Sanofi Pasteur Inc. And Watson’s Ordered To Cease And Desist From The Promotion And Distribution Of The Dengue Vaccine; Dengue By The Numbers

Dengue counts as one of the Philippines’ worst health crises, so it is understandable that excitement over the latest breakthroughs in developing a vaccine for the highly communicable disease is high. Just today, the 10^th of May, 2017, it has been reported that Watson’s Personal Care Stores and Sanofi Pasteur, Inc. were ordered by the Food and Drug Administration to cease and desist from promoting and administering Dengvaxia as an Over The Counter drug, which, the Philippine FDA clarified, is not the case: Dengvaxia is a PRESCRIPTION-ONLY DRUG, which can be administered to patients between 9 and 45 years old only. The FDA has since imposed a cease and desist order on Watson’s and Sanofi, and also asked them to explain why they violated the FDA’s ruling for the second time.
 
Late last year, Watson’s and Sanofi was also given a cease and desist order from the promotion of Dengvaxia.
 
In April 2017, the two companies had excitedly broadcast the news that Dengvaxia is ready for consumption from Watson’s stores across the country, and that the two companies are rolling out vaccination drives in Watson’s outlets nationwide. Amidst this excitement, however, the two companies had sidestepped the limitations that the FDA has set on the drug, and chosen to allow the public to believe that the drug can be administered on anyone regardless of age, and without prescriptions. Moreover, the drug has not yet been given the full clearance for distribution and promotion, as the full decision on its regularization and authorization have yet to be finalized. While the public is waiting, the FDA is correct: Rules are meant to be followed. With a new drug such as Dengvaxia, it makes sense to “quarantine” it before releasing it for regulated public consumption.
 
The need for a Dengue vaccine is great. While the numbers are encouraging, as the Philippines’ 2017 Dengue statistics have fallen 35.8% from the cases in 2016 for the same time period, the numbers of affected patients, plus mortality, are still rather high. The Philippines ranks as the 7^th country with the highest number of Dengue cases in the world. Thus, the clamor and excitement for the availability of a drug such as Dengvaxia is understandable.
 

The Philippines’ Dengue Progress, By The Numbers:

• 2017 Data [Week 1 up to Week 12: 1/1/2017 to 3/25/2017]:

o Total Number of Cases: 18,120
o Suspected Cases: 6,794
o Probable Cases: 44
o Casualties: 149

• Same Time Period for 2016 [Week 1 up to Week 12: 1/1/2016 to 3/26/2016]:

o Total Number of Cases: 29,993
o Suspected Cases: 8,942
o Probable Cases: 178
o Casualties: 119

• 2016 Whole-Year Data:

o Total Number of Cases: 208,372
o Suspected Cases: 995
o Casualties: 1,009

• 2015 Data:

o Total Number of Cases: 207,566
o Suspected Cases: 1,981
o Casualties: 598

As the numbers show, there has been a marked decline of Dengue cases for 2017 so far, which is rather encouraging. This goes to show that the care and management of Dengue patients has gotten better in 2017. The numbers may also be an indication that the management of the environmental factors that aid and abet the spread of dengue have been effective. However, more work has to be done.
 
Sanofi Pasteur, Inc. is not the only company to develop a vaccine for Dengue. The Medigen Vaccine Biologics Corporation in Taiwan is targeting the release of a more powerful and affordable vaccine for release in Asia. It is currently undergoing approval in the US National Institutes of Health, and the Philippines is among the top priorities for its release.
 
While the recent news has been a blow for Sanofi and Watson’s, hope is still on the horizon for more solutions in combating Dengue.
 
The news was first scooped from UNTV News & Rescue via Yahoo! News.

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All raw data has been gathered from the DOH Official Website’s Statistics section.

Photo Credits: Wikimedia Commons

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