New initiative launched to advance mRNA vaccine development against human avian influenza (H5N1)

A new project aiming to accelerate the development and accessibility of human avian influenza (H5N1) messenger RNA (mRNA) vaccine candidates for manufacturers in low- and middle-income countries has been launched today. The Argentinian manufacturer Sinergium Biotech will lead this effort leveraging the World Health Organization (WHO) and the Medicines Patent Pool (MPP) mRNA Technology Transfer Programme.

The mRNA Technology Transfer Programme, jointly developed by WHO and MPP, was launched in July 2021 with the aim to build capacity in low- and middle-income countries (LMICs) for the development and production of mRNA-based vaccines. Sinergium Biotech, a partner in the mRNA Technology Transfer Programme, has developed candidate H5N1 vaccines and aims to establish proof-of-concept in preclinical models. Once the preclinical data package is concluded, the technology, materials, and expertise will be shared with other manufacturing partners, aiding the acceleration of the development of H5N1 vaccine candidates, and bolstering pandemic preparedness efforts.

“This initiative exemplifies why WHO established the mRNA Technology Transfer Programme – to foster greater research, development and production in low- and middle-income countries, so that when the next pandemic arrives, the world will be better prepared to mount a more effective and more equitable response,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

“When we created the mRNA Technology Transfer Programme with WHO, our goal was to enable low- and middle-income countries to lead development efforts, foster collaboration, share resources, and disseminate knowledge,” said Charles Gore, Executive Director of MPP. “This project embodies our vision and demonstrates a strong commitment to future pandemic preparedness and response.”

Avian influenza viruses are a significant public health risk due to their widespread circulation in animals and potential to cause a future pandemic. This development supplements ongoing work under the Pandemic Influenza Preparedness Framework to improve and strengthen the sharing of influenza viruses with human pandemic potential and increasing LMIC access to vaccines.

“This announcement underscores the importance of not only geographically diversifying the innovation and production of health technologies including and recognizing the capacities in Latin American and the Caribbean, but also the importance of early planning for access and the sharing of knowledge and technologies during the research and development processes,” said Dr Jarbas Barbosa, Director of the Pan American Health Organization.

Dr Alejandro Gil, Chief Executive Officer of Sinergium, said, “Sinergium’s enhanced capacity and readiness to apply our expertise to H5N1 will play a vital role in this effort towards global pandemic preparedness. I would also like to thank PAHO who have also been instrumental through the strong support it offers to regional manufacturers in the Americas. We are excited to tackle this public health challenge and our R&D team will continue to work closely with the Programme Partners.”Since its inception, the mRNA Technology Transfer Programme has developed and implemented a platform that was used to establish the immunogenicity, efficacy, and safety of a COVID-19 vaccine candidate in preclinical animal models. Afrigen is the centre where the platform was created and is being validated and this technology is now being transferred to manufacturing partners to adapt and enhance it for other critical disease targets. The progress made by the mRNA Technology Transfer Programme is a vital part of WHO and MPP’s efforts to improve the availability, access, and use of mRNA vaccines for better vaccine equity globally.

To see published note click here.

WHO mRNA Technology Transfer Program Meeting

Meeting of the WHO mRNA Technology Transfer Programme to discuss investment opportunities with multilateral development banks, hosted by PAHO. 

Washington, DC – April 17, 2024 – (PAHO)- The Pan American Health Organization (PAHO) hosted a meeting of the WHO mRNA Technology Transfer Programme, with the participation of the fifteen mRNA programme members and major multilateral development banks. This event is part of the global effort to strengthen vaccine manufacturing capacity in LMICs, as well as a key platform for stakeholders to explore investment opportunities. 

The meeting contributed to promoting alliances and fostering bridges between funding and manufacturing institutions, to build a future where developing countries are not only prepared for future crises but become leaders in innovative solutions for global public health. 

In her opening words, Judit Rius Sanjuan, Director of PAHO’s Department on Innovation, Access to Medicines and Health Technologies, highlighted PAHO’s efforts in innovation and production towards fostering regional collaboration an promoting equity in acccess.  

Rius Sanjuan referred to current PAHO’s project in Argentina, where a partnership has been formed with Sinergium Biotech, one of the programme partners, and ANLIS, a public producer, to establish a national mRNA vaccine production ecosystem. The partnership -ensures that during public health emergencies, there will be access to real-time vaccine production to countries in the Region through the Revolving Fund at production cost-linked prices. Also mentioned the ongoing project in Brazil with BioManguinhos/FIOCRUZ to support pre-clinical trials for an mRNA vaccine, whose technology might be licensed to regional manufacturers in LMIC at no cost if studies are successful. Both manufacturers from the region and members of the mRNA program, were part of the meeting.  

