Mica for cartelinsider.com
The Committee of New Molecules (CMN), of the Federal Commission for Protection against Sanitary Risks (COFEPRIS), approved, on January 26, 2024, the emergency use of the Mexican vaccine “Patria” – developed in Mexico by the National Council of Humanities, Sciences, and Technologies (CONAHCYT) and Avi-Mex Laboratory, S.A. of C.V.-, against the SARS-CoV-2 coronavirus (which causes COVID-19).
In an extraordinary meeting, the experts of the decentralized body of the Federal Secretariat of Health (SSa) endorsed the biological, by determining that the Mexican vaccine was safe and served as a booster against COVID.
Doctor Arturo Reyes Sandoval, member of the New Molecules Committee, stated that the evidence showed that the vaccine was safe. On her part, Doctor Lena Ruiz Azuara said that the safety evidence for Patria was feasible, but that follow-up should be given to the people who participated in the studies.
Likewise, Ruiz Azuara questioned the demographic distribution of the volunteers; to which the collaborators of the private laboratory answered that the studies of phases 1 and 2 were carried out in Mexico City, while phase 3 was developed in other states, such as San Luis Potosí, Oaxaca and Yucatán.
During his turn, Dr. Miguel Ángel Jorge Guevara considered it to be a safe vaccine and that the data presented by Avi-Mex supported it. Additionally, he requested strict epidemiological surveillance in the administration of the vaccine.
While Dr. Rosana Pelayo Camacho stated that the presentation of the vaccine would make it accessible and provide long-term protection to the population, Dr. Sergio Ponce de León asserted during his participation that the evidence presented endorsed the safety of Patria and met international standards of non-inferiority.
Ponce de León also emphasized that the Patria vaccine should not be administered to people with chronic diseases, such as diabetes and hypertension, as studies have shown that it was not effective for them.
As collaborators of the private laboratory noted, among the preclinical studies that would be carried out in the future, was one with an updated vaccine against the Omicron variant, as Patria was developed with the NDV-LaSota virus.
The employees of Avi-Mex also confirmed that the phase II and phase II-III clinical trials had not yet been published, but stated that they would do so soon. They reported that according to preclinical results in mice, hamsters, pigs, and rats, Patria induced a protective response. They also conducted tests on people who had no vaccine against SARS-CoV-2 and obtained the same result.
On October 24, 2023, President Andrés Manuel López Obrador promised that the Mexican vaccine “Patria” -developed in Mexico by CONAHCYT- against the SARS-CoV-2 coronavirus (which causes COVID-19 disease), would soon be applied to people on a mass and free basis, as it was already in its final stage of processing.
On January 25th, 2024, COFEPRIS stated that the New Molecules Committee was an auxiliary advisory body that formed part of the decentralized unit of the Federal Health Secretary (SSa) and its function was to issue non-binding technical opinions regarding health products, based on presented scientific and medical evidence. Therefore, the approval of Patria in the New Molecules Committee did not constitute the final authorization for obtaining the sanitary registration of Diva vaccine.
“Through this pioneering regulatory process, COFEPRIS reaffirms its commitment to be an agile, fair and transparent health authority, focused on protecting health and guaranteeing access to health with high quality standards,” stated the Federal Commission for Protection against Sanitary Risks in a statement.”
In addition to the above, COFEPRIS stated that for more than a decade, the Pan American Health Organization (PAHO) had recognized the Mexican Commission as the national regulatory authority of reference. Therefore, the decisions taken by this institution were “widely recognized and valued in different countries in the region, benefiting the health of millions of people.”
On October 24, 2023, President Andrés Manuel López Obrador promised that the Mexican vaccine “Patria” -developed in Mexico by CONAHCYT and Avi-Mex, against the SARS-CoV-2 coronavirus- would soon be administered to people on a mass and free scale, as it was already in its final stage of processing.
“The ‘Patria’ vaccine is doing very well. We will have the ‘Patria’ vaccine this year; all the tests have been completed and have passed. Mexico has its own vaccine and I believe it will be available next month, towards the end of November. Special laboratories have been built, its efficacy has been tested, and soon we will have our vaccine injected,” said the Tabasco politician during his morning press conference held at the Treasury Room of the National Palace.
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Mica
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