Takeda Pharma begins regulatory submissions for its dengue vaccine candidate to EMA :
Japan’s Takeda Pharmaceuticals has recently started the regulatory submissions for its dengue vaccine candidate to EMA[1]. This was announced by the company on 25 March 2021. This vaccine is being developed for individuals aged 4 to 60. [4]
The drug firm stated that EMA would conduct an assessment of the vaccine called TAK – 003. This assessment allows EMA to assess and give opinions on medicines intended for use in countries outside the EU[2].
About Dengue Vaccine
A large–scale trial of this vaccine has already been conducted, and initial and additional data has been collected from it. The data revealed that the vaccine showed a successful result in children but had a shortcoming. It failed to protect against one of the four types of virus in children and teens who had not been previously – exposed to dengue.
Takeda has also added that it would submit the regulatory filings in certain Latin American and Asian countries in 2021. It also plans to submit a regulatory filing of this vaccine candidate in the US in 2021.
Abbreviation :
- European Medicines Agency
- European Union