Cuba COVID-19 Vaccines 2023
Cuba's COVID-19 vaccines (Soberana 02, FINLAY-FR-2, Pastu Covac, Abdala) are conjugate vaccines with the virus antigen, the receptor-binding domain (RBD), which is chemically bound to the tetanus toxoid.
The technological platform used in the Soberana 02 vaccine is the same method developed and used to produce the active principle of the Cuban conjugate Quimi-Hib® vaccine, which has demonstrated its safety and efficacy in the lactating population and has been incorporated into the National Program of Vaccination since 2004. In addition, conjugated polysaccharide vaccines, such as Abdala, generate a long-lasting and protective immune response in the general population, particularly in those under two years of age, an age group in which unconjugated polysaccharide vaccines have little or no effect.
On August 13, 2020, Cuba's national regulatory agency, the Center for Quality Control of Medicines, Equipment, and Medical Devices (CECMED), authorized clinical trials for SOBERANA 01, Cuba's first vaccine candidate. Dr. C. Vicente Vérez, General Director of the Finlay Vaccine Institute, marked the industrial production of the first 150 thousand doses of the Soberana 02 vaccine on February 8, 2021.
A non-peer-reviewed study was published on March 3, 2021: A single dose of SARS-CoV-2 FINLAY-FR-1A dimeric-RBD recombinant vaccine enhances neutralization response in COVID-19 convalescents with an excellent safety profile. A preliminary report of an open-label phase 1 clinical trial. This short report shows a) an excellent safety profile one month after vaccination for all participants, similar to that previously found during vaccination of naïve individuals; b) a single dose of vaccine induces a > 20-fold increase in antibody response one week after vaccination and remarkably 4-fold higher virus neutralization compared to the median obtained for Cuban convalescent serum panel.
As of August 22, 2021, about 10 million Cubans (90% of the population) had received at least their first dose of Soberana 02 or Abdala. A study reported by a peer-reviewed journal found after the three-dose cycle, Soberana 02 is 91.2% effective after two doses when followed by a booster of Soberana Plus. Cuban health authorities have committed to vaccinating the entire population, including children aged 3-18, using these vaccines by the end of 2021.
The Lancet published a study on September 15, 2021: A single dose of SARS-CoV-2 FINLAY-FR-1A vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial. A single dose of the FINLAY-FR-1A vaccine against SARS-CoV-2 was an efficient booster of pre-existing natural immunity with an excellent safety profile. FINLAY-FR-1A is a vaccine based on recombinant d-RBD on aluminum hydroxide gel. It is being studied to protect naïve individuals and COVID-19 convalescent subjects, and its use as a booster for persons already immunized with other vaccines is being considered.
The Finlay Vaccine Institute (IFV), a Cuban epidemiological research institute, officially announced on June 19, 2021, that SOBERANA 02, developed together with the Center for Molecular Immunology and the University of Havana, had shown the first efficacy data clinic against symptomatic disease COVID-19 in a schedule of two doses every 28 days.
On October 11, 2021, a phase III clinical trial developed by the Pasteur Institute of Iran confirmed the efficacy of the SOBERANA-02 and SOBERANA Plus vaccines against the SARS-CoV-2 Delta strain. Then, on November 1, 2021, a late-stage study reported that SOBERANA Plus, after two doses of SOBERANA 02, increased efficacy from 71.0 % to 92.4%.
On November 22, 2021, the journal Nature published an article: Cuba's bet on homegrown COVID vaccines is paying off. A non-peer-reviewed clinical study found that a three-dose combo of Soberana jabs has 92.4% efficacy. Protein-based vaccines like Soberana 02 may have advantages over other vaccine types, says Craig Laferrière, head of vaccine development at Novateur Ventures in Toronto, Canada.
On July 27, 2022, AFP reported Belarus became the first European country to approve the emergency use of Soberana Plus. On November 3, 2022, Harvard University stated Cuba's ability to develop homegrown COVID-19 vaccines and immunize most of its citizens should serve as a model for developing countries around the world dealing with public health emergencies, according to a report published on October 31, 2022.
On May 21, 2023, Soberana 02, Soberana Plus, and Abdala received the sanitary registration granted by the Center for State Control of Medicines, Medical Equipment, and Devices for its proven efficacy.
Instituto Finlay de Vacunas Cuba: FINLAY-FR-2 clinical trial listing and SOBERANA PLUS, Abdala information.
