Lancet: Pandemic Containment Requires Increased Vaccine Production, Affordable Pricing & Global Allocation; WHO Calls For Tech Transfer To Scale Up Manufacturing Intellectual Property 14/02/2021 • Madeleine Hoecklin Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Pfizer’s COVID-19 vaccine during the manufacturing process. The contribution COVID-19 vaccines can make to beating the pandemic will depend on the extent to which they are produced at scale, priced affordably, and deployed globally, says the first peer reviewed study on equitable access to vaccines, published in The Lancet on Friday. The Lancet article comes in the wake of a joint appeal by WHO and UNICEF for governments to share vaccines through the WHO co-sponsored COVAX facility, and for vaccine manufacturers to maximise production and transfer technology to help scale up the global supply of vaccines. In The Lancet study, researchers from universities and research centres in the United Kingdom, the United States, Thailand and Singapore evaluated the potential global contributions of each of the 26 leading vaccine candidates, scoring them based on their potential role in achieving global herd immunity. “Several manufacturers have successfully developed COVID-19 vaccines in under 12 months, an extraordinary achievement. But the stark reality is that the world now needs more doses of COVID-19 vaccines than any other vaccine in history in order to immunise enough people to achieve global vaccine immunity,” said Olivier Wouters, lead author of the study and assistant professor at the London School of Economics and Political Science, in a press release. “Unless vaccines are distributed more equitably, it could be years before the coronavirus is brought under control at a global level. The questions now are when these vaccines will become available, and at what price,” he added. The 26 vaccine candidates, several of which are still in development, were scored using a traffic light system. Some 13 of the 26 vaccine candidates got a green light across at least one of the categories of development and production, affordability, allocation and deployment, including vaccine’s produced or in late stage development by Oxford/AstraZeneca, Novavax, Sinopharm/Beijing Institute, and Gamaleya, which is developing Russia’s Sputnik V vaccine. Key characteristics of leading vaccine candidates with traffic-light system signalling potential for achieving global vaccine immunity. Only five of the vaccines reviewed have already been authorised by a stringent regulatory agency. Just five of the vaccines have a supply agreement with COVAX, the WHO-supported a global initiative to procure and equitably distribute vaccines, and only one vaccine, China’s Sinovac vaccine, was assigned a green light for its ease of cold-storage in low-resourced settings. Pricing and Accessibility of Vaccines The pricing of the 26 vaccine candidates varies from US$5 to US$62 per vaccine course. Advanced deals between pharma companies and high-income countries have limited supplies available to low- and middle-income countries, and potentially caused the prices to rise, the study’s authors found. “Securing large quantities of vaccines in this way amounts to countries placing widespread vaccination of their own populations ahead of the vaccination of health-care workers and high-risk populations in poorer countries,” said Mark Jit, co-author and professor at the London School of Hygiene & Tropical Medicine. “Based on known deals, governments in high-income countries representing 16% of the global population have secured at least 70% of doses available in 2021 from five leading vaccine candidates,” said Jit. The COVAX facility is attempting to combat this uneven access to vaccines by securing low prices to vaccines and developing a diversified portfolio for the 190 participating countries, particularly for the 92 low- and middle-income countries eligible for donor-supported vaccine supplies through the Advanced Market Commitment of GAVI, The Vaccine Alliance, which is a key COVAX partner along with WHO and UNICEF. “With additional funding, COVAX could compete better in the global scramble for vaccines,” said Wouters, but the global initiative is facing a US$6.8 billion funding gap that needs to be closed to fulfil the goal of delivering two billion doses by the end of 2021. There is a total US$ 27 bilion funding gap for all arms of the global Act Accelerator Initiative – including tests, treatments and health systems strengthening as well as vaccine rollout. In addition to the challenges of basic vaccine affordability and access, many low- and middle-income countries lack the infrastructure needed for vaccination registries and for the storage, delivery and waste management of the vials and syringes, the study notes. This is particularly an issue for COVID-19 vaccines that require ultra-cold chain storage and have multiple doses. Single-dose vaccines that only require regular refrigeration temperatures, such as AstraZeneca/Oxford and Novavax vaccines, will likely be preferable in resource-constrained countries – while the Sinovac vaccine, which can be stored at room temperature, has the most modest requirements of all. The cold chain storage for the Pfizer/BioNTech vaccine at Pfizer’s warehouse in Kalamazoo, Michigan. “Both globally and nationally, the availability of diversified sets of vaccine options is likely to be needed to bring the global pandemic under control,” stated the study. A select few