The Drug Controller General of India (DCGI) has approved Takeda Biopharmaceuticals India’s dengue vaccine, QDENGA, for the prevention of dengue in individuals aged 4–60 years under the New Drugs and Clinical Trials (NDCT) Rules, 2019.

QDENGA is the first dengue vaccine approved in India and can be used in individuals regardless of previous dengue exposure, without the need for pre-vaccination testing.

This approval marks an important step in strengthening dengue prevention efforts in India, where the disease remains a significant public health challenge.

Dengue is a mosquito-borne viral disease that poses a significant global public health threat, with prevalence in over 125 countries.

India accounts for nearly one-third of the global dengue burden. In 2025, reported cases exceeded 113,000, but modelling analyses suggest the dengue burden in India appears to be higher than reported, likely representing tens of millions of infections each year. 

QDENGA is a tetravalent, live-attenuated vaccine designed to provide protection against all four dengue virus serotypes. The vaccine is administered subcutaneously as a 0.5 mL two-dose regimen, with doses given three months apart.

QDENGA is recommended by the WHO for use in dengue-endemic settings and supports its introduction into public immunisation programmes in areas with high transmission, without the need for pre-vaccination screening. The vaccine has also received WHO pre-qualification, confirming it meets global standards for quality, safety, and efficacy, and enabling eligibility for procurement through international agencies such as UNICEF and PAHO to support wider access.

QDENGA has been approved in 43 countries across Asia, Latin America, and Europe, including India, with more than 32 million doses distributed globally through public and private programmes. It is included in Brazil’s National Immunisation Programme and is available through public programmes in Argentina, Colombia, and Indonesia.

Dr. Mahender Nayak, Head of Intercontinental Markets, said, “The latest seven-year data for QDENGA show continued protection against dengue infection and hospitalisation across all four serotypes, an important milestone for communities and health systems. Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India.”

Millions of Indians remain at risk each year due to widespread endemicity, rapid urbanisation, and climate-related factors that drive mosquito proliferation. This has made dengue a year-round public health threat, with seasonal surges continuing to strain healthcare systems.

Dengue is also complex to manage, with no specific treatment. It can rapidly progress to severe, life-threatening complications requiring hospitalisation and intensive care.

Peter Streibl, General Manager, Southeast Asia and India Cluster, said, “Dengue is a shared regional challenge that requires collaboration across borders and sectors. Takeda is committed to working with governments, public health authorities, healthcare professionals, and partners across South and Southeast Asia not only to support access to QDENGA, where approved and recommended, but also to strengthen broader dengue prevention efforts, including surveillance, awareness, vector control, and community engagement.”

Dr. Goh Choo Beng, Medical Affairs Head, Southeast Asia & India Cluster, added that India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions. QDENGA is designed to protect against all four serotypes, regardless of prior exposure. 

QDENGA APPROVAL BASED ON CLINICAL TRIALS

The approval in India is based on results from Takeda’s global clinical development program, involving 19 Phase 1, 2, and 3 clinical trials with over 28,000 participants in both endemic and non-endemic regions. This included the pivotal Phase III TIDES (DEN-301) trial, which evaluated the vaccine in over 20,000 participants across eight countries over an extended period to assess both the long-term safety and efficacy of QDENGA.

At 12 months following the second dose, the study met its primary endpoint, demonstrating an overall vaccine efficacy of 80.2% against virologically confirmed dengue (VCD). At 18 months, the study also demonstrated 90.4% efficacy against dengue-related hospitalisation, meeting a key secondary endpoint of the study.

After 4.5 years, two doses of QDENGA provided 84.1% vaccine efficacy in preventing dengue-related hospitalisations. Notably, the vaccine has also shown sustained safety and efficacy for up to seven years across all four dengue virus serotypes.

This approval is also supported by data from a Phase III clinical trial (DEN-302) conducted in Indian participants, which evaluated the safety and immunogenicity of the vaccine in individuals aged 4–60 years. The study demonstrated that QDENGA was well tolerated, safe, and immunogenic in healthy adults, adolescents, and children.

