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The rapid innovation response to COVID-19 and the role of IP


Our team studied how COVID vaccines and other technologies were rapidly developed and brought to society, to identify in particular the role of IP protection. Our sources were media reporting, reports, and relevant academic literature. We also interviewed a number of senior executives at bio-pharmaceutical companies that were involved in the COVID response.  We endeavored to tell the innovation stories of as many of the COVID vaccines and therapeutics as possible in our report. Our research effort generated an extensive bibliography, which is presented and searchable in the References section below. We are grateful to IFPMA and Interpat for funding this research effort.

  • Pfizer/BioNTech
    mRNA technology was also used by partners BioNTech and Pfizer. BioNTech, the creator of the Pfizer-BioNTech vaccine’s core technology, has been researching and developing mRNA technology for the last 25 years, with a specific focus on immunology treatments for cancer. Even before the pandemic, the company had formed a range of global partnerships with organizations with patents for technology and research relating to mRNA. The most crucial partnership was, of course, that with Pfizer, a collaboration dating back to 2018, when the two firms agreed to work together on an mRNA-based influenza vaccine. In fact, Pfizer and BioNTech were about to enter their influenza vaccine into clinical trials in 2020. However, as COVID took on pandemic proportions, the companies turned their attention to creating a COVID-19 vaccine. The trust formed during the initial relationship aided the collaboration on an mRNA-based COVID-19 vaccine. After signing an initial Material Transfer and Collaboration Agreement on March 17, 2020, the two were able to begin work rapidly on their COVID-19 vaccine. They agreed to finalize the details of the collaboration at a later date. With regards to the licensing of their COVID-19 vaccine, BioNTech negotiated ownership of the IP for the COVID-19 vaccine produced; reportedly, the BioNTech CEO, Dr Ugur Sahin, insisted that, although Pfizer would be the company to seek a US license, it would be on BioNTech’s behalf and under its name. In relation to this deal, reportedly, although the IP for the initial vaccine would be owned by BioNTech, the partners agreed that any new discoveries could be owned by either one of them, depending on the details and nature of the discovery. The efficacy of the Pfizer BioNTech vaccine is the highest of the currently approved vaccines, reaching 95 per cent after two doses. The Pfizer BioNTech vaccine was also the first to receive emergency regulatory approval in both the UK and the United States, with the Medicines & Healthcare Products Regulatory Agency in the UK approving the vaccine on December 2, 2020, and the FDA granting Emergency Use Authorization shortly afterwards, on December 11. The use of mRNA in a vaccine is a novel technique that works by modifying the mRNA to instruct the body to create the spike proteins found on the SARS-CoV-2 coronavirus. These spike proteins are then identified by the body as foreign, and an immune response is mounted to attack them. This primes the body to generate the proper antibodies if it comes into contact with COVID-19 in the future. Katalin Karikó, with the help of Drew Weissman, made a vital discovery in relation to the use of using mRNA in humans in 2005. The patent resulting from her research, which was filed for by the University of Pennsylvania, forms the basis for today’s mRNA-based COVID-19 vaccines. The University of Pennsylvania first licensed this patent to a company known as mRNA RiboTherapeutics; this firm then sublicensed the patent to another company – Cell Script – which, in turn, sublicensed it to both BioNTech and Moderna. It took significant academic research, private investment, and the work of start-ups, such as BioNTech, to develop clinical applications derived from Kariko and Weissman’s research. The successful use of this innovative technology to create a COVID-19 vaccine was considered a breakthrough, and one that is expected lead to more mRNA products becoming available in the future. The production process for mRNA is complex. The whole production process needs to be kept within a hermetically-sealed system, which involves pressurized ethanol (which is explosive), repeated filtration, and, importantly, large quantities of specialized equipment, raw materials, and sterilized supplies. The process requires 50,000 steps and, and can be completed from start to finish in under two weeks. Further, the quality control required for release of the product can take an extra four and a half weeks. In addition, there were challenges to scaling the production of lipid nanoparticles. Despite the challenges, mRNA vaccines do have certain advantages overall, including, importantly, their replicability; mRNA vaccine production is a standardized process that can be repeated for different types of mRNA vaccines with only slight tweaks to the modified mRNA. This makes it possible to create new vaccines using this platform. Manufacturing and distribution partnerships were key to enabling BioNTech and Pfizer to produce their