WHO Certification Procedure of Cuban Vaccines To Start Soon

On Thursday, Cuba will begin exchanges with the World Health Organization (WHO) experts to ensure that the Abdala and Sovereign 02 vaccine are qualified as suitable products for COVID-19 emergency treatment, announced Rolando Perez, the director of Science & Technological Innovation at BioCubaFarma.

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“The WHO certification of our vaccines will facilitate their entry into other countries’ markets once the needs of the Island are met,” Perez stressed. He also recalled that this certification process would not hinder the national coronavirus immunization campaign with Abdala and Sovereign vaccines, which already received authorization from the Center for State Control of Medicines, Equipment, and Medical Devices (CECMED) for their emergency use.

In the coming days, the WHO will designate an expert team to analyze the Abdala and Sovereign 02 dossiers submitted by the Cuban Center for Genetic Engineering and Biotechnology (CIGB) and Finlay Vaccine Institute (IFV), which developed the vaccines.

Previously, the Pan American Health Organization (PAHO) recognized Cuba’s efforts in developing COVID-19 vaccines, recalling that each country has the authority to approve the emergency use of COVID-19 vaccines it deems relevant even if they do not yet count with WHO certification.

So far, the Abdala and Sovereign 02 vaccines are being used in Venezuela and Iran as part of bilateral agreements and collaboration in clinical studies. Vietnam, Mexico, and Argentina also expressed interest in acquiring them.

The COVID-19 immunization campaign is also progressing in the Island. As of Sept. 12, about 4,3 million Cubans had been fully immunized against COVID-19 and over 62 percent of the population had received the first dose of one of the locally produced vaccines. 

Currently, Cuban scientists and health authorities are working together so that Abdala and Sovereign 02 vaccines do not contain Thiomersal, an antiseptic and antifungal agent to which some people may be allergic.

The CECMED is also likely to give emergency use authorization to Sovereign Plus, which is the only COVID-19 vaccine in the world designed for disease convalescents. This vaccine’s clinical trials in the pediatric population are expected to begin soon.