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The marketing authorisation for Sanofi’s dengue vaccine Dengvaxia has been revoked in the Philippines after the country’s Food and Drug Administration accused the French drugmaker of failing to comply with its stipulated post-marketing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

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.  

Philippines' Department of Health demands full refund of $70m Dengvaxia programme from Sanofi

Image Credit: Sanofi

In the latest development in Sanofi’s Philippines dengue vaccine scandal, the nation’s Department of Health has demanded that the French pharma firm pay out a full refund of the 3 billion Philippine pesos the government paid to immunise its citizens “because the purported or reported or claimed protection [of Dengvaxia] wasn’t felt and wasn’t there.”

Philippines' FDA suspends Dengvaxia marketing, Sanofi responds

As the Dengvaxia scandal in the Philippines rolls into 2018, it emerges that the country’s Food and Drugs Administration has suspended clearance for the Sanofi vaccine for a year, after concerns over its safety flared following a recent follow-up study which revealed that dengue-naïve patients receiving the therapy could face a life-threatening reaction if they were to contract the virus after administration.

Philippines to investigate “shameless public health scam”

The Philippines has announced that it will investigate how more than 730,000 children received a dengue vaccine, despite safety concerns over the therapy.

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