"According to supporting clinical study data, indications for the use of Qdenga vaccine is for people aged 6-45 years in two doses, with an interval of three months between doses via subcutaneous injection into the upper arm muscle," Head of BPOM Penny K. Lukito stated in a press release received here on Friday.
The distribution permit for Qdenga was issued on Friday. Qdenga is a vaccine for the prevention of dengue disease caused by the dengue virus among people aged six to 45 years, produced by IDT Biologika GmbH Germany and registered under the name of Takeda GmbH Germany.
This vaccine is the second dengue vaccine to be approved by BPOM after Dengvaxia, which is registered under the name of PT Aventis Pharma.
Qdenga vaccine is a Live Attenuated Tetravalent Dengue Vaccine (TDV) that comprises four strains of dengue virus: attenuated dengue serotype 2 strain (TDV-2), recombinant dengue serotype 2/1 strain (TDV-1), recombinant dengue serotype 2/3 strain (TDV-3), and recombinant dengue serotype 2/4 strain (TDV-4).
"The TDV-2 strain vaccine is made from the attenuated Dengue Virus type 2," she said.
The overall efficacy of the Qdenga vaccine for dengue fever prevention is 80.2 percent, while its efficacy for preventing hospitalization due to the dengue virus is 95.4 percent.
The vaccine showed good efficacy on seropositive subjects, or those who have antibodies against the dengue virus, and seronegative subjects, or those not having antibodies against the dengue virus.
In addition, the side effects reported were mild to moderate in general.
According to Lukito, approval of the Qdenga vaccine had been discussed at a meeting of the National Committee for Drug Evaluation involving experts in various fields, including pharmacology, epidemiology, immunology, pharmacy, vaccinology, clinicians, regulators, related clinicians association, and other government institutions.
"The distribution permit for the Qdenga vaccine by BPOM is in accordance with the requirements for a new vaccine that refers to the WHO standards," she stated.
Moreover, the approval is based on results of the evaluation of pre-clinical trial results' data, clinical trial results, and data on vaccine quality tests, she remarked.
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Translator: Andi Firdaus, Raka Adji
Editor: Rahmad Nasution
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