Mexico has a long-standing commitment to public health, a legacy that includes pioneering vaccination efforts against diseases like smallpox since the 19th century. This historical dedication has fostered a national drive toward self-sufficiency in vaccine production. Global health challenges, particularly recent pandemics, have underscored the importance of robust domestic capabilities in vaccine development.
The Patria Vaccine: A National Endeavor
The Patria vaccine emerged as Mexico’s primary national vaccine project, driven by the ambition to achieve vaccine sovereignty and lessen dependence on international supply chains. The development process involved a collaborative effort between governmental and scientific entities.
The National Council of Science and Technology (CONACYT, now CONAHCYT) played a central role in orchestrating this endeavor, working alongside the Mexican company Avimex, which brought expertise from its background in animal vaccine development. This collaboration also leveraged international technological contributions, including insights from the Icahn School of Medicine in New York and the HexaPro protein from the University of Texas at Austin. The vaccine’s platform utilizes a recombinant Newcastle disease virus (rNDV), which was selected due to its established safety profile in veterinary applications and its potential for efficient, low-cost production. This approach involved using the rNDV to express the spike protein of SARS-CoV-2, mimicking natural infection to elicit an immune response.
Scientific Development and Regulatory Approval
The scientific journey of the Patria vaccine progressed through a structured series of preclinical and clinical trials. Initial preclinical studies conducted on mice, pigs, hamsters, and rats demonstrated the vaccine’s ability to induce protection against early variants of COVID-19, including Alpha, Beta, and Gamma, without observed adverse effects.
Phase 1 clinical trials, which began in April 2021, involved approximately 91 to 100 healthy unvaccinated adult volunteers. These trials assessed the vaccine’s safety and immunogenicity, showing it to be safe with only mild, transient side effects such as fatigue and headache. The vaccine was administered both intramuscularly and intranasally, with both routes proving immunogenic. Subsequently, Phase 2 trials enrolled 158 volunteers who had previously received other COVID-19 vaccines, confirming the Patria vaccine’s safety as a booster and its capacity to significantly increase neutralizing antibodies against the ancestral Wuhan strain and Omicron subvariants (BA.2 and BA.5). A combined Phase 2/3 trial, involving 4,056 volunteers from November 2022 to September 2023, further evaluated the vaccine as a booster dose, demonstrating its safety, tolerability, and immunogenicity, meeting the World Health Organization’s non-inferiority standards when compared to the AstraZeneca vaccine. Mexico’s regulatory body, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), played a diligent role throughout this process. On January 26, 2024, the New Molecules Committee of COFEPRIS provided a unanimous favorable resolution regarding the vaccine’s data. This rigorous evaluation culminated in COFEPRIS granting emergency use authorization for the Patria vaccine on June 6, 2024, signifying its adherence to high standards of quality, safety, and efficacy.
Deployment and Broader Implications
With its emergency use authorization, the Patria vaccine is now being integrated into Mexico’s public health strategy, primarily for use as a booster shot. As of December 2024, plans were in place to administer over 700,000 doses during the winter season.
The development and deployment of the Patria vaccine hold significant broader implications for Mexico. It represents a substantial stride toward vaccine equity and national preparedness for future pandemics. This achievement also enhances Mexico’s standing in global health, with COFEPRIS’s authorization being recognized by over 20 countries in Latin America and the Caribbean, potentially facilitating broader access to the vaccine in the region. The Patria vaccine stands as a testament to Mexico’s scientific self-reliance, demonstrating the nation’s capacity to innovate and produce essential health tools.