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Soberana 02 or Soberana 2, technical name FINLAY-FR-2, is a
COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 ( COVID19). Knowledge about the structure and fun ...
produced by the Finlay Institute, a
Cuba Cuba, officially the Republic of Cuba, is an island country, comprising the island of Cuba (largest island), Isla de la Juventud, and List of islands of Cuba, 4,195 islands, islets and cays surrounding the main island. It is located where the ...
n epidemiological research institute. The vaccine is known as PastoCovac () in
Iran Iran, officially the Islamic Republic of Iran (IRI) and also known as Persia, is a country in West Asia. It borders Iraq to the west, Turkey, Azerbaijan, and Armenia to the northwest, the Caspian Sea to the north, Turkmenistan to the nort ...
, where it has been developed in collaboration with the
Pasteur Institute of Iran Pasteur Institute of Iran is a medical research center located in Tehran, Iran. The institute is one of the oldest leading research and public health centers in Iran and the Middle East, established in 1920 following an agreement between the Past ...
. It is a
conjugate vaccine A conjugate vaccine is a type of subunit vaccine which combines a weak antigen with a strong antigen as a carrier so that the immune system has a stronger response to the weak antigen. Vaccines are used to prevent diseases by invoking an immune ...
that requires two doses, the second one being administered 28 days after the first shot. A third (
booster Booster may refer to: Amusement rides * Booster (Fabbri ride), a pendulum ride * Booster (HUSS ride), an evolution of the Breakdance ride * Booster (KMG ride), a pendulum ride Arts, entertainment, and media Fictional characters * Booster, a cha ...
) dose of Soberana Plus may also be given on day 56. It has received emergency use authorization in Iran in June 2021, and in Cuba in August 2021, where it has also been approved for children above 2 years old. The name of the vaccine, Soberana, is a
Spanish Spanish might refer to: * Items from or related to Spain: **Spaniards are a nation and ethnic group indigenous to Spain **Spanish language, spoken in Spain and many countries in the Americas **Spanish cuisine **Spanish history **Spanish culture ...
word that means "sovereign". It followed a previous candidate vaccine called SOBERANA-01 (FINLAY-FR-1).


Medical uses

The vaccine requires two doses, the second one being administered four weeks after the first shot. A third (boost) dose of Soberana Plus may also be given on eight weeks.


Efficacy

The interim results of a Phase III trial in Cuba has shown an efficacy of 71.1% after only two doses, increasing to 92.4% after adding a dose of Soberana Plus. The trial was undertaken while the delta variant was gradually taking over from beta in Havana. The interim results of the Phase III trial in Iran show that the efficacy of a two-dose regimen is 51.31% against symptomatic disease, 78.35% against severe disease, and 76.78% against hospitalization. A third dose of Soberana Plus increases the efficacy against symptomatic disease to 70.58%, 83.52% against severe disease, and 91.76% against hospitalization. 89% of the cases in the Iranian trial were identified as having the delta strain. The final results of the Phase III trials in Cuba show an efficacy against symptomatic disease of 71.0% against the beta and delta strains, while a third dose of Soberana Plus increased the efficacy up to 92.4%. Efficacy against severe disease and death is 100% for the heterologous three-dose regimen. The final results of the Phase III trial in Iran show an efficacy of 67% against symptomatic disease and 96.5% against severe disease and hospitalization for a heterologous three-dose regimen. No deaths were observed in the trial group that received the three-dose regimen. Unlike the Phase III trials in Cuba, the majority of cases throughout the entire trial were of the delta strain (more than 90% at the time of vaccine evaluation). A 2021 multicentre, randomised, double-blind, placebo-controlled, phase III trial of Soberana 02 showed acceptable vaccine efficacy against symptomatic COVID-19 and COVID-19–related severe infections. The trial was conducted in Iran and, for a 2-dose treatment, showed an efficacy of 49.7% against symptomatic disease, 76.8% against severe disease and 77.7% against hospitalisation. When a third dose of Soberana Plus was added to the treatment, the efficacy improved to 64.9% for prevention of symptomatic disease, 96.6% for prevention of severe disease, and 96.6% for prevention of hospitalisation.


Pharmacology

FINLAY-FR-2 is a
conjugate vaccine A conjugate vaccine is a type of subunit vaccine which combines a weak antigen with a strong antigen as a carrier so that the immune system has a stronger response to the weak antigen. Vaccines are used to prevent diseases by invoking an immune ...
. It consists of the receptor binding domain of the SARS-CoV-2
spike protein In virology, a spike protein or peplomer protein is a protein that forms a large structure known as a spike or peplomer projecting from the surface of an viral envelope, enveloped virus. as cited in The proteins are usually glycoproteins that ...
conjugated chemically to
tetanus toxoid Tetanus vaccine, also known as tetanus toxoid (TT), is a toxoid vaccine used to prevent tetanus. During childhood, five doses are recommended, with a sixth given during adolescence. After three doses, almost everyone is initially immune, but ...
. Professor Ihosvany Castellanos Santos said that the antigen is safe because it contains parts instead of the whole live virus, and therefore it does not require extra refrigeration, like other candidates in the world.