Regarding investment opportunities in the region, Rius Sanjuan stated that it is not possible to achieve sustainability without rethinking how technology development projects as well as policy ecosystems that promote innovation and production in LMICs are financed.  

Claudia Nannei, Senior Programme Manager at WHO, mentioned that the WHO mRNA Technology Transfer Programme facilitates that countries and partners participating acquire know-how for mRNA vaccines production; facilities will have to produce both pandemic and non-pandemic products to ensure sustainability in the long term. PAHO and WHO are promoting South-South collaboration to undertake R&D of vaccines. Know-how developed under these collaborations is to be shared freely with mRNA Programme partners.

To see published note click here.

Sinergium Biotech present at the PAHO Dialogue

It was an honor for SINERGIUM Biotech, together with Fernando Lobos to have participated last March 14 in the Dialogue: Opportunities and Challenges for Increasing Vaccine Innovation and Production Capacities in Latin America and the Caribbean, held by Pan American Health Organization.

Today I spoke with health technology innovation and production institutions in Latin America and the Caribbean to learn more about the challenges they face and how together we can improve equitable access to these critical inputs. We know that the production of vaccines, medicines and strategic supplies is geographically concentrated in the world, which contributes to the vulnerability of many countries. This calls us to redouble our efforts to strengthen capabilities, and the Pan American Health Organization is committed to assuming a transformative role to support regional innovation and production. [Jarbas Barbosa, Director at the Pan American Health Organization (PAHO/AMRO)]

To see published note click here.

Hepatitis A

Technology transfer and tender won: Sinergium biotech creates a strong alliance with the company Sinovac in order to complete a new technology transfer for the production of the hepatitis A vaccine.

The successful introduction of a vaccine into an immunization program is a significant achievement for any country, with vaccines being a fundamental tool in disease prevention. Its availability and adequate coverage can have a positive impact on the health of the population. Argentina has demonstrated notable success in implementing a vaccination scheme against Hepatitis A, being a model in the region of the Americas, which has contributed to the reduction of cases of this disease and the protection of the health of its citizens.

In this context, Sinergium Biotech, as a pharmaceutical company, plays an essential role in the production and distribution of vaccines in our country. Through the replication of successful cases of technology transfer, our company has partnered with Sinovac to complete a technological transfer for the production of the Hepatitis A vaccine. During the year 2023, our company has taken the first step to finalize this alliance by participating in the public tender for the supply of 710,000 doses of vaccines for adults and children. Recently, our offer has been the only one valid for the award because it has the lowest price and complies with all the conditions required by the specifications. With our VAXIPAT vaccine, we have the opportunity to significantly contribute to improving vaccination coverage next year at a price lower than what Argentina would have accessed through the Revolving Fund of the Pan American Health Organization, competing with the largest multinational laboratories.

This implies that more Argentines will have access to vaccines produced by an Argentine company, recognized as a model in the region. Through its commitment to vaccine production and distribution, Sinergium Biotech can help ensure that a greater number of Argentines receive the Hepatitis A vaccine and other essential vaccines. This not only protects individuals from potentially serious diseases, but also contributes to herd immunity and overall public health.

About Sinovac:

Sinovac Biotech is a Chinese biopharmaceutical company that focuses on the research, development, manufacturing and marketing of vaccines, including Healive (hepatitis A). The company is headquartered in Haidian District, Beijing.

Director of PAHO visits Sinergium Biotech

Last Friday we had the honor of receiving Jarbas Barbosa Da Silva Jr, General Director of the Pan American Health Organization and Regional Director for the Americas of the World Health Organization, at our facilities, along with a delegation of PAHO advisors, where signed a new agreement within the program to promote the development and production of vaccines based on mRNA technology.
This development in the country will contribute to reducing the region’s external dependence and moving towards more equitable access to vaccines and innovative health technologies in Latin America and the Caribbean.

To see published note click here.

Sinergium Biotech welcomes the MPP and the WHO

During 24-26 October, we had the privilege of hosting a visit from the Medicines Patent Pool (MPP) as part of the mRNA Technology Transfer Programme. This visit marked a significant step in our ongoing efforts to strengthen our capabilities in the field of mRNA technology.

