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WHO and MPP announce agreement with NIH for COVID-19 health technologies

WHO’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) today finalized a licensing agreement with the United States National Institutes of Health (NIH) for the development of several innovative therapeutics, early-stage vaccines and diagnostic tools for COVID-19.

The licenses, which are transparent, global and non-exclusive, will allow manufacturers from around the world to work with MPP and C-TAP to make these technologies accessible to people living in low- and middle-income countries and help put an end to the pandemic.

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The 11 COVID-19 technologies offered under two licences include the stabilized spike protein used in currently available COVID-19 vaccines, research tools for vaccine, therapeutic and diagnostic development as well as early-stage vaccine candidates and diagnostics. The full list of the NIH COVID-19 technologies covered in the agreement is here.

“I welcome the generous contribution NIH has made to C-TAP and its example of solidarity and sharing,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Whether it’s today’s pandemic or tomorrow’s health emergency, it’s through sharing and empowering lower-income countries to manufacture their own health tools that we can ensure a healthier future for everyone.”

“We are honoured to sign these public health-driven licence agreements with NIH under the auspices of C-TAP with the goal of providing equitable access to life-saving health products for the most vulnerable in the world,” said Charles Gore, MPP Executive Director.

“NIH were the first to share their patents with MPP for an HIV product back in 2010 when we were created, and we are delighted to continue strengthening our partnership. It is clear that MPP’s model works across different health technologies.”

The announcement was made today by the US Government at the second Global COVID-19 Summit, co-hosted by the United States, Belize, Germany, Indonesia and Senegal.

Licensing the NIH technologies to MPP under the auspices of C-TAP will allow greater access to these technologies and hopefully lead to the development of commercial products that can address current and future public health needs. In most circumstances, NIH will not collect royalties on sales of products licensed in 49 countries classified by the United Nations as Least Developed Countries.

Launched in 2020 by the WHO Director-General and the President of Costa Rica, and supported by 43 Member States, C-TAP aims to facilitate timely, equitable and affordable access to COVID-19 health products by boosting their production and supply through open, transparent and non-exclusive licensing agreements. MPP provides the licensing expertise to this initiative and holds the licences.

The 11 technologies include:

  1. Prefusion spike proteins  (Vaccine Development)
  2. Structure-Based Design of Spike Immunogens  (Research Tool for Vaccine Development)
  3. Pseudotyping Plasmid (Research Tool for Vaccine Development)
  4. ACE2 Dimer construct (Research Tool for Drug Development)
  5. Synthetic humanized llama nanobody library and related use  (Research Tool for Drug and Diagnostic Development)
  6. Newcastle Disease Virus-Like Particles Displaying Prefusion-Stabilized  Spikes (Vaccine Candidate)
  7. Parainfluenza virus 3 based vaccine (Vaccine Candidate)
  8. A VSV-EBOV-Based Vaccine (Vaccine Candidate)
  9. RNASEH-Assisted Detection Assay for RNA (Diagnostic)
  10. Detection of SARS-CoV-2 and other RNA Virus (Diagnostic)
  11. High-Throughput Diagnostic Test  (Diagnostic)

WHO’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) today finalized a licensing agreement with the Spanish National Research Council (CSIC) for a COVID-19 serological antibody technology. The test effectively checks for the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine.  This represents the first transparent, global, non-exclusive licence for a COVID-19 health tool, and the first test licence signed by MPP and included in the WHO Pool.

The aim of the licence is to facilitate the rapid manufacture and commercialization of CSIC’s COVID-19 serological test worldwide. The agreement covers all related patents and the biological material necessary for manufacture of the test. CSIC will provide all know-how to MPP and/or to prospective licensees as well as training. The licence will be royalty-free for low- and middle-income countries and will remain valid until the date the last patent expires.

“This licence is a testament to what we can achieve when putting people at the centre of our global and multilateral efforts,” said Carlos Alvarado Quesada, President of Costa Rica, the founding country of C-TAP. “It shows that solidarity and equitable access can be achieved and that it is worthwhile continuing to support the principles of transparency, inclusiveness and non-exclusivity that the C-TAP defends. Costa Rica welcomes the signing of this licence and is convinced, today more than ever, that mechanisms such as C-TAP can help us overcome the current situation, while being beneficial for future health crises. I thank the Spanish Government and CSIC, for taking a step forward in solidarity and prioritizing health as a global public good.”

“This is the first technology developed by a public-funded institution that joins the C-TAP initiative,” said Diana Morant, Spanish Minister of Science and Innovation. “With agreements like this, we protect lives. Science has the universal purpose of improving people’s lives. Therefore this is also a firm commitment of our government: supporting a public system of science to serve all citizens.”

“I highly commend CSIC, a public research institute, for its commitment to solidarity and for offering worldwide access to their technology and know-how,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This is the kind of open and transparent licence we need to move the needle on access during and after the pandemic. I urge developers of COVID-19 vaccines, treatments and diagnostics to follow this example and turn the tide on the pandemic and on the devastating global inequity this pandemic has spotlighted.”

“Our strong partnership with WHO and C-TAP partners has been essential in negotiating this licence, and I look forward to our continued collaboration, drawing on WHO’s expertise and guidance going forward,” said Charles Gore, Executive Director of MPP. “What is clear is that MPP’s model can work across different health technologies, and we are thrilled to be signing our first C-TAP/MPP test licence with CSIC.”

Dr. Rosa Menéndez, president of CSIC, emphasized how important it is to seek solutions so that technologies related to the COVID-19 pandemic in particular, and health in general, reach all countries, including those most in need. “In this sense, we would like this action by CSIC, of taking part in the international initiatives of MPP and WHO, to become an example and a reference for other research organizations in the world.”

The technology to date has resulted in four different tests, one of which has the potential to distinguish the immune response of COVID-19 infected individuals from vaccinated individuals. This should aid further research into the level and length of immunity and the efficacy of the tools at our disposal.

The tests are simple to use and suitable for all settings with a basic laboratory infrastructure, such as those found in rural areas in low- and middle-income countries. The reading can theoretically be done manually (with naked eye comparing the colour of the wells against the colour chart), but an ELISA reader is recommended for greater accuracy of results.

Promising performance data in the European population will need to be supplemented by the companies that will produce this technology if they plan to sell the test in low- and middle-income countries.

Access the licence agreement

Interested manufacturers based anywhere I the world are invited to express their interest in obtaining a sublicence by submitting a single email to CTAPDiagnostics@medicinespatentpool.org, with complete, detailed responses to the questionnaire provided here.

About C-TAP

Launched in 2020 by the WHO Director-General and the President of Costa Rica, and supported by 44 Member States, C-TAP aims to facilitate timely, equitable and affordable access to COVID-19 health products by boosting their production and supply through open, non-exclusive licensing agreements. The C-TAP platform provides a global one-stop-shop for developers of COVID-19 therapeutics, diagnostics, vaccines and other priority health technologies to share knowledge and data and license their intellectual property to additional manufacturers through public health-driven, voluntary, non-exclusive and transparent licences. By pooling technologies, developers of COVID-19 health products can boost manufacturing capacity in all regions and expand access to life-saving tools.

About CSIC

The Spanish National Research Council (CSIC) is the largest public research organization in Spain, the fourth largest in Europe and the seventh largest in the world. The mission of the Spanish National Research Council is to promote, coordinate, develop and disseminate scientific and technological multidisciplinary research, in order to contribute

About MPP

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.

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