Latest news with #BiologicalE
Zawya
15 hours ago
- Health
- Zawya
South Africa's Biovac to make, distribute pneumonia vaccine across Africa
Cape Town-based biopharmaceutical company Biovac has signed a transfer agreement with Biological E in India to manufacture and distribute a pneumonia vaccine across Africa. Biological E's PCV14 – a 14-valent pneumococcal conjugate vaccine, having broad serotype coverage – was found to be non-inferior to Prevenar 13 for all shared serotypes in the pivotal phase-three randomised, active control trial. Biological E's PCV14 vaccine is already licensed in India and is currently undergoing World Health Organisation (WHO) prequalification with the aim being to make the vaccine available to Unicef and Gavi markets soon thereafter. In parallel, a technology transfer is being initiated with Biovac that is anticipated to take three years including regulatory approval. Pneumococcal infection, which the vaccine protects against, is a cause of significant disease, being a leading cause of pneumonia, bacterial meningitis, and sepsis. WHO estimated that in 2005, pneumococcal infections were responsible for the death of 1.6 million children worldwide and while this has reduced significantly over time, newer and better vaccines are still needed. Dr Morena Makhoana, Biovac CEO, states: 'Biovac is on a steady journey of ensuring that it expands its footprint beyond South Africa. We do so by carefully selecting our partners and the type of products that meet our customers' needs.
&w=3840&q=100)
Business Standard
30-04-2025
- Health
- Business Standard
India's first dengue vaccine Qdenga to launch in 2026: Check details here
If you have ever found yourself waging war against mosquitoes like your life depended on it (because sometimes, it really does), here's some hopeful news: help may finally be on the way. Japanese drugmaker Takeda is gearing up to launch its dengue vaccine, Qdenga, in India next year through a partnership with Hyderabad-based Biological E (Bio E), in line with the 'Make-in-India' initiative, The Times of India reported. Which countries have approved TAK-003 and how effective is it? The vaccine expected to be offered is TAK-003, marketed under the brand name Qdenga. It received prequalification from the World Health Organization (WHO) in May 2024. It has already been approved for use in several countries including Indonesia, Thailand, Argentina, Brazil, and members of the European Union (EU). Since its launch in 2023, over 10 million doses have been sold. Takeda was recently given the green light to conduct trials of Qdenga in India by the Central Drugs Standard Control Organisation (CDSCO). It has not been approved for use in India yet. How does the Qdenga dengue vaccine work against all four strains? TAK-003 or Qdenga is a tetravalent live-attenuated vaccine designed to protect against all four dengue serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). It contains weakened (attenuated) forms of the virus that are still alive but have been modified so they do not cause disease in healthy individuals. These weakened viruses stimulate the immune system to produce a strong and lasting immune response. It mimics a natural infection closely enough to train the immune system effectively, offering broad protection against all major strains of the virus. Who can get the Qdenga dengue vaccine? WHO age and eligibility guidelines The WHO recommends the use of Qdenga in children aged 6 to 16 years in areas with high dengue transmission. It is not currently recommended for children under 6 years of age due to lower efficacy observed in this group. According to WHO, people with comorbidities residing in dengue-endemic countries may be considered for vaccination even if they fall outside the recommended programme age range of 6 to 16 years, provided there is documented evidence of a significant burden of severe dengue outcomes within these subpopulations. However, until additional data on the efficacy and safety profile become available, WHO recommends a lower age limit of 6 years and an upper limit of 60 years for vaccinating people with comorbidities. Who should not take TAK-003 dengue vaccine: WHO issues safety exclusions According to WHO, the TAK-003 vaccine should not be administered to: Women who are pregnant or planning to become pregnant at least one month following vaccination Women who are breastfeeding People with congenital or acquired immune deficiency, including those receiving immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (for example 20 mg/day or 2 mg/kg body weight/day of prednisone for two weeks or more) within four weeks prior to vaccination People with symptomatic Human Immunodeficiency Virus (HIV) infection or with asymptomatic HIV infection associated with evidence of impaired immune function Dengue vaccine dosage: How Qdenga is administered and how long it lasts Qdenga is administered in a two-dose regimen spaced three months apart. According to WHO, currently, no annual or booster doses are recommended. Long-term studies have demonstrated sustained protection for up to 4.5 years, and ongoing research is evaluating the potential need for booster doses in the future. What do clinical trials say about Qdenga's efficacy and safety? According to a February 2024 paper titled Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4.5-year results from a phase 3, randomised, double-blind, placebo-controlled trial, published