“Favorable Opinion Issued for Cuban Vaccine Abdala by Mexican New Molecules Committee (CMN) for Pediatric Use against Covid-19”

The New Molecules Committee (CMN) of the Federal Commission for the Protection against Sanitary Risks (Cofepris) issued this Saturday a favorable opinion on the recombinant protein vaccine of the receptor binding domain of the SARS-CoV-2 virus, known as Abdala , produced by Cuban scientists and used to prevent Covid-19.

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In a statement published by the Mexican Government website, the organization states that “the vaccine, developed by the Center for Genetic Engineering and Biotechnology (CIGB) of the Republic of Cuba, is indicated for specific active immunization against SARS infection. -CoV-2, in boys and girls from the age of five”.

He adds that Abdala shows “efficacy for mild, moderate and severe clinical forms of Covid-19 of 92.13 percent, 88.99 percent and 92.33 percent, respectively.”

Likewise, it reports that on April 3, the Cuban vaccine “obtained from the National Committee for Science, Technology and Innovation in Public Health (CNCTI-SP), of the now National Council of Humanities, Sciences and Technologies (Conahcyt), a recommendation favorable for the extension of the indication for emergency use (…) against Covid-19 for primary vaccination in the pediatric population from five to 17 years of age”.

Our Abdala received a favorable opinion from the New Molecules Committee of @COFEPRIS, to extend its use in pediatrics. Born from the intelligence and tenacity of Cuban scientists, she has saved thousands of lives. Thanks to her and Sovereign, #Cuba keeps under control the #COVID19.

— Miguel Díaz-Canel Bermúdez (@DiazCanelB)
May 13, 2023

At the same time, the entity pointed out that the opinion issued by the CMN is part of the process to obtain the emergency use authorization issued by the Cofepris Sanitary Authorization Commission, once the information presented has been evaluated.

On December 1, 2022, the application of booster vaccines for people over 18 years of age using the aforementioned Cuban drug began in Mexico. Now it seeks to extend the authorization for emergency use in pediatric ages.

Since 2021, the Center for the State Control of Medicines, Equipment and Medical Devices (Cecmed) of Cuba authorized the emergency use of said vaccine in the Greater Antilles, confirming that it met the requirements and parameters demanded in terms of quality, safety and efficacy.