July 20, 10:31

India Approves First Dengue Vaccine QDENGA Following DCGI Clearance

India has granted marketing approval for the first dengue vaccine, QDENGA, which was issued by the Drugs Controller General of India (DCGI). This vaccine was developed by Takeda Biopharmaceuticals India.

Indications and Features of the Vaccine

The vaccine is approved for individuals aged 4 to 60 years and can be administered regardless of whether the person has previously had dengue. A distinguishing feature of QDENGA is that it does not require prior screening before vaccination, allowing eligible patients to receive the shot without mandatory testing for past dengue infection.

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India Approves Takeda's Dengue Vaccine QDENGA, Expected Market Launch in 2027

Takeda stated that this approval marks a significant step forward in India's fight against dengue—a mosquito-borne disease that affects millions annually. Mahender Nayak, Head of Intercontinental Markets at Takeda, noted that since its launch in 2022, QDENGA has been approved in 43 countries, with over 32 million doses distributed globally. He emphasized that this approval is an important step in strengthening dengue prevention in India.

Scientific Data and Application

According to the company, long-term studies conducted over seven years have demonstrated that the vaccine continues to provide protection against infection and hospitalization caused by all four serotypes of the dengue virus. The Indian approval is based on the results of Takeda's global clinical development program, which included 19 Phase I, II, and III clinical trials involving over 28,000 volunteers in regions where dengue is prevalent and in areas where it is not found.

The decision was also supported by data from the Phase III clinical trial DEN-302, conducted in India, which assessed the safety and immune response of the vaccine in people aged 4 to 60. QDENGA is administered as two 0.5 ml injections given subcutaneously three months apart.

Global Context and Recommendations

Takeda pointed out that India faces one of the highest rates of dengue incidence globally, as all four serotypes of the virus circulate simultaneously in different parts of the country. Goh Chu Beng, Head of Medical Affairs for the Southeast Asia and India Cluster at Takeda, stressed that QDENGA is designed to protect against all four serotypes, irrespective of previous exposure. He added that its approval contributes to strengthening India's comprehensive approach to dengue prevention, which includes vector control, epidemiological surveillance, public awareness, and other public health measures.

The company also reported that the World Health Organization (WHO) recommends using QDENGA in dengue-endemic regions and supports its inclusion in national immunization programs in high-risk areas without the need for prior screening. Furthermore, QDENGA has received WHO prequalification, confirming compliance with international standards of quality, safety, and efficacy, making the vaccine available for procurement by global agencies such as UNICEF and the Pan American Health Organization (PAHO).

Dengue is a mosquito-borne viral disease registered in over 125 countries. According to the company, India accounts for nearly a third of the global dengue burden, with urbanization, climate change, and widespread mosquito proliferation continuing to increase the risk of infection across the country.

olhardigital.com.brJuly 9, 16:36

Anvisa requires update of Covid-19 vaccines to combat new strains in Brazil

The National Health Surveillance Agency (Anvisa) issued a new regulatory instruction that requires manufacturers to modernize the composition of Covid-19 vaccines used in Brazilian territory. From this moment on, the immunizers must be monoclonal and adjusted to face the most recent variants of the coronavirus circulating.

Details of the New Regulation

This determination, formalized in regulatory instruction number 454 and published on page 113 of the Thursday (09) edition of the Official Gazette of the Union, aims to synchronize the population's immune protection with the genetic changes of SARS-CoV-2. The standard specifies that new batches must focus on the LP.8.1 strain or antigens from the JN.1 lineage, including variants such as XFG and NB.1.8.1.

The regulatory document also clarified that older vaccine stocks do not need to be discarded immediately, granting them a maximum usage period of up to nine months after the approval of the update carried out by each manufacturer.

Motivation for Vaccine Update

The need for this continuous update mirrors the annual procedure applied to the flu vaccine. Due to the constant mutations of the Covid-19 virus, its structure changes, allowing it to partially evade defenses created by previous infections or outdated immunizers. Although reformulation does not mean that previous doses have lost their effectiveness, it ensures that the new doses provoke a more robust immune response.

Industrial Adaptation Process

To comply with this new directive, pharmaceutical companies responsible for the vaccines must submit a formal request for formula change to Anvisa. This process requires the presentation of detailed information about the production process, quality control of the modified immunizer, results of specific laboratory tests, and, if applicable, new clinical data on safety and efficacy.

The regulatory agency communicated that it will expedite the evaluation of these requests, using international parameters and taking into account the accumulated safety history of each vaccine platform. Since this is an adjustment to an already widely tested and validated technology, the release process for the renewed versions occurs more swiftly, dispensing with the complete repetition of testing stages.

Impact on the Brazilian Health System

With this decision, Brazil reinforces its model of genomic surveillance and continuous immunization, even after the most critical phase of the Covid pandemic. Instead of developing a completely new product with each outbreak, industry and diagnostic medicine adapt existing tools in real time. The ultimate goal is to ensure that both the Unified Health System (SUS) and the private network provide current and efficient compounds against current threats.