These clinical outcomes are further supported by real-world evidence generation and ongoing pharma-covigilance to deepen understanding of the vaccine’s safety and impact.

Following approval by the DCGI, Takeda will continue to collaborate with Indian regulatory authorities, public health stakeholders, and healthcare providers to support the planning, delivery, and availability of QDENGA in India. (India Today)

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The Ministry of Health and the National Medicines Regulatory Authority (NMRA) have launched separate probes into the deaths of two patients at the National Institute of Infectious Diseases (NIID) in Angoda, after being administered an injection containing ondansetron.

According to the Lankadeepa newspaper, the patients were given Ondansetron, a prescription anti-sickness medication used to prevent and treat nausea and vomiting. 

Chairman of the NMRA, Dr. Ananda Wijewickrama, said a comprehensive probe has been launched to ascertain whether the deaths were caused due to the medicine.

He further said that the Indian company that had imported the medicine has also been informed in writing to suspend the use of the medication. 

Ananda Wijewickrama revealed that, as such, the use of the medication has been suspended at both government and private hospitals and clinics. 

An investigation report into the vaccines by the Kandy Hospital’s Microbiology Laboratory said that the vaccinations contained bacteria, and based on this report, the vaccine was removed from use, he said.

Stating that the NMRA has launched a comprehensive investigation based on the report, the NMRA Chairman said that the vaccine is prohibited from being used until the conclusion of the probe. 

He added that the NMRA has written to the Indian Company that imported the medicine to provide details on the vaccination to the NMRA before December 28. (Newswire)

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The Ministry of Health has received nine refrigerated trucks procured by UNICEF with funding from the Government of Japan to further improve the delivery system of vaccines to all children, across Sri Lanka.

According to a UNICEF statement, the trucks were handed over by the Ambassador of Japan to Sri Lanka MIZUKOSHI Hideaki and Acting UNICEF Representative in Sri Lanka Begoña Arellano, during a ceremony held at the Ministry of Health and they were received by the Minister of Health, Dr. Ramesh Pathirana.

Speaking at the handover ceremony, Dr. Pathirana said, “I welcome the support of the Government of Japan and UNICEF to further strengthen immunization, which is a key pillar of Sri Lanka’s healthcare system. These refrigerated trucks will boost the ability of the Ministry of Health to transport vaccines in a safe and timely manner.”

The trucks are part of a total contribution of US$ 3 million from the Government of Japan that funded cold chain equipment, including large, walk-in cold rooms to store vaccines at safe temperatures, portable vaccine carriers and temperature monitors, which have already been handed over to the Ministry of Health intermittently from 2021 to date.

Japanese Ambassador MIZUKOSHI Hideaki said, “I am honoured to announce the forthcoming handover of nine Refrigerated Trucks, a tangible symbol of Japan’s enduring commitment to Sri Lanka’s public health endeavours. These trucks will serve as vital conduits in the seamless transportation of vaccines throughout the nation, ensuring that every community receives the necessary protection against preventable diseases.”

The trucks will facilitate the transportation of vaccines from central to regional storehouses and onwards to the health facilities. The vaccine carriers and cold boxes are already procured and distributed to the offices of the Medical Officers of Health and hospitals.

“Vaccination protects children from many preventable diseases and enables them to live a healthy life. Vaccines are temperature-sensitive and need to be transported in appropriate conditions. These trucks will help us reach every child in every corner of Sri Lanka with the right vaccine at the right time. UNICEF values the long-standing support of the Government of Japan and the collaboration with the Ministry of Health in improving the health of all children in the country,” added Begoña Arellano, Acting UNICEF Representative in Sri Lanka. 

Over the years, the Government of Japan has made significant contributions to support the joint efforts of UNICEF and the Ministry of Health in addressing both the long- and short-term health needs of children. (Newswire)

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The suspects who were remanded after being implicated in the alleged importation of substandard Immunoglobulin vaccines, including former Health Minister Keheliya Rambukwella, have been refused bail. 

