Moderna and Pfizer have obtained health registration from the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) to market their COVID-19 vaccines in Mexico.
This regulatory process was carried out in "record time", according to the agency, after an exhaustive technical analysis and evaluation of the clinical performance of Moderna Tx. Inc.'s Spikevax vaccines and Pfizer's Comirnaty.
Cofepris specified that the registration was granted under strict medical recommendation and covers the Spikevax (monovalent XBB. 1.5) vaccines from ModernaTx. Inc. and Comirnaty from Pfizer, updated for the Omicron XBB. 1.5 variant of the SARS-CoV-2 virus.
It is worth mentioning that Pfizer's Comirnaty vaccine had already received initial approval in October by the Committee of New Molecules in Mexico, with a favorable opinion on this monovalent mRNA biological.
COFEPRIS highlighted that a multidisciplinary team of federal personnel determined that both vaccines meet the requirements of quality, safety and efficacy. Furthermore, it stressed that this regulatory process, carried out in public sessions of the Committee of New Molecules for the first time, was conducted efficiently.
The agency reiterated that the application of these vaccines outside the National Vaccination Policy must be under strict medical recommendation, warning that their supply must be supervised and should not be carried out indiscriminately, as it could represent health risks.
With information from: El Economista.
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