vaccine with the speed and scale necessitated by the pandemic. The companies’ production facilities are based mainly in Germany, Belgium and Switzerland, and the two companies formed partnerships with companies such as Baxter, Sanofi and Novartis to increase their capacity. BioNTech also entered into a partnership with Chinese firm Fosun Pharma to produce vaccine for the Chinese market. Through their partnerships, Pfizer and BioNTech have created a production capacity that is set to reach 4 billion doses in 2022 and 3 billion in 2021, respectively. Pfizer designed a distribution strategy earlier than companies typically do, laying the foundations for its supply chain as soon as vaccine development started. The company purchased raw materials, arranged manufacturing supply chains, and set up distribution lines simultaneously and early on, even brefore clinical trials had begun. At this time, regulatory approval was still far in the future, and this entailed a huge financial risk. This risk paid off; Pfizer was able to start the distribution of the vaccine as soon as it received regulatory approval. The Pfizer/BioNTech vaccine was shipped directly from production facilities which meant foregoing certain of the normal steps in the distribution process, as well as the funding that was made available under Operation Warp Speed. This was reportedly due to the company’s desire to keep third-party involvement to a minimum in order to ensure an efficient distribution process. In addition, the company innovated in the area of packaging. Like the Moderna vaccine, the Pfizer/BioNTech vaccine requires ultra-cold temperatures during transport and storage. Pfizer has designed its own shipping box, in collaboration with Softbox Thermal Packaging Systems, which has an unheard-of 1 per cent rate of escaping CO2 and which contains built in temperature trackers to monitor the vaccine’s temperature throughout transport. Reference List Arthur, Rachel. “Pfizer and BioNTech Ramp up COVID-19 Vaccine Production to 2.5 Billion Doses.”, March 31, 2021. BioNTech. “BioNTech: Be Unique, Treat Individualized.” Accessed July 28, 2021. Bourla, Albert. “An Open Letter from Pfizer Chairman and CEO to Colleagues | Pfpfizeruscom.” Accessed July 28, 2021. Burger, Ludwig, and Caroline Copley. “BioNTech to Build MRNA Vaccine Manufacturing Site in Singapore.” Reuters, May 10, 2021. CDC. “Understanding MRNA COVID-19 Vaccines.” Centers for Disease Control and Prevention, March 4, 2021. Crow, David. “How MRNA Became a Vaccine Game-Changer.” Financial Times, May 13, 2021. Dougherty, Elizabeth. “Novartis Joins Pharma-Wide Effort to Meet Global Demand for COVID-19 Vaccines.” Novartis, March 22, 2021. Douglass, John Aubrey. “Who Owns Covid Vaccine Intellectual Property?” LA Progressive (blog), March 1, 2021. Filiou, Despoina. “The Pfizer-BioNTech Vaccine: Openness and Collaboration to Tackle the World’s Problems.” The Open University Business School, 2021. Garde, Damian, and Jonathan Saltzman. “The Story of MRNA: How a Once Dismissed Idea Became a Leading in the Covid Vaccine Race,” October 11, 2020. Gaviria, Mario, and Burcu Kilic. “BioNTech and Pfizer’s BNT162 Vaccine Patent Landscape.” Public Citizen, June 11, 2020. Leonard, Matt. “What We Know about Pfizer’s Coronavirus Vaccine Distribution Plan.” Supply Chain Dive, November 11, 2020. May, Mike. “After COVID-19 Successes, Researchers Push to Develop MRNA Vaccines for Other Diseases.” Nature Medicine, May 31, 2021, 1–3. Neubert, Jonas, and Cornelia Scheitz. “Exploring the Supply Chain of the Pfizer/BioNTech and Moderna COVID-19 Vaccines.” Jonas Neubert .Com ● Blog (blog), February 7, 2021. Packaging Europe. “Softbox Supports Pfizer in Global Cold Chain Distribution of COVID-19 Vaccine,” March 11, 2021. Pancevski, Bojan, and Jared S. Hopkins. “How Pfizer Partner BioNTech Became a Leader in Coronavirus Vaccine Race.” Wall Street Journal, October 22, 2020, sec. Business. Paris, Costas, and Jared S. Hopkins. “Pfizer Sets Up Its ‘Biggest Ever’ Vaccination Distribution Campaign.” Wall Street Journal, October 21, 2020, sec. C Suite. Park, Alice, and Aryn Baker. “Exclusive: Inside the Facilities Making the World’s Most Prevalent COVID-19 Vaccine.” Time, April 19, 2021. Philippidis, Alex. “Pfizer, BioNTech Win $1.95B ‘Warp Speed’ Order for COVID-19 Vaccine.” GEN - Genetic Engineering and Biotechnology News (blog), July 22, 2020. Pfizer. “Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19 | Pfpfizeruscom,” February 12, 2020. Pfizer. “Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational MRNA-Based Vaccine Candidates Against SARS-CoV-2 | Pfpfizeruscom,” July 13, 2020. Pfizer. “Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19 | Pfpfizeruscom,” November 12, 2020. Pfizer. “Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints | Pfpfizeruscom,” November 18, 2020. “Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine,” March 17, 2020. Sofia, Madeline K., Rebecca Ramirez, and Emily Kwong. “The Science Behind The Historic MRNA Vaccine : Short Wave.”, December 17, 2020. Sealy, Amanda. “Manufacturing Moonshot: How Pfizer Makes Its Millions of Covid-19 Vaccine Doses.” CNN, April 2, 2021. UKRI, Coronavirus: the science explained-. “What Is Coronavirus? The Different Types of Coronaviruses.” Accessed June 10, 2021.
