Soberana 02
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![]() A vial of Soberana 02 | |
Vaccine description | |
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Target | SARS-CoV-2 |
Vaccine type | Conjugate |
Clinical data | |
Trade names | Pasteur |
Other names | FINLAY-FR-2, Pasteurcovac, پاستوکووک |
Routes of administration | Intramuscular |
Legal status | |
Legal status |
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Part of a series on the |
COVID-19 pandemic |
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Soberana 02 or Soberana 2, technical name FINLAY-FR-2, is a COVID-19 vaccine produced by the Finlay Institute, a Cuban epidemiological research institute. The vaccine is known as Pasteurcovac (Persian: پاستوکووک) in Iran where it has been developed in collaboration with the Pasteur Institute of Iran.[1][2][3]
It is a conjugate vaccine that requires two doses, the second one being administered 28 days after the first shot. A third (booster) dose of Soberana Plus 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".[4] It followed a previous candidate vaccine called SOBERANA-01 (FINLAY-FR-1).[5]
Efficacy[]
It has shown an efficacy of 62% after only two doses,[6][7][8] when combined with a booster dose of Soberana Plus, the vaccine showed an efficacy of 91.2%,[9] according to BioCubaFarma.
No pre-print or details of a study have been released as of 9 July 2021.[9]
Pharmacology[]
FINLAY-FR-2 is a conjugate vaccine. It consists of the receptor binding domain of the SARS-CoV-2 spike protein conjugated chemically to tetanus toxoid.[5]
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.[10]
The vaccine requires two doses, the second one being administered 28 days after the first shot.[11][12][13] A third (boost) dose of Soberana Plus may also be given on day 56.[11][12]
Manufacturing[]
The spike protein subunit is produced in Chinese hamster ovary cell culture.[5] In the ACS Chemical Biology article, scientists from Cuba explain details of the vaccines technology and production.[14]
Production
Deliveries
Planned Production
Potential Production |
- Production
- Planned production
- Iran
- 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.[17][18] Cuba has also suggested that, once it's approved, it will offer the vaccine to tourists visiting the country.[19][20][21]
The production of the first batch of about 100,000 doses will start in April.[22] José Moya, representative of the World Health Organization and the Pan American Health Organization (PAHO) in Cuba, suggested that after the vaccine passes all clinical stages, it could be included as part of PAHO's Revolving Fund.[23]
The roll-out began with an "Interventional Trial"[24] that consisted of inoculating 150,000 at-risk participants which seems to be defined as health-care workers.[25][26] 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).[27][28]
Outside Cuba[]
Vietnam, Iran, Venezuela, Argentina,[29][30][31] Pakistan, India, the African Union, Jamaica and Suriname[32] have expressed interest in purchasing the vaccine, although they are waiting on Phase 3 results.[33][34]
Iran has signed an agreement to manufacture the vaccine[35] and Argentina is negotiating one.[29][30][31] Additionally, the Cuban government offered a "transfer of technology" to Ghana and will also supply "active materials" needed to make the vaccine.[36][37][38]
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.[39]
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.[40]
Phase II[]
Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years.[41][42] Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days.[43] The second phase has been supervised by Iranian officials from the Pasteur Institute.[4]
Phase III[]
![](http://upload.wikimedia.org/wikipedia/commons/thumb/a/a6/Cuba-iran_vaccine.jpg/220px-Cuba-iran_vaccine.jpg)
Phase III commenced at the beginning of March as originally scheduled,[44][20] and "ready to publish" results are expected by June.[45][46][47] 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[48][49][50]), and the third a placebo.[44]
Although the trials involve thousands of adult volunteers recruited in Havana,[51] 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.[4][19]
On 13 March 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 for clinical testing, “as part of the collaboration with other countries in the development of COVID-19 vaccines.” [52]
On 26 April 2021, it was reported that a Phase III conducted by the Pasteur Institute of Iran was approved to be started in Iran[53][54][55] It was previously reported that the Institute will host Phase 3 but the pre-requisites were "technology transfer and joint production".[56][4]
The Phase III trial in Iran has been conducted on 24,000 adults, aged between 18 and 80 years old in 8 cities.[13]
Mexico plans to host a phase 3 trial.[57]
Children and adolescents trials[]
In June 2021, Soberana started clinical trials for children and adolescents aged 3-18 from Phase I/II.[58][59]
Interventional Study[]
![]() | Some of this article's listed sources may not be reliable. (August 2021) |
The "Interventional Study" is set both in Havana,[60] Cuba's capital and Santiago de Cuba, Cuba's second most populous city [61][62] and in other provinces.[63] 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%).[64][65]
Authorizations[]
Full authorization
Emergency authorization |
On 29 June 2021, Soberana 02 was authorized for emergency use in Iran.[66]
On 20 August 2021, Soberana 02 was authorized for emergency use in Cuba.[67] On 3 September 2021, the authorization has been expanded to children in the age 2-18 years old.[68]
References[]
- ^ Mallapaty, Smriti (17 August 2021). "Iran hopes to defeat COVID with home-grown crop of vaccines". Nature. 596 (7873): 475–475. doi:10.1038/d41586-021-02216-z.
