USA —The US Food and Drug Administration has begun a priority six-month review of Takeda’s dengue fever vaccine TAK-003, which is expected to be a blockbuster product, with a decision expected in the first half of 2023.
The vaccine has already been approved as Qdenga in Indonesia – where the disease is endemic – to protect people in the six to 45 age bracket.
Qdenga isn’t the first dengue vaccine to hit the market, but it lacks the severe restrictions that plagued its only predecessor, Sanofi’s Dengvaxia, which was approved for marketing in 2015 but was later found to have a serious safety issue.
Dengvaxia is now approved in many countries, including the United States.
Post-marketing studies have revealed that Sanofi’s jab could cause more severe dengue fever in people who were seronegative, meaning they had never been infected with the virus.
Dengue fever is unique in that a first infection is rarely fatal, but a second infection can result in a much more serious disease.
Initial dengue infection usually results in either no symptoms or a mild illness that can be misdiagnosed as the flu or another viral infection.
Subsequent infection can result in severe dengue, including dengue hemorrhagic fever, a potentially fatal form of the disease.
According to the World Health Organization, dengue fever is a leading cause of illness and death in many parts of the world, particularly in some Asian and Latin American countries.
Cases have increased dramatically in recent decades—eightfold in the last 20 years—though some of the startling increase can be attributed to better reporting practices.
Global dengue cases appear to have decreased during the Covid-19 pandemic, and research indicates that pandemic curbs may have prevented 750,000 cases in 2020.
However, the issue is far from resolved, and the WHO notes that data for the years is still incomplete, and that the pandemic may have hampered reporting efforts in some countries.
However, the shot is only given to people who have already been diagnosed with dengue because it has been shown to increase the risk of severe dengue.
TAK-003 has not yet been approved anywhere else in the world and Takeda will continue to initiate and progress regulatory filings in other dengue-endemic and non-endemic countries.
Qdenga is meant for use without prior dengue exposure. It appears promising and could solve the problem of increased risk of severe disease when exposed to dengue a second time, which has complicated efforts to develop a vaccine.
Regulatory approval and use of the vaccine are dependent on evaluation by relevant local authorities and for the indication they deem appropriate.
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