  • Moderna
    Moderna’s Covid-19 vaccine, mRNA-1273, uses the novel mRNA vaccine technology. mRNA vaccine technology has never been approved before for use in vaccines, and the successful use of mRNA technology in the Moderna and the Pfizer/BioNTech vaccines is proprietary. The Moderna vaccine has demonstrated 94 per cent effectiveness after two doses, and FDA Emergency Use Authorisation was granted on December 18, 2020. To date, the Moderna vaccine has been given at least conditional approval in 53 countries. The mRNA technology in the Moderna vaccine is novel. With this vaccine, mRNA is modified to contain the genetic instructions for building the Covid-19 specific spike protein and then is inserted into a lipid nanoparticle, which acts as the carrier that allows the mRNA vaccine to enter the cell. When the vaccine is injected into the arm of the patient, it bumps into the body’s cells and fuses with them, releasing the mRNA. The mRNA then undergoes protein synthesis and builds the spike proteins that are presented to the immune system. Subsequently, the spike proteins are recognised by the body as foreign, and an immune response is initiated. The history of mRNA vaccines goes back decades. The first successful use of mRNA in animals was published in 1990, with the use in humans being discovered in 2005 by Katalin Karikó and Drew Weissman. One of the companies that built on Karikó and Weissman’s research was Moderna. His initial insight was that the technique might be used to create embryonic stem cells without using human embryos. In 2009, they succeeded not only in creating stem cells, but in developing a technology that could program human cells to produce any protein. Moving Rossi’s research from the lab and toward clinical application required private investment. In 2010, Rossi presented his work to Robert Langer, a serial entrepreneur at MIT, and Noubar Afeyan, CEO of VC firm Flagship Pioneering. They immediately saw the potential of the work and supported the launch of Moderna that year. By the time it went public in 2018, it had raised over $2 billion in investments and partnership funding, and another $600 million in a record-setting IPO. By the time of the pandemic, however, Moderna had not yet launched a product or turned a profit. There is a complex manufacturing process for the Moderna vaccine with a variety of different processes including mRNA production, making the lipid nanoparticle production, combining mRNA with lipids to create a lipid nanoparticle assemblies, and fill-and-finish. Due to the novel nature of mRNA vaccine technology, the manufacturing process had never been done at the global scale that was needed. Therefore, there were certain challenges such as lack of availability of raw materials, insufficient infrastructure, and a dearth of highly trained workers. The complex manufacturing process means that once the lipids and mRNA are created, they need to be combined rapidly using a particular process that only a certain number of people are capable of executing. This process entails the application of substantial know-how. The vaccines require very cold temperatures during transportation, which necessitates specific technology. The vaccines arrive their destination frozen between -50 and -15 degrees Celsius. The development of the Moderna vaccine involved a broad set of partnerships. One of the most important was a collaboration between Moderna and the National Institutes of Health’s (NIH) National institute of Allergy and Infectious Diseases (NIAID). Moderna and NIAID had previously worked together to try to find a vaccine for Middle Eastern Respiratory Syndrome (MERS), but this work was unsuccessful. When the COVID-19 pandemic began, they turned their focus and attention towards creating a coronavirus vaccine. The quick progress that Moderna and NIAID were able to make was remarkable, with the NIH scientists designing the spike protein molecule that was needed to trigger the body’s immune response in a single weekend in January 2020. Moderna accepted assistance from the US Government’s Operation Warp Speed program, receiving $1 billion for design and testing, and a further commitment of $1.5 billion in exchange for a commitment to deliver 100 million vaccine doses. Subsequently, different partnerships were formed during the manufacturing and distribution process. Partners included CordenPharma for lipid production, Sanofi for fill-and-finish, McKesson for vaccine distribution, and many others. The network of partners, which spans the United States, Switzerland, France, Israel, Saudi Arabia, Spain, and South Korea, helped to significantly increase Moderna’s global capacity. Seven patents are held by Moderna in relation to the mRNA-1273 vaccine. With regard to IP in the pandemic, Moderna announced that it will not be enforcing COVID-19 related patents in order to avoid any perception of there being IP barriers. In addition, both the NIH and Moderna signed an agreement that stated their vaccine candidate would be jointly owned by both parties. Although Moderna has publicly committed that it would not enforce its COVID-19 related patents against those making vaccines during the pandemic, and that it would also be willing to licence its IP during