Vaccine Info

Soberana 02 COVID-19 Vaccine

Last Reviewed
February 17, 2021

Soberana 02 COVID-19 Vaccine Description

Soberana 02 (FINLAY-FR-2) COVID-19 vaccine candidate is a conjugate vaccine in which the virus antigen, the receptor-binding domain (RBD), is chemically bound to the tetanus toxoid.

On August 13, 2020, Cuba's national regulatory agency, the Center for Quality Control of Medicines, Equipment, and Medical Devices, authorized clinical trials for SOBERANA 01-Cuba's first vaccine candidate.

Vicente Verez, Finlay Vaccine Institute, Center for Vaccine Research and Production, is reported by the Agencia Cubana de Noticias news agency to have said 'The age range of the sample of volunteers in this phase of the test will span from five to 19 years. Vérez Bencomo emphasized that the Institute has vast experience in clinical trials in pediatric ages since previously all its vaccines were intended for this population.'

On January 21, 2021, the BBC reported 'the Cuban government will produce 100 million doses of its vaccine, Soberana 02, against the new coronavirus this year in order to respond to its own demand and those of other countries. The 100 million doses planned would be only from Soverana 02. There are already several countries interested in acquiring it, such as Vietnam, Iran, and Venezuela, and with those with which the island has collaboration agreements, including Pakistan and India.'

Soberana 02 is produced by the Finlay Vaccine Institute (IFV) is a Cuban epidemiological research institute. The IFV was created in 1991 to expand the achievement of a group of Cuban scientists who investigated, produced, and presented the VA-MENGOC-BC vaccine,

Soberana 02 COVID-19 Vaccine Indication

Soberana 02 COVID-19 Vaccine is indicated to prevent COVID-19 disease caused by the SARS-Cov-2 virus. According to the WHO candidate landscape vaccine document, this vaccine requires two doses, the second one being administered 28 days after the first vaccination.

Soberana 02 COVID-19 Vaccine News

February 17, 2021 - Local media reported the Mexican Foreign Minister, Marcelo Ebrard, said that there is communication on the part of the Ministry of Health with the laboratory in Cuba, which is carrying out the realization and development of this vaccine, so that part of its phase three tests can be carried out in Mexico. Soberana 02, one of the four vaccine candidates from Cuba in the fight against the Covid-19 pandemic, could be the subject of trials in Mexico, according to what was reported by that country.

February 16, 2021 - BBC reported, 'Researchers are working long shifts on Cuba's best shot to solve its coronavirus crisis: Soberana 2, the island's domestically-produced Covid-19 vaccine. Soberana (Spanish for "sovereign") 2 is a conjugate vaccine - meaning an antigen is fused to a carrier molecule to bolster the vaccine's stability and effectiveness.'

February 5, 2021 - Cuba will test more than 42,000 people in Phase 3 trials and affirms that it has the capacity to produce 100 million

February 5, 2021 - Cuba to deliver 1 million COVID-19 vaccine doses by April. "Soberana 02 is due to begin the third phase of clinical trials in March, involving some 42,600 participants," said  IFV Director-General Vicente Verez.

January 21, 2021 - Covid 19: Hope is being eclipsed by deep frustration. In the coming weeks, vaccination will be extended to 150,000 people on the island, on the way to mass immunization, and a test will be carried out in February to protect children with Soverana 02.

January 12, 2021 - COVID-19 vaccine made in Cuba: when and for whom? While part of the world has already begun to vaccinate, Cuba waits for Soberana 01, Soberana 02, Mambisa, or Abdala. The island's four vaccine candidates against COVID-19 are developed as subunit vaccines, one of the most economical approaches and "the type for which Cuba has the greatest know-how and infrastructure," Riverol told DW.

November 2, 2020 - Phase-1 of clinical trials with Soberana 02 candidate begins in Cuba. Soberana 02 ended all the research phases required in experimental animals, demonstrating a powerful and effective immune response against the virus, for which the Finlay Institute requested authorization to start Phase 1 clinical trial in healthy adults from the Center for State Control of Medicines, Equipment, and Medical Devices (CECMED).

Soberana 02 COVID-19 Vaccine Clinical Trials

Soberana 02 COVID-19 Vaccine has been in human clinical trials since October 30, 2020. Phase 2a and 2b clinical trials began on December 18, 2020, jabbing 910 subjects. Phase 3 is expected to commence in March 2021 following the Phase 2 trials' success. 

The Phase 1 clinical trial was conducted at the Instituto de Medicina Tropical. 40 subjects were jabbed with Soberana 02. Additionally, Phase 1 and 2 pediatric clinical trials are expected to commence in March 2021.