The information was published by COFEPRIS in a statement after a meeting on Friday as part of the 165th Extraordinary Session of the CMN.
It is the second Latin American vaccine to be submitted for consideration to the CMN and the result is a step prior to the authorization for emergency use in the country, the statement underlined.
It added that in that session, the technical-scientific information for the evaluation of the Soberana vaccine for adults was submitted, and it received a favorable technical opinion.
On this occasion, evidence was presented for the use of the Soberana vaccine as a primary vaccination in adults, that is, for the population that has not been previously immunized.
The product consists of a recombinant SARS-CoV-2 protein S receptor binding domain (RBD) protein conjugated with tetanus toxoid, and aluminum hydroxide as adjuvant.
It should be noted, COFEPRIS said, that this vaccine, presented by Neuronic Mexicana S.A. of C.V. and Cuba’s Finlay Institute of Vaccines, is the second of Latin American origin to be evaluated by this group of experts, followed by Abdala, also from Cuba, the first Hispanic-American biologic agent against Covid-19, presented on August 31, 2021.
COFEPRIS explained that the CMN is an auxiliary consultation body that is part of the regulatory agency; issues non-binding opinions on medicines and medical supplies, based on scientific and medical evidence presented, so this step does not represent the final authorization for emergency use.