Sanofi Pasteur’s license to market Dengvaxia

The Philippines has banned Sanofi Pasteur’s controversial dengue vaccine, Dengvaxia.

The Philippines FDA announced that it permanently revoked the certificates of product registration (CPR) of the vaccine because of “continued failure of Sanofi Pasteur Inc. to submit postapproval commitment documents,” according to a news release.

“[Sanofi Pasteur’s] 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,” FDA Director General Nela Charade G. Puno, RPh, said in the release.

According to the release, Puno signed the order on Dec. 21. The FDA found that Sanofi Pasteur failed to comply with its postmarketing authorization requirements.

“Sanofi Pasteur respectfully disagrees with the conclusions stated in the order and considers that the Philippines FDA has taken the decision despite our diligence, including the submission of documents from completed postapproval commitments and regular updates on the status of postmarketing studies,” Sanofi Pasteur told Infectious Disease News in a statement. “Therefore. the company filed a motion for reconsideration of the FDA order.”

In October, the United States FDA granted Dengvaxia priority review. A decision on the approval is expected by May 1. If approved, it would be the first vaccine against dengue available in the U.S., including Puerto Rico and the U.S. Virgin Islands, where the disease is endemic.

“The vaccine has been evaluated in studies involving more than 40,000 people from 15 countries around the world with up to 6 years of follow-up data from large-scale investigations that included Puerto Rico as a study site,” Sanofi’s David Greenberg, MD, said in a statement in October.

Regarding the recent Philippines FDA action, Sanofi Pasteur said “it is important to note that the Philippines FDA is not questioning the safety and efficacy of Dengvaxia, which is consistent with [WHO’s] position on the vaccine and also with the European Medicines Agency’s recent decision to grant market authorization for the use of Dengvaxia in Europe.”

The Philippines FDA initially suspended the CPR in 2017 and directed Sanofi Pasteur to suspend sales, marketing and distribution of Dengvaxia after the company announced that the vaccine raises the risk for severe dengue and hospitalization in people with no prior exposure to the virus. More than 830,000 children in the Philippines received at least one dose of the vaccine before the campaign was halted.

An expert committee that advises WHO on vaccine policy has recommended that Dengvaxia be given only to people in countries where dengue is endemic who have confirmation of prior dengue infection.

“Dengue continues to pose a threat to public health in tropical and subtropical countries and territories around the world where dengue is endemic, including the Philippines,” Sanofi Pasteur said. “Dengvaxia clearly has the potential to play a public health role in the global fight against dengue, and we will continue to work with health authorities to help secure access to the vaccine in countries where appropriate populations can benefit from vaccination against the disease.” – by Bruce Thiel

Disclosures: Puno is an employee of the Philippines FDA. Greenberg is an employee of Sanofi Pasteur.

The Philippines has banned Sanofi Pasteur’s controversial dengue vaccine, Dengvaxia.

The Philippines FDA announced that it permanently revoked the certificates of product registration (CPR) of the vaccine because of “continued failure of Sanofi Pasteur Inc. to submit postapproval commitment documents,” according to a news release.

“[Sanofi Pasteur’s] 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,” FDA Director General Nela Charade G. Puno, RPh, said in the release.

According to the release, Puno signed the order on Dec. 21. The FDA found that Sanofi Pasteur failed to comply with its postmarketing authorization requirements.

“Sanofi Pasteur respectfully disagrees with the conclusions stated in the order and considers that the Philippines FDA has taken the decision despite our diligence, including the submission of documents from completed postapproval commitments and regular updates on the status of postmarketing studies,” Sanofi Pasteur told Infectious Disease News in a statement. “Therefore. the company filed a motion for reconsideration of the FDA order.”

In October, the United States FDA granted Dengvaxia priority review. A decision on the approval is expected by May 1. If approved, it would be the first vaccine against dengue available in the U.S., including Puerto Rico and the U.S. Virgin Islands, where the disease is endemic.

“The vaccine has been evaluated in studies involving more than 40,000 people from 15 countries around the world with up to 6 years of follow-up data from large-scale investigations that included Puerto Rico as a study site,” Sanofi’s David Greenberg, MD, said in a statement in October.

Regarding the recent Philippines FDA action, Sanofi Pasteur said “it is important to note that the Philippines FDA is not questioning the safety and efficacy of Dengvaxia, which is consistent with [WHO’s] position on the vaccine and also with the European Medicines Agency’s recent decision to grant market authorization for the use of Dengvaxia in Europe.”

The Philippines FDA initially suspended the CPR in 2017 and directed Sanofi Pasteur to suspend sales, marketing and distribution of Dengvaxia after the company announced that the vaccine raises the risk for severe dengue and hospitalization in people with no prior exposure to the virus. More than 830,000 children in the Philippines received at least one dose of the vaccine before the campaign was halted.

An expert committee that advises WHO on vaccine policy has recommended that Dengvaxia be given only to people in countries where dengue is endemic who have confirmation of prior dengue infection.

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“Dengue continues to pose a threat to public health in tropical and subtropical countries and territories around the world where dengue is endemic, including the Philippines,” Sanofi Pasteur said. “Dengvaxia clearly has the potential to play a public health role in the global fight against dengue, and we will continue to work with health authorities to help secure access to the vaccine in countries where appropriate populations can benefit from vaccination against the disease.” – by Bruce Thiel

Disclosures: Puno is an employee of the Philippines FDA. Greenberg is an employee of Sanofi Pasteur.