The Federal Commission for the Protection against Sanitary Risks (Cofepris) reported that it has received four applications from pharmaceutical companies seeking sanitary registration for the sale of COVID-19 vaccines in the national market. This comes on the eve of the winter season and the rise in cases.
On September 22, Cofepris issued letter CFS-365-2023, recalling that on May 9, the Official Gazette of the Federation published the decree declaring the end of the extraordinary action in matters of general health that aimed to prevent, control, and mitigate the disease caused by the SARS-CoV-2 virus.
In the letter, it announced that, given the end of the COVID-19 health emergency and the start of the transition period from emergency use authorization to health registration for coronavirus vaccines, it issued a call for applications for companies that have such emergency use authorization.
The New Molecules Committee (CMN) will meet next week to evaluate the clinical performance of the vaccines. The meetings will be public through Cofepris' social media channels (YouTube and Facebook).
The applications received correspond to the following vaccines: Comirnaty, from Pfizer SA de CV; Vaxzevria, from AstraZeneca SA de CV; Spikevax, from ModernaTx, Inc.; and Spikevax bivalent, from ModernaTx Inc. These last two vaccines, through their legal representative in Mexico, Asofarma.
400 new cases per week
Data from the Ministry of Health, based on PCR tests and notifications from 464 sentinel medical units located across the country, indicate that since the beginning of August, COVID cases have increased, with a weekly average of 400 new confirmed cases.
The National Center for National Health (CMN) will meet on Monday, October 16, from 1:00 p.m. to 3:00 p.m. to analyze the case of Pfizer's Comirnaty vaccine. That same day, from 4:30 p.m. to 6:30 p.m., it will review the application for AstraZeneca's Vaxzevria vaccine. On Tuesday, October 17, from 12:00 p.m. to 3:00 p.m., it will evaluate the cases of ModernaTx's Spikevax and ModernaTx's Spikevax bivalent vaccines.