vaccine developers have committed to maintain a low price globally for their vaccines during the pandemic, including Oxford/AstraZeneca, Gamaleya, J&J, Novavax, and Bharat/BioNTech, whose vaccine is still in development. However, AstraZeneca’s licensees as well as other vaccine developers in India and elsewhere are also making arrangements to sell a portion of their vaccines production on the private market in countries such as India, Bangladesh, and Brazil, raising concerns that private sales in poor countries could further undermine the aim of equitable access. According to Wouters, “vaccines developed by Chinese, Indian, and Russian manufacturers may…offer a lifeline for the lowest-income nations if they show good results in phase 3 trials, allowing them to procure abundant doses of vaccines that have not yet been authorised in most high-income countries. Once authorised by WHO, these vaccines could also potentially contribute to the COVAX portfolio.” The vaccines developed by Chinese manufacturers, however, are among the most expensive, with Sinopharm charging US$62 and Sinovac charging US$21 for both doses. It is currently unclear if the companies intend to reduce their prices for low- and middle-income countries. Challenge of Scaling up Production Expanding production capacity is a “monumental challenge” at the moment and disruptions in manufacturing have been announced by AstraZeneca, Pfizer, Moderna, and Johnson & Johnson, all of which have delayed initial deliveries of promised doses in Europe, the United States and elsewhere due to production kinks in the initial rollout phases. According to the authors of the study, the more widespread transfer of technology, knowledge and data would provide a solution to the production bottleneck. So far, vaccine knowledge sharing efforts, including through WHO’s COVID-19 Technology Access Pool (C-TAP), which calls on member states and manufacturers to share intellectual property on vaccines, have been limited. The significant amount of public funding that has gone towards the development of COVID-19 vaccines enables governments to “insist that, as a condition of getting public funding, companies engage in sufficient licensing to enable widespread global production, and they must set affordable prices,” said Kenneth Shadlen, co-author of the Lancet study, and a professor at the London School of Economics and Political Science. WHO/UNICEF Call on Countries to Share Excess Doses and For Pharma To Rapidly Scale Up Production – Pharma Warns Against Unrealistic Expectations The study follows on the heels of last week’s joint statement UNICEF’s Executive Director, Henrietta Fore and Dr Tedros Adhanom Ghebreyesus, WHO Director General, which criticised the “vaccine nationalism” that has dominated the first phases of global vaccine rollout, with 75% of the total doses administered so far taking place in 10 countries. “COVAX participating countries are prepared to receive and use vaccines. Health care workers have been trained, cold chain systems primed. What’s missing is the equitable supply of vaccines,” said the statement. In order to achieve the goal of beginning vaccinations in all countries in the first 100 days of 2021 – among which 57 countries have not launched vaccine campaigns at all – Tedros and Fore called on governments and pharma leaders to do the following: Governments to share vaccine doses obtained through bilateral deals so that healthcare workers and high risk individuals in low- and middle-income countries can get vaccinated; Donor countries to fill the US$27.2 billion funding gap for the Access to COVID-19 Tools (ACT) Accelerator, the global initiative to ensure equitable access to COVID-19 health products and technology, and its vaccine pillar COVAX; and Vaccine manufacturers to allocate their limited vaccine supplies equitably, step up production, and transfer technology and knowledge to other manufacturers to expand the global supply of vaccines. In response to the WHO/UNICEF statement, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) warned against setting unrealistic goals for vaccine rollout. The IFPMA also said IP rules were enabling innovation that also expands access. “Having condensed four or more years of vaccine development into less than a year, through unparalleled partnerships, underpinned by IP, we now have one vaccine that the WHO has approved and others hopefully will be approved shortly,” said Thomas Cueni, Director General of IFPMA. Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), speaking at the World Health Summit in October. In response to the calls by UN agencies and civil society for greater technology sharing, IFPMA stated that, “most collaborations – if not all – involved some sort of licensing and transfer of technology, which would not be possible in the absence of a robust global IP system.” IFPMA noted that there are already 234 manufacturing and production deals arranged for COVID-19 vaccines, representing partnerships that are scaling up to meet the global demands. Examples of deals include those between Johnson & Johnson and Aspen in South Africa; AstraZeneca and the Serum Institute in India; BioNTech and Fosun Pharma in China; and the US-based Novavax and Takeda in Japan. “We will continue to do all we can to support [COVAX] delivering the 2 billion doses target for 2021…But understanding the urge for early and equitable vaccine rollout, we warn against setting unrealistic expectations given the inherent risk of vaccine