About 100 volunteers to take part in phase 2

Cuba is now entering the second phase of clinical trials of its vaccine to prevent COVID-19, called Soberana 02.

Havana’s Finlay Institute reported on Tuesday that the communist-led Caribbean island has begun vaccinating volunteers. The scientific centre dedicated to research and vaccine production tweeted, “This week the vaccination process of the Phase II Clinical Trial of vaccine #Soberana02 began. Everything has gone normally and complying with good practices”.s

Vicente Vérez, director general of the Finlay Vaccine Institute, said that, in this Cuban vaccine, the virus antigen and tetanus toxoid are combined. Phase 2 should involve about a hundred people, which will increase to between 300 and 600 in a phase II-B.

Phase 3, which is more complex to develop on the island due to the low incidence of the disease, should include an even greater number of volunteers.

Vérez described this future conjugate vaccine as “innovative”, assuring that its formulation is unprecedented among all those currently being developed in the world to face SARS-CoV-2.

 Soberana 02 received authorisation

On December 17, Soberana 02 received authorisation from the island’s Center for State Control of Medicines, Equipment and Medical Devices to advance to phase II of clinical trials, after preliminary positive results of phase I. Soberana 02 constitutes the first Latin American drug to reach that stage.

Cuba is developing three other coronavirus vaccine projects, classified as Soberana 01, Abdala and Mambisa. The clinical trials of Soberana 01 began at the end of last August.

The developers of the drug say the process, which has had the participation of more than 700 volunteers, is progressing without incident. Unlike other more advanced projects, made from adenoviral vectors or inactivated viruses, this Cuban vaccine is based on a recombinant protein.

Two other vaccines being investigated

In the case of Abdala (intramuscular) and Mambisa (intranasal), the vaccines are being investigated at the Center for Genetic Engineering and Biotechnology (CIGB) in Cuba. It has been announced that clinical trials will begin in which each one will be tested in two phases.

Cuba, which has recorded a total of 10,384 positive cases since the start of the global pandemic, with 139 deaths, has a recognised biotechnology and pharmaceutical industry that currently produces eight vaccines against diseases such as meningitis, lung cancer (therapeutic) and solid tumors, among others.

The Cuban authorities have already said they plan to vaccinate against COVID-19 an “important part” of the Cuban population before the end of the first half of 2021.