- ^ "pasteurcovac.ir". Retrieved 7 September 2021.
- ^ "Iran-Cuba vaccine enters phase three clinical trials". Tehran Times. 26 April 2021. Retrieved 7 September 2021.
- ^ Jump up to: a b c d Rasmussen SE, Eqbali A (12 January 2021). "Iran, Cuba, Under U.S. Sanctions, Team Up for Covid-19 Vaccine Trials". The Wall Street Journal.
- ^ Jump up to: a b c Malik JA, Mulla AH, Farooqi T, Pottoo FH, Anwar S, Rengasamy KR (January 2021). "Targets and strategies for vaccine development against SARS-CoV-2". Biomedicine & Pharmacotherapy. 137: 111254. doi:10.1016/j.biopha.2021.111254. PMC 7843096. PMID 33550049.
- ^ "Cuba's homegrown Covid vaccine shows promise". www.ft.com. Retrieved 20 June 2021.
- ^ "Cuba encouraged by early efficacy results of homegrown COVID-19 vaccine". www.zawya.com. Retrieved 20 June 2021.
- ^ Acosta, Nelson (20 June 2021). "Cuba encouraged by early results of homegrown COVID-19 vaccine amid worst outbreak". The Age. Retrieved 20 June 2021.
- ^ Jump up to: a b "Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy". Reuters. Retrieved 9 July 2021.
- ^ Santos IC (January 2021). "Rapid response to: Covid 19: Hope is being eclipsed by deep frustration". BMJ. 372: n171. doi:10.1136/bmj.n171.
- ^ Jump up to: a b "Draft landscape and tracker of COVID-19 candidate vaccines". www.who.int. World Health Organization. Retrieved 4 February 2021.
- ^ Jump up to: a b "SOBERANA 02-FaseIII". Retrieved 9 September 2021.
- ^ Jump up to: a b "IRCT | Efficacy, safety, and immunogenicity of Soberana recombinant vaccine (product of Finlay Institute) based on RBD protein subunit of Sars-Cov-2 in a 2-dose regimen with and without a booster dose: a double-blind, randomized, placebo-controlled phase III clinical trial in the Iranian population of 18-80 years". en.irct.ir. Retrieved 7 September 2021.
- ^ Valdes-Balbin, Y; Santana-Mederos, D; Quintero, L; Fernández, S; Rodriguez, L; Sanchez Ramirez, B; Perez-Nicado, R; Acosta, C; Méndez, Y; Ricardo, MG; Hernandez, T; Bergado, G; Pi, F; Valdes, A; Carmenate, T; Ramirez, U; Oliva, R; Soubal, JP; Garrido, R; Cardoso, F; Landys, M; Gonzalez, H; Farinas, M; Enriquez, J; Noa, E; Suarez, A; Fang, C; Espinosa, LA; Ramos, Y; González, LJ; Climent, Y; Rojas, G; Relova-Hernández, E; Cabrera Infante, Y; Losada, SL; Boggiano, T; Ojito, E; León, K; Chiodo, F; Paquet, F; Chen, GW; Rivera, DG; Garcia-Rivera, D; Verez Bencomo, V (16 July 2021). "SARS-CoV-2 RBD-Tetanus Toxoid Conjugate Vaccine Induces a Strong Neutralizing Immunity in Preclinical Studies". ACS Chemical Biology. 16 (7): 1223–1233. doi:10.1021/acschembio.1c00272. PMID 34219448.
