Latest news with #vaccine
Associated Press
13 hours ago
- Business
- Associated Press
mRNA Technology Transfer Programme's Phase 2.0 discussed with partners on the sidelines of G20 Summit
With the G20 Health Working Group, global health leaders are coming together to set the foundation for a new phase of the mRNA Technology Transfer Programme 'This is a unique opportunity, driven by the pandemic. The foundations are in place — but without sustained political will, the promise of equitable mRNA access could slip through our fingers.'— Charles Gore, Executive Director of the Medicines Patent Pool JOHANNESBURG, GAUTENG, SOUTH AFRICA, June 20, 2025 / / -- In parallel with the G20 Health Working Group, global health leaders are coming together in Johannesburg to set the foundation for a new phase of the mRNA Technology Transfer Programme – a pioneering initiative transitioning from proof of concept to sustainable, commercially viable manufacturing, while enhancing pandemic preparedness and regional health security. Launched in 2021 by the World Health Organization (WHO) and the Medicines Patent Pool (MPP), with the support of the Government of South Africa, France, Belgium, Canada, the European Union, Germany and Norway, the Programme has successfully enabled 15 Partners across Latin America, Africa, Eastern Europe and Asia to receive foundational mRNA technology. Now, it is moving into Phase 2.0 (2026–2030), with the aim of empowering regional manufacturers to scale up commercially sustainable production of mRNA-based vaccines and therapeutics at Good Manufacturing Practices (GMP)-grade. 'The mRNA Technology Transfer Programme is delivering on its promise to build capabilities in low- and middle-income countries,' said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. 'The Pandemic Agreement adopted by the World Health Assembly also includes legally-binding commitments to strengthen local production. We must now translate those commitments into capacity on the ground, so that when the next pandemic strikes, we meet it more equitably and more effectively.' 'This is a unique opportunity, driven by the pandemic. The foundations are in place — but without sustained political will, the promise of equitable mRNA access could slip through our fingers.' said Charles Gore, Executive Director of the Medicines Patent Pool. 'What we need now is the courage to build on our investment to date, to align, and to realise the full value and impact of what we started.' From technology access to market-ready solutions The Programme is moving from focus on technology acquisition to defining how each partner will translate it into real-world impact. Each manufacturer is now focused on developing an economic case for long-term, flexible, and commercially viable manufacturing — with the capacity to produce mRNA vaccines in inter-pandemic periods and pivoting rapidly in response to future health emergencies. Product focus areas include: mRNA vaccines – for pandemic and priority diseases (e.g., influenza, TB, HIV, malaria, dengue, leishmaniasis); mRNA therapeutics – such as oncology and monoclonal antibody (mAb) treatments; and Biologicals beyond mRNA – including near-term commercial products to support facility viability. 'We have successfully progressed with the technology transfer to eight Partners — a testament to the strength and openness of this platform,' said Prof. Petro Terblanche, CEO of Afrigen Biologics. 'What comes next is even more exciting: Afrigen is on the cusp of receiving GMP accreditation, positioning us not only as a technology originator but as a sustainable manufacturing and innovation partner for the Global South. We will continue to work with local and global partners on the development of new vaccines prioritizing the burden of disease in LMICs.' A diversity of models, one global goal The Programme's Phase 2.0 recognises that there is no one-size-fits-all model. Manufacturers will develop tailored business strategies based on national health needs and policy, regulatory maturity and regional market dynamics. Some, like Bio-Manguinhos and Sinergium in Latin America, BioFarma in Indonesia, and Biovac in South Africa, are already piloting investment roadmaps with detailed market, regulatory, and COGS (cost of goods sold) modelling. Others will receive bespoke support to develop their investment cases. Crucially, sustainability will depend on country and regional-level procurement commitments, pooled purchasing mechanisms, and cross-border alignment — especially in Africa and Asia, where national markets alone may be insufficient to support GMP-level manufacturing scale. 'We need to back science with smart policy,' said Dr Mmboneni Muofhe of South Africa's Department of Science, Technology and Innovation. 'This is about creating a new ecosystem for public health security, grounded in regional ownership, long-term strategy and investments.' Rising demand meets structural barriers While market opportunities for mRNA vaccines and therapeutics are growing — from seasonal influenza and HPV to innovative cancer treatments — the Programme acknowledges structural hurdles: Misinformation and vaccine hesitancy; Shifting donor funding priorities that reduce funding availability; High clinical trial costs; and Need for supportive policies and well-defined procurement pathways. The mRNA Programme highlights both the growing interest in regional R&D consortia focused on target diseases of regional relevance like leishmaniasis and malaria, and the drive to advance next-generation technologies focusing on dose sparing, reduced cost of goods and thermostability. Edwin Reichel Flow Communications +27 114404841 email us here Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Yahoo
17 hours ago
- Business
- Yahoo
EMA Accepts GSK's Filing for Expanded Use of RSV Vaccine Arexvy
