Dengue Vaccine – Dengvaxia Update

Dengue Vaccine – Dengvaxia Update
 
Editor’s Note:
We will continue to monitor and present major announcements and milestones around Dengvaxia as below.

 

Philippines fines Sanofi, suspends clearance for Dengvaxia
Reuters | 4 January 2018
MANILA (Reuters) – The Philippines has fined Sanofi $2,000 and suspended clearance for the French drug maker’s controversial dengue vaccine Dengvaxia, citing violations on product registration and marketing, its health secretary said on Thursday.

… The country ordered Sanofi to stop the sale, distribution and marketing of Dengvaxia after the company last month warned the vaccine could worsen the disease in some cases.

“They were fined and their certificate of product registration was suspended,” Health Secretary Francisco Duque said told Reuters.

The Food and Drugs Administration of Philippines found Sanofi violating post-marketing surveillance requirements, he added…

 

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FDA Advisory No. 2017-327 || CREATION OF A TASK FORCE THAT WILL REVIEW, SUBMIT RECOMMENDATIONS AND TAKE APPROPRIATE ACTIONS RELATING TO THE DENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED), REGISTERED AS DENGVAXIA…

Republic of the Philippines – Created on 03 January 2018

CREATION OF A TASK FORCE THAT WILL REVIEW, SUBMIT RECOMMENDATIONS AND TAKE APPROPRIATE ACTIONS RELATING TO THE DENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED), REGISTERED AS DENGVAXIA, AND THE TRANSMITTAL OF APPLICATIONS, LETTERS, REQUESTS, CORRESPONDENCE AND OTHER RELEVANT DOCUMENTS ONLY TO THE TASK FORCE SO CREATED.

In view of the recent clinical findings released by Sanofi Pasteur Inc. (SPI) on the possible effects of the Dengue Tetravalent Vaccine (Live, Attenuated), registered as Dengvaxia, (to those inoculated without prior history of dengue), the FDA created a Task Force (TF) on 3 December 2017, through FDA Personnel Order No. 2017-1019, to: conduct a comprehensive review of all the records relating to the approval of the said vaccine; submit appropriate recommendations; and take appropriate actions, having in mind its fundamental mandate to protect and promote the right to health of the people.

The TF was given the authority retrieve and retain custody of ALL files involving the said vaccine, pending the said review, issuance of recommendations, and the taking of appropriate actions, among other authorities.

The public is thus advised that all applications, requests, letters, correspondence and other documents related to Dengvaxia should be directly forwarded to the FDA Action Center (FDAC), Attention: Atty. Kevin Jardine S. Lozano, TF Dengvaxia, Secretary. Any and all documents transmitted to or by offices, other than the TF on Dengvaxia, shall not be considered official.