AstraZeneca Breakthrough Heightens Competition Between Two Different World Views On Vaccine Procurement & Distribution Medicines & Vaccines 23/11/2020 • Elaine Ruth Fletcher, Menaka Rao & Kerry Cullinan 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) Norway’s Minister of International Development, Dag Inge Ulstein and South Africa’s Minister of Health Zweli Mkhize issue urgent appeals at WHO press briefing for $US 28 billion in funding for COVID 19 vaccines, tests and treatments. The vaccine zero hour is approaching. As Norway’s Minister of International Development Dag Ulstein and South Africa’s Minister of Health Zweili Mkhize made yet another urgent plea Monday for some US$4.3 billion right now and another $US23.9 billion in 2021 to massively roll out new COVID19 vaccines, drugs and tests that are now coming on line, it’s increasingly clear that the funds available to support the ambitious worldwide COVAX vaccine procurement and distribution facility planned by WHO and its partners through its ACT Accelerator initiative, is, at present, woefully inadequate. And following the lukewarm G20 pandemic commitments at last Saturday’s Summit, which failed to include any new offers of serious vaccine finance, the upcoming holiday season could feature heavy TV coverage of the first Americans getting a freshly-approved Pfizer COVID vaccine – with Europeans, Japan, Australia and other high-income countries next in line – as the rest of the world watches the show. “The ACT Accelerator has compiled the world’s largest portfolio of these tools to continue rolling up rapid testing, evaluating new treatments and ensuring access to vaccines as soon as they are licensed. The accelerator urgently needs US$4.3 billion, and the further US$23.9 billion in 2021,” said Ulstein in his appeal on the WHO stage. “I would argue that this is a no brainer for world leaders. US$23.9 billion sounds a lot, yet the total needed is less than one-tenth, or one percentage point of global GDP. In other words, if G20 countries were to devote just 1% of the current stimulus spending on efforts to alleviate the economic consequences of the pandemic,” he said, “they would actually more than cover the needs of the next generation. I would argue that this is a small price to pay to getting the world back on track.” It may be a small price, but there is also much more at stake. Any deadlocked funding also threatens to pit two long standing world views against each other – in much more direct competition than what has been seen in decades. One, led by the G20 economies, is hugely invested in their pharma industries, and a donor-driven regime of massive vaccine purchases at reduced prices, and distribution for poorer countries. They argue that the private sector confidence that they will reap as a reward for their efforts is necessary to incentivize the expensive investments required for any vaccine R&D, let alone the COVID research effort that has taken place at unprecedented scale and speed. R&D at AstraZeneca with robotics-supported technologies Another vision, led by South Africa and India, is challenging that more fundamentally. They are pressing ahead for an IP “waiver” in the World Trade Organization (WTO) – so that countries would have the discretion to waive, for the period of the pandemic, not only COVID-related patents, but also trade secrets, industrial designs and copyrights associated with prized vaccines, tests or treatment technologies. This, South Africa, India and its partners say, would greatly expand countries’ own ability to produce, as well as to export and import desperately needed vaccines, tests, and treatments quickly, and at much reduced prices – while bolstering the greater self-sufficiency that has become so important in the pandemic. “We find that COVAX is a good start, but it’s not the solution,” said a leading South African diplomat, speaking with Health Policy Watch. “We are happy to work with multilateral approaches, of which COVAX is an example, and we are also able to work with voluntary licenses given by countries like AstraZeneca. Every little bit helps. “But these approaches do not result in ramping up the production capacity, if they are limited to only a handful of producers. There’s no guarantee in terms of the volumes being supplied, within the timelines that are required to establish effective access. And even if we had volumes procured through COVAX that would cover 20% of the population for low- and middle-income countries (LMICs) … then you still don’t reach herd immunity.” South Africa & Norway – Seeking a Way Forward To be sure, as evidenced by the joint appearance of Ulstein and Mkhize today at the WHO press conference, both sides are trying to find new modus vivendi for bridging the stark differences between rich and poor countries in the global North and South, and create a practical way forward for sharing the benefits of new technologies more broadly – during a pandemic. Ulstein said: “We have a wide portfolio of candidates on the cusp of finalizing Phase 3 trials; we need to make sure that we do not end up with having these tools, but not the infrastructure to make them available at all.” Mkhize added: “Global solidarity isn’t just the right thing to do, it’s the smartest thing to do, ensuring that tools are allocated equitably, and not just based on income, but based on universal protection against COVID-19. It is the fastest and most effective way to defeat the pandemic and get our lives and our economies back to normal again. “The lack of adequate financing for the ACT Accelerator is an existential threat to the economic and health security of all countries and their citizens.” Whether due to its youthful population, strict preventive measures, or prior experience with dangerous outbreaks and epidemics, African countries have largely succeded in restraining the spread of the pandemic – in a success story that other regions have sometimes envied – but this has also come at a huge economic and social costs. Up until now, the entire continent has recorded just 2 million cases and 14,000 deaths – just 2.5% of the global caseload – and a fraction of the 12 million cases and 250,000 deaths see in just one country, the United States, which