The objectives of this visit encompassed several key areas:
Facility Assessment: Our visitors assessed the current state of our plant, gaining a comprehensive understanding of our facilities, quality control systems, equipment, personnel, and regulatory compliance.
Strategy Analysis: A rigorous analysis of Sinergium’s strategy for implementing mRNA technology was conducted, focusing on the steps taken to establish and advance on our mRNA platform.
Action Plan Development: A crucial outcome of this visit is the collaborative development of an action plan. This plan will outlines specific activities, budget allocations, and timelines, all aimed at ensuring that Sinergium is well-prepared to receive and implement mRNA technology effectively.

Our team remains dedicated to becoming the leading mRNA vaccine producer in Argentina. The knowledge and insights gained from this visit are invaluable in helping us achieve this goal. We extend our gratitude to the Medicines Patent Pool (MPP) for their support and guidance throughout this endeavor.

You can learn more about this Programme by visiting the following links:
www.mrnaprogramme.org

About SINERGIUM Biotech – Argentine biopharmaceutical company is specialized in the research, development, production and commercialization of vaccines and highly complex biopharmaceutical products.  https://lnkd.in/d-cMPhRf

About MPP – The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries.  https://lnkd.in/dJvmU_V

To see published note click here.

PAHO Director completed visit to Argentina focusing on vaccine production and community approach to mental health

Buenos Aires, October 7, 2023 (PAHO/WHO). The Director of the Pan American Health Organization (PAHO), Jarbas Barbosa, participated yesterday in the closing of the 5th World Summit on Mental Health where he emphasized the importance of integrating this issue into all public policies in order to address social determinants, economic and environmental aspects of mental health.

“The incorporation of mental health in all policies will reinforce recovery efforts from the pandemic and will contribute to rebuilding better health systems and services,” the PAHO Director said in Buenos Aires.

Dr. Barbosa highlighted that “investing in the development of human capital and social protection is essential to promote and protect mental health” while considering it necessary to “increase investment in community-based care” to improve the recovery results of the people with mental health problems.

He also indicated that childhood and adolescence “constitute an important window of opportunity to promote and protect good mental health, identify people at risk and provide early care.” He also highlighted old age, a time of life when “older adults also face significant mental health risks.” For this, “the expansion of community-based services and care, as well as integrated networks of services and support beyond the health sector,” is essential.

Another of the axes that he highlighted was the value of mental health and psychosocial support as essential components in the response to public health emergencies, humanitarian crises, and the present and future threats of climate change.

“I am confident that if we, as a global community, work together, we can build on the momentum generated by this summit to transform mental health for the good of all, including future generations,” concluded the PAHO Director.

mRNA technology transfer

In the morning, Dr. Barbosa visited the Sinergium Biotech plant in order to see the facilities and sign the cooperation agreement for the production of mRNA vaccines in Argentina, within the framework of the Regional Platform for the innovation and production of vaccines and other PAHO health technologies.

This cooperation is complemented by the World Health Organization (WHO) and Medicines Patent Pool (MPP) technology transfer program for the development of mRNA vaccines in low- and middle-income countries. Thus, in September 2021, PAHO/WHO announced that Sinergium Biotech, from Argentina, and the Bio-Manguinhos Institute of Immunobiology, from Brazil, were selected to join the WHO network for technology transfer for the mRNA vaccines.

The agreement was also signed on Monday with national authorities so that the National Administration of Laboratories and Health Institutes “Dr. Carlos Malbrán” (ANLIS-Malbrán), dependent on the Ministry of Health of Argentina, is part of the production chain through the development of lipid nanoparticles, essential inputs in the production of mRNA vaccines. In addition, it includes the National Agency for the Promotion of Research, Technological Development and Innovation (R&D+i Agency) which will contribute to the promotion of studies and the creation of capabilities in the country.

These activities culminated yesterday in the official visit to Argentina of the Director of PAHO, which began on Monday and included a work agenda that included meetings with national and jurisdictional authorities in the field of government, health, science and technology, as well as with members of the Commission for Social Action and Public Health of the Chamber of Deputies of the National Congress where Dr. Barbosa advocated for Argentina’s ratification of the Framework Convention for Tobacco Control (FCTC) of the World Health Organization (WHO).

In addition, during the week the Director of PAHO toured the ANLIS – Malbrán laboratories and the vaccination center and the facilities of the Garrahan Hospital. He also announced the creation of the Pharmaceutical Services Network of the Americas (RedSFar), presented a new tool to evaluate the quality of the provision of pharmaceutical services, held a meeting with representatives of the PAHO Collaborating Centers in Argentina, and spoke at a conference on the challenge of health systems organized by the Latin American Association of Private Health Systems (ALAMI).