in The Lancet Global Health, clinical trials have demonstrated that TAK-003 is efficacious in preventing symptomatic dengue infections. Over a follow-up period of 4.5 years, the vaccine showed an overall efficacy of 64.2 per cent in individuals with prior dengue exposure and 53.5 per cent in those without prior exposure. Efficacy against hospitalised dengue cases was reported at 84.1 per cent. The company says the vaccine has been well tolerated, with a safety profile consistent across various age groups and baseline serostatus. India dengue vaccine rollout: Pricing, manufacturing and availability In India, as of April 2025, TAK-003 has not been approved for market use. Takeda has initiated local clinical trials in collaboration with Biological E to scale up production. The vaccine is expected to be available in Indian markets by 2026, pending regulatory approvals. 'Biological E Limited (BE) to manufacture up to 50 million doses of Qdenga per year,' the company said in a statement. Takeda plans to implement a dual pricing strategy in India, with different pricing for public and private markets. Specific price points have not been disclosed. Will Qdenga be included in India's public vaccination programme? Providing an update on the regulatory process, Derek Wallace, president of the global vaccine business unit at Takeda, said it was 'ongoing and on track', with clinical trials currently being conducted to generate local safety data. 'We have already submitted a comprehensive data package that supported registration in 40 countries, and we expect the vaccine to be licensed in India by 2026,' he told The Times of India. 'We intend to introduce the vaccine simultaneously in both the private and public sectors. Like in many other countries, India's National Immunisation Program is largely focused on the paediatric population. The initial discussions are aligned with WHO guidelines for implementing public programmes for children. However, in the private sector, we will offer the vaccine to both paediatric and adult populations,' Wallace added. He further said, 'Given that dengue threatens half the world's population, ensuring a sufficient vaccine supply is critical. Not only does this partnership enable local manufacturing in India, but it also expands our global footprint. Our goal is to produce 100 million doses annually by the end of the decade, with Bio E contributing half. Additionally, Bio E will be our sole manufacturer of multi-dose vials.' At present, the company's German facility manufactures only single-dose vials, whereas Bio E will produce both single- and multi-dose formats. Multi-dose vials are favoured in public health programmes as they lower costs, improve storage efficiency, and ease distribution. TAK-003 is not a standalone solution to dengue According to WHO, dengue vaccination should be considered one element of a broader, integrated disease control strategy. This includes effective vector control measures, appropriate case management, and active community education and engagement. While the vaccine is a huge leap forward, it's not a silver bullet. Medical experts say mosquito control measures like clean water storage and avoiding stagnant water will still be critical. Why the dengue vaccine launch is critical for India Dengue cases have been rising steadily across the country. According to the National Center for Vector Borne Diseases Control (NCVBDC) of the Ministry of Health and Family Welfare (MoHFW), in 2024 alone, India reported over 230,000 dengue cases and 236 related fatalities.
&w=3840&q=100)
First Post
28-04-2025
- Health
- First Post
‘Made in India' dengue vaccine likely to be launched next year. Here's what we know
India may have a dengue vaccine as early as next year. Developed by Japanese major Takeda, the vaccine named 'Qdenga' will be rolled out in India with the help of Hyderabad-based firm Biological E (Bio E). Qdenga will offer protection against all four dengue virus serotypes and will have two doses read more Qdenga's India rollout will be supported by Hyderabad-based Biological E, which will locally manufacture the dengue vaccine. Image for Representation. Pixabay India may soon see a major leap forward in its battle against dengue, as a 'Made in India' version of the vaccine 'Qdenga' could be launched as early as next year. The vaccine, originally developed by Japanese pharmaceutical company Takeda, is being manufactured in India through a collaboration with Hyderabad-based firm Biological E. As per a report by The Times of India, it is likely to be available by 2026 under the government's 'Make in India' initiative. STORY CONTINUES BELOW THIS AD Over the past few years, India has witnessed a troubling surge in dengue cases, leading to increased hospitalisations and fatalities. In 2023 alone, nearly 3 lakh cases were reported across the country, highest in the last 5 years, as per the information provided by the National Centre for Vector Borne Diseases Control. Also read: Over 12 million cases, 8,000 deaths in 2024: Is dengue the new global pandemic? Given the scale of the disease and its impact across India, the arrival of this dengue vaccine could prove to be a game-changer. Here's what we know so far about Qdenga. What is Qdenga, and how does it work? Dengue fever is a viral infection spread by the Aedes Aegypti mosquito. The virus has four distinct strains — DENV-1 to DENV-4 — which has long made developing an effective vaccine particularly challenging. That's where Qdenga, also known as TAK-003, comes in. This live-attenuated vaccine contains weakened forms of all four dengue virus serotypes and is designed to offer broad protection. It's administered in two doses, given three months apart. Also read: In Graphics | How do mosquitoes detect people, spread diseases? 