GSK plc GSK announced that the European Medicines Agency (EMA) has accepted the regulatory application seeking approval to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, for use in adults aged 18 years and above. With the EMA accepting the application for review, a final decision from the regulatory body in Europe is expected in the first half of 2026. Arexvy is currently approved for the prevention of lower respiratory tract disease ('LRTD') caused by RSV in all individuals aged 60 years and above, as well as for high-risk individuals aged 50-59 years. GSK is currently seeking approval for the expanded use of Arexvy in adults aged 18 years and above in the United States and Japan. Year to date, shares of GSK have risen 20.8% against the industry's decline of 0.6%. Image Source: Zacks Investment Research Arexvy was the first RSV vaccine for older adults to be approved anywhere in the world. However, sales of the vaccine have been lukewarm, mainly due to the revised recommendations for RSV vaccinations issued by the Advisory Committee on Immunization Practices ('ACIP') in June 2024. In June, the ACIP recommended the use of Arexvy for all adults aged 75 years and above. However, for adults aged 60-74 years, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. Arexvy generated sales worth £78 million in the first quarter of 2025, down 57% year over year due to lower demand in the United States. Pfizer's PFE Abrysvo is approved for the prevention of RSV-associated LRTD in all individuals aged 60 years and above, as well as in infants, through maternal immunization. PFE's Abrysvo is also approved for use in high-risk adults aged 18-59 years in the United States and Europe. Earlier this year, the ACIP recommended the expanded use of Arexvy and Abrysvo for use in adults aged 50-59 years who are at high risk for severe RSV disease. The updated ACIP recommendation lowers the recommended age for RSV vaccination from 60 years to 50 years for high-risk adults. The ACIP's recommendation is pending final approval by the director of the U.S. Centers for Disease Control and Prevention ('CDC') and the Department of Health and Human Services. Moderna's MRNA RSV vaccine, mResvia, was approved last year by the FDA and the European Commission to prevent RSV-LRTD in older adults aged 60 years and above. Last week, the FDA approved MRNA's mResvia for use in high-risk adults aged 18-59 years. Moderna is also working on expanding the vaccine's use in pediatric populations. We note that RSV vaccine sales have been weak across the industry for the 2024-2025 vaccination season due to the restrictive recommendation issued by the U.S. CDC last year for individuals in the 60-74 age bracket. mResvia generated sales worth $2 million during the first quarter of 2025, while sales of Pfizer's RSV vaccine, Abrysvo, fell 9% year over year to $131 million. GSK currently carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
CNN
a day ago
- Health
- CNN
Infectious disease expert explains why she resigned from the CDC
Former CDC infectious disease expert Dr. Fiona Havers tells CNN's Jake Tapper why she resigned her post as a senior vaccine adviser, citing concerns about changes to the agency's vaccine processes under US Health and Human Services Secretary Robert F. Kennedy Jr.
CNN
a day ago
- Health
- CNN
Infectious disease expert explains why she resigned from the CDC
Former CDC infectious disease expert Dr. Fiona Havers tells CNN's Jake Tapper why she resigned her post as a senior vaccine adviser, citing concerns about changes to the agency's vaccine processes under US Health and Human Services Secretary Robert F. Kennedy Jr.
The Independent
a day ago
- Health
- The Independent
Groundbreaking single-dose vaccine found effective in preventing HIV
Scientists have developed a vaccine which provides a strong immune response against HIV in mice, an advance that could lead to potent single-dose vaccines for a range of infectious diseases. The vaccine candidate, when delivered along with two powerful adjuvants that stimulate the immune system, could produce a wide diversity of antibodies against the HIV virus, according to a new study published in the journal Science Translational Medicine. Researchers from the Massachusetts Institute of Technology in the US found that the vaccine accumulated in the lymph nodes and remained there for up to a month, allowing mice to build up a much greater number of antibodies against the HIV protein. This strategy may lead to new vaccines that only need to be taken once for a range of infectious diseases, including HIV or Sars-CoV-2, scientists say. 'This approach is compatible with many protein-based vaccines, so it offers the opportunity to engineer new formulations for these types of vaccines across a wide range of different diseases, such as influenza, Sars-CoV-2, or other pandemic outbreaks,' said Christopher Love, a co-author of the study from MIT. Adjuvants are commonly given along with vaccines to help stimulate a stronger immune response against proteins present on pathogens. For instance, protein-based vaccines like those for hepatitis A and B are delivered along with the adjuvant aluminium hydroxide, also known as alum, which helps the body form a stronger memory of the infectious agent. Scientists previously developed another adjuvant called saponin derived from the bark of the Chilean soapbark tree. Researchers have shown that a tiny nanoparticle formulation of saponin, along with an inflammation-promoting molecule called MPLA, can be used as an adjuvant for an HIV vaccine under trial. An alum and SMNP combination used as an adjuvant for the vaccine could generate even more powerful immune responses against HIV or SARS-CoV-2, scientists say. Scientists suspect this combination boosts the immune response, specifically via the body's B cells, which produce antibodies. They found that such a vaccine combination accumulated in the mice lymph nodes, causing their B cells to undergo rapid mutations to generate a mix of antibodies against HIV. Researchers showed that the SMNP and alum combination helped an HIV protein penetrate through a protective layer of cells around the lymph nodes without being broken down. 'As a result, the B cells that are cycling in the lymph nodes are constantly being exposed to the antigen over that time period, and they get the chance to refine their solution to the antigen,' Dr Love explained. Scientists liken this process to what occurs during a natural infection, when antigens can remain in the lymph nodes for weeks, giving the body time to mount an immune response. 'What's potentially powerful about this approach is that you can achieve long-term exposures based on a combination of adjuvants that are already reasonably well-understood, so it doesn't require a different technology,' Dr Love said. 'It's just combining features of these adjuvants to enable low-dose or potentially even single-dose treatments,' he said.