Manufacturing

The spike protein subunit is produced in
Chinese hamster ovary cell Chinese hamster ovary (CHO) cells are a family of immortalized cell lines derived from epithelial cells of the ovary of the Chinese hamster, often used in biological and medical research and commercially in the production of recombinant therap ...
culture. In the ''
ACS Chemical Biology ''ACS Chemical Biology'' is a monthly peer-reviewed scientific journal published since 2006 by the American Chemical Society. It covers research at the interface between chemistry and biology spanning all aspects of chemical biology. The founding ...
'' article, scientists from Cuba explain details of the vaccines technology and production.
;Production # Cuba # Iran (under name of PasteurCoVac) ;Potential Production #Ghana #Argentina


In Cuba

The Cuban government says it is planning to produce 100 million doses of its vaccine to respond to its own demand and that of other countries. Cuba has also suggested that, once it's approved, it will offer the vaccine to tourists visiting the country. The production of the first batch of about 100,000 doses will start in April. José Moya, representative of the
World Health Organization The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
and the
Pan American Health Organization The Pan American Health Organization (PAHO) is a specialized agency of the United Nations (UN) in charge of international health cooperation in the Americas. It fosters technical cooperation among member countries to fight communicable and non ...
(PAHO) in Cuba, suggested that after the vaccine passes all clinical stages, it could be included as part of PAHO's Revolving Fund. The roll-out began with an "Interventional Trial" that consisted of inoculating 150,000 at-risk participants which seems to be defined as health-care workers. On April 11, 2021, the Ministry of Public Health of Cuba announced that 75,000 health-care workers were inoculated with their first dose of either of the two Cuba's Phase III vaccines (the other being Abdala). By April 2022, Cuba inoculated 9.9 million of its 11.2 million residents, 6.4 million have received booster doses. The vaccine campaign using domestic products was heralded as a huge success by Cuban President
Miguel Diaz-Canel --> Miguel is a given name and surname, the Portuguese and Spanish form of the Hebrew name Michael. It may refer to: Places * Pedro Miguel, a parish in the municipality of Horta and the island of Faial in the Azores Islands * São Miguel (disam ...
when case loads were down significantly since January 2022. The Soberana vaccine preparations were particularly effective in children, preventing 70,000 pediatric cases before the Omicron wave hit.


Outside Cuba

Vietnam, Iran, Venezuela, Argentina, Pakistan, India, the African Union, Jamaica, and Suriname have expressed interest in purchasing the vaccine, following Phase 3 results. Iran has signed an agreement to manufacture the vaccine and Argentina is negotiating one. Additionally, the Cuban government offered a "transfer of technology" to
Ghana Ghana, officially the Republic of Ghana, is a country in West Africa. It is situated along the Gulf of Guinea and the Atlantic Ocean to the south, and shares borders with Côte d’Ivoire to the west, Burkina Faso to the north, and Togo to t ...
and will also supply "active materials" needed to make the vaccine. While the price is currently unknown, the commercialization strategy of the vaccine will be a combination of the "impact on health" and the capability of Cuba's system to financially support "the production of vaccines and drugs for the country", per the director of the Finlay Institute, Vicente Vérez. Up to 27 November 2021, 8 millions doses of Pasteurcovac have been produced in Iran.


Clinical trials


Phase I

FINLAY-FR-2, which started being developed in October 2020, had 40 volunteers for its Phase I, according to the Cuban Public Registry of Clinical Trials, with an open, sequential and adaptive study to assess safety, reactogenicity and explore immunogenicity of the vaccine.


Phase II

Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years. Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days. The second phase has been supervised by
Iran Iran, officially the Islamic Republic of Iran (IRI) and also known as Persia, is a country in West Asia. It borders Iraq to the west, Turkey, Azerbaijan, and Armenia to the northwest, the Caspian Sea to the north, Turkmenistan to the nort ...
ian officials from the
Pasteur Institute The Pasteur Institute (, ) is a French non-profit private foundation dedicated to the study of biology, micro-organisms, diseases, and vaccines. It is named after Louis Pasteur, who invented pasteurization and vaccines for anthrax and rabies. Th ...
.


