The PAHO/WHO technology transfer program advances for Argentina to produce messenger RNA vaccines

Buenos Aires, February 15, 2023 (PAHO) — A mission of delegates from the Pan American Health Organization (PAHO), the World Health Organization (WHO), and the Medicines Patent Pool visited Argentina and met with authorities national health agencies and the biopharmaceutical company Sinergium Biotech in order to continue advancing technological transfer for the production of messenger RNA (mRNA) vaccines in the country for regional destination.

During the meeting that took place last Tuesday, the PAHO representative in Argentina, Eva Jané Llopis; the Minister of Health of the Nation, Carla Vizzotti; the senior technical officer at the WHO, Claudia Nannei, the director of Business Development at Sinergium Biotech, Fernando Lobos, and other officials evaluated the progress of the transfer program and analyzed the possibilities that this technology offers for the development of vaccines against the virus. SARS-CoV-2 as well as other priority pathogens for the region, and biotherapeutic products.

“The need for self-sufficiency in the region during the pandemic made us all wake up,” said Jané Llopis after giving the welcome and added that “it is a challenge and we will continue working from PAHO together with the Ministry of Health of the Nation and all the actors , to face the pandemics that may appear, and at the same time go further and investigate the different opportunities that messenger RNA technology allows and offer them to the entire Region of the Americas.”

The PAHO representative in Argentina highlighted the country’s leadership in the region in health matters, its ability to face this new challenge and celebrated the Argentine laboratory’s goal of “becoming a pioneer in the production of mRNA vaccines” among the 15 centers chosen in different places in the world.

Then, the minister referred to the importance of working together and with a strategic perspective and expressed the need to “develop sustainable public policies aimed at promoting the development of vaccines and other biotechnological products, expanding our production capacities for these strategic inputs and contributing to regional health self-sufficiency.”

Along the same lines, Nannei explained that in order to promote equitable access to vaccines, the purpose of the WHO and PAHO initiative is to establish a sustainable production capacity for mRNA vaccines in different countries and contribute to the collaboration and exchange of research between countries to expand knowledge about the potential of this technology.

For his part, the regional advisor on Pharmaceutical Policies and Innovation of the Medicines and Health Technologies Unit of the Department of Health Systems and Services of PAHO, Tomás Pippo, indicated that “local production is the way to improve access” and that “PAHO works to promote cooperation among member states and strengthen common policies.”

During his speech, Lobos mentioned the value of the existing collaboration between the different national and international actors, and “of PAHO, which has been on par since the beginning of the project to have the potential to move forward firmly and faster.” . The director of the laboratory also referred to the importance of choosing priority diseases for the region and Argentina in order to demonstrate the operation of the platform, and achieve a strong impact on the health of the entire region of the Americas.

The joint visit, which took place from February 7 to 9, is part of the global work program coordinated by WHO and the regional activities of the agreement between PAHO and the Department of Foreign Affairs, Trade and Development of the Government of Canada to increase local production capacities and improve equitable access to vaccines in Latin America and the Caribbean.

The mission was also made up of Christopher Chadwick, Cristina Bruno and Martin Nicholson from the WHO; Ike James of the Medicines Patent Pool; and the advisor of the PAHO Office in Brazil, María de los Ángeles Cortés who participated in the meeting, in addition to the advisor on Health Systems and Services, Sonia Quezada Bolaños, the head of the National Administration of Medicines, Foods and Medical Technology (ANMAT), Manuel Limeres; the director of the National Administration of Laboratories and Health Institutes (ANLIS) “Dr. Carlos Malbrán”, Pascual Fidelio, the president of the National Agency of Public Laboratories (ANLAP), Ana Lía Allemand; and the national director of Studies of the Ministry of Science, Technology and Innovation, Vanesa Lowenstein, among others.

The visit concluded with a tour of the Sinergium Biotech facilities followed by a technical meeting on first and second generation mRNA vaccines, intellectual property rights, purchasing processes, and financial and commercialization strategy and planning next steps. This activity also included the participation of representatives from the Bio-Manguinhos Institute of Technology in Immunobiology of the Oswaldo Cruz Foundation (Fiocruz), Patricia Cristina Da Costa Neves and Sotiris Missailidis.

More about the technology transfer program

En septiembre de 2021, la OPS anunció que la empresa Sinergium Biotech, en Argentina, y el Instituto de Tecnología en Inmunobiológicos de la Fundación Oswaldo Cruz (Bio-Manguinhos/Fiocruz), en Brasil, fueron seleccionados para la transferencia tecnológica.

