Rich fly to Singapore for lifesaving dengue vaccine; poor helpless due to Health Ministry delay

With deaths caused by dengue nearing 300, concerned affluent Lankans have been travelling to Singapore to get a lifesaving dose of the vaccine whilst a delay in Health Ministry approval locally has left most poor people helpless.

Sources said the rich in recent weeks have flown to Singapore, one of the 17 countries where the world’s first WHO-approved dengue vaccine by pharmaceutical giant Sanofi Pasteur is available for sale. A one-time dose is 128 Singapore dollars, which must be repeated twice within six-month intervals. 

The Philippines has become the first country to initiate a public program with the vaccine targeting schools.

In Sri Lanka, Daily FT learns Sanofi Pasteur in June 2016 submitted an application for marketing approval to the Ministry of Health, and patients as well as medical industry analysts are fuming over the undue delay in its final approval. 

“What is good in Singapore and 16 other countries is being unnecessarily questioned, opposed or delayed by Sri Lankan doctors and the Ministry of Health,” said one parent whose child was diagnosed with dengue. 

Among the other Asian countries where the vaccine is available are Malaysia, Indonesia and Thailand. The vaccine has been administered to over 800,000 people since it was released globally following the WHO in July last year issuing its recommendation that countries with a high dengue burden consider the introduction of the dengue vaccine to help better control the disease.

Sanofi Pasteur is effective against all four dengue virus types (serotypes).

In March 2017, the National Medicines Regulatory Authority had informed Sanofi Pasteur that it needs to assess post-marketing surveillance data from countries in which the vaccine has been used for a period of one year before making a decision on approval of the vaccine. 

A spokesperson for Sanofi Pasteur told Daily FT that the company responded to the queries of NMRA in a letter dated 4 April 2017 and provided long-term safety and efficacy data from clinical trials involving over 35,000 subjects and post-marketing safety surveillance. 

“Since then we have been closely engaged with the NMRA and await their decision on approval of the vaccine for use in Sri Lanka,” the spokesperson added.

Sanofi Pasteur said it has long-term data on the safety of the vaccine for six years post-vaccination from a Phase IIB efficacy study (involving 4,002 subjects) and for five and four years respectively from two phase III studies conducted in 10 dengue-endemic countries of Asia and Latin America (involving over 31,000 subjects). 

The results consistently showed a continued reduction of hospitalised dengue cases. In addition, two Periodic Benefit-Risk Evaluation Reports have been published since post-marketing approval. 

These include safety data collected by Sanofi Pasteur from worldwide sources till 7 December 2016 and do not warrant any significant regulatory authority actions (e.g., restrictions in approved indications, suspensions or withdrawal of a marketing authorisation, new contraindications for use and new or strengthened warnings). 

The long-term data on Sanofi Pasteur vaccine and the post-marketing safety surveillance reassure the long-term efficacy and safety of the vaccine. This new tool will have a significant impact on Sanofi Pasteur’s fight against dengue when used along with other dengue control measures such as vector control, best practices for clinical care and strong dengue surveillance.

The vaccine by Sanofi Pasteur is the culmination of over two decades of scientific innovation and collaboration as well as 25 clinical studies in 15 countries involving 40,000 volunteers around the world.