Health authorities have given Takeda Pharmaceutical Co.'s breakthrough dengue vaccine the signal in Europe. This decision may open the way for its deployment in the global fight against the deadly mosquito-borne illness.
According to The Wall Street Journal (WSJ), Tokyo-based Takeda confirmed on Thursday, Dec. 8, that the European Commission (EC) had given its clearance to the two-dose injection for individuals aged four and above.
'Qdenga' Vaccine
The dengue vaccine Qdenga has been given the go-ahead, which should hasten its assessment in several nations outside of Europe, including Mexico, Argentina, and Thailand, where the disease is prevalent.
Last summer in Indonesia, the Takeda vaccine was licensed for use in persons aged 6 to 45.
Dengvaxia is the only other approved vaccination, although safety concerns have hampered it. It is manufactured by Sanofi SA.
In WSJ's report, more than 20,000 healthy youngsters between the ages of 4 and 16 participated in a Phase 3 study of Qdenga.
Participants were followed up on for an additional 4.5 years of research.
Takeda reported in the New England Journal of Medicine in 2019 that the vaccine decreased the likelihood of dengue diseases in children by roughly 80% some 12 months after the second dosage.
The company researchers discovered the vaccination was 84% effective against hospitalized dengue and 61% against symptomatic dengue.
After doing extensive testing, scientists reported finding no significant safety risks.
Qdenga vaccines cannot be used in countries that have not given their own stamp of approval. Takeda has also applied for clearance from US regulators.
Takeda predicted Qdenga's peak yearly sales might reach at least $700 million.
Dengue Risk
The virus is spread by an aggressive mosquito that thrives in residential areas. It puts an estimated four billion people in tropical countries at risk of infection.
Although most dengue cases are asymptomatic or moderate, the disease may cause flu-like complications, including high fever and muscular discomfort. In rare circumstances, it can even be fatal.
The World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) calculate that 390 million people have dengue every year. Around 100 million of them become sick, and 40,000 die from severe symptoms, as reported by WSJ.
In 2017, Sanofi reported that Dengvaxia might cause additional dengue symptoms rather than prevent them.
Vaccinated children in the Philippines became sick, some requiring hospitalization while others died.
Since Sanofi's disclosure of the safety risks, governments and public health organizations throughout the globe have been anticipating the possible release of a replacement vaccine.
For this reason, the WHO advises against administering Dengvaxia to healthy individuals who have never had dengue.
Vaccine Comparison
The public health benefit of the vaccine in dengue prevention, according to a Sanofi representative, is supported by the approval of the vaccine in endemic regions in the US and Europe.
He added that Dengvaxia is used as a preventative measure in certain countries, and the company is dedicated to eradicating the illness wherever the vaccine is approved.
Officials from Takeda noted that, in contrast to Sanofi's vaccine, Qdenga does not need a test for a prior dengue illness.
Takeda CEO Christophe Weber compared their vaccine to Sanofi, saying their vaccine may be utilized regardless of past exposure to the disease.
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