COFEPRIS released an official communication that provided the sanitary certificate to Pfizer y Moderna Covid-19 vaccines.
A multidisciplinary federal staff team determined that the Pfizer & Moderna biologicals met the quality, safety and efficacy requirements complying with the total commitment to transparency, under the crystal box principle, the Federal Commission for the Protection Against Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, (COFEPRIS)) informs its granting of the health registration for the Spikevax vaccine (monovalent XBB.1.5) by ModernaTx. Inc. (requested by its legal representative in Mexico, Asofarma S.A. de C.V.) and to the Comirnaty vaccine (Omicron XBB. 1.5) by Pfizer S.A. de C.V. Said regulatory process, pioneer in the world, in the transition for the Authorization of Emergency Use regarding the Health Registration for Covid-19 vaccines, has been achieved in record time, after a rigorous technical analysis performed by this health authority’s specialized staff and of the clinical evaluation on the performance of these vaccines biologicals in the sessions of the New Molecules Committee (Comité de Moléculas Nuevas, (CMN)), made public for the first time.
As reported, in a transparent and opportune manner, a multidisciplinary federal staff team determined that the Pfizer & Moderna biologicals met the quality, safety and efficacy requirements, in the files presented before this federal commission.
The simultaneous ruling to issue the health registration for vaccines against Covid-19, allowing their commercialization in México, sets a precedent towards a regulation focused to ensure its access without benefitting any particular user and, eliminating any need for an intermediary or agent.
As indicated in the Decree declaring the end of the health emergency caused by COVID-19, the authorizations issued by the COFEPRIS that are still in place shall remain valid as long as said medicines and supplies be deemed necessary in accordance with the National Vaccination Policy against the SARS-CoV-2 virus, for the prevention of COVID-19 in Mexico, or for the long-term process plan determined by the Health Ministry (Secretaría de Salud).
This health authority encourages the population not to use any COVID-19 vaccine randomly in any way, as the risk-benefit in any application must first be taken into consideration. COVID-19 vaccines included in the National Vaccination Policy (Política Nacional de Vacunación) for protection against the SARS-CoV-2 virus, are universal and free. COFEPRIS reiterates that the application of vaccines not within the National Vaccination Policy must be applied under a strict medical attention.
The supply of these biologicals must be supervised under strict medical supervision and not applied randomly under any circumstance, for that may cause health risks. In the event of showing any adverse effect attributable to the vaccination and immunization (esavi), please report it by email to: farmacovigilancia@COFEPRIS.gob.mx or in the link gob.mx/COFEPRIS
This health agency has complied with the Cristal Box Principle, to be transparent in the process of attaining the health registration of these biologicals requested by the applicants, benefitting the access to health consumables that meet the quality, safety and efficacy requirements.