To see published note click here.

PAHO Director meets with the President of Argentina to discuss regional vaccine development and other priority health issues

Buenos Aires, October 3, 2023 (PAHO/WHO) – The Director of the Pan American Health Organization (PAHO), Dr. Jarbas Barbosa, held a meeting today with the President of Argentina, Alberto Fernández, in which they highlighted the need to strengthen the production of vaccines and medical supplies in Latin America and the Caribbean, in order to move towards regional self-sufficiency.

In this sense, Dr. Barbosa highlighted the agreement signed yesterday with health, science and technology authorities of the country for the transfer of technology to the National Administration of Laboratories and Health Institutes (ANLIS-Malbrán), in order to develop nanoparticles of lipids, essential inputs in the production of mRNA vaccines.

Argentina, through the biopharmaceutical company Sinergium Biotech, was selected in 2021 by the WHO to receive technology transfer for the production of mRNA vaccines, which may eventually be offered to other countries in the region through the Regional Revolving Funds of the WHO. OPS.

Now, ANLIS-Malbrán will contribute to the production chain with the development of nanoparticles. In addition, the National Agency for the Promotion of Research, Technological Development and Innovation (R&D&i Agency) will join in by promoting studies and creating capabilities.

The future development of these vaccines and supplies in the country will help reduce the region’s external dependence and move towards more equitable access to vaccines.

A few days after the inauguration in the Autonomous City of Buenos Aires of the V World Summit on Mental Health, the Director of PAHO and the Argentine President analyzed the challenges in the matter after the impact of the COVID-19 pandemic, and the progress of the country from the perspective of human rights and inclusion.

The PAHO/WHO representative in Argentina, Eva Jané Llopis, and the Minister of Health, Carla Vizzotti, also participated in the meeting at the Casa Rosada.

The official visit to Argentina of the Director of PAHO, which began yesterday, has a work agenda that includes meetings with health, science and technology, and defense authorities, as well as meetings with parliamentarians and representatives of the United Nations and the centers PAHO collaborators in the country. It also includes visits to the Garrahan Hospital and the ANLIS-Malbrán and Sinergium Biotech laboratories.

To see published note click here.

Argentina and PAHO signed an agreement to strengthen the transfer of RNA technology for the production of vaccines and other health technologies

Furthermore, as part of the official visit of the PAHO director to Argentina, Vizzotti led a meeting with him together with authorities from ANLIS Malbrán, ANMAT and ANLAP in which they worked on axes prioritized by the national government on health research and development.

Within the framework of a high-level meeting with the director of the Pan American Health Organization (PAHO), Jarbas Barbosa da Silva, to address the national health research and production policy and the experience of Argentina’s incorporation into the HUB for the transfer of technology from the WHO, the Minister of Health of the Nation, Carla Vizzotti, signed a technical cooperation agreement between the portfolio she directs, the National Administration of Laboratories and Health Institutes (ANLIS) “Dr. Carlos Malbrán”, the National Agency for the Promotion of Research, Technological Development and Innovation (R&D&I), the biopharmaceutical company Sinergium Biotech and the PAHO with the aim of strengthening and increasing vaccine development and production capacities and other quality, safe and effective health technologies in Argentina and the Region of the Americas.

“It is extremely important that Argentina has been selected along with Brazil to carry out the technology transfer of a messenger RNA vaccine,” highlighted Vizzotti, while maintaining that “after a long year of work together with the R&D+ Agency “i, the Malbrán Institute, the Ministry of Health and a private production plant reached the signing of this agreement that will allow us to advance with equipment, strengthening and the transfer of the necessary technology to benefit the region.”

“With this agreement we are strengthening the mRNA vaccine production ecosystem and giving greater sustainability” to the PAHO/WHO technology transfer project in Argentina, stated the director of PAHO/WHO, Jarbas Barbosa. In addition, he added that the future development of these vaccines in the country “will help reduce the region’s external dependence on this technology and move towards more equitable access.”

