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Cuban anti-COVID-19 vaccines obtain health registration

The Center for the Control of Medicines, Equipment and Medical Devices (Cecmed) has granted health registration to the Cuban anti-COVID-19 vaccines Abdala (from the Center for Genetic Engineering and Biotechnology), Soberana 02 and Soberana Plus (from the Finlay Institute of Vaccines).

Liz Conde Sanchez, May 22, 2023

On May 19, 2020, the First Secretary of the Party and President of the Republic, Miguel Díaz-Canel Bermúdez, had met with a group of Cuban researchers and scientists whom he asked to create their own vaccine that would give the nation the sovereignty needed to deal with the COVID-19 pandemic.
Today, three years after this historic meeting, the three nationally produced anti-COVID-19 vaccines, which were born from the efforts of Cuban scientists and saved the country from the ravages of the epidemic, now have a registration. sanitary, granted by the State Control Center for Medicines, Equipment and Medical Devices (Cecmed).  

During the ceremony which took place this Saturday at the Palais des Congrès in the capital, on the occasion of the third anniversary of the creation of national immunogens against the pandemic, Olga Lidia Jacobo Casanueva, director of Cecmed, announced the granting by the regulatory body of health registration to Cuban anti-COVID-19 vaccines: Abdala, from the Center for Genetic and Biotechnological Engineering (CIGB), and Soberana 02 and Soberana Plus, from the Finlay Institute of Vaccines (IFV) .
The official clarified that at the end of the process of evaluating the files presented by the institutions, "and considering that the Cuban vaccines have completed their studies and that the information presented complies with the requirements established by Cecmed in terms of demonstration quality, safety and efficacy", it was decided to grant health registration to the three vaccines.
She also said that once health registration is obtained, emergency use authorizations granted in 2021, during the pandemic, are no longer in effect.
During the ceremony, chaired by Martha Ayala Ávila, member of the Political Bureau of the Party and General Director of the CIGB, Jorge Luis Perdomo Di-Lella, Deputy Prime Minister, Eduardo Martinez Diaz, President of the BioCubaFarma business group, as well as d Other officials, directors and representatives of various institutions, the IFV has been granted the status of High Technology Company (Empresa de Alta Tecnología).
Elba Rosa Pérez Montoya, Minister of Science, Technology and Environment, underlined that the IFV presented a complete and solid dossier, which is why all the evaluation teams unanimously recognized that this institution fulfilled all the requirements to be a high-tech company, making it the eighth of its kind in the country, seven of them owned by BioCubaFarma.
The event was also an opportunity to pay tribute to Commander-in-Chief Fidel Castro Ruz, historic leader of the Cuban Revolution, as the main architect of the development of science in the country.
The book Fidel, interferon and Cuban biotechnology, by Dr. Manuel Limonta Vidal, was also presented. The author declared that this work was intended to pay a deserved tribute to the memory of the unforgettable Fidel, and to show the new generations of young researchers in the country all the effort, support and direct participation of the commander in leader in this project.
“We had the historic privilege of being chosen to take on the challenge of producing leukocyte interferon in Cuba, at a time when Finland was the only country in the world to produce it, and at a time of great change and development. 'significant opportunities for biotechnology around the world were on the horizon,' he said.
During the ceremony, the main institutions involved in the development and production of Cuban vaccines against COVID-19 were recognized.

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