South Africa prepares to introduce new tuberculosis vaccine with support from the Bill & Melinda Gates Foundation

The Western Cape Province has become the first in South Africa to launch a public toxicology laboratory, achieving international accreditation.

Accreditation and its Significance

The Department of Health's forensic toxicology laboratory in the Western Cape received ISO/IEC 17025 accreditation following an assessment conducted by the South African National Accreditation System (SANAS). This marks a significant step forward for forensic science in the country. The laboratory is located at the Observatory.

This accreditation covers methods for detecting carbon monoxide poisoning, as well as identifying and measuring drugs in forensic samples. These analyses are used in investigating fires, suspected poisonings, possible drug overdoses, and sudden or unexplained deaths.

Assistance to Families and Justice

Mireille Wenger, Minister of Health and Wellness for the Western Cape, noted that forensic toxicology can provide answers to families when the cause of death is not obvious. She emphasized that toxicology plays a vital role in uncovering circumstances in such cases.

Wenger stated that the accreditation guarantees independent confirmation that the toxicological data obtained by the unit meets internationally recognized standards. The results of these studies are used by forensic pathologists, police investigators, prosecutors, and courts in medico-legal and criminal investigations.

Structure and Quality of Work

The forensic toxicology unit is part of the Provincial Department of Health and Wellness's Forensic Pathology Service and supports death investigations in the Western Cape. Toxicologists work directly within the Forensic Pathology Service, which has improved collaboration, increased testing reliability, and reduced turnaround times for results.

Although testing was conducted before receiving certification, the accreditation independently confirms that the laboratory's methods and quality control meet international requirements. Before accreditation, the method undergoes rigorous testing to determine its accuracy, sensitivity, specificity, and reliability. The laboratory also participates in international proficiency testing and conducts continuous quality assurance assessments.

Commitment to Quality

Chief Forensic Toxicologist and Scientific Manager of the unit, Bronwen Davis, stated that the accreditation demonstrates a commitment to maintaining reliable services and continuously improving the laboratory's operations. She called this achievement a promise of quality and reliability, strengthening the Western Cape's healthcare system.

Wenger added that forensic pathology stands at the intersection of healthcare and the justice system. The work of scientists helps authorities determine causes of death, support investigations, and identify new public health threats, which is an important confirmation of the quality of forensic science in the Western Cape's public sector.

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.

Significance of the Approval for India

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.