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).
Prior to the COVID19 pandemic, an e ...
produced by the
Finlay Institute
The Finlay Institute (''Instituto Finlay de Vacunas'' lit. ''Finlay Vaccine Institute'') is a Cuban organization that carries out medical research and mainly produces vaccines. It is named after the Cuban doctor Carlos Finlay who was the first ...
, a
Cuba
Cuba ( , ), officially the Republic of Cuba ( es, República de Cuba, links=no ), is an island country comprising the island of Cuba, as well as Isla de la Juventud and several minor archipelagos. Cuba is located where the northern Caribbea ...
n epidemiological research institute. The vaccine is known as PastoCovac ( fa,
پاستوکووک) in
Iran
Iran, officially the Islamic Republic of Iran, and also called Persia, is a country located in Western Asia. It is bordered by Iraq and Turkey to the west, by Azerbaijan and Armenia to the northwest, by the Caspian Sea and Turkmeni ...
, 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 Inst ...
.
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) dose of
Soberana Plus
Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.
Medical uses
It can be used as a third (booster) dose for Soberana 02 vaccine at eight ...
may also be given on day 56. It has received emergency use authorization in Iran on June 2021, and in Cuba on August 2021, where it has also been approved for children above 2 years old.
The name of the vaccine, Soberana, is a
Spanish 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
Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.
Medical uses
It can be used as a third (booster) dose for Soberana 02 vaccine at eight ...
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
Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.
Medical uses
It can be used as a third (booster) dose for Soberana 02 vaccine at eight ...
.
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).
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 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 a ...
.
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 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 specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
and the
Pan American Health Organization
The Pan American Health Organization (PAHO) is an international public health agency working to improve the health and living standards of the people of the Americas. It is part of the United Nations system, serving as the Regional Office for ...
(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 Abdala or Abdalá is both a given name and a surname. It is a Spanish variation of the common Arabic name Abdullah. Notable people with the name include:
Surname
*Alberto Abdala (1920–1986) Uruguayan politician, painter and Vice President of Urug ...
).
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 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 (; tw, Gaana, ee, Gana), officially the Republic of Ghana, is a country in West Africa. It abuts the Gulf of Guinea and the Atlantic Ocean to the south, sharing borders with Ivory Coast in the west, Burkina Faso in the north, and To ...
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, and also called Persia, is a country located in Western Asia. It is bordered by Iraq and Turkey to the west, by Azerbaijan and Armenia to the northwest, by the Caspian Sea and Turkmeni ...
ian officials from the
Pasteur Institute
The Pasteur Institute (french: Institut Pasteur) 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 f ...
.
Phase III
![Así es la tercera fase de Soberana 02 - snap](https://upload.wikimedia.org/wikipedia/commons/6/6f/As%C3%AD_es_la_tercera_fase_de_Soberana_02_-_snap.png)
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 ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures.
In general ...
.
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 Inst ...
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 Inst ...
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 (; Spanish: ''La Habana'' ) is the capital and largest city of Cuba. The heart of the La Habana Province, Havana is the country's main port and commercial center. , Cuba's capital and
Santiago de Cuba, 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 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 COVID-19 vaccine, vaccines. These characteristics include #Efficacy, efficacy, #Effectiveness, effectiveness and safety. , 40 vaccines are ...
*
COVID-19 pandemic in Cuba
The COVID-19 pandemic in Cuba is 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 Itali ...
*
COVID-19 pandemic in Iran
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quickly ...
*
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. There are no private hospitals or clinics as all health services are government-run. The presen ...
*
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 NGOs. The healthcare and medical sector's market value in Iran was almost US$24 billion in 2002 ...
References
External links
{{Portal bar , Medicine , Viruses , COVID-19
Clinical trials
Cuban COVID-19 vaccines
Science and technology in Cuba
Conjugate vaccines