Sanofi: Latest word from WHO confirms public health value of Dengvaxia

The World Health Organization (WHO)-Strategic Advisory Group of Experts' (SAGE) recent recommendation on Dengvaxi confirms the "public health value" of the controversial anti-dengue vaccine, its manufacturer Sanofi Pasteur said in a statement on Friday.

"The new SAGE recommendation confirms the public health value of Dengvaxia and its potential to reduce the overall burden of dengue in high endemic populations," Sanofi Pasteur said in a statement.

This came after the WHO-SAGE recommended that Sanofi's Dengvaxia should only be used after testing on individuals to assess whether they have ever been exposed to the infection after a two-day meeting of experts in Switzerland. 

"We have now clear information that the vaccine needs to be dealt with in a much safer way by using it exclusively in people already infected with dengue before," Alejandro Cravioto, Chair of the WHO-SAGE on Immunization, said.

"It requires for the people to be tested through a system that is not currently available but that we feel will be developed in the next years," Cravioto added.

For dengue-endemic countries that would like to use Dengvaxia as part of their integrated dengue control and prevention strategy, SAGE recommends as a preferred option pre-vaccination screening in which only previously dengue infected individuals are vaccinated, according to Sanofi.

"As will be made clear in forthcoming published documents from SAGE, current available sero-tests or Rapid Diagnostic Tests (RDT) could be considered in high transmission settings until better tests are available. We maintain our efforts to develop a dengue RDT that can reliably assess prior dengue infection as an aid to vaccination," the pharmaceutical giant said.

Sanofi said that SAGE also acknowledges the public health value of vaccinating without pre-vaccination screening in very high endemic settings.

"This guidance from the SAGE will help to inform an updated World Health Organization position on the vaccine expected to be published in the coming months," the company said.

"The WHO’s mandate is to promote global public health, and their positions on new vaccines provide guidance to countries to make decision on public program implementation, based on their specific disease burden and epidemiology," it added.

The SAGE updated their recommendation on the vaccine taking into account the results of a supplementary analysis of clinical data on the vaccine, for which findings were communicated publically last year by Sanofi.

"These new data, which were finalized and shared by Sanofi at the end of November 2017 and submitted to a peer-reviewed medical journal, contribute to the scientific understanding of how this vaccine can be used optimally in dengue prevention efforts at individual and population," the company said.

"They show that for people 9 years of age or older who had a dengue infection prior to vaccination, which includes most of the people living in high transmission areas, the vaccine provides sustained protective benefit up to 5 years after the first injection which highlights the public health value of the vaccine in high endemic settings," it added.

Such findings also represent the first clinical evidence that the vaccine’s long-term safety profile in individuals 9 years and older differs according to prior dengue infection exposure, according to Sanofi.

It took note that it has proposed a label update for the vaccine that takes these new findings into account.

"The label update is currently under review or has been accepted already by some of the regulatory agencies in the countries where the vaccine is either approved today or under regulatory consideration," Sanofi said.

"We are confident in Dengvaxia’s safety and its proven potential to reduce dengue disease burden in endemic countries," Sanofi said.

Citing its previous update in November, the company said the risk and severity of cases in vaccinated individuals not previously infected with dengue was similar to those observed in unvaccinated individuals previously infected.

"Over five years, in vaccinated individuals not previously infected this increased risk was of 0.2% for vaccinated vs unvaccinated individuals," it said.

"The severe dengue symptoms observed were a temperature over 38°C for two days or more coupled with symptoms such as bruising and abnormal laboratory findings. All fully recovered after symptomatic treatment," it added. —NB, GMA News