India has approved Qdenga, its first dengue vaccine developed by Takeda Pharmaceuticals, which is a tetravalent live attenuated vaccine protecting against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). The vaccine is approved for individuals aged 4 to 60 years and can be administered without pre-vaccination screening regardless of prior dengue exposure. It requires a two-dose regimen of 0.5 mL each, administered subcutaneously three months apart. Clinical trials demonstrated 80.2% overall efficacy at 12 months post-second dose, 90% efficacy against hospitalizations at 18 months, and 84.1% sustained protection through 4.5 years. India accounts for approximately one-third of the global dengue burden, making this vaccine particularly significant for the country's public health.
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India’s First Dengue Vaccine Approved | Who Should Get Qdenga? | Latest Update | Drishti IAS Englis
Added:Hello everyone, welcome back to the latest update series of Dishias. This is Dy Kumastra and today we are discussing about a very important development that is the first deni vaccin. That's right, we have developed the first deni vaccine. Let's understand what that is and how does it work. So India has approved its first vaccine giving Japanese drug maker Takira Pharmaceutical company India that is Indian arm uh an authorization for Cudena. What is the name here? Qangga.
All right. The permission has been granted for this. The drug controller general of India has given a live attenuated vaccine for people aged 4 to 60. Remember the age? What is the age? 4 to 60. For whom is this? For people aged 4 to 60 under the CT 20 new drugs and clinical trial rule 2019 that Takira India said in a statement already they have done this. Kurena can be administered without prevaccination without prevaccination screening regardless of prior dingy exposure even if you've not had any exposure even then the vaccin can be administered all right let's understand what what the vaccin is how does it work and uh what other features does it have first of all let's talk about the approval regulatory approval came from DECGI they granted market authorization market authorization has come already and via Indian subsidiaries also target age group as we discussed 4 to 60 under the new drug clinical trials rule and no pre-screening is required what is that unlike some earlier deni vaccines kurena can be given without testing for prior dingi infection you don't need to test for uh any infection you can just directly give the vaccination it is safe and effective regardless whether a person has had fever or uh before or not right what is the dozing regimen and two do series. It is a two do series 0.5 mlh given subcont uh subcutaneously 3 months apart right yeah one today one 3 months later two doses of 0.5 ml each how many doses do we have two doses for this and it is safe regardless of your testing regardless of whether you have had di before or not it is safe anyway all right so we before we understand more about it uh let me tell you about the new session sale that is going on.
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All right.
Okay. Moving forward we have vaccine efficacy and safety. What uh efficacy and safety do we have for this? The broad protection that is given is it is a tetraalent live attenuated vaccin that is specifically designed to protect against all four dingy virus serotypes that is den one den 2 den three and den four will get protection against all four of them not specifically working for any one of them we'll be getting uh from all four of them a proper protection right high efficacy global phase three trials including 20,000 participants has shown 80.2% 2% overall efficacy against lab confirmed uh at 12 months post second dose 90% efficacy related hospitalizations at 18 months 84.1% sustained protection against hospitalization through 4.5 years this is the success rate that it has shown and according to the local data approval was supported by Indian phase 3 trial also where participants aged 4 to 60 confirmed that vaccin was well tolerated safe and produced strong immune response response to this structure. All right, that is wax and efficacy. If we talk about the global standing and significance for India, Cudena is already approved in 43 countries. It is already approved in 43 countries like Brazil, Argentina, Colombia, Indonesia with over 32 million doses distributed globally. Now it has pre-qualification for international agency procurement.
also India's disease burden if we talk about India accounts for nearly onethird of words total deni burden right and according to that we definitely need this so what is the treatment gap because it had no specific antiviral treatment it doesn't have any specific antiviral treatment it is supportive symptom focused so preventive vaccines were a vital line of defense alongside mosquito control we were running on preventive vaccin because obviously there is no antiviral treatment specific antiviral treatment So in domestic pipeline what have we done? Indian pharmaceutical companies including Panatia biotech, Bharat Biotech, Serum Institute of India and Indian immunologicals they're currently testing their own candidate Deni vaccines in clinical trials and if they come forward with something better obviously we'll have that too but for now this is what we have approved that is Qenga what is it Q denga here all right if we compare this globally if we compare this on a global scenario we'll see that who is the developer here who is the developer here Takira Pharmaceuticals for Cudena, right? Then we have Dengaxia for uh for Dengia we have France. For Bhutantin DV we have Brazil and US. All right. What are the viral backbones here? Deni virus type 2 ina yellow fever 17D rain and dangexia and live attenuated uh chimeri deni in vitant. Right. What are the dozing schedules? Doing schedule is two doses for kadena 3 months apart. We just talked about it. Then dangia they have three doses 0 6 and 12. Now today then after 6 months and then after 12 months three doses are there. In vitant there's only one single dose. For age group we have 4 to 60. WH has given 6 to 16 years. Dangia 6 to 45 and vitantin 12 to 59. These are the age groups that can benefit from this. Is there a prior infection needed for this vaccine? For cudena, we said that no history regardless of the history with deni virus you can still get this and denexia. Yes, they need ceropositive only. In case of ceropositive only you can get this vaccine and in betant also no history is require required here, right? Yeah. In terms of global status, we see it has been approved in 40 plus countries. Cudena has been approved in 40 plus countries. Dangexia has been phased out is heavily restricted due to low demand or risk. There are high risks related to dangexia. It is very uh limited today in the global scenario if we talk about that. Then Bhutantan DV approved in Brazil tech licensed to global developers also. So that is still working. Bhutantan is working. Kanga is now also working and it is working in India also. And other than that we had Dangexia but it is getting phased out.
Clear. This is regarding the global comparison of the um medicines that are going on and how do they work? What are the different criterias that they can work upon and what do we have? We have Kadena. Clear? All right. Reminder once again for you. ISDS foundation course along with mains and optional courses.
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Clear? All right. Let us know your answer in the comment section. We'll look out for that. And that's about it.
That was our session for the day. Thank you so much for joining in. That was about uh Qangga, the uh final medicine that India has approved. All right. I hope you understood all about that all the important facts. Yes. All right.
I'll see you in the next session. Till then, take care. Thank you. Bye-bye.
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