the post-pandemic period, no entity appears to have taken advantage of the company’s non-enforcement commitment to make a competing vaccine. This is likely owing to the fact that myriad factors are necessary to develop and commercialize a new vaccine including other third-party licenses to mRNA technology, trained scientists, appropriate facilities, access to inputs and equipment, and ongoing technology partnerships, financial investments – and time. As of June 16, 2021, Moderna had successfully delivered 154,675,860 doses of its mRNA vaccine within the United States, and, as of May 6, it aimed to increase its supply to between 800 million and 1 billion doses by the end of 2021. To this end, the company is currently investing with a goal of increasing the global supply of its COVID-19 vaccines to up to 3 billion doses by 2022. Reference List CDC. “Information about the Moderna COVID-19 Vaccine.” Centers for Disease Control and Prevention, June 11, 2021. CDC. “Moderna COVID-19 Vaccine Storage and Handling Summary,” April 27, 2021. Garde, Damian, and Jonathan Saltzman. “The Story of MRNA: How a Once Dismissed Idea Became a Leading in the Covid Vaccine Race,” October 11, 2020. Herman, Bob. “The NIH Claims Joint Ownership of Moderna’s Coronavirus Vaccine.” Axios, June 25, 2020. Loftus, Peter. “Moderna Vaccine Distributor McKesson Has Shipped 25 Million Doses in U.S.” WSJ, February 2, 2021. McGill COVID19 Vaccine Tracker Team. “COVID19 Vaccine Tracker,” n.d. Moderna. “Moderna Announces Additional Capital Investments to Increase Global Manufacturing Capacity for COVID-19 Vaccine.” Moderna, February 24, 2021. Moderna. “Moderna Announces Additional Investments to Increase Global Supply for COVID-19 Vaccine to up to 3 Billion Doses in 2022.” Moderna, April 29, 2021. Moderna. “Moderna Reports First Quarter Fiscal Year 2021 Financial Results and Provides Business Updates | Moderna, Inc.” Moderna, May 6, 2021. Moderna. “Patents | Moderna, Inc.” Moderna, n.d. Moderna. “Statement by Moderna on Intellectual Property Matters during the COVID-19 Pandemic | Moderna, Inc.” Moderna, October 8, 2020. National Institutes of Health. “Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine.” National Institutes of Health (NIH), December 18, 2020. Neubert, Jonas, and Cornelia Scheitz. “Exploring the Supply Chain of the Pfizer/BioNTech and Moderna COVID-19 Vaccines.” Jonas Neubert .Com ● Blog (blog), February 7, 2021. Pardi, Norbert, Michael J. Hogan, Frederick W. Porter, and Drew Weissman. “MRNA Vaccines — a New Era in Vaccinology.” Nature Reviews Drug Discovery 17, no. 4 (April 2018): 261–79. Rowland, Christopher. “Advocates Want NIH to Use Its Moderna Vaccine Patent to Push for Global Access.” Washington Post, March 25, 2021. Zimmer, Carl. “Is Moderna in Operation Warp Speed?” The New York Times, November 16, 2020, sec. Health.
  • Johnson & Johnson
    Johnson and Johnson’s coronavirus vaccine, known as Ad26.COV2.S, uses the viral vector technology. It works by inserting the coronavirus spike protein gene into Adenovirus 26, (Ad26), allowing the virus to enter cells without exposing the patient to the dangers of the pathogen, due to the virus’ inability to replicate. The reason that Ad26 is unable to replicate is the absence of the E1 gene. Once the viral vector is in the body, the body recognizes Ad26 as a foreign substance, and launches an immune response. There are a variety of different advantages to using viral vector technology including its easy application into the systemic and respiratory mucosal routes, its ability to grow in high titers and its higher thermostability. Its ability to grow in high titers means that there is a high concentration of antibodies in blood, allowing the creation of a large immune response. An adenovirus also has a tough protein coat meaning that Johnson and Johnson have the ability to keep their vaccine between 2-8 degrees Celsius for up to three months and can be kept at the lower temperature of -20 degrees Celsius for two years. One of the key advantages for their vaccine is its ability to provide an effective immune response in only one dose. The Johnson and Johnson vaccine demonstrated efficiency of 67 per cent after one dose, with FDA Emergency Use Approval being granted on February 27, 2021, Conditional Market Authorization from the European Union on March 11, 2021 and the WHO granting Emergency Use Listing on March 12, 2021. During the clinical trial process there was a pause due to six women developing rare blood clots. However, the trials and vaccine roll-out were resumed after medical authorities in both Europe and America decided that the benefits outweighed the risks. Technology from research institutions played an important role in the development of the Johnson & Johnson vaccine. Research institutions that had done the basic science were able to license their IP rights to biopharma companies, such as Johnson & Johnson, that had the capability to apply the research to develop a vaccine, take it though approval, and develop a manufacturing process working with other partners. IP rights made these hand-offs work smoothly by defining and securing the rights each party brought to the relationship. In addition, much of the basis for today’s viral