Bharat Biotech Vaccine
Fair Pharma Scorecard
Applying human rights to pharma
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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.
Novavax has entered into a partnership with the Serum Institute of India. The two companies have made a joint commitment to increase production capacity to over 2 billion doses annually
Novavax states in its 2020 annual report: “We have made it among our core values to ensure that those in economically disadvantaged countries have the opportunity to receive our vaccine in parallel with the rest of the world.”
Novavax has not published a human rights statement.
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.
Novavax has not made a commitment to C-TAP or the MPP.
Novavax has made no commitment not to enforce the exclusive rights of Covid-19 related patents. It also opposes the TRIPS waiver.
Novavax has pledged 350 million doses to the ACT Accelerator.
Novavax has a supply and license agreement with the Serum Institute of India; a production, manufacturing and marketing agreement with SK Bioscience in the Republic of Korea; and a manufacturing agreement with Takeda in Japan, among others.
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]
Novavax has not committed to full technology transfer, nor to open or non-exclusive licensing agreements to other manufacturers. However, it does have multiple sublicensees in different geographical areas. (see C4)
Novavax charged 20,90 US dollars for Denmark; and 3 US dollars for COVAX (produced by the Serum Institute of India).
Novavax has sold all of its doses to high-income countries and middle-income countries
Novavax made a statement in opposition to TRIPS waiver.
No information has been 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.
Novavax states in its annual report (p 44) that research and development expenses for 2020 (in thousands) were 747,027 US dollars. For 2019, these expenses were 113,842 US dollars (difference: 633,185)
It states that ‘during 2020, our research and development activities were primarily focused on the development of NVX-CoV2373.’ It therefore spent (in thousands) 609,401 US dollars on Covovax in 2020
Novavax publishes its total revenue for 2020 in its annual report, but not for 2021 and not specific to its Covid-19 vaccine.
Novavax does not publish the average costs of producing the vaccine.
Novavax states in its annual report (p41): “we expect our projected global manufacturing production rate of NVX-CoV2373 to be over two billion doses annually when we are at full capacity, which we expect to occur in mid-2021. Of this anticipated capacity, approximately one billion doses will be manufactured by Serum Institute of India Private Limited (“SIIPL”).
Novavax states in its annual report: “We expect revenue in 2021 to significantly increase due to our NVX-CoV2373 program, which we anticipate will continue to be funded by OWS and CEPI and/or other revenue sources.” (page 44)
The company has published statements that it received funding from CEPI, the US Defense Department and Operation Warp Speed. It also received funding from the Bill & Melinda Gates Foundation, but did not publish a statement on that..
Novavax has not published the texts of licensing agreements online.
Novavax registers its clinical trials on clinicaltrials.gov.
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