Phase III

Phase III commenced at the beginning of March as originally scheduled, and "ready to publish" results are expected by June. The trial volunteers are divided into three groups: some will receive two doses of the vaccine 28 days apart, another group will get two doses plus a third immune booster (Soberana Plus), and the third a
placebo A placebo ( ) can be roughly defined as a sham medical treatment. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures. Placebos are used in randomized clinical trials ...
. Although the trials involve thousands of adult volunteers recruited in Havana, Cuba's public health officials have said that they will also need to conduct phase III trials abroad because the island doesn't have an outbreak of sufficient scale to produce meaningful statistics on vaccine protection. On March 13, 2021, the Cuban Biotechnology and Pharmaceutical Industries Business Group (BioCubaFarma) announced on social media that it had sent 100,000 doses of its Soberana 02 coronavirus vaccine candidate to the
Pasteur Institute of Iran Pasteur Institute of Iran is a medical research center located in Tehran, Iran. The institute is one of the oldest leading research and public health centers in Iran and the Middle East, established in 1920 following an agreement between the Past ...
for clinical testing, "as part of the collaboration with other countries in the development of COVID-19 vaccines." On April 26, 2021, it was reported that a Phase III conducted by the
Pasteur Institute of Iran Pasteur Institute of Iran is a medical research center located in Tehran, Iran. The institute is one of the oldest leading research and public health centers in Iran and the Middle East, established in 1920 following an agreement between the Past ...
was approved to be started in Iran It was previously reported that the Institute will host Phase 3, but the pre-requisites were "technology transfer and joint production". The Phase III trial in Iran has been conducted on 24,000 adults, aged between 18 and 80 years old in 8 cities. The interim results of the Phase III trial in Iran show that the efficacy of a two-dose regimen is 51.31% against symptomatic disease, 78.35% against severe disease, and 76.78% against hospitalization. A third dose of Soberana Plus increases the efficacy against symptomatic disease to 70.58%, 83.52% against severe disease, and 91.76% against hospitalization. The study was conducted when the delta variant was predominant in the country, with 89% of the cases in the Iranian trial identified as having the delta strain. Given the limited number of reported deaths in the trial, it was virtually impossible to analyze efficacy against death for both the two and three dose regimens. Mexico plans to host a phase 3 trial. The final results of the Phase III trials in Cuba show an efficacy against symptomatic disease of 71.0% against the beta and delta strains, while a third dose of Soberana Plus increased the efficacy up to 92.4%. Efficacy against severe disease and death is 100% for the heterologous three-dose regimen. The final results of the Phase III trial in Iran show an efficacy of 67% against symptomatic disease and 96.5% against severe disease and hospitalization for a heterologous three-dose regimen. No deaths were observed in the trial group that received the three-dose regimen. Unlike the Phase III trials in Cuba, the majority of cases throughout the entire trial were of the delta strain (more than 90% at the time of vaccine evaluation).


Children and adolescents trials

In June 2021, Soberana started clinical trials for children and adolescents aged 3–18 from Phase I/II.


Interventional Study

The "Interventional Study" is set both in
Havana Havana (; ) is the capital and largest city of Cuba. The heart of La Habana Province, Havana is the country's main port and commercial center.Santiago de Cuba Santiago de Cuba is the second-largest city in Cuba and the capital city of Santiago de Cuba Province. It lies in the southeastern area of the island, some southeast of the Cuban capital of Havana. The municipality extends over , and contains t ...
, Cuba's second most populous city and in other provinces. On May 6, 2021, the Finlay Institute of Vaccines announced on social media that the following
adverse events In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medicatio ...
have been observed: injection site pain (20%), inflammation at the injection site (5%), and general discomfort (5%).


Authorizations

On June 29, 2021, Soberana 02 was authorized for emergency use in Iran. On August 20, 2021, Soberana 02 was authorized for emergency use in Cuba. On September 3, 2021, the authorization has been expanded to children in the age 2–18 years old.


See also

*
COVID-19 vaccine clinical research COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness, and safety. , 40 vaccines are authorized by at least one national regulator ...
*
COVID-19 pandemic in Cuba The COVID-19 pandemic in Cuba was a part of the worldwide pandemic of coronavirus disease 2019 () caused by severe acute respiratory syndrome coronavirus 2 (). The virus was confirmed to have spread to Cuba on 11 March 2020 when three It ...
*
COVID-19 pandemic in Iran The COVID-19 pandemic in Iran has resulted in confirmed cases of COVID-19 and deaths. On 19 February 2020, Iran reported its first confirmed cases of infections in Qom. The virus may have been brought to the country by a merchant from Qom ...
*
Healthcare in Cuba The Cuban government operates a national health system and assumes fiscal and administrative responsibility for the health care of all its citizens. All healthcare in Cuba is free to Cuban residents, although challenges include low salaries for ...
*
Pharmaceuticals in Iran ''For health issues in Iran see Health in Iran.'' Healthcare in Iran is based on three pillars: the public-governmental system, the private sector, and Non-governmental organization, NGOs. The healthcare and medical sector's market value in Iran w ...


References


External links

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