Sanofi wins USFDA approval to sell dengue vaccine Dengvaxia in parts of US

Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given six and twelve months later.

New Delhi: The U.S. Food and Drug Administration on Wednesday approved Sanofi SA's dengue vaccine Dengvaxia for use in the United States among people aged 9 through 16 who have laboratory-confirmed previous dengue infection and live in endemic areas.

Commenting on the grant, Anna Abram, USFDA deputy commissioner for policy, legislation, and international affairs said, "While there is no cure for dengue disease, today's approval is an important step toward helping to reduce the impact of this virus in endemic regions of the United States."

Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.

Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given six and twelve months later.

The safety and effectiveness of the vaccine were determined in three randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and the Asia Pacific region.

The vaccine was determined to be approximately 76 per cent effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals 9 through 16 years of age who previously had laboratory-confirmed dengue disease. Dengvaxia has already been approved in 19 countries and the European Union.

However, Dengvaxia is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. This is because, in people who have not been infected with dengue virus, Dengvaxia appears to act like a first dengue infection, without actually infecting the person with wild-type dengue virus, such that a subsequent infection can result in severe dengue disease.

In late 2017, Sanofi disclosed that Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus, triggering a government investigation in the Philippines where 800,000 school-age children had already been vaccinated.

In March, the Philippine Justice Department said it found probable cause to indict Sanofi officials and former Philippine health officials over 10 deaths it said were linked to the dengue vaccine. Sanofi has said it "strongly disagrees" with those findings.

Medical Dialogues had earlier reported that the Philippines had suspended clearance for Sanofi's dengue vaccine Dengvaxia and had fined the French drugmaker a symbolic $2,000 citing violations on product registration and marketing.

Concerns over the dengue immunization of nearly 734,000 children aged nine and above had resulted in two Philippine congressional inquiries and a criminal investigation.

The country had ordered Sanofi to stop the sale, distribution, and marketing of Dengvaxia after the company last month warned the vaccine could worsen the disease in some cases.

Also Read: Philippines fines Sanofi, suspends clearance for Dengvaxia

However, in October 2018 Europe's medicines regulator had recommended the approval of the first vaccine for dengue despite concerns about the vaccine's wide use and a lawsuit in the Philippines alleging it was linked to three deaths.

Also Read: Dengue vaccine should be approved: European Medicines Agency