Bajo esta iniciativa de cooperación internacional, expertos de ambos laboratorios trabajan en colaboración con el centro de transferencia de tecnología de ARNm establecido por la OMS en Sudáfrica para generar capacidades locales destinadas al desarrollo y producción de vacunas y otros productos biológicos.

To see published note click here.

In Rio de Janeiro, Vizzotti highlighted the alliance between Brazil and Argentina to strengthen regional production of technology and health supplies

Furthermore, during the 6th G-STIC Conference, the Minister of Health of the Nation referred to the need to consolidate the coordination between the public and private sectors to achieve this objective.

The Minister of Health of the Nation, Carla Vizzotti, participated today in the panel “Vaccine Production in Developing Countries”, organized by G-STIC, the global meeting that brings together the highest leaders in technology and innovation to analyze strategies for of achieving the Sustainable Development Goals carried out for the first time in the Region of the Americas.

Throughout her presentation, the person in charge of the national health portfolio emphasized the importance of strengthening alliances between the public sector and the private sector in order to continue deepening the articulation between health needs and the scientific-technological framework. , with the aim of closing the innovative-productive circle and promoting the exchange of technical knowledge.

In turn, she highlighted the national and regional collaborations that were carried out with countries such as Mexico, Brazil, Russia and China. In this sense, the minister highlighted the work carried out between Argentina and Brazil for the development and manufacturing of mRNA vaccines, and celebrated the advances of the Institute of Technology in Immunobiologicals (Bio-Manguinhos/Fiocruz) and the Argentine pharmaceutical company Sinergium Biotech to develop and manufacture the APIs vaccine.

“Argentina and Brazil have always defended international alliances that collaborate in promoting equitable access to health technologies, including vaccines, therapies and diagnostics,” Vizzotti stressed.

In this regard, the minister added that, faced with the challenge that developing countries encounter in creating capacities, “innovation, manufacturing and model markets are needed” while “shortage and inequities in access to supplies must be overcome.” , medicines, vaccines and other essential technologies for health.” In this regard, she pointed out “the great regional dependence on imports from other regions” and “the heterogeneity of innovation and industrial capabilities of regional countries.”

Thus, in relation to the prospects for capacity building in developing countries, she highlighted the need to “evaluate vaccine acquisition mechanisms and capacities for supply by the domestic market.” Along these lines, he maintained that to improve local manufacturing there are different factors to take into account: both the impact on the national and regional population, as well as the need to create public and private capacities, the availability of human resources, the complexity of manufacturing, national and regional markets, regulatory provisions and patents and licenses.

On the other hand, she detailed the main guidelines of the Argentine national immunization policy and the vaccination program in the country. In this regard, she maintained that “we have a long tradition that considers immunization as a public good and promotes vaccination at all stages of life.”

Along the same lines, she highlighted that “immunization is a problem of national interest. It includes research, epidemiological surveillance, evidence-based decision making, while requiring the acquisition, storage, distribution and supply of vaccines, cold chain conservation, manufacturing, and all measures intended to promote vaccinating people and strengthening surveillance of vaccine safety.”

The minister highlighted that, in recent years, the National Calendar introduced five vaccines in its schedule: pentavalent, DTaP for adolescents and pregnant women, influenza, gender-neutral HPV and pneumococcal conjugate vaccine. Chickenpox, rotavirus, and meningococcal vaccines were also introduced in 2016.

In this sense, he specified the achievements and challenges regarding COVID-19 vaccination for the year 2023. Thus, he indicated that the objective for this year is focused on completing the schedule and applying reinforcements to all risk groups, especially in those over 18 years of age. “All strategies aimed at completing vaccination coverage are a priority to strengthen and improve public health in the 24 provinces with a federal perspective,” said the minister.

At the same time, he recalled that the COVID-19 pandemic revealed the lack of transparency of markets, prices, manufacturing costs and trade agreements, thus limiting the impact of vaccination policies and evidencing inequities. in access to vaccines.

“We believe that strengthening local production of technology and products for health and strengthening scientific and regulatory capacities will help prevent this situation in future epidemiological emergencies,” the official added.

Finally, Vizzotti highlighted: “This is the right moment to place health at the center of Agenda 2023, recognizing the need to carry out intersectoral actions and implementing policies that are effective in reducing inequities.”

To see published note click here.