The Federal Commission for the Protection against Sanitary Risk has issued an unfavorable recommendation regarding the AstraZeneca vaccine, known as Vaxzevria ChAdOx-1-S, requesting updated information before considering its authorization for sale in Mexico.
This recommendation comes from Cofepris' New Molecules Committee (CMN), following a recent technical and scientific analysis.
Although the vaccine's safety has been confirmed, CMN experts have requested updated data on its efficacy and immunogenicity before moving forward with the authorization of sanitary registration.
It has also been noted that AstraZeneca has not provided information about the variants of the SARS-CoV-2 virus present in Mexico and globally. As a result, AstraZeneca will have to resubmit its sanitary registration request.
It is important to note that this recommendation does not constitute final authorization for sanitary registration. The AstraZeneca vaccine still has authorization for emergency use, and the company will have the opportunity to resubmit its request to the CMN, focusing on addressing the previous observations and complying with the required legal, administrative, and scientific standards.
In an act of transparency, the CMN's evaluation sessions have been conducted publicly and broadcast live. Since the AstraZeneca vaccine still has emergency use authorization, it has been suggested that it could be considered as part of booster schemes for the 2023-2024 winter season, especially if no other vaccination options are available.
The CMN has emphasized that its evaluation process is based on the scientific and medical evidence presented, and its objective is to advise Cofepris in determining the usefulness of a product in prevention and treatment in Mexico, considering the current epidemiological situation.
It is important to remember that the CMN's opinion is of a technical nature and is not binding, and final authorization for sanitary registration remains pending evaluation.
With information from: El Economista.
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