Takeda Announces Dengue Virus Vaccine Approved by Indonesia
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Takeda Announces Dengue Virus Vaccine Approved by Indonesia.
On August 24, 2022, Takeda announced that its dengue virus (dengue) vaccine, Qdenga (TAK-003), was approved by the Indonesian National Agency for Drugs and Foodstuffs (BPOM) for use in people aged 6-45 to avoid any serotype of dengue fever Infect.
Qdenga is currently the first dengue virus vaccine approved in Indonesia that does not require pre-vaccination testing and regardless of past dengue exposure history.
The press release pointed out that this is also the first time that this vaccine has been approved by regulatory agencies worldwide.
The approval of Qdenga is based on the ongoing Phase 3 TIDES trial in patients 3 years after vaccination.
Data analysis showed that Qdenga continued to protect vaccinated recipients from dengue illness and hospitalization for 3 years after vaccination, regardless of whether the participants had previously been infected with dengue.
In addition, Qdenga was well tolerated, with no serious safety risks observed in trials to date.
Dengue fever is a mosquito-borne viral disease, mainly transmitted by Aedes aegypti, followed by Aedes albopictus.
It is endemic in more than 125 countries and was listed by WHO as one of the top ten global health threats in 2019.
Any of the four dengue virus serotypes can cause dengue or severe dengue.
Currently, about half of the world’s population lives under the threat of dengue fever, which is estimated to cause 390 million infections and 20,000 deaths each year.
Indonesia experiences almost half of the dengue disease burden in Southeast Asia and has one of the highest dengue burdens in the world.
In the first half of 2022, Indonesia reported more than 63,000 dengue cases and nearly 600 deaths in 455 cities.
In December, Takeda said peak sales of the vaccine could reach $1.6 billion.
Gary Dubin, President of Takeda’s Vaccines Business Unit, said: “Dengue can affect anyone living in or traveling to an endemic area. Developing this innovative dengue vaccine is an exciting challenge, and its approval in Indonesia is a result of Takeda Pharmaceuticals and Public An important achievement for health. We are proud to introduce QDEGA as a new dengue prevention tool to the people of Indonesia, and we will continue to work with other regulatory agencies to make QDEGA available globally.”
About QDEGA® ▼ (Dengue Quadrivalent Vaccine [Live Attenuated Vaccine])
QDEGA® (TAK-003) is a dengue vaccine based on attenuated dengue virus serotype 2 that provides the genetic “backbone” of all four dengue virus serotypes and is designed to protect against any viral serotype type.
Medication Instructions :
QDEGA should be administered by subcutaneous injection, preferably in the deltoid region of the upper arm.
QDEGA should not be administered by intravascular, intradermal, or intramuscular injection. Subjects with acute severe febrile illness should defer vaccination. People with mild infections such as colds do not need to delay vaccination.
An individual’s medical history (especially illnesses associated with previous vaccinations and possible post-vaccination hypersensitivity reactions) should be reviewed prior to vaccination.
Appropriate medical care and supervision must be available at all times in the event of a rare allergic reaction following vaccination.
Anxiety reactions associated with vaccination, including vasovagal reactions (syncope), hyperventilation, or stress-related reactions, may be psychological reactions induced by needle injection.
It is important to take precautions to avoid injury from fainting.
The QDEGA vaccine against all dengue virus serotypes may not induce a protective immune response in all vaccinated individuals. This protective immune response may decline over time.
It is not known whether lack of protection contributes to increased dengue severity.
It is recommended to continue taking personal protection measures to prevent mosquito bites after vaccination. Individuals should seek medical attention if they develop dengue symptoms or dengue warning signs.
Contraindications:
Hypersensitivity to the listed active substances or excipients or prior administration of QDEGA;
individuals with congenital or acquired immunodeficiency, including patients receiving immunosuppressive therapy within 4 weeks prior to vaccination, such as chemotherapy or high-dose of systemic corticosteroids (eg, 20 mg/day or 2 mg/kg bw/day of prednisone for 2 weeks or more);
symptomatic HIV-infected or asymptomatic HIV-infected individuals with compromised immune function victims;
pregnant and breastfeeding women.
Adverse Reactions :
In subjects aged 4 to 60 years, the most frequently reported reactions were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), asthenia (24%), asthenia (20%) and fever (11%).
Very common: (≥1/10 subjects): upper respiratory tract infectiona , decreased appetitec , irritabilityc , headache, somnolencec , myalgia , injection site pain, injection site erythema, asthenia, asthma, fever .
Common (≥1/100 to <1/10): nasopharyngitis, pharyngitisb , injection site swelling, injection site bruisinge , injection site itchinge , flu -like illness.
a. Includes upper respiratory tract infection and viral upper respiratory tract infection.
b. Includes pharyngeal tonsillitis and tonsillitis.
c. Data collected on children aged 4-6 years in clinical studies.
d. Includes rash, viral rash, maculopapular rash, and pruritus rash.
e. Data reported by adults in clinical studies. For a complete side effect profile and interaction details, see the Summary of Product Characteristics.
Takeda Announces Dengue Virus Vaccine Approved by Indonesia
(source:internet, reference only)
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