WHO to review the Sanofi’s Dengue vaccine, Dengvaxia; concerns raised over its safety

Earlier, in the year 2016 WHO had recommended the usage of Sanofi's dengue vaccine to control Dengue.

Shaloo Tiwari | Published: December 5, 2017 10:44 am

In the year 2015, the world’s first vaccine for dengue was approved by the Mexican government called Dengvaxia, that was developed by France-based Sanofi Pasteur. Designed to protect people in the age group of 9-45, this vaccine claimed to protect people from all the four subtypes of the virus. However, this month the World Health Organisation (WHO) is keen on reviewing the Sanofi’s safety data for the dengue vaccine. This is happening soon after the Philippines decided to halt their huge immunization plan against dengue with Dengvaxia. Grave safety issues are being taken into consideration in regards to the vaccine as according to WHO’s report concerned with the safety of the drug says, ‘The risk of hospitalised and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied.’ WHO believes that the safety the drug may pose a threat to people who had not been exposed to the dengue virus previously i.e. before being vaccinated with Dengvaxia.

Owing to the safety concerns WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and Strategic Advisory Group of Experts on Immunization (SAGE). After which it will issue the revised guidance of the use of the vaccination. Earlier, in the year 2016 World Health Organisation’s Strategic Advisory Group of Experts on Immunization (SAGE) had recommended the usage of Sanofi’s dengue vaccine to control the widespread of the life-threatening Dengue. However, WHO has kept its stand by saying that, ‘The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia® so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects.’ In 2014, scientists, however, had warned beforehand about the dengue vaccines saying that it could cause short-term but major spikes in the coming years after the vaccines have been used. The WHO has set an objective to reduce dengue morbidity rate by 25% and mortality rate by 50% by the year 2020.

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Published: December 5, 2017 10:44 am

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