'TAK-003 showed an excellent safety profile, and the immunogenicity after two doses against the four DENV serotypes was higher than 90 per cent among both adults and children/adolescents who were either seronegative or seropositive at baseline,' researchers noted in a review published in the journal Vaccines, based on clinical trial data from multiple countries. For context, 'seropositive' individuals have previously been exposed to dengue, while 'seronegative' individuals haven't, making the vaccine's performance across both groups especially effective. Qdenga is a live-attenuated vaccine that contains weakened forms of all four dengue virus serotypes. It's administered in two doses, given three months apart. AI-generated representative image As per Economic Times, Takeda's work on a dengue vaccine dates back to the 1980s, beginning with studies in Thailand. The company later joined hands with the US Centers for Disease Control and Prevention (CDC). In 2012, it launched one of its largest clinical trials — the TIDES study — which included 20,000 children across eight dengue-endemic nations. This was published alongside four-and-a-half years of follow-up data in The Lancet in 2023. STORY CONTINUES BELOW THIS AD In May 2024, the World Health Organization (WHO) granted prequalification status to Qdenga, after reviewing 19 studies that showed the vaccine reduced dengue cases by over 50 per cent. With the WHO's green light, global agencies like UNICEF and the Pan American Health Organization could procure the vaccine. Qdenga has already been approved in several countries, including Brazil, Indonesia, Thailand, Argentina, and across the European Union. Since its launch in 2023, more than 10 million doses of the vaccine have been administered. All about its launch in India Qdenga is currently undergoing clinical trials in India to gather local safety data, Derek Wallace, president of Takeda's global vaccine business unit, told The Times of India. 'We've already submitted a comprehensive data package that supported registration in 40 countries, and we anticipate the vaccine will be licensed in India in 2026,' he said. Wallace also confirmed that the vaccine will be launched simultaneously in both the private and public sectors. Qdenga is currently undergoing clinical trials in India to gather local safety data. It will be licensed in India in 2026. Image for Representation. Reuters 'Like in many other countries, India's National Immunisation Program is very paediatric-focused. The initial conversation aligns with WHO guidelines for implementing public programs for the paediatric population. However, we are introducing the vaccine in the private sector for both paediatric and adult populations,' he added. STORY CONTINUES BELOW THIS AD Also read: Russia's cancer vaccine is ready. Here's why it matters The Indian rollout will be supported by Hyderabad-based Biological E, which will locally manufacture the vaccine. While Takeda's German facility currently produces single-dose vials, Bio E will handle the production of both single- and multi-dose formats for the Indian market. 'Our goal is to produce 100 million doses annually by the end of the decade, with Bio E contributing half of that,' Wallace said. Bio E will also become Takeda's exclusive manufacturer for multi-dose vials, formats that are preferred in government health programmes due to their affordability, easier storage, and simpler logistics. With input from agencies
Time of India
27-04-2025
- Health
- Time of India
Dengue vaccine 'Qdenga' to launch in India next year
Representative image NEW DELHI: Japanese major Takeda plans to launch its dengue vaccine, Qdenga, in India next year, partnering with Hyderabad-based Biological E (Bio E) to align with the 'Make-in-India' initiative. Having recognised dengue as a "global health challenge," the over $23 bn company will adopt a "tiered pricing model for its first global vaccine to maximise access'', Derek Wallace, president, global vaccine business unit, Takeda, told TOI in an exclusive interview. The company, with focus on oncology, rare diseases and gastroenterology, negotiates lower prices for centralised govt procurement on a country-by-country basis, and a similar strategy will be implemented in India, he said. Elaborating on the regulatory process, he said, it "is ongoing and on track", with clinical trials underway to generate local safety data. "We've already submitted a comprehensive data package that supported registration in 40 countries and we anticipate the vaccine will be licensed in India in 2026'', he added. "We plan to introduce the vaccine in both private and public sectors simultaneously. The initial conversation aligns with WHO guidelines for implementing public programs for the pediatric population. However, we are introducing the vaccine in the private sector for both pediatric and adult populations'", Wallace added. Qdenga is the company's first globally developed and marketed vaccine. It is a tetravalent live-attenuated vaccine targeting all four dengue serotypes, and has a two-dose regimen with a three-month interval.
