Dengue Vaccine – Dengvaxia Update
Sanofi updates information on dengue vaccine
New analysis of long-term Dengvaxia® data found differences in vaccine performance based on
prior dengue infection
Company will ask regulators to update product label to reflect new information
PARIS, FRANCE – November 29, 2017 – Sanofi will ask health authorities to update information provided to physicians and patients on its dengue vaccine Dengvaxia® in countries where it is approved. The request is based on a new analysis of long-term clinical trial data, which found differences in vaccine performance based on prior dengue infection.
Based on up to six years of clinical data, the new analysis evaluated long-term safety and efficacy of Dengvaxia in people who had been infected with dengue prior to vaccination and those who had not. The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.
“These findings highlight the complex nature of dengue infection. We are working with health authorities to ensure that prescribers, vaccinators and patients are fully informed of the new findings, with the goal of enhancing the impact of Dengvaxia in dengue-endemic countries,” said Dr. Su-Peing Ng, Global Medical Head, Sanofi Pasteur.
About half of the world’s population lives in countries where four serotypes of dengue virus are in circulation. Every year an estimated 390 million dengue infections are reported. People can be infected with dengue up to four times in their lifetime and they can get severely ill after any of these infections. Surveillance data from some endemic countries indicate that between 70 and 90 percent of people will have been exposed to dengue at least once by the time they reach adolescence. There are many factors that can lead to severe dengue infection. However, the highest risk of getting more severe disease has been observed in people infected for the second time by a different dengue virus.
Dengvaxia is currently indicated in most of the countries for individuals 9 years of age and older living in a dengue-endemic area. In this indicated population, Dengvaxia has been shown to prevent 93 percent of severe disease and 80 percent of hospitalizations due to dengue over the 25 month phase of the large-scale clinical studies conducted in 10 countries in Latin America and Asia where dengue is widespread.
Proposed Label Update
Based on the new analysis, Sanofi will propose that national regulatory agencies update the prescribing information, known as the label in many countries, requesting that healthcare professionals assess the likelihood of prior dengue infection in an individual before vaccinating. Vaccination should only be recommended when the potential benefits outweigh the potential risks (in countries with high burden of dengue disease). For individuals who have not been previously infected by dengue virus, vaccination should not be recommended.
The Sanofi label proposal will be reviewed by national regulatory agencies in each of the countries where the vaccine is registered or under registration. Following their review, each agency might amend the company proposed label.
WHO: Updated Questions and Answers related to information presented in the Sanofi Pasteur press release on 30 November 2017 with regards to the dengue vaccine Dengvaxia®
30 November 2017
What is WHO’s interim interpretation of the data?
WHO’s interim interpretation of data is that:
:: The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied;
:: The risk of hospitalized 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 will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®.
Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination.
Philippines Suspends Dengue Shots After Drug Firm’s Warning
More than 740,000 students have already received Dengvaxia vaccinations, which could pose health risks for people not previously infected.
New York Times, December 01, 2017 – By FELIPE VILLAMOR