Soberana is produced by the Finlay Vaccine Institute, located at Avenue No. 21, No. 19810, Reparto Atabey, Playa, Havan, and the Pasteur Institute of Iran, founded in Tehran in the 1920s. 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 Plus Vaccine
The Soberana Plus vaccine has been approved in Cuba combined with Soberana 02. Soberana 2 is 92.4% effective after two doses and an additional dose of Soberana Plus, non-peer-reviewed studies have shown. In November 2021, a phase-3 study of a three-dose, heterologous COVID-19 vaccine and two doses of SOBERANA 02 were found safe and attained efficacy of 71% in the adult population 19-80 y/o; incorporating SOBERANA Plus increased effectiveness from 71% to 92.4%.
Abdala (CIGB-66) COVID-19 Vaccine
The Abdala (CIGB-66) vaccine has been shown 92.3to be % effective against symptomatic infection after three doses. On April 9, 2022, a study published by The Lancet found the Abdala vaccine was safe, well-tolerated, and induced humoral immune responses against SARS-CoV-2 in a phase 3 study. In the context of the emergency COVID-19 pandemic, these results support the 50 μg dose, applied in a 0-14-28 days schedule for further clinical trials to confirm vaccine efficacy. On September 23, 2022, The Lancet published results from a study: The Cuban Abdala protein subunit vaccine was highly effective in preventing severe illness and death from COVID-19 under real-life conditions.
Abdala was approved for emergency use by Mexico's Federal Commission for Protection against Health Risks (Cofepris) on December 29, 2021. The vaccine arrived at the Felipe Angeles International Airport in Zumpango, State of Mexico, in late November 2022.
BIV1-CovIran COVID-19 Vaccine
The results from a study highlight the BIV1-CovIran vaccine's ability to induce a strong and potent immune response that may be a promising and feasible vaccine to protect against SARS-CoV-2 infection.
Cuba COVID-19 Vaccine Indication
According to the WHO, this vaccine requires two doses, the second being administered 14 days after the first vaccination. The Pastu Covac brand is the only Iranian vaccine available for injection in children aged 2-18.
Cuba COVID-19 Vaccine Dosage
Three doses of the Soberana 02 are more than 90% effective in protecting against symptomatic COVID-19 infection. In addition, the third dose of SOBERANA Plus (RBD-dimer) further increased the specific anti-RBD neutralizing antibodies, according to a study reviewed by the journal Nature on November 22, 2021.
Cuba COVID-19 Vaccine Availability
Cuba exports its vaccines to Iran, Nicaragua, Venezuela, and Vietnam and is in discussion with more than 15 countries, most of which are low-income nations, said Rodríguez. In addition, it recently donated covid-19 vaccines to Syria and St Vincent, and the Grenadines and is sharing knowledge and technical know-how with other countries to help them locally manufacture the vaccines.
Soberana COVID-19 Vaccine Clinical Trials
Soberana 02 COVID-19 Vaccine has been in human clinical trials since October 30, 2020.
A separate Phase 3 study of a three-dose heterologous vaccine enrolled over 40,000 participants in various clinics throughout Havana. The non-peer-reviewed results were published on 11/01/2021. The heterologous three-dose combination with SOBERANA Plus protected against symptomatic COVID-19: 15 cases in the vaccine groups (13 833) vs. 155 in the placebo group (14 303), VE 92.4%, adjusted (CI 95% 86.9-95.6%). For two-dose schedule VE against severe COVID-19 was 63.0% and for death 59.0%; for heterologous three-dose schedule, 100% in both cases.
A Phase 3 study which was developed by the Pasteur Institute of Iran confirmed the efficacy of the SOBERANA VACCINES against the Delta strain of the virus. The double-blind, randomized, placebo-controlled trial enrolled 24,000 subjects who used the SOBERANA-02 vaccine in a two-dose regimen in eight cities and a booster dose (three-dose regimen) with the SOBERANA-Plus vaccine in 2 cities. During the trial, the Delta variant July (71.9%) and August (95.4%) was widely predominant. The vaccine efficacy in preventing hospitalization was 76.8% with the two-dose regimen and 91.7% in the three-dose regimen.
Based on the results of the Phase I / II trial in pediatric ages with SOBERANA02, on August 27, 2021, CECMED was requested to extend the authorization of emergency use for a population between 3 and 18 years of age, and it was requested to include the cohort of children between 2 -3 years in the authorization under clinical and epidemiological arguments endorsed by the National Group of Pediatrics. Therefore, on September 3, CECMED authorized the use of emergencies for ages 2-18 years. On September 5, 2021, the vaccination of children and adolescents of these ages begins, beginning in the province of Cienfuegos and with an extension schedule throughout the country according to MINSAP planning.