La imagen tiene un atributo ALT vacío; su nombre de archivo es image-1-1024x682.png

In turn, the Minister of Science, Technology and Innovation, Daniel Filmus, highlighted that the vaccine “represents a before and after for the history of clinical studies in our country because it is the first time they have been carried out with our own vaccine. For us, it is also very important not only the possibility of substituting imports but also the ability to export, for which we have already started conversations. The ARVAC-Cecilia Grierson vaccine is also a successful case of public-private coordination between the Ministries of Science and Health, the R&D&I Agency, the National University of San Martín (UNSAM), CONICET and the laboratory. “Cassara.”

The R+D+i president, Fernando Peirano, stated that “Argentina has guaranteed and universalized the right to health and this can also be a good engine to value our industrial capacity, our scientific capacity to develop new solutions and it is That is why we have been accompanying the process. This agenda must aim to reach the ultimate consequences, which is neither more nor less than becoming a new treatment or a new health solution.”

Finally, the Secretary of Industry and Productive Development, José Ignacio de Mendiguren, highlighted that “for Minister Sergio Massa the articulation between science, health and industry is fundamental to consolidate a development model centered on import substitution and greater presence of Argentine work and innovation in the world.” And he added: “Something that the pandemic taught us was the importance of that synergy, which is why from the Ministry of Economy we have specific financing and development plans, in absolute coordination with the ministries of Health and Science, so that all these efforts are sustainable.”

It is worth remembering that in 2021, the WHO carried out a global call for expressions of interest in which manufacturers and public and private research institutions were invited to contribute to the establishment of technology transfer centers for messenger RNA vaccines against COVID-19. 19 in emerging economies. In this context, for the development and production of mRNA vaccines in Latin America, two regional centers were selected, both in Argentina and Brazil, with the private sector biopharmaceutical company Sinergium Biotech being chosen in Argentina.

Meeting with authorities from ANLIS Malbrán, ANMAT and ANLAP

During the day, Vizzotti led, together with the director of PAHO, a meeting with the head of ANLIS Malbrán, Pascual Fidelio, the head of the National Administration of Medicines, Food and Medical Technology (ANMAT), Manuel Limeres, and the president of the National Agency of Public Laboratories (ANLAP), Ana Lía Allemand, in which prioritized axes in health research and development were addressed, such as the production of messenger RNA vaccines, the transfer of new genomic and proteomic technologies to the countries of the region, the development of new Collaborating Centers and Reference Laboratories, and the advances of the Federal Network of Genomics and Bioinformatics of Argentina.

In addition, together with the WHO/PAHO representative in Argentina, Eva Jané Llopis, they took a tour of ANLIS-Malbrán where they visited the International Workshop on Poliovirus Sanger Sequencing, sponsored by PAHO.

Previously, they participated in the opening of the 9th Meeting of the ANLAP Executive Committee, where the management report and the research work of the scholarship recipients of the doctoral and postdoctoral scholarships co-financed by the National Scientific and Technical Research Council were presented. (CONICET) and the ANLAP of the 2020-2021 cohorts.

To see published note click here.

The president received the head of the PAHO after the agreement for the production of vaccines and health technologies

President Alberto Fernández received today the Director of the Pan American Health Organization (PAHO), Jarbas Barbosa, and the Minister of Health, Carla Vizzotti, within the framework of the recent cooperation agreement that Argentina signed with that public health agency to increase vaccine development and production capacities, and two days before the start of the 5th World Mental Health Summit in Buenos Aires.

During the meeting, in which the PAHO Representative in Argentina, Eva Llopis, also participated, the president appreciated that the health portfolio worked together with the National Administration of Laboratories and Health Institutes (ANLIS) “Dr. Carlos Malbrán”, the National Agency for the Promotion of Research, Technological Development and Innovation (R+D+i) and the biopharmaceutical company Sinergium Biotech, signed an agreement this week for the production of vaccines and other health technologies.

For Barbosa, “vaccine production remains very centralized in developed countries,” which is why he congratulated “the effort that Argentina, the public sector and the private sector, are making to produce vaccines that will serve the population of Argentina and of Latin America and the Caribbean”.

The agreement reached with PAHO aims to advance with equipment and strengthen the transfer of technology necessary to develop and produce messenger RNA vaccines in the region.

The development of these vaccines in the country, through the coordination between science, health and industry, will allow progress towards more equitable access and reduce the region’s external dependence on this technology, with a greater presence of Argentine work and innovation in the world.

Meanwhile, the President will open this Thursday the 5th World Mental Health Summit, which for the first time will be held in Latin America with the presence, in addition to Barbosa, of the Director General of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus. , Ministers of Health from around the world, national, regional and international experts in mental health and representatives of user associations and civil society organizations.

To see published note click here.