2023-07-30 00:10:34
According to the Finlay Vaccine Institute, this immunization option is 91.2% effective in preventing severe Covid-19 cases.
Based on the decision of the New Molecules Committee, now the Cuban Sovereign vaccine could begin to be applied to children over 5 years of age.
Since the end of 2022, this biological was authorized for emergency use in Mexico, although only in adults.
The Federal Commission for the Protection against Sanitary Risks (Cofepris), through the New Molecules Committee (CMN), analyzed the technical-scientific information of the Sovereign Cuban vaccine against Covid-19. As a result, a favorable opinion was offered for emergency use in the pediatric population.
This subsidiary body of Cofepris issued favorable opinion for the use of Soberana 02 and Soberana PL in the pediatric population from 5 years of age. Said vaccines are composed of: recombinant protein of the receptor binding domain of the SARS-CoV-2 virus (RBD), conjugated to tetanus toxoid and recombinant protein of the receptor binding domain of the SARS-CoV-2 virus (dimeric RBD), respectively.
Efficacy and necessary doses
The combination of both biologics Finlay Institute of Vaccines (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.
The favorable opinion towards the biological prepared by the Finlay Institute of Vaccines of Havana, Cuba, is a step prior to the authorization of emergency use to give access to a greater number of people to quality, safe and effective vaccines.
In addition, on March 31 of this year, this vaccine had the favorable opinion of the National Committee for Science and Technology and Innovation in Health of the National Council of Humanities, Sciences and Technologies (Conahcyt).
Cofepris specifies that the CMN is an auxiliary consultation body that is part of the regulatory agency. It issues non-binding technical opinions on medicines and health supplies, based on the scientific and medical evidence presented, so this step does not represent the final authorization for emergency use.
This health authority reminds the population that the supply of vaccines is universal and free, and that in the country its application is established in the National Vaccination Policy against the SARS-CoV-2 virus for the Prevention of COVID-19 in Mexico .
Finally, it is necessary to remember that on November 19, 2022, Cofepris authorized the Cuban Sovereign vaccine for its application in Mexican adults. While now, based on the result of the New Molecules Committee, it is expected that it will be fully approved in the following days to protect minors.
Also read:
More choice for the world! Soberana 2 and Soberana Plus, new vaccines approved against Covid-19
At last! The first shipment of the Cuban Abdala vaccine arrives in Mexico
Holiday bridge surprise! Cofepris authorizes the Cuban Sovereign vaccine against Covid-19
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