Japanese dengue vaccine QDENGA approved by European Union


The European Union has approved Takeda’s dengue vaccine, making it the second such vaccine to receive approval from the bloc. Takeda is a Japanese pharmaceutical company.

According to the WHO, mosquito-borne dengue infects between 100 and 400 million people annually and can result in hemorrhagic fever, though more than 80 percent of cases are mild or asymptomatic.

“The European Commission’s approval marks an important turning point for QDENGA as we are one step closer to achieving our aspiration to help reduce the global burden of dengue. We are proud to introduce QDENGA in many parts of the EU, offering healthcare providers a new tool in dengue prevention for their patients living in the EU and traveling to endemic regions around the world,” said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda.

According to Takeda Pharmaceutical, the European Commission on Thursday gave its vaccine, known as QDENGA, regulatory approval for individuals four and older, regardless of their history of virus exposure.

Dengvaxia, the first dengue vaccine in the world, is already available in the European Union, but it is only for people who have already had a confirmed infection.

When the Philippines banned Dengvaxia in 2019 due to safety concerns, which its manufacturer, French pharmaceutical juggernaut Sanofi, denies, the drug became the centre of controversy.

Indonesia approved QDENGA earlier this year for use by people six years of age and older.

According to the World Health Organization, which states that “about half of the world’s population (is) now at risk,” the number of reported dengue cases has increased more than eight-fold in the last two decades.

About QDENGA vaccine

QDENGA (TAK-003) is a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four dengue virus serotypes and is designed to protect against any of these serotypes.

QDENGA is also approved in Indonesia for the prevention of dengue disease by any serotype in individuals six years to 45 years of age. Takeda continues to progress regulatory filings in other dengue-endemic countries in Asia and Latin America.

(With inputs from AFP)

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