leads the world in terms of its COVID-19 infections, pointed out Mkhize. However, Africa is not immune either, he added, noting a resurgence of the virus underway just now, with a more than 20% increase in cases just over the past week. “The resurgence on the African continent will evolve, and therefore early equal access to vaccines and therapeutics will be critical to mitigating the threat posed,” he said. “We must treat access to COVID-19 tools as a global public health initiative: collective efforts to stamp out the virus now would also mean that future virus strains or mutations, that are more difficult to treat, could be avoided. It is clear that every country will need to play a part in financing an end to this crisis, and every leader has a political choice to make.” AstraZeneca Vaccine Results Accelerate Access Debate Vaccine deals by country and for the COVAX pool as of mid-October – by Suerie Moon, Co-Director at Global Health Centre, Geneva Graduate Institute For LMICs, the promising Phase 3 trial results of 24,000 volunteers, announced by AstraZeneca and its research partner Oxford on Monday – which saw 90% protection from the virus in one stream of dosing strategies, are a beginning, in terms of the concrete possibilities to deliver vaccines that can be handled through the normal supply chains. WHO’s Chief Scientist Soumya Swaminathan, speaking at the WHO press conference, said the AstraZeneca results are particularly important due to their modest cold chain requirements – refrigerator storage at 2-8 C is sufficient. “This has, of course, huge logistical advantages for transporting and delivering this vaccine to cities and towns and villages and rural areas around the world,” she added. Soumya Swaminathan, WHO Chief Scientist Unlike the Moderna and Pfizer vaccines, AstraZeneca’s candidate also is based upon a tried and tested “viral vector strategy” she noted. That means that it uses a weakened form of another virus (a common adenovirus) to deliver the genetic code for a protein that is part of the characteristic a SARS-COV-2 spike – prompting a person’s body to mount an immune reaction. But it also means that the vaccine was developed and can be produced at a much lower cost than counterparts by Moderna and Pfizer that rely upon newly developed mRNA technologies. Manufacturers like India’s Serum Institute, which have already acquired a license from AstraZeneca to produce its vaccine, have said that they will be able to produce and sell it for as little as US$ 3 a dose (it requires two shots), as compared to a cost of US$25-30 for the Moderna and Pfizer alternatives, which rely upon newer mRNA technology. The low-cost is also due to the fact that AstraZeneca’s licensing agreements with manufacturers in India, Brazil and elsewhere are on ‘no-profits’ basis until the pandemic is over. Althought that pledge may have its limits in the light of revelations that the company reserved the right to declare an “end” to the pandemic as early as July 2021, according to one agreement made with Brazil’s Fiocruz Institute. But while AstraZeneca’s deals with the Serum Institute and other similar partners could allow for the production of some 2 billion vaccine doses or more in the coming year, at two doses a person, expected global demand will still be 7-8 times that. Vaccine pre-orders by COVAX and countries to pharma firm as of mid-October; Suerie Moon, Co-Director at Global Health Centre, Geneva Graduate Institute And the AstraZeneca commitments only channel about 300 million doses to COVAX, while the lion’s share would still go directly to the countries hosting production, like India and Brazil, as well as middle or high-income countries such as the United Kingdom, the European Commission (400 million doses), and others. Like counterpart vaccines produced by Moderna and Pfizer, middle and high income countries have pre-orders or options to purchase a sizeable chunk of the doses likely to be available next year from manufacturers – not including vaccine candidates being developed by China and Russia, which may open up other alternatives. As Swaminathan noted, still more vaccines will be needed: “Remember we have to cover a huge number of people, billions and billions of people this is unprecedented. And we will need all the manufacturing capacity in the world, to be able to do that”. India’s Serum Institute – India First Strategy & A few Hundred Million Doses for COVAX By July Speaking at a live “Leadership Summit” last week in India sponsored by the Hindustan Times, Adar Poonawala, head of India’s Serum Institute stressed that the first cut of the Serum Institute vaccines would also go to India and Bangladesh, as part of the company’s national and regional commitments. The Serum Institute would be positioned to having “a few hundred million” vaccine doses to offer to COVAX by July or August of 2021, he said. And those commitments already represent the upper limits of production capacity, he added, cautioning, that “we don’t want to partner with anyone [more] right now … We will be committing to more than what we can handle”. Along with the logistical barriers of production, there remains the barrier of cost – or conversely that of finance – for other vaccine options. Poonawala said: “Indian vaccine prices will always be probably half or less than what we are seeing in the West with US$20 and US$30 dollar pricing that Pfizer and Moderna have publicly announced. Ultimately, I don’t know if they will come down on price. They might with public pressure, global pressure which is there. “If we are talking about a US$10-US$20 dollar vaccine, you will need a budget of US$60-US$70-US$100 billion dollars, which the world doesn’t have for vaccinating everyone. “Initially there might not be a choice for governments but to just pay these high prices. But eventually, when there is enough supply and alternatives you will see prices coming down drastically. “Because the world will soon realise that there are other options coming from India and China at more affordable prices.” With reporting by Kerry Cullinan in Cape Town and Menaka Rao in Delhi, India. Image Credits: AstraZeneca , R Santos/HP Watch, WHO. 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