HAVANA, Cuba, Jul 2 (ACN) The Islamic Republic of Iran authorized the emergency use of the Cuban vaccine against COVID-19 Soberana 02, according to Dr. Said Nemeki, Iranian Health Minister.
This Tuesday, the Health Minister announced to the Iranian media that the drug will be marketed under the name Pasteur, as part of the collaboration agreement with the Finlay Vaccine Institute (IFV), the entity promoting the formulation, and today that institution and BioCubaFarma confirmed the news on Twitter, in two messages.
The regulatory authority of that Asian nation took into account the safety and immunogenicity evidenced by the product in phase I and II of the clinical trial carried out in Cuba, and the 62 percent efficacy proven with its two-dose schedule.
It also considered the safety of the vaccine in the second Phase III clinical trial carried out with 24,000 subjects in several Iranian provinces.
Iran’s Pasteur Institute granted the authorization on June 29 and today media outlets such as The New York Times and Vaccine Tracker are echoing the news.
BioCubaFarma specified that the “Pasteur Institute of Iran (IPI) will market the vaccine in Iranian territory under the name Pasteur, within the framework of a collaboration agreement signed with the Finlay Institute of Vaccines last January”.
At present, Cuba is waiting for the results of the efficacy of the drug with its three-dose schedule: two doses of Soberana 02 and one of Soberana Plus as a booster.
Once this is known, the IFV will present the dossier to the Center for State Control of Medicines, Equipment and Medical Devices to request the authorization for emergency use in the Caribbean nation.
In addition, the clinical trial in the pediatric population began on June 14 at the Juan Manuel Márquez hospital in the capital.
Soberana 02 is the only anti-SARS-Cov-2 conjugate vaccine in the world, in which the virus antigen – the receptor binding domain (RBD) – is chemically linked to the tetanus toxoid.
