Avimex interim Phase 3 results showed their NDV-based vaccine, licensed from CastleVax, was effective as a booster against COVID-19.
The Final Stage of Clinical Development of the Patria® vaccine project yields favorable data (AVX/COVID-12)
2023-05-04 | https://avimexhumana.com.mx/noticias-y-eventos/46
The Patria® vaccine generates antibodies similar to a vaccine approved by the WHO according to the data available from the Final Stage of Clinical Development, as a booster vaccine.
To date, no serious adverse events related to the application of the vaccine have been observed in the volunteers participating in the protocol; however, research continues to confirm the safety shown since the earlier phases of clinical development.
Information on the clinical advances in the development of Patria® has been shared and will be shared in strict adherence to regulatory processes and national and international standards. The results will be published in peer-reviewed scientific journals upon completion of the protocols that support the robustness of the data obtained.
The industrial scale of the Patria® production processes is accelerated with the aim of obtaining the authorization of the industrial production plants and the vaccine.
Mexico City, May 3, 2023 . LABORATORIO AVI-MEX, SA DE CV (Avimex®) regarding the announcement made by the National Council of Science and Technology (Conacyt) on the available data from the Final Stage of Clinical Development of the Patria® vaccine project (AVX/COVID-12) against the SARS-CoV-2 virus, which causes COVID-19, communicates the following:
The available data show that the biological, applied as a booster vaccine, generates neutralizing antibodies, and behaves, according to the parameters measured according to the research protocol, in a similar way to the WHO-approved vaccine against which it was compared, without having shown up to now serious adverse events attributable to its application, safety that will continue to be monitored in accordance with the research protocol that is still underway for these purposes.
The Patria® vaccine has been shown to be a safe, immunogenic biologic with performance similar to the active comparator used, based on data obtained from volunteers participating in the eleven clinical research sites set up in various cities of the Mexican Republic, based on the protocol approved by the National Committee for Science, Technology and Innovation in Public Health (CNCTI-SP), by the ethics, research and biosafety committees of each of the clinical research sites and by the Federal Commission for Protection against Risks Sanitary (Cofepris).
The next steps in the development of the project are to obtain the authorization of the production plants on an industrial scale, the analysis of the data by various independent committees, and the emergency approval of the product, which requires continuous visits and inspections to the facilities, the integration of definitive reports with the results obtained in the clinical phases, as well as the safety monitoring of the participating volunteers.
In this sense, if the certifications are obtained within the estimated times, manufacturing would begin in the last quarter of this year. Under the strict supervision of Cofepris as the highest level regulatory agency, efforts are being redoubled so that the Patria® vaccine fully complies with the requirements requested in the development of safe and effective biologicals for humans. This meticulous follow-up is aimed at the eventual recognition and approval of the Patria® vaccine internationally by the World Health Organization (WHO).
The Avimex® project, chosen and financed by Conacyt for the clinical development of the Patria® vaccine, has faced great challenges in terms of regulations, infrastructure, availability of supplies, services and equipment, as well as recruitment of volunteers with the profile required to participate in the research phases. However, the collaboration between Conacyt and Avimex® has made it possible to achieve this unprecedented level of progress for our country.
The advances in the development of Patria® have been disseminated with strict adherence to the national and international regulations and standards required to obtain the approvals of the corresponding instances, as well as for the proper handling of information for regulatory purposes. Avimex® remains committed to the transparency of clinical development results, which will be submitted to scientific journals for peer review and made available to the public.
Finally, Avimex® reiterates its gratitude to the thousands of volunteers who have participated, and continue to participate, in the various stages of clinical development, and to the dozens of technicians and scientists who continue working to achieve the goal of having a quality Mexican vaccine. international.
About Avimex®
Since its foundation in 1952, LABORATORIO AVI-MEX, SA DE CV, has been a bioinnovation company with 100% Mexican capital, dedicated to the research, development, manufacturing, import, export, and marketing of biological, pharmaceutical, and mycotoxin detoxifiers for animal health. In 2009, it ventured into the pharmaceutical development of human vaccines with a collaboration for the AH1N1 influenza vaccine, and in 2020 it began its biopharmaceutical division with the investment in a pilot plant and an industrial plant dedicated exclusively to the 100% national production of vaccines. recombinants for human use; It has also obtained recognitions such as Family-Responsible Company (2006), Highly Exporting Company (2007), National Technology and Innovation Award (2011), ADIAT Award for Technological Innovation (2012), National Export Award (2012), Best Mexican Companies (2012 to 2022), National Award for Technology and Innovation Endorsement (2015), Great Place to Work (2018), Socially Responsible Company (2018 to 2022) and Super Mexican Expansion Companies (2018 to 2023). For more information, visit the page: www.avimex.com.mx
Avimex® press contact: PR Kaleidoscope
Karina Mendez Erika Reyes Romina Muñoz
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