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Strong Phase 3 showing for Takeda's dengue vaccine, but concerns remain over consistent coverage

Takeda has unveiled new data from its ongoing Phase 3 trial investigating the efficacy of its vaccine candidate TAK-003 in the prevention of the mosquito-borne virus dengue, confirming its ability to convey protection against virologically-confirmed cases in paediatric patients from four to 16 years old.

In the 12-month period following the second dose of the vaccine, which was administered three months after the first dose, Takeda’s product was found to be 80.2% effective.

Sanofi's Dengvaxia becomes first FDA-approved dengue vaccine, but with caveats...

Sanofi has announced that the FDA has granted authorisation to its tetravalent vaccine Dengvaxia for prevention of dengue disease originating from all four virus serotypes, making it the first therapy to secure approval from the US regulator in that indication.

The ruling specifically indicates use of the vaccine in patients between the ages of nine and 16, and only those who have laboratory-confirmed previous dengue infection and who live in endemic areas. These include the United States territories of American Samoa, Guam, Puerto Rico and the US Virgin Islands.

FDA advisory panel recommends Sanofi's dengue vaccine in children, but rejects its use in adults

Dengvaxia, Sanofi’s vaccine for dengue fever, has been burdened with further negative scrutiny after the FDA’s vaccine advisory panel passed mixed judgements on its efficacy and safety in adults and children with the disease.

The agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) decided that Sanofi’s vaccine was not effective in preventing the disease in adult patients aged between nine and 45 living in endemic regions who have been previously diagnosed with dengue, with seven votes to six and one abstention.  

Philippines Department of Justice recommends charges against six Sanofi officials

The Philippine Justice Ministry has said it has found probably cause to charge officials working for French drugmaker Sanofi over the death and injury of hundreds of children and adults relating to a dangerous dengue vaccine.

One hundred and eighteen people, including 115 children and 33 adults, died after receiving Sanofi’s dengue vaccine, Dengvaxia, in 2016 after the Philippines became one of the first countries to use the vaccine in a mass immunisation programme.

Philippines' FDA halts sales of Sanofi's dengue vaccine

The marketing authorisation for Sanofi’s dengue vaccine Dengvaxia has been revoked in the Philippines after the country’s Food and Drug Administration accused the French drugmaker of failing to comply with its stipulated post-marketing requirements.

The decision means that all sales, distribution and marketing of Sanofi’s product in the country are currently on hold. The drugmaker is being reprimanded for what FDA Director General Nela Charade Puno called a “brazen defiance” of his organisation’s directives.

Diet drugs supress appetite in mosquitoes, study shows

Scientists were able to supress mosquitoes appetites using diet drugs for humans, according to research published in the journal Cell.   

The drugs could one day be used to curtail the spread of diseases such as malaria, Zika virus and dengue.

Like other mosquitoes, female Aedes aegypti, feed on human blood to get the proteins necessary to produce their eggs. Once they have their fix they stop biting and lay their eggs.

Takeda's dengue vaccine proves efficacious in massive Phase 3 trial

Takeda’s dengue vaccine candidate TAK-003, has proved efficacious in preventing dengue fever in healthy children and adolescents in an ongoing Phase 3 trial.

The tetravalent vaccine, which was found to be well tolerated, met its primary efficacy endpoint in a pivotal Phase 3 trial.

“We are very encouraged by the performance of our dengue vaccine candidate in the study. This brings us one step closer to helping the world tackle the massive burden of dengue,” said Dr Rajeev Venkayya, President of the Global Vaccine Business Unit at Takeda.

Danger of Sanofi’s dengue vaccine confirmed in new study

A study that thoroughly analyses the impact of Sanofi’s dengue vaccine has confirmed what was feared – children without prior exposure to dengue had an increased risk of hospitalisation and the development of severe dengue.

Sanofi's controversial dengue vaccine may still hit US market, despite Philippines disaster

Image Credit: Sanofi

Sanofi has revealed that the ongoing debacle in the Philippines concerning its dengue vaccine Dengvaxia has not deterred it from looking to market the drug elsewhere as the company announced it would soon reach a decision on whether or not to file for regulatory approval in the US.

Philippines' launches legal action after Sanofi refuses to refund over dengue vaccine damages

Sanofi has refused both requests from the Government of the Philippines to refund used doses of its Dengvaxia vaccine as well as the costs of medical treatment of first-time dengue patients who were harmed after its use in the nation’s vaccination programme of 837,000 children.  

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