vector COVID-19 vaccines was provided by a patented technology that was, initially, unrelated to COVID-19 research. Jason McLellan and his post-doctoral fellow, Nianshuang Wang, found that, by adding two prolines (rigid amino acids), they could also prevent the spike protein in the MERS coronavirus from shifting shape. They then filed for a patent in 2017, calling their invention the “2P mutation.” Their work was widely published and, in 2020, innovators such as J&J leveraged this work when developing vaccine candidates. There has been collaboration throughout the process of vaccine development manufacturing and distribution. One important example is the company’s collaboration with the Beth Israel Deaconess Medical Centre (BIDMC) for research and development. Having already worked together with this same technology on other vaccines, such as HIV, Zika, and tuberculosis, the parties were able to quickly come to an agreement to create a COVID-19 vaccine. In addition, Johnson and Johnson also made some collaborations with the US Government’s Operation Warp Speed program to support the development and production of COVID-19 vaccines. Collaboration was crucial to the company’s manufacturing and distribution processes, and the company’s current network of partners spans the United States, Netherlands, France, South Africa, India, Italy, and other countries. One of the major manufacturing partnerships formed was between the US-based company Merck & Co. and Johnson & Johnson on March 2, 2021. After Merck & Co was unsuccessful in producing its own vaccine, it contracted with Johnson & Johnson to support manufacturing of its vaccine. The US Government provided $268.8 million to support this arrangement, including $105.4 million to upgrade Merck & Co’s manufacturing facilities.[1] Johnson & Johnson have also used the US Government’s contracted distributor, McKesson, to help with the global supply of their vaccine. McKesson have identified and established distribution centres for the vaccine distribution, and contracts with FedEx and UPS to distribute the vaccine from these centres. Johnson & Johnson took early steps to prepare for the manufacturing and distribution of its vaccine. They had started to produce materials for human clinical trials as soon as they could see the animal trials move in a positive direction. This decision allowed human clinical trials to be moved from September 2020 to July 2020. Another decision that they made was in April 2020, to begin the process of ensuring capacity to manufacture, package, and distribute vaccines on a large scale, before the clinical trial results had even come in. This was a risk in case their vaccine did not make it through clinical trials. When it got approved in February 2021 by the FDA, the risk paid off. Reference List “Background Document on the Janssen Ad26.COV2.S (COVID-19) Vaccine: Background Document to the WHO Interim Recommendations for Use of Ad26.COV2.S (COVID-19) Vaccine.” Accessed June 14, 2021. BusinessWire. “McKesson Begins Distributing the Johnson & Johnson COVID-19 Vaccine,” March 1, 2021. Corum, Jonathan, and Carl Zimmer. “How the Johnson & Johnson Vaccine Works.” The New York Times, July 5, 2021, sec. Health. Dutta, Sanchari Sinha. “What Are Adenovirus-Based Vaccines?”, September 17, 2020. Dunleavy, Kevin. “Merck Plant in Durham, N.C. Gets $105M to Upgrade for J&J Vaccine Production.” FiercePharma, November 3, 2021. Garland, Max. “FedEx Shipping Johnson & Johnson’s COVID-19 Vaccine, Entering Network via Memphis Hub.” The Commercial Appeal, January 3, 2021. “HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses,” May 8, 2020. Johnson&Johnson. “Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of Its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate | Johnson & Johnson,” April 2, 2021. Johnson&Johnson. “Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) ReviewEMA Confirms Overall Benefit-Risk Profile Remains Positive | Johnson & Johnson,” April 20, 2021. Johnson&Johnson. “Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision | Johnson & Johnson,” April 23, 2021. Johnson&Johnson. “Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine | Johnson & Johnson,” April 21, 2021. Kansteiner, Fraiser. “Merck Snares $269M in U.S. Funding to Prep Manufacturing for Johnson & Johnson’s COVID-19 Vaccine.” FiercePharma, March 3, 2021. Kramer, Jillian. “They Spent 12 Years Solving a Scientific Puzzle. It Yielded the First COVID-19 Vaccines.” Science, December 31, 2020. “Why We’re Excited to Partner on Johnson & Johnson’s COVID-19 Vaccine.” Accessed June 16, 2021. Sullivan, Nancy J, Gary J Nabel, Clement Asiedu, Cheng Cheng, Maria Grazia Pau, and Jaap Goudsmit. Adenovirus serotype 26 and serotype 35 filovirus vaccines, issued December 14, 2011. VOA News. “US to Pay Johnson and Johnson $1 Billion for COVID-19 Vaccine | Voice of America - English.” VOA, May 8, 2020. Weiland, Noah, Sharon LaFraniere, and Carl Zimmer. “Johnson & Johnson Vaccinations Paused After Rare Clotting Cases Emerge.” The New York Times, April 13, 2021, sec. U.S. Wise, Jeff. “The Story of One Dose.” Intelligencer, April 5, 2021. Yamanouchi, Kelly. “UPS Ships Out First Batch of Johnson & Johnson Vaccine.” Transport Topics, March 2, 2021.
