Bharat Biotech Vaccine
Fair Pharma Scorecard
Toetst farmaceutische bedrijven op mensenrechten.
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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.
Texas Children’s CVD claims to have developed the first low-cost Covid-19 vaccine designed for global access. It has also signed a non-exclusive license with Biological E Limited (Bio E) to license the Covid-19 vaccine. It has also stated that it would not patent the vaccine in order to make it available to all manufacturers globally.
Texas Children’s does not mention human rights on its website.
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.
The company is in discussions with C-TAP about “formalizing their patent-free model for sharing the vaccine technology”.
The vaccine itself is not under patent.
The company has not yet signed an agreement with the ACT Accelerator, but it plans to during this year, once it gets regulatory approval.
The Baylor team is intending to widely license the vaccine to manufacturers in low- and middle-income countries. They have already licensed their product to producers in Bangladesh, South Africa, and Botswana, with potential deals for Taiwan and Vietnam also. The vaccine is also licensed to Biological E.
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.
[Only applies to therapeutics]
The vaccine has been licensed to Biological E with no patent “and no strings attached”. Texas Children’s Hospital has initiated a full technology transfer process to immunity Bio. It has also been approved in Botswana, where it will be produced in a new Covid-19 manufacturing plant.
Doses of the vaccine will cost around 2-3 US dollars and the developers have no financial stake in the vaccine (Baylor College will receive a fee).
The vaccine so far has been distributed in India, South Africa and Botswana.
Texas Children’s Hospital is committed to open licensing, no patents, and full technology transfer to other manufacturers.
No information was found on this criterion.
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.
Nothing specific was found on the website – Texas CVD is supported by BioE and the government of India. The developers have stated that the vaccine is cheap to make. Elena Bottazzi, one of the vaccine developers, stated that the process of producing the vaccine from lab to authorization cost between 5 and 7 million US dollars.
The developers have stated that they have “little to gain financially”, because neither Texas CVD nor Baylor College own any IP around the vaccine itself.
Peter Hotez, one of the vaccine developers, stated that the vaccine can be produced for around 1.50 US dollars per dose. The whole process is said to have cost between 5-7 million US dollars (see T1).
BioE plans to produce 100 million or more doses per month starting in February. In addition to what the company is supplying to India, BioE plans to deliver more than one billion additional doses to other countries.
Developers of the vaccine (Hotez and Bottazzi) stated that they “never got real support from the US government or from the G7 countries.” They stated having received a “modest” NIH bridge funding which was not enough to advance to real development of the vaccine, but gave them a head-start. Otherwise, they received around 7 million US dollars mostly from private investors (Tito’s Vodka, and other anonymous individual donors).
The company has not published the texts of any licensing agreements.
Texas Children’s Hospital has registered its clinical trials in clinicaltrials.gov, however, data from a clinical trial with over 3000 participants has not yet been published.
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