Jakarta, Beritasatu.com – The pharmaceutical company Takeda Pharmaceutical Company Limited (Takeda) filed a regulation on the dengue hemorrhagic fever vaccine (TAK-003) to the European Medicines Agency (EMA).
“Submitting the submission of vaccine candidate regulations DBD The TAK-003 marks an important development for people living in or traveling to various communities burdened by the threat of dengue hemorrhagic fever, “said Takeda Vice President and Global Dengue Program Head Derek Wallace in an accepted press release. Beritasatu.com, Sunday (28/3/2021).
Wallace added, Takeda also intends to submit regulatory filings in Indonesia, Argentina, Brazil, Colombia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand in 2021. “Candidates for the TAK-003 vaccine are being studied for the prevention of dengue hemorrhagic fever (DHF) which caused by viral serotypes in individuals aged four to 60 years, “he said.
Wallace added that the dengue epidemic that kills half a million people around the world each year can overwhelm governments and communities because of its huge impact on the health care system.
He said, in Indonesia alone cases of dengue hemorrhagic fever in 2020 reached 95,893 people with a death toll of 661 people. According to Wallace, with limited options for preventing the disease, there is an urgent need for a dengue vaccine. “Takeda is committed to working with relevant regulatory authorities and recommendation agencies to support the evaluation of the delivery of our regulations and gain access to the TAK-003 vaccine,” he said.
Wallace said, Takeda participated in EMA’s first parallel assessment of the use of medicinal products in the European Union, and carried out the procedure through the EU-M4all or before it was known as Article 58 for countries outside the European Union region.
According to him, in conjunction with the scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP), regulators at the national level of countries participating in the EU-M4all procedure will conduct an assessment to determine which national marketing authorization for the TAK-003 vaccine can be administered. . “Takeda is also seeking approval for the TAK-003 vaccine in dengue-endemic countries that do not participate in the EU-M4all procedure,” said Wallace.
The submission of regulatory submissions for the TAK-003 vaccine includes long-term safety and efficacy data for 36 months from the Phase three Tetravalent immunization trial against the Dengue Hemorrhagic Fever Efficacy Study, namely Phase 3 Tetravalent Immunization against Dengue Efficacy Study / TIDES).
Source: BeritaSatu.com
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