  • AstraZeneca
    The Oxford-AstraZeneca COVID-19 vaccine, as the name would suggest, is the result of a partnership between the large pharmaceutical firm and the Jenner Institute at Oxford University. It’s an example of a successful commercialization via public-private collaboration supported by IP licensing. Before the pandemic, the Jenner institute had been working on viral vector technology, which is the technology used in the Oxford-AstraZeneca vaccine. As was also the case with the Moderna vaccine, legal frameworks allowing public research outcomes to be IP-protected and then licensed for further development made this vaccine possible. AstraZeneca was able to work with the Jenner Institute to transform its research into an approved product in the market. The Oxford-AstraZeneca vaccine works by using a modified chimpanzee adenovirus – known as ChAdOx1 – as the so-called “viral vector,” by which genetic material can be transported into the body without causing disease. The viral vector is used to insert a gene into the patient that will instruct the body to create the spike proteins of the SARS-CoV-2 virus. The body then recognizes these proteins as foreign and mounts an immune response of the kind that it would need to fight an active case of COVID-19. Of crucial importance in this process is the fact that the ChAdOx1 virus used in the vaccine has been modified so that it cannot replicate and cause an active infection. The Oxford-AstraZeneca vaccine demonstrated an efficacy rate of 76 per cent after two doses. The viral vector technology platform has certain advantages over others, notably the mRNA platform. For instance, it does not need to be stored at ultra-cold temperatures during transport and storage; it can be held for up to six months at 2-8 degrees Celsius. This is because the ChAdOx1 adenovirus has a tough protein coat to protect the genetic material it is transporting, and also because the DNA used in this vaccine is more robust than the mRNA used in competing vaccines. Emergency authorization was granted for the Oxford-AstraZeneca vaccine in the United Kingdom on December 30, 2020. There was some controversy over the vaccine when reports of rare blood clots were found in certain people who had received it, which, it was thought, were due to the formation of unusual antibodies. Although some countries took measures to limit the use of the Oxford-AstraZeneca vaccine for this reason, medical associations have publicly stated that its benefits outweigh the risks. Manufacturing and distribution partnerships have been crucial in allowing AstraZeneca to produce and distribute the vaccine. Based on information published by the company, the vaccine is produced at more than 20 manufacturing sites across 15 countries. One example is a partnership that AstraZeneca formed with the Japanese firm Daichi Sanyko to undertake bulk manufacturing and fill-and-finish operations. Another is a collaboration with IDT Biologika to set up a facility in Germany, under which IDT Biologika has stated that it will spend in the hundreds of millions of euros to enhance its facilities. AstraZeneca currently has manufacturing agreements in the UK, the Netherlands, Japan, Germany, Mexico, the United States, South Korea, Belgium, Australia, and China, and distribution agreements in Bangladesh, the Philippines, Belgium, Ghana, and Australia, China, Egypt, Canada, and Switzerland. The company aims to deliver up to 3 billion doses of its COVID-19 vaccine by the end of 2021. Reference list “About the Oxford COVID-19 Vaccine,” July 19, 2020. “AstraZeneca Advances Response to Global COVID-19 Challenge as It Receives First Commitments for Oxford’s Potential New Vaccine.” Accessed July 16, 2021. “AstraZeneca Receives $1.2 Billion BARDA Contract for COVID-19 Vaccine,” May 22, 2020. Couronne, Ivan. “Pre-Orders of COVID-19 Vaccine Top Five Billion.” Medical Press, 2020. “COVID-19 Vaccine Doses Shipped by the COVAX Facility Head to Ghana, Marking Beginning of Global Rollout,” February 24, 2021. Finch, Hannah. “The Factories Making AstraZeneca, Pfizer and Other Covid-19 Vaccine in the UK.” Business Live, January 27, 2021. Gross, Anna. “AstraZeneca Agrees German Manufacturing Deal to Fill Vaccine Gap.” Financial Times, February 10, 2021. McKeever, Vicky. “AstraZeneca Receives $1 Billion in U.S. Funding for Oxford University Coronavirus Vaccine.” CNBC, May 21, 2020. ReliefWeb. “UNICEF Signs COVID-19 Vaccine Supply Agreement with AstraZeneca - World,” February 26, 2021. Triggle, Nick. “Covid: Under-30s Offered Alternative to Oxford-AstraZeneca Jab.” BBC News, April 7, 2021, sec. Health. Zimmer, Carl, Jonathan Corum, and Sui-Lee Wee. “Coronavirus Vaccine Tracker.” The New York Times, sec. Science. Accessed July 3, 2021.
