- According to clinical trials, the Sovereign vaccine is 91.2% effective.
- It requires the application of 3 doses to complete the vaccination schedule.
- Cofepris ensures that the biological meets the quality, safety and efficacy requirements necessary to be applied.
The Federal Commission for the Protection against Sanitary Risks (Cofepris) ruled appropriate the authorization for emergency use of the Soberana and Soberana PL vaccine for adults, with the distinctive names: recombinant protein of the receptor binding domain of the SARS-CoV-2 virus (RBD) conjugated to tetanus toxoid; and recombinant SARS-CoV-2 virus receptor binding domain (RBD) protein.
All the revisions that were carried out
The authorizations issued by this commission are part of the National Health Regulation Strategy, which allows reviewing and giving access to the largest number of health supplies, as long as the quality, safety and efficacy of the product is verified.
As a reference National Regulatory Authority (ARNr), qualified by the Pan American Health Organization (PAHO), Cofepris decisions are recognized by various countries on the continent, which is why the approved vaccines are likely to be used in other nations.
Being a member of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use, better known as ICH, all the decisions of this authority are made based on the technical-scientific evidence presented. .
The biological received a favorable opinion from the National Committee for Science and Technology and Innovation in Health of the National Council of Science and Technology (Conacyt), in an opinion held on November 26, 2021.
Subsequently, the New Molecules Committee (CMN) met on September 9 of this year on the use of this biological, which received a favorable technical opinion from the experts. The results of the session are available at this link.
After integrating the opinion of the CMN and submitting the authorization request for emergency use to Cofepris, personnel specialized in vaccines analyzed the files, certifying that the biological meets the quality, safety, and efficacy requirements necessary to be applied.
Efficacy and necessary doses
The combination of both biologics from the Finlay Vaccine Institute (IFV) demonstrated an efficacy of 91.2 percent in the prevention of symptomatic disease. This was confirmed by an interim analysis corresponding to phase 3 clinical trials. More than 40,000 volunteers participated in its preparation in eight municipalities of Havana.
For their part, the Cuban authorities explained that the general indications are that three doses are required to complete the vaccination schedule. First you must receive two injections of Soberana 02 and then one of Soberana Plus. While at the moment the main instruction is that it is only recommended for adults.
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