The Committee for New Molecules (CMN) and experts issued a favorable opinion on the authorization for emergency use of the Cuban vaccine Abdala, with the therapeutic indication for active immunization to prevent Covid-19, the Federal Commission for Protection reported Monday against Sanitary Risks (Cofepris).
This biological, added Cofepris in a statement, is made with the recombinant protein of the receptor-binding domain of the SARS-CoV-2 virus.
“It is the first vaccine of Latin American origin to be held by the CMN of Cofepris. The favorable technical opinion represents an advance in the approval processes necessary for the fulfillment of the quality, safety and efficacy requirements, essential when considering a product ”, indicated the agency.
The next step, added Cofepris, consists of the submission of files by the pharmaceutical company, which will be ruled by expert personnel from the Sanitary Authorization Commission (CAS), since this stage does not yet represent an authorization for use.
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Cuba approved Abdala vaccine on July 9, with an efficacy of 92.2%
The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) of Cuba granted on July 9 the authorization of emergency use to the Cuban vaccine against the coronavirus Abdala, which in its clinical trials showed an efficacy of 92.2%.
Cuba decided to approve the vaccine on that date based on “the data obtained in the Phase I and Phase II clinical trials (already concluded) and the Phase III clinical trial (in progress), which has demonstrated efficacy in the prevention of symptomatic forms 92.28% of the disease, as well as an adequate safety profile ”.
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