The former minister and five other suspects, who are already in remand custody over the matter, were refused bail again today.

The Maligakanda Magistrate’s Court has denied bail till conclusion of the case on the importation of substandard Immunoglobulin vaccines.

The Criminal Investigations Department (CID) had commenced an investigation into allegations that the pharmaceutical company had imported 22,500 vials of substandard Immunoglobulin vaccines by creating forged documents with the assistance of the two senior state officials. 

Investigations revealed that financial fraud of Rs. 130 million had occurred via the imports of the said substandard medicine.

Based on the investigations, several Health Ministry officials, including former Minister Keheliya Rambukwella were arrested and remanded over the matter. (NewsWire)

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Covid vaccines from companies like Pfizer, Moderna and AstraZeneca were linked to rare occurrences of heart, brain and blood disorders, a recent peer-reviewed study found, though experts say the risks of developing Covid-19 greatly outweigh the risks of getting vaccinated.

KEY FACTS

• Researchers from the Global Vaccine Data Network—a research arm of the World Health Organization—looked at expected versus observed rates of 13 medical conditions that were considered “adverse events of special interest” in a study population of 99 million vaccinated people eight countries, making it the largest Covid vaccine study to date.
• Rare cases of myocarditis—inflammation of the heart—were identified in the first, second and third doses of Pfizer-BioNTech’s and Moderna’s mRNA vaccines: The highest rate was seen after the second Moderna dose (6.1 times the expected rate of cases), according to the study published in the journal Vaccine.
• Another heart condition called pericarditis had a 6.9-fold increased risk in those who took a third dose of AstraZeneca’s viral-vector vaccine, while a first and fourth dose of Moderna’s vaccine had a 1.7-fold and 2.6-fold increased risk, respectively.
• There was a 2.5-times greater risk of developing the rare autoimmune disorder Guillain-Barre syndrome among those who took AstraZeneca’s vaccine compared to the rate researchers expected, and a 3.2-times greater risk of getting blood clots among the same population.
• There was a 3.8-times greater risk of developing the neurological disorder acute disseminated encephalomyelitis after the Moderna vaccine was administered, and a 2.2-fold increased risk after AstraZeneca’s vaccine, according to the study.

BIG NUMBER

13.5 billion. That’s how many Covid vaccines have been administered worldwide since the start of the Covid pandemic, according to science research organization Our World in Data. Around 71% of the world’s population has received at least one dose of a Covid vaccine.

CRUCIAL QUOTE

“The odds of all of these adverse events is still much, much higher when infected with SARS-CoV-2 (COVID-19), so getting vaccinated is still by far the safer choice,” CEO of biotechnology company Centivax Jacob Glanville, who is not involved in the study, told Forbes.

KEY BACKGROUND

Covid vaccines are meant to prevent severe infection, and studies have indicated Moderna, Pfizer-BioNTech and AstraZeneca’s vaccines are effective at preventing severe illnesses, hospitalizations and death. Meanwhile, the chances of having a neurological event after a Covid infection were up to 617-fold higher than following COVID vaccination, which suggests “the benefits of vaccination substantially outweigh the risks,” according to the Vaccine study researchers. The risk of developing myocarditis is higher post-Covid infection than after getting a Covid vaccine, according to Akiko Iwasaki, PhD, professor of Immunobiology at Yale University. Myocarditis risk after the second dose of a Covid vaccine is 35.9 per 100,000 people, compared to a 64.9 per 100,000 risk after Covid infection. The risk of developing Guillain-Barre syndrome after Covid infection was six times greater, and the risk of developing it after vaccination was 0.41 times greater than the control group, according to a 2023 study published in Neurology. While most Americans have received at least one Covid-19 vaccine shot, uptake for booster shots that are updated to combat new coronavirus strains has remained slow.

