Cuban Soberana 02 Vaccine Receives Emergency Use Authorization in Iran
The Iranian Ministry of Health gives the Cuban Soberana 02 vaccine an emergency use authorization, its manufacturing company states that the vaccine proved to have an efficacy rate of 62%.
Iranian Minister of Health Saeed Namaki announced that the Cuban Soberana 02 vaccine received an emergency use authorization in Iran.
According to the official page of the Biotechnology and Pharmaceutical Industries Group in Cuba, BioCubaFarma, this authorization was granted to the Pasteur Institute of Iran. The institute will market the Cuban vaccine in Iranian territory under the name Pasteur, within the framework of a cooperation agreement signed with BioCubaFarma's Finlay Institute of Vaccines in January.
BioCubaFarma stated that the regulatory authority granted the Pasteur Institute of Iran permission to use the Cuban vaccine in emergencies. The decision cam based on the results of the product's pharmaceutical development and the evidence of safety and efficacy demonstrated during the first and second phases of clinical trials conducted in Cuba. The clinical trials showed that the vaccine has an efficacy rate of 62%.
BioCubaFarma indicated that the vaccine's safety, which was demonstrated in the second clinical trials phase, was taken into account. It is currently being applied to 24,000 people in various Iranian provinces, noting that international media outlets, such as The New York Times and Vaccine Tracker, covered it.
BioCubaFarma's Finlay Institute signed a bilateral agreement with Iran on January 8 to complete clinical trials in order to develop the Soberana 2 (Sovereignty 2) COVID-19 vaccine.
The Finlay Institute indicated that this agreement with the Pasteur Institute of Iran would allow for faster progress towards a vaccine in both countries, stressing the importance of cooperation between the two countries, especially in light of the ongoing COVID-19 pandemic.
The Director of Scientific Research at BioCubaFarma, Rolando Perez Rodriguez, had previously confirmed to Al Mayadeen that the agreement with Iran aims for joint efforts between the two countries to develop a COVID-19 vaccine. They will proceed by conducting part of Soberana 02's third phase of clinical trials in Iran. The transfer of this technology in the vaccine industry to it, as Iran is working with Cuba to manufacture similar vaccines for pneumococcal disease.