The Federal Commission for the Protection against Health Risks (Cofepris) reported that it received requests from pharmaceutical companies to obtain the health registration of four vaccines against COVID-19 for marketing in the country.
By a statement, the Cofepris reports that the vaccines are Comirnaty, from Pfizer SA de CV; Vaxzevria, from AstraZeneca SA de CV; as well as Spikevax and Spikevax bivalent, from ModernaTx Inc.
These pharmaceutical companies submitted applications after the regulator launched the call for the commercialization of vaccines on September 22.
Also, he pointed that out Pfizer Comirnaty is the first vaccine to be reviewed by the New Molecules Committee (CMN), as part of the transition process from emergency use authorization to health registration.
“Through this regulatory process, pioneering the world, Cofepris “Reaffirms its commitment to be an active, fair and transparent health authority, focused on protecting the health and guaranteeing access to health with high-quality standards,” explained the regulator.
Later, it will be evaluated Vaxzevria from AstraZeneca, and finally Spikevax and bivalent Spikevax from ModernaTx, through its legal representative in Mexico, Asofarma SA de CV
“It is important to mention that the CMN consulting body issues technical opinions on the safety, quality, and effectiveness of various health supplies. However, these opinions are not necessary for the final approval given by Cofepris”, he said.
Cofepris He pointed out in the call that before obtaining their health registration, companies must check the quality, safety, and effectiveness of the products, which will be checked by expert staff specialized in biological and biotechnological medicines.
He pointed out that the companies must avoid any attempt to interfere directly or indirectly with the evaluation of the pharmaceutical product and warned that any irregular activity will be reported to the Secretariat of Public Administration (SFP).