TANGENT

The rapidly spreading Covid variant JN.1 caused an uptick in cases during the fall and winter months, causing a resurgence of the tripledemic—when cases of Covid, flu and respiratory syncytial virus simultaneously increase. JN.1 made up 96.4% of all cases in the two week period ending in Feb. 17. However, Covid cases (down 0.6%) and deaths (down 6.9%) are declining—though hospitalizations are up 0.8%—signaling an end to the tripledemic. The variant was classified as a “variant of interest”—meaning it’s spreading in a way that may pose “an emerging risk to global public health”—by the World Health Organization in December. JN.1 is an offshoot of the highly mutated Pirola (BA.2.86) virus that some experts worried wouldn’t be protected against the updated monovalent Covid boosters, which specifically target XBB variants. However, vaccine makers ensured their shots provided some protection. (Forbes)

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Criminal Investigations Department (CID) officials visited the residence of former Health Minister Keheliya Rambukwella to obtain a statement on the importation of substandard medicines, based on a request by the latter to voluntarily provide a statement on the matter, the Police said.

Responding to questions raised by the media on why the CID officials had not summoned the minister to record a statement, which had also been the talk on social media, Police Spokesman SSP Nihal Thalduwa issued a clarification.

Addressing the media yesterday, SSP Thalduwa revealed that as the investigations were ongoing the CID had not made a decision at the time to question Keheliya Rambukwella.

“Only when the CID has enough evidence will they summon an individual for questioning. However, Minister Rambukwella had voluntarily informed the CID that he was willing to provide a statement and that he was also able to provide sufficient evidence, requesting the officers to visit his residence. Based on this, the CID had decided to record the statement at the minister’s residence,” he clarified. 

The CID recorded a statement from Minister Keheliya Rambukwella at his residence on Tuesday (Dec 26) on the importation of substandard stocks of Immune Globulin vaccines during his tenure as the Health Minister.

A probe was initially launched into allegations that a pharmaceutical company had imported 22,500 vials of substandard Immune Globulin vaccines by creating forged documents with the assistance of the two senior state officials. 

CID investigations also found that financial fraud of Rs. 130 million had occurred via the imports of the said substandard medicine. 

Further investigations found that Sudath Janaka Fernando alias ‘Aruna Deepthi’ who owns the pharmaceutical company had imported the stock of substandard medicines.

Chief Executive Officer of the National Medicines Regulatory Authority (NMRA) Dr. Vijith Gunasekera and the Director of Supply at the Ministry of Health Dr. Kapila Wickramanayake were found to have assisted the importation by providing forged ministry documents. 

The group was arrested and remanded, after which Former Health Ministry Secretary Janaka Chandragupta was also arrested over the matter.

The Maligakanda Magistrate’s Court yesterday remanded five suspects, including  Former Health Ministry Secretary Janaka Chandragupta until January 10, 2024. (NewsWire)

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Sri Lanka’s former Health Ministry Secretary Janaka Chandraguptha has been arrested over the case filed on the importation of substandard stocks of Immune Globulin vaccines.

Janaka Chandraguptha was arrested by the Criminal Investigations Department (CID) today (Dec 18).

The arrest comes after the CID commenced an investigation into allegations that a pharmaceutical company had imported 22,500 vials of substandard Immune Globulin vaccines.

It was revealed that the importation had been carried out by creating forged documents with the assistance of the two senior state officials and that financial fraud of Rs. 130 million had occurred via the imports of the said substandard medicine.

The suspects involved in the fraudulent importation were Sudath Janaka Fernando alias ‘Aruna Deepthi’ who owns the pharmaceutical company, the Chief Executive Officer of the National Medicines Regulatory Authority (NMRA) Dr. Vijith Gunasekera, and the Director of Supply at the Ministry of Health Dr. Kapila Wickramanayake.

The suspects were arrested by the CID following investigations launched into the matter, with the arrest of the former Health Ministry Secretary Janaka Chandraguptha being the latest apprehension related to the case. (NewsWire)

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