- ^ Melimopoulos, Elizabeth. "Is Cuba closing in on COVID vaccine sovereignty?". www.aljazeera.com. Retrieved 7 May 2021.
- ^ "Optimism as Cuba set to test its own Covid vaccine". BBC News. 16 February 2021. Retrieved 7 May 2021.
- ^ "Cuba espera fabricar 100 millones de dosis de su candidato vacunal Soberana 02". Nodal (in Spanish). 21 January 2021.
- ^ "Vaccino, Cuba pronta a produrre 100 milioni di dosi di 'Soberana 02'". Dire (in Italian). 21 January 2021.
- ^ Jump up to: a b Ribeiro G (4 February 2021). "Cuba to offer coronavirus vaccines to tourists". Brazilian Report.
- ^ Jump up to: a b "Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos". Deutsche Welle (in Spanish). 5 February 2021.
- ^ Meredith S (23 February 2021). "'Sun, sea, sand and Soberana 02': Cuba open to inoculating tourists with homegrown Covid vaccine". CNBC.
- ^ "Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos". Deutsche Welle (in Spanish). 5 February 2021.
Las expectativas sobre Soberana 02 son tales que el titular del organismo estatal que desarrolló la vacuna, Vicente Vérez, confirmó que mientras se aguarden los resultados de la Fase 3 solo en La Habana, en abril se dará inicio a la producción del primer lote, de alrededor de 100 mil dosis.
- ^ "Cuba anuncia fase 3 de la vacuna Soberana 02". La Jornada (in Spanish). 7 February 2021.
Una vez que superen las etapas clínicas, la OMS podría contar con el fármaco cubano, afirmó Moya, y “pasar a ser parte del grupo de vacunas que se oferten a través del Fondo Rotatorio”, un mecanismo que desde hace cuatro décadas permite gestionar antígenos e insumos a los países de las Américas.
- ^ "SOBERANA – INTERVENTION | Registro Público Cubano de Ensayos Clínicos". rpcec.sld.cu. Retrieved 11 April 2021.
- ^ "Cuba says it's 'betting it safe' with its own Covid vaccine". NBC News. Retrieved 11 April 2021.
- ^ "Cuba begins testing 2nd COVID-19 vaccine on health care workers". medicalxpress.com. Retrieved 11 April 2021.
- ^ Ministry of Public Health of Cuba (11 April 2021). "[Translated] "The administration of the 1st dose of the Cuban vaccine candidates #Soberana02 and #Abdala to the 75 thousand health workers and Biocubafarma who are part of the intervention study taking place in #LaHabana has concluded."". Twitter. Retrieved 11 April 2021.
- ^ "Cuban scientists, health workers received first anti-Covid-19 dose". www.plenglish.com/index.php?o=rn&id=66247&SEO=cuban-scientists-health-workers-received-first-anti-covid-19-dose (in Spanish). Retrieved 11 April 2021.
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- ^ admin (9 April 2021). "Cuba's COVID-19 Vaccines Being Sought After by CARICOM Countries". Caribbean News. Retrieved 7 May 2021.
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- ^ Página12 (22 January 2021). "Soberana 02: Cuba prepara cien millones de dosis de la vacuna contra el coronavirus | "No somos una multinacional. Nuestro fin es crear salud", dijo el director del Instituto Finlay de Vacunas". PAGINA12. Retrieved 7 May 2021.
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- ^ BioCubaFarma (6 April 2021). "[Translated] Updating the vaccination process with vaccine candidates #Soberana02 and #Abdala during ongoing clinical trials.#VacunasCubanasCovid19". Twitter (in Spanish). Retrieved 11 April 2021.
- ^ "Intervention study with Covid-19 vaccine candidate Abdala begins". Radio Cadena Agramonte. Retrieved 28 April 2021.
- ^ "Cuba administers over 62,000 doses in intervention trials". www.plenglish.com/index.php?o=rn&id=66012&SEO=cuba-administers-over-62000-doses-in-intervention-trials (in Spanish). Retrieved 28 April 2021.
- ^ "[Trnslated] In more than 62 thousand applied doses of #Soberana02 the safety of the vaccine has been demonstrated. Adverse effects have been: