COVID-19

As of November 2020, at least 44 manufacturing and production deals for COVID-19 therapeutics around the globe were made public. A number of these deals were intended to expand access to therapeutics to low and middle-income countries. In relation to all of them, licensing, enabled by a well well-functioning intellectual property system, has been a key enabler.

• Eli Lilly and Company and the Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, have entered into an agreement to facilitate access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19, to benefit low- and middle-income countries. Lilly’s collaborators have agreed to waive their royalties on the Lilly therapeutic antibodies distributed in low- and middle-income countries as part of this initiative.
• Gilead has entered into voluntary licensing agreements with nine generics manufacturers to further expand supply of remdesivir to 127 countries that represent nearly all low-income and lower-middle income countries. Gilead has completed technology transfers with these companies, and they are beginning the manufacturing process.
• Merck, IAVI, and Serum Institute of India are collaborating to develop a neutralizing monoclonal antibody treatment for COVID-19. If successful, Merck will lead commercialization in developed countries and the Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India.

The need for the rapid development and global distribution of a vaccine to prevent COVID-19 infection has spurred a number of novel collaborations between the pharmaceutical companies, research entities, and other stakeholders. These collaborations aim to ensure broad access to new health technologies to address the pandemic.

• One example is the University of Oxford Jenner Institute vaccine candidate, developed with AstraZeneca, that included collaborations with Catalent Biologics (Italy), Symbiosis Pharmaceutical Services (UK), Oxford Biomedica (UK), Emergent BioSolutions, BioKangtai (China), and R-Pharm (Russia). Through the WHO’s Access to COVID-19 Tools Accelerator, AstraZeneca signed an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance, on vaccine development, manufacturing, and procurement, ensuring 300 million doses of the vaccine for low- and middle-income countries. Separately, AstraZeneca also signed a license agreement with the Serum Institute of India (SII) to supply 1 billion doses of vaccine to low- and middle-income countries.
• Another example involves Sanofi and GSK, which signed a Statement of Intent with Gavi, to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities.
• A third example focuses on Johnson & Johnson.  The company has committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021.

This article examines the context in which the Oxford COVID vaccine was developed – such as the slow response to the Ebola outbreak – and new technological breakthroughs at Oxford’s Jenner Institute that enabled researchers to cut 10 years of vaccine work down to 10 months.

Around the world, multiple vaccines against COVID-19 are on track for regulatory approval. Arriving at safe, efficacious vaccines of consistent quality will be a major scientific achievement. No less a feat will be manufacturing and delivering COVID-19 vaccines globally – a challenge of unparalleled scale, reach, and complexity. This checklist from the WTO breaks down the regulatory, IP-related, and trade-related concerns that must be considered at each step, from development to distribution. This accompanying infographic illustrates these steps visually.

In this article, IAM examines the approaches taken by – and the issues facing – the leading companies in the race to find effective coronavirus inoculations.

It has been announced today that the covid-19 vaccine being developed by Pfizer and BioNTech has been found to be 90% effective in preventing the disease, without presenting any safety concerns in the first interim analysis from its Phase 3 clinical study. This puts it at the head of the pack of candidate vaccines in the race to achieve regulatory approval. But there are major IP obstacles for any organisation seeking to produce a copycat version; while Pfizer/BioNTech themselves are embroiled in a patent dispute over the vaccine. Read more.

SalivaDirect™ is a new process developed at the Yale School of Public Health to test persons suspected of having COVID-19 for the virus, SARS-CoV-2. It is ideal for large-scale testing and offers a number of advantages over traditional testing methods.

During the October 2020 TRIPS Council meeting, 40 TRIPS Council members discussed a proposal submitted by India and South Africa for a temporary waiver of a broad range of TRIPS obligations. The sponsors argued that this could facilitate the global response to COVID-19. The proposal endorses a waiver for all WTO members of the implementation, application, and enforcement of certain provisions of the TRIPS Agreement – including all the patent protection and enforcement provisions – in order to enhance access to new therapeutics, vaccines, and diagnostics. This proposal warrants careful examination. IP rights will be an important tool underpinning the collaborations required to develop and get the relevant technologies to patients everywhere, and quickly. They can be expected to play a constructive and important role, thus accelerating the global COVID response.