Category: news

Pfizer and Sinergium Biotech entered into a collaboration agreement that will allow comprehensive production of the twenty-valent pneumococcal vaccine to begin in the country. It is expected that this private association will allow coverage to be extended nationally and the vaccine exported to the entire region, generating a foreign exchange income for the country of close to 100 million dollars.

The Minister of Health of the Nation, Mario Lugones, met today with authorities of the Pan American Health Organization (PAHO/WHO) and the Cooperative Consortium of Pfizer and the Argentine pharmaceutical company Sinergium Biotech S.A. to celebrate collaboration agreements that will enable the transfer of highly complex technology for the local production of the Twenty-Valent Pneumococcal Conjugate Vaccine (VCN20) in Argentina and that will improve access to it throughout the region of the Americas.

The initiative was presented by Pfizer and Sinergium Biotech to the National Ministry of Health and declared of public interest through Resolution 4844/2024 in October of last year. It represents an approximate investment of 20 million dollars for training, engineering works and acquisition of state-of-the-art equipment and transfer of technological knowledge.

During the meeting, the agreement signed between PAHO/WHO and Pfizer was also celebrated so that the pneumococcal vaccine produced in the country can be distributed to the rest of the region through the Revolving Fund that allows the countries of the Americas to access vaccines and public health supplies at affordable prices, in a timely and transparent manner.

meeting in the ministry of health for a public-private agreement in health

The local production of VCN20 will make it possible for Argentina to become the first producing country in Latin America and one of the few countries in the world with this capacity. This enables an export potential that in economic terms represents close to 100 million dollars.

The initiative also marks a before and after in the production of vaccines at the regional level, improving accessibility for the population throughout the region of the Americas. Likewise, it is a clear example of the benefits that can be obtained from the coordination between private parties and the collaboration of the State and international organizations.

The development and local availability of VCN20 provides the opportunity to optimize vaccine coverage. The new vaccine incorporates 7 serotypes that are responsible for causing invasive pneumococcal disease (IPD) in children in countries with existing pneumococcal vaccination programs.

photo agreement ops pfizer sinergium and health

On behalf of the Ministry of Health of the Nation, the vice minister, Cecilia Loccisano, participated in the meeting; the head of the Cabinet of Advisors, Roberto Olivieri Pinto, the secretary of Health Management, Alejandro Vilches, the undersecretary of Health Planning and Programming, Saúl Flores, the national director of International Relations, Mariana Vázquez Durán and the general director of Administration, Sabrina Fittipaldi . On behalf of PAHO/WHO, the manager of the Revolving Fund and Strategic Fund of PAHO Washington, Santiago Cornejo, the director of Purchasing, Daniel Rodríguez and the representative of PAHO/WHO in Argentina, Eva Jané Llopis, were present.

Representing Pfizer, the president for Latin America, Sinan Atlig, the General Manager in Argentina, Agustina Ruiz Villamil, the Regional Director of Vaccines, Ignacio Romano, and the Director of Corporate Affairs, Santiago Veiga, participated in the meeting. Finally, on behalf of Sinergium Biotech, the CEO, Alejandro Gil, the Business Development Director, Fernando Lobos, the Commercial Manager, Leonardo Ruiz Díaz, and the Head of Communication, Belén Varela, participated.

To see published note click here.

Buenos Aires, January 15, 2025 (PAHO) – The Pan American Health Organization (PAHO), the Government of Argentina, the Pfizer laboratory and the pharmaceutical company Sinergium Biotech announced a joint effort that will facilitate local production and regional access to the 20-valent pneumococcal conjugate vaccine (PCV20). This vaccine will help reduce the burden of pneumococcal diseases, offering improved protection for vulnerable populations, including children and older adults.

“PAHO is committed to increasing regional production of sustainable and innovative technologies, strengthening existing capacities and our regional purchasing mechanism, the Revolving Fund for Access to Vaccines,” said PAHO Director Jarbas Barbosa. “This collaboration reflects our commitment to ensuring equitable access to safe and effective vaccines that prevent serious diseases and save lives,” he added.

Through this initiative, not only Argentina will be a beneficiary of the local production of Sinergium Biotech, but also the rest of the countries in the region will be able to access doses of the vaccine through the PAHO Regional Revolving Funds, allowing be introduced more quickly and at competitive prices.

The countries of the region will be able to access it at competitive prices through the PAHO Regional Revolving Funds

The PCV10 and PCV13 vaccines have had a positive impact on the health of children in Latin America and the Caribbean. Estimates of the 2016 global burden of lower respiratory tract infections revealed that after the introduction of these vaccines, cases of invasive pneumococcal disease (IPD) caused by the serotypes covered in these vaccines in children under 5 years of age were significantly reduced. However, an increase was observed in other serotypes not covered by those vaccines.

PCV20, which includes seven additional serotypes compared to PCV13, promises to further strengthen protection against serious diseases caused by the bacteria Streptococcus pneumoniae or pneumococcus, responsible for pneumonia, meningitis and other serious infections, including those serotypes associated with antibiotic resistance. .

Pneumococcus remains a global public health problem. According to estimates by the Institute of Health Metrics and Evaluations (IHME), in 2021, 155,000 children under 5 years of age died worldwide due to pneumonia and meningitis caused by pneumococcus, of which 3,345 occurred in Latin America and the Caribbean. That same year, pneumococcal disease caused around 243,000 deaths in adults aged 70 years or older, of which around 18,000 were in Latin America and the Caribbean.

The PCV20 vaccine will be available for Latin America and the Caribbean from the beginning of 2025, with the estimate that the first doses produced in Argentina will be available in 2026. Thus, this vaccine, which is recommended for children under 2 years of age and adults over 60 and which is already being introduced in high-income countries, will also be available for countries in the region.

For more than 40 years, the PAHO Revolving Fund for Access to Vaccines has consolidated the demand of the countries of the region to make joint purchases, which gives them negotiating power and guarantees a uniform price under competitive conditions, regardless of the demand of each country. In the case of PCV20, countries will also be able to purchase it at a favorable price. Plus, shipping will be done regionally, reducing costs and carbon footprint. Another benefit of this vaccine, unlike PCV13, is that it will come in a prefilled syringe, making the administration process easier.

This effort, by helping to develop an ecosystem ready for the production and distribution of vaccines on a larger scale, also seeks to increase the region’s resilience to future pandemics and outbreaks, one of the lessons learned from the COVID-19 pandemic.

To see published note click here.

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.

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.

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.

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.

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.

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.

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.

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.