development and the complexity of scaling up manufacturing from scratch,” said Cueni. Behind the scenes, there are also some voices in pharma noting that the first port-of-call for WHO and its partners should be at those developed countries that have monpolized markets by purchasing 2-3 times more vaccines than needed to vaccinate everybody – and which could turn the surplus over to COVAX. IP Waiver Described As Effort to “Erode Intellectual Property Policies” Meanwhile, the US-based Pharmaceutical Research and Manufacturers of America (PhRMA), called upon the Office of United States Trade Representative (USTR) to oppose a proposal submitted by South Africa and India for a World Trade Organization waiver of IP rules on essential COVID health products – saying that it would undermine the global intellectual property system that fosters pharma innovation. The South African and Indian proposal, requesting that the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council temporarily waive certain IP obligations on COVID-19 tests, treatments and vaccines, has become another big bone of contention between developed and developing countries – which see it as a means of gaining faster access to manufacturing capacity. The IP waiver proposal by South Africa and India to suspend the protection of IP related to COVID-19 health products is due to be debated again this month in the TRIPS Council, after being shelved late last year, and then being debated again in January – meeting stiff oppositiong from G-20 countries. In a submission presented on 28 January to the USTR for its “Special 301” report for 2021, which reviews the global state of IP, the US-based PhRMA group also heaped blame on WHO, the UN Development Programme (UNDP), the UN Conference on Trade and Development (UNCTAD), and Unitaid for supporting the waiver moves behind the scenes and thus – “seeking to undermine and even eliminate intellectual property protections that drive and sustain biopharmaceutical innovation…. “The WHO Director-General even publicly supported an extreme and unnecessary proposal at the WTO TRIPS Council to waive entirely certain international obligations with respect to COVID-19 technologies, even as Member States were still debating this proposal,” said PhRMA’s statement. The South African and Indian IP waiver prposal “marks a significant escalation in anti-IP global activism” the PhRMA group added, saying, “Some countries are using the COVID-19 pandemic opportunistically to advance longstanding industrial policies to further erode intellectual property policies.” But it warned that “The proposal will do nothing to address the production and distribution challenges for making COVID-19 vaccine globally available. If anything the proposal [will] threaten to undermine the ability to respond to another pandemic.” PhRMA laments that "WHO, the World Intellectual Property Organization (WIPO), the WTO, UNDP, and UNCTAD often focus their work inappropriately on limitations and exceptions to intellectual property rights". @WIPO @wto @WHO pic.twitter.com/FeHKLTlFIC — Balasubramaniam (@ThiruGeneva) February 12, 2021 At the most recent WTO meeting in mid-January, opponents to the waiver, which include the US, Australia, Brazil, Canada, the EU, Japan, Norway, Switzerland, and the UK, showed no signs of changing their position on the proposal – which typically would require a consensus agreement by the TRIPS Council, in order to go before the entire membership body of the WTO General Council’s 164 member representatives for approval. In a document published on 15 January, proponents of the WTO waiver provided evidence of the disparity in access to COVID-19 health products. The document was supported by Bolivia, India, Kenya, Mongolia, South Africa, and Zimbabwe, among others. “Per capita imports of the medical goods essential to mitigate the COVID-19 pandemic have been about 100 times larger in high-income countries in comparison to low-income countries,” stated the document, submitted to the TRIPS Council to respond to questions from several of the waiver’s critics. “A solution to this challenge is to diversify and increase production and supply. This requires addressing the legal barrier of IP that prevents diversification and production,” specifically the relevant categories of IP that are implicated are patents, trade secrets, industrial designs, and copyright, said the document. The next meeting of the TRIPS Council, on 23 February, will come right on the heels of Monday’s expected election of a new WTO Director General Okonjo Ngozi-Iweala – after the new administration of President Joe Biden removed the US opposition to the candidacy of Iweala which had blocked her election under the tenure of former President Donald Trump. Iweala, a former high-ranking World Bank official and dual US citizen, was nominated by Nigeria where she both served as a finance minister and economic minister over the past two decades, helping rescue the debt-ridden country from financial ruin. As chair of GAVI, and a special WHO envoy on the COVID-19 pandemic, she has spoken up frequently on global health issues, expressing her own deep commitment to ensuring vaccine equity for low- and middle-income countries. In her new WTO role, she will have to steer a delicate course between LMIC’s demands and those of the WTO’s powerful G-20 member states. Image Credits: Johnson & Johnson, Pfizer, The Lancet, World Health Summit. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.