Vaxine Vaccine - Product Scorecard

Company: Vaxine

Type: Covid-19 Vaccine
Product (brand name): COVAX-19 (SpikoGen)
0%
compliance
with criteria
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Explore the results of PAF’s research into the behaviour of Vaxine. Each section is given an overall score; individual criteria are also scored (see icon following the criteria heading).

Click on ‘Explanation about the score’ sign next to each entry to expand and learn more.

Category A: Commitments and Accountability

The company should publicly commit to human rights in relation to product development and marketing, by adopting an official human rights policy statement recognising the right to the highest attainable standard of health. The company should endeavour to integrate human rights into its strategies, policies, programmes, projects, and activities.

The company should also have a publicly available global access plan for their Covid-19 product, based on human rights standards, with measurable targets and lines of accountability.

A1: Does Vaxine publish a global access plan for its product?

Vaxine has not published a global access plan for its vaccine.

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A2: Does Vaxine commit to comply with human rights standards in relation to product development and marketing?

Vaxine has not made any commitment to comply with human rights.

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Category C: International cooperation

The company should constructively engage with international initiatives for the equitable distribution of vaccines and therapeutics, such as the Covid-19 Technology Access Pool (C-TAP) or the Medicines Patent Pool (MPP), and the ACT Accelerator (COVAX). The company should also publicly commit to not enforcing the exclusive rights of Covid-19 related patents, and enter into non-exclusive, transparent licensing agreements for its Covid-19 products with other companies.

C1: Does Vaxine commit to C-TAP or MPP?

Vaxine has not committed to C-TAP or the MPP.

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C2: Does Vaxine commit to not enforcing the exclusive rights of Covid-19 related patents?

There is no evidence of the company not enforcing patents.

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C3: Does Vaxine supply to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator?

Vaxine has not signed an agreement with the ACT Accelerator so far.

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C4: Does Vaxine agree to license its Covid-19 medical products to other companies?

The vaccine Spikogen was developed jointly with CinnaGen, an Iran-based biotechnology producer. The agreement between the two companies is a cooperation agreement where CinnaGen sponsored phase II and III clinical trials in Iran and will participate in the production process. It seems that SpikoGen (the Iranian replica of Vaxine’s product) is a biosimilar of Covax-19 (Vaxine’s vaccine).

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Category E: Equality, non-discrimination & equity

The company should engage in efforts to further equitable distribution of Covid-19 vaccines/therapeutics, by equitably distributing its supplies globally, devising fair pricing strategies, and making the active ingredient for its product available to other manufacturers. The company should also engage in full technology transfer to other manufacturers, including the necessary transfer of skills, legal components, knowledge and intellectual property. Where applicable, the company should agree to waive rights in regulatory test data, and refrain from enforcing TRIPS+ measures.

E1: Does Vaxine make the active ingredient available on reasonable grounds? [Only for therapeutics]

[Only applies to therapeutics]

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E2: Does Vaxine commit to full technology transfer to other manufacturers?

CinnaGen is producing a biosimilar of Vaxine’s Spikogen, which involved technology transfer. Vaxine also has a commercial collaboration agreement with Medytox, a biotech company in South Korea: “The partners will jointly carry out product and process development, clinical trial programme and commercial scale-up for the Australian and Asian markets, including Korea.”

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E3: Does Vaxine commit to non-profit, ‘fair’, or differential pricing?

Vaxine has not published any information on pricing.

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E4: Does Vaxine equitably distribute supplies globally? [Only applies to vaccines]

The vaccine has only been made available in Iran so far, but there are plans to make it available in the Australian and Asian markets.

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E5: Does Vaxine not seek protection beyond the minimum criteria in TRIPS, or not enforce TRIPS+ measures? [where applicable]

No information was found on this criterion.

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E6: Does Vaxine agree to waive exclusive rights in regulatory test data? [where applicable]

No information was found on this criterion.

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Category T: Transparency

The company should be as transparent as possible, by publishing its research and development costs, profit margin, average costs of production, and production capacity for its Covid-19 product. It should also disclose the amount of public subsidies received during product development and/or testing. Licensing agreements should also be made publicly available and clinical trials should be registered in public repositories.

T1: Does Vaxine publish its R&D costs?

Vaxine has not published any information on its research and development costs.

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T2: Does Vaxine publish its profit margin?

Vaxine has not published any information on its profit margin.

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T3: Does Vaxine publish the average and/or marginal costs of production?

A crowdfunding page was used for the funding of the clinical trials: some of the costs are published here.

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T4: Does Vaxine publish its production capacity?

Vaxine plans to produce 5 million doses/month in Tehran.

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T5: Does Vaxine publish the public subsidies it received during product development and/or testing?

The clinical trials were funded through a crowdfunding platform; Vaxine is also partly funded by the US NIH

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T6: Does Vaxine publish the text of licensing agreements?

Vaxine’s agreement with CinnaGen is not published.

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T7: Does Vaxine register its clinical trials in public repositories?

Vaxine registers its clinical trials on clinicaltrials.gov.

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