Covid-19 vaccine breakthroughs heighten tensions over 'vaccine nationalism'

The vaccine ‘zero hour’ is approaching. Norway’s Minister of International Development Dag Ulstein and South Africa’s Minister of Health Zweili Mkhize made yet another urgent plea on Monday at a World Health Organization event for some $4.3bn immediately, and another $23.9bn in 2021 to finance a massive rollout of new Covid-19 vaccines, drugs and tests. But it has become increasingly clear that the funds available to support the ambitious Covax vaccine facility, a global procurement and distribution plan devised by WHO and its partners as part of the broader ACT Accelerator initiative, are, at present, woefully inadequate.

Following the lukewarm G20 statements 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 $4.3bn, and the further $23.9bn in 2021,” said Ulstein in his appeal at a WHO media event attended by journalists around the world.

“I would argue that this is a no brainer for world leaders. $23.9bn sounds a lot,” he added. But if G20 countries were to devote just one per cent of the current stimulus spending…they would actually more than cover the needs…I would argue that this is a small price to pay to get the world back on track.”

It may be a small price, but there is also much more at stake. Any deadlock over funding also pits two long standing world views against each other – in much more direct competition than what has been seen in decades.

One view, led by the G20 economies, is hugely invested in their pharma industries and a donor-driven regime of bulk vaccine purchases at reduced prices and distribution for poorer countries in need. Supporters of the existing order argue that this preserves private sector rights over their patented products, and also incentivises pharma make the huge investments required for vaccine research and development generally, let alone the Covid research, which has taken place at unprecedented scale and speed.

Another vision, led by South Africa and India, is challenging the status quo more fundamentally. The two countries are leading a charge in the World Trade Organization (WTO) for an IP “waiver” – so that countries would have the discretion to waive, for the period of the pandemic, Covid-related patents, trade secrets, industrial designs and copyrights associated with vaccines, tests or treatment technologies.

South Africa, India and its alliles say this 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 to countries in the pandemic.

“We find that Covax is a good start, but it’s not the solution,” said a Mustaqeem De Gama, Counsellor at the South African Permanent Mission in Geneva, and a leading figure in the WTO initiative. “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 per cent of the population for low- and middle-income countries (LMICs) … then you still don’t reach herd immunity.”

Promising approaches. For low- and middle-income countries, the promising Phase 3 results announced by AstraZeneca and its research partner Oxford on Monday – which saw 90 per cent protection from the virus in one arm of the trial of the vaccine is at least a beginning. Among the frontrunners in late stage trials, the vaccine is likely to be one of the lowest-priced.

That 90 per cent efficacy was only achieved, however, in a part of the trial that tested a ‘half dose’ of the first shot on participants aged 55 or under. A second trial arm, with a higher initial dose and a wider age range, protected only 62 per cent of those who received shots. So the more effective half-dose strategy still needs to be tested further on older people, who are more vulnerable to Covid.

But if those results hold, they would suggest that a highly effective vaccine could, in principle, be delivered through established vaccine supply chains, which exist throughout most of the world. AstraZeneca’s vaccine has very 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,” said WHO’s chief scientist Soumya Swaminathan this week.

Similar logistical advantages also exist for the “Sputnik V” vaccine candidate being trialled by the Russian-based Gamaleya Research Institute of Epidemiology and Microbiology. On Tuesday, the Institute declared that its vaccine had achieved a 92 per cent rate of efficacy in its clinical trial underway, as of 28 days after the first dose and seven days after a second dose. Results as of 42 days after the administation of two doses were over 95 per cent, said the Institute.

Other vaccine experts have expressed wariness about the institute’s declarations, in light of the secrecy surrounding Sputnik’s clinical trial protocols. But the Gamaleya Institute has declared that it will submit trial results for a peer-reviewed publication, and apply for licenses through national regulatory channels, as well as through the European Medicines Agency.

Viral vector technologies are less expensive. Both the Sputnik V and AstraZeneca’s candidates are based upon a tried and tested “viral vector” strategies. That means that it uses a weakened form of another virus (a common adenovirus that can cause colds) to deliver the genetic code for a protein characteristic of a SARSCoV-2 spike – prompting a person’s body to mount an immune reaction. Use of well-known technology also means that the vaccines are developed, and can be produced, at a much lower cost than counterparts produced by Pfizer and Moderna. The two companies were the first to announce their interim trial results last week, showing 94-95 per cent levels of efficacy. Since then Pfizer’s vaccine has already been submitted to the US FDA for emergency approval, which could happen as early as 10 December, with Moderna’s likely to follow soon after. But both vaccines rely upon new and more expensive mRNA vaccine technologies. And these have been priced at an estimated $25-30 per dose, for a two-dose regime.

In contrast, manufacturers such as India’s Serum Institute, which has already acquired a license to produce the AstraZeneca vaccine, have said that they will be able to sell it for as little as $3 a dose (the vaccine also requires two shots). At $10 per dose, the Sputnik V would be somewhere in the middle range.

AstraZeneca licenses are non-profit, for now. One major factor keeping AstraZeneca’s prices low, for now, is the company’s ‘no-profit’ pledge, incorporaed into the licensing agreements that have been concluded with manufacturers in India, Brazil and elsewhere - until the pandemic is over. But many fear that AstraZeneca’s pledge may reach a hard stop as early as July 2021