The Federal Commission for Protection against Sanitary Risks (Cofepris) has announced the emergency use authorization for the Patria COVID-19 vaccine, developed by Laboratorio Avimex S.A. de C.V. This authorization follows a comprehensive and rigorous technical analysis conducted by Cofepris’s specialized personnel, along with a favorable unanimous decision from the New Molecules Committee (CMN) during a public session on January 26.
The multidisciplinary review team confirmed that the Patria vaccine meets the highest standards of quality, safety, and efficacy based on data presented in the technical dossier submitted to Cofepris. This COVID-19 vaccine is now authorized for use in public health institutions across Mexico, enhancing the country’s ability to combat COVID-19 effectively.
The decision to authorize the Patria COVID-19 vaccine aligns with the decree declaring the end of the COVID-19 health emergency. According to this decree, authorizations issued by Cofepris that remain valid will continue to be effective as long as these medicines and supplies are necessary to support the National Vaccination Policy against SARS-CoV-2 and the long-term management plan established by the Ministry of Health.
Cofepris’s International Recognition Enhances Access to Patria COVID-19 Vaccine
Cofepris’s authorizations are recognized by more than 20 countries in Latin America and the Caribbean. This international recognition will facilitate access to the Patria vaccine without requiring additional evaluations, highlighting the rigorous and experienced review process of Cofepris. As a level 4 regulatory agency, Cofepris is on par with other major agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Associate Health Minister Casey Costello emphasized the importance of this development: “The medicines and products we are discussing are critical to New Zealanders’ health. We want cost-effective access to the right products to support health outcomes and ensure there aren’t unnecessary barriers for our exporters.” Costello stressed that the current Medicines Act is outdated, and while the Therapeutic Products Act (TPA) was not the appropriate solution, the focus will now shift to developing a modern, risk-proportionate regulatory regime.
Public Urged to Follow Guidelines for COVID-19 Vaccination as Patria Vaccine Gains Approval
The public is urged to avoid the indiscriminate administration of COVID-19 vaccines. It is crucial to consider the risk-benefit ratio of each dose. Vaccines included in the National Vaccination Policy against SARS-CoV-2 are free and universally accessible. Cofepris emphasizes that any vaccination outside the National Vaccination Policy should be administered under strict medical supervision and with specialized follow-up to prevent potential health risks.
Laboratorio Avimex S.A. de C.V. expressed their gratitude for the authorization, noting that the Patria COVID-19 vaccine represents a significant milestone in Mexico’s fight against COVID-19. The company is committed to ensuring the vaccine is distributed efficiently and safely across the country.
In summary, the emergency use authorization of the Patria COVID-19 vaccine by Cofepris is a pivotal step in Mexico’s ongoing efforts to manage and mitigate the impacts of COVID-19. This development not only enhances the country’s vaccination capabilities but also reinforces the importance of maintaining stringent regulatory standards to ensure public health and safety. The collaboration between Cofepris, healthcare providers, and the public will be vital in the continued fight against the pandemic.
Resource: Government of Mexico, June 07, 2024
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