Four Serotypes, One Vaccine: Why India's First Dengue Approval Took This Long
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Article summary
The Central Drugs Standard Control Organisation has granted marketing authorisation to the Dengue Tetravalent Vaccine (Live, Attenuated), marketed as Qdenga, making it the first dengue vaccine approved for use in India. It is manufactured by Takeda GmbH of Germany and imported by Takeda Biopharmaceuticals India, and is cleared for persons aged 4 to 60 years. The vaccine is built by recombinant DNA technology in Vero cells, with genes encoding the surface proteins of each dengue serotype engineered onto a dengue virus type-2 backbone, so that a single product raises immunity against all four serotypes at once. Approval followed evaluation of quality, safety and efficacy under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. Dengue is endemic across most Indian States, and the approval marks a shift from purely vector-control strategies toward immunisation.
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Sample questions — answers revealed after test
Q1. With reference to the dengue vaccine approved by the CDSCO, which one of the following statements is correct?
Q2. A dengue vaccine must protect against all four serotypes in a balanced way. Which one of the following best explains why balanced tetravalent protection is a design requirement rather than a mere convenience?
Q3. Consider the following statements regarding dengue and its vaccine: 1. Dengue is transmitted primarily by Aedes mosquitoes, which also transmit chikungunya and Zika, and which breed in clean stagnant water in and around dwellings. 2. The approved vaccine was granted marketing authorisation by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. 3. Because an effective vaccine now exists, vector-control measures against Aedes mosquitoes are no longer relevant to dengue prevention in India. Which of the statements given above are correct?