Soberana 02

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Soberana 02
Soberana 02 vaccine logo.png
Soberana 02 vaccine vial.png
A vial of Soberana 02
Vaccine description
TargetSARS-CoV-2
Vaccine typeConjugate
Clinical data
Trade namesPasteur
Other namesFINLAY-FR-2, Pasteurcovac, پاستوکووک
Routes of
administration		Intramuscular
Legal status
Legal status
  • Full and Emergency Authorizations: List of Soberana 02 authorizations
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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
  1. Cuba[15][16]
Planned production
  1. Iran
Potential Production
  1. Ghana
  2. 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[]

SOBERANA vaccine family clinical trials
Registration Group Participants Phase
Date ID Title
2020-08-13 RPCEC00000332 SOBERANA 01
  • two low doses FINLAY-FR-1
  • two high doses FINLAY-FR-1
  • control (VA-MENGOC-BC®)
 676 I/II
2020-10-17 RPCEC00000338 SOBERANA 01A
  • two high doses FINLAY-FR-1 + booster FINLAY-FR-1
  • two high doses FINLAY-FR-1 + booster FINLAY-FR-1A
  • two high doses FINLAY-FR-1A + booster FINLAY-FR-1A
  • two low doses FINLAY-FR-1A + booster FINLAY-FR-1A
 60 I
2020-10-27 RPCEC00000340 SOBERANA 02
  • two low doses FINLAY-FR-2 + booster FINLAY-FR-2
  • two high doses FINLAY-FR-2 + booster FINLAY-FR-2
  • two low doses FINLAY-FR-2 + booster FINLAY-FR-1A
  • two high doses FINLAY-FR-2 + booster FINLAY-FR-1A
 40 I
2020-12-17 RPCEC00000347 SOBERANA 02A
  • two doses FINLAY-FR-2 (batch 1) + booster FINLAY-FR-2
  • two doses FINLAY-FR-2 (batch 2) + booster FINLAY-FR-2
  • two doses FINLAY-FR-2 (batch 1) + booster FINLAY-FR-1A
  • two doses FINLAY-FR-2 (batch 2) + booster FINLAY-FR-1A
 100 IIa
  • two doses batch 1 FINLAY-FR-2 + booster FINLAY-FR-1A
  • two doses batch 2 FINLAY-FR-2 + booster FINLAY-FR-1A
  • placebo
 810 IIb
2021-01-05 RPCEC00000349 SOBERANA 01B
  • 1-dose FINLAY-FR-1A
 30 I
2021-03-03 RPCEC00000354 SOBERANA 02-FaseIII
  • two doses FINLAY-FR-2
  • two doses FINLAY-FR-2 + booster FINLAY-FR-1A
  • placebo
 44,010 III
2021-03-19 RPCEC00000360 SOBERANA - INTERVENTION
  • two doses FINLAY-FR-2 + booster FINLAY-FR-1A
 150,000
2021-04-09 RPCEC00000366 SOBERANA PLUS
  • 1-dose FINLAY-FR-1A
 20 IIa
  • 1-dose FINLAY-FR-1A
  • placebo
 430 IIb
2021-04-24 IRCT20210303050558N1 Phase III in Iran
  • two doses Soberana 02
  • two doses Soberana 02 + booster Soberana Plus
  • placebo
 24,000 III
2021-06-10 RPCEC00000374 SOBERANA PEDIATRIA
  • two doses FINLAY-FR-2 + booster FINLAY-FR-1A
 350 I/II

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[]

A vial of Soberana 02 vaccine in Iran for use in the phase III clinical trials

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[]

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
See also: List of COVID-19 vaccine authorizations § Soberana 02

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[]

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  64. ^ "[Trnslated] In more than 62 thousand applied doses of #Soberana02 the safety of the vaccine has been demonstrated. Adverse effects have been: