Iran Authorizes Emergency Use of Cuba’s Soberana 02 Vaccine

Cuba’s Soberana 02 vaccine has been granted authorization for emergency use in the Islamic Republic of Iran, as announced by Iranian Minister of Health, Dr. Said Nemeki.

The authorization was granted on June 29th to the Pasteur Institute of Iran (IPI), which will market the vaccine in Iranian territory under the name Pasteur, within the framework of a collaboration agreement signed with the Finlay Vaccine Institute of Cuba in January.

The Iranian Regulatory Authority granted the emergency use authorization based on the recognition of the results of the pharmaceutical development of the product, the evidence of safety and immunogenicity demonstrated in Phases I and II of clinical trials carried out in Cuba, as well as the 62% clinical efficacy for the two-dose schedule reported in the intermediate analysis of the Phase III trial.

Some 24,000 Iranian volunteers in seven provinces are part of Phase III clinical trials of the vaccine which began in April. The Pasteur Institute of Iran has a long history of collaboration with BioCubaFarma and the two have other scientific exchange agreements.

Mohamad Mehdi, Director of the Center for Management of Infectious Diseases of the Ministry of Health and the Director of the Pasteur Institute of Iran, Alireza Biglarí, were the first injected with Soberana 02. Iran is currently experiencing a the fourth wave of Covid-19.

With information from Cubadebate