  • Novavax
    Novavax is a biotech company that was founded in Maryland in 1987. Previous to the COVID-19 pandemic, the company had never brought a vaccine to market. The technology used by Novavax for its vaccine – protein subunit technology – sets it apart from other vaccines that have been approved to treat COVID-19. Reportedly, this technology has the potential to create a vaccine that is safer, has fewer side effects, and is potentially more effective than Novovax’ competition. The Novavax vaccine has not yet been approved: as of June 11, 2021, Novovax had just finished its Phase III trials, and was beginning to scale up its manufacturing and distribution capabilities. Novavax’s protein subunit vaccine works by leading the body to believe that a spike-shaped protein (known as an “antigen”) is actually the whole virus. In this way, it provokes the body to mount an immune response without exposing the patient to the whole virus. A chemical known as an “adjuvant,” which strengthens the immune response, is included in the vaccine in order to supplement this process. In addition to strengthening the immune response, this adjuvant, known as “Matrix M,” helps to speed up the production process by reducing the amount of active vaccine that is needed per dose. Few to no side effects are associated with this vaccine platform, due to the use of pre-made antigens. Partnerships have been crucial in moving this vaccine to market. Although the company’s vaccine has not yet been approved, Novovax has already partnered with Takeda for the clinical development, production, and distribution of its vaccine within Japan. This agreement requires Novovax to share and transfer COVID-19 technology and knowledge to Takeda, with the goal to produce more than 250 million doses per year. Novovax produces the antigen component of its vaccine via several partnerships. Outside of its own facility in Bohumil, Czech Republic, Novovax’s antigen-production partners include Biofabri in Spain, UJIFILM Diosynth Biotechnologies (FDB) in the United States and the U.K., SIIPL in India, SK Bioscience in the Republic of Korea, and the Takeda Pharmaceutical Company Limited in Japan. Novavax’s adjuvant is also being produced by a Novavax facility in Uppsala, Sweden, at facilities of AGC Biologics in the United States and Denmark, and by the Polypeptide Group in the US and Sweden. In addition to development partnerships, Novovax also entered into funding partnerships, in order to accelerate the vaccine’s development and distribution. In May, 2020, the Coalition for Epidemic Preparedness Innovations (CEPI) invested $388 million into the clinical development of Novavax’s vaccine, and, in June of 2020, Novavax entered into a funding agreement with the US Government: the US Department of Defense helped to fund the manufacture of the Novavax vaccine, granting the company $70 million. In in July 2020 Operation Warp Speed granted Novavax $1.6 billion. Reference List “COVID-19 PROGRAM UPDATE World Vaccine Congress,” 2021. “Emergent BioSolutions Signs Agreement with Novavax to Manufacture NanoFluTM.” Nasdaq, 2020. Foley, Katherine Ellen. “What Is the Novavax Vaccine, and How Does It Work?” MSN, 2020. Glenn, Dr. Gregory. “NVX-CoV2373 Vaccine for COVID-19,” 2020. Palca, Joe. “A New Type Of COVID-19 Vaccine Could Debut Soon.”, June 6, 2021. Klein, Dr. Nicola. “How Do the COVID-19 MRNA Vaccines Work?” Kaiser Permanente, 2021. Kuchler, Hannah. “Novavax Closes in on Covid Triumph after 33 Years of Failure,” 2021. Lodaya, Rushit N, and Mansoor M Amiji. “Vaccine Adjuvants.” Pharma Focus Asia, n.d. “Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan.” Takeda News Release, 2020. “Novavax and Takeda Finalize License Agreement for Novavax’ COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan.” Novavax Press Release, n.d. “Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax’ Global Production Capacity to Over 2 Billion Doses Annually.” Novavax Press Release, n.d. “Novavax Advances Development of Novel COVID-19 Vaccine.” Novavax Press Release, 2020. “Novavax Buys Praha Vaccines for Covid-19 Vaccine Manufacturing.” Pharmaceutical Technology, 2020. “Novavax Contact Information.” Novavax, n.d. “Novavax Covid-19 Pipeline.” Novavax, 2021. “Novavax Science and Technology Summary.” Novavax, n.d. Sheryl, Authors, Gay Stolberg, Sharon Lafraniere, and Chris Hamby. “Official Warned That Covid Vaccine Plant Had to Be ’ Monitored Closely ’.,” 2021. “Vaccine Adjuvants.” National Institute of Allergy and Infection Diseases, 2019. “Vaccine Types.” National Institute of Allergy and Infection Diseases, 2019. Wadman, Meredith. “Will a Small, Long-Shot U.S. Company End up Producing the Best Coronavirus Vaccine?” Science Magazine, 2020. “What Are Protein Subunit Vaccines and How Could They Be Used against COVID-19?” Gavi, n.d.
  • Remdesivir
    Remdesivir (brand name Veklury) is a broad-spectrum anti-viral medication that was developed by the pharmaceutical company Gilead Sciences. Remdesivir was developed in 2009 as a treatment for Hepatitis C (HCV) and respiratory syncytial virus (RSV) syndromes. This then led to two different development leads in 2014, one via a partnership with the CDC and the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and another via a collaboration with the University of North Carolina and Vanderbilt University. The partnership with the CDC and the USAMRIID was focused on creating an emergency treatment for global threat level pandemics. Remdesivir was not successful in the use against HCV and RSV, but the company later discovered that it had the potential to become a broad-spectrum antiviral. This research then progressed to the trial of Remdesivir on patients with Ebola in West Africa, under a “compassionate use” protocol. Although the results of these trials indicated that there was a reduction in virus replication, Remdesivir did not prove as effective as other Ebola treatments. Gilead stopped its Ebola research for Remdesivir in 2018. The collaboration between Gilead, the University of North Carolina, and Vanderbilt University was focussed on researching Remdesivir’s therapeutic effects against SARS, MERS, and a variety of other different viruses. This research led to a broader collaboration, led by the University of Alabama at Birmingham (UAB) and funded by the National Institute of Health. There was positive preliminary data throughout 2016-2018 regarding the treatment of SERS and MERS with Remdesivir, but this never progressed to full clinical trials, due to the relative rarity of the viruses and qualified test subjects. Reportedly, Gilead scientists initially did not fully understand how the company’s medicine functioned. It was in 2020, through research at the University of Alberta, that the picture emerged as to the details of how it works. The researchers found that, as Remdesivir is chemically similar to the RdRp polymerase, which viruses use to reproduce, when a virus encounters Remdesivir molecules, it mistakenly incorporates the drug into its own RdRp polymerases. Remdesivir thus functions by inhibiting the virus’ replication process, acting as a deadweight that reduces the rates at which the virus can spread. When the COVID-19 pandemic struck, Gilead Sciences identified a possibility for Remdesivir to be used as a treatment. In February 2020, a small, random trial was started by Gilead – with 1063 patients – to see if Remdesivir could reduce the virus’ replication rates over a 10-day treatment period. It found that, on average, patients who were treated with the drug recovered from a COVID-19 infection in ten days, which is five days sooner than patients who did not receive the drug. On March 25, 2020, Gilead asked the FDA to remove Remdesivir’s orphan drug status, and the FDA granted Emergency Use Authorization to Remdesivir on May 1 for experimental use against COVID-19. Other countries followed suit and granted regulatory approval for Remdesivir. Seeking to scale its production quickly, Gilead invested to decrease the timeframe that it takes for Remdesivir to be produced, with the initial timeframe at the start of 2020 taking a year. By October 2020, after investing over $1 billion, the company had reduced this timeframe to six months. Gilead also increased its global manufacturing network by entering into non-exclusive voluntary licensing agreements to pharmaceutical manufacturers in Egypt, India and Pakistan. The company’s work with contract manufacturers has been a cornerstone of its efforts to scale up production. Later, in a surprising turn of events, a double-blind study – carried out by the WHO Solidarity Group – cast doubt on Remdesivir’s effect on COVID-19 recovery. Today there is an ongoing discussion among medical professionals about Remdesivir’s relevance for treating COVID. In any event, the FDA has not removed its EAU status. The case of Remdesivir highlights the risks involved in producing and scaling a product during a pandemic situation. Like several of the developers of COVID-19 vaccines, Gilead Sciences invested significantly in both in-house capacity and manufacturing partnerships before its product was proven. Reference list Barone, Emily, and Lon Tweeten. “How Remdesivir Works to Fight COVID-19 Inside the Body.” Time, May 27, 2020. How Remdesivir Works to Fight COVID-19 Inside,Tiny particles in the host cell%2C... More. Beigel, John H., Kay M. Tomashek, Lori E. Dodd, Aneesh K. Mehta, Barry S. Zingman, Andre C. Kalil, Elizabeth Hohmann, et al. “Remdesivir for the Treatment of Covid-19 — Final Report.” New England Journal of Medicine, 2020. Chamary, JV. “The Strange Story Of Remdesivir, A Covid Drug That Doesn’t Work.” Forbes, 2021. Dyer, Owen. “Covid-19: Remdesivir Has Little or No Impact on Survival, WHO Trial Shows.” BMJ, 2020. Eastman, Richard T., Jacob S. Roth, Kyle R. Brimacombe, Anton Simeonov, Min Shen, Samarjit Patnaik, and Matthew D. Hall. “Remdesivir: A Review of Its Discovery and Development Leading to Emergency Use Authorization for Treatment of COVID-19.” ACS Central Science 6, no. 5 (2020): 672–83. GAO Biomedical Research. “Information on Federal Contributions to Remdesivir,” n.d. Gilead. “DEVELOPMENT OF REMDESIVIR,” 2020. Gilead. “Voluntary Licensing Agreements for Remdesivir,” 2020. Gilead. “Working to Supply Veklury® for COVID-19.” Gilead, 2020. Gordon, Calvin J., Egor P. Tchesnokov, Emma Woolner, Jason K. Perry, Joy Y. Feng, Danielle P. Porter, and Matthias Götte. “Remdesivir Is a Direct-Acting Antiviral That Inhibits RNA-Dependent RNA Polymerase from Severe Acute Respiratory Syndrome Coronavirus 2 with High Potency.” Journal of Biological Chemistry 295, no. 20 (2020): 6785–97. Koplon, Savannah. “Investigational Compound Remdesivir, Developed by UAB and NIH Researchers, Being Used for Treatment of Novel Coronavirus.” UAB News, July 2, 2020. McDole, Jaci, and Stephen Ezell. “Ten Ways IP Has Enabled Innovations That Have Helped Sustain the World Through the Pandemic.” Information Technology and Innovation Foundation, April 29, 2021. NIH. “Early Results Show Benefit of Remdesivir for COVID-19.” NIH Website, 2020. NIH. “Final Report Confirms Remdesivir Benefits for COVID-19.” NIH Website, 2020. O’Day, Daniel. “An Update on COVID-19 from Our Chairman & CEO.” Gilead Stories, 2020. Rees, Victoria. “Mechanism of Action Revealed for Remdesivir, Potential Coronavirus Drug.” Drug Target Review, 2020. “Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results.” New England Journal of Medicine 384, no. 6 (2021): 497–511. Rutherford, Gillian. “Study Finds Remdesivir Effective against a Key Enzyme of Coronavirus That Causes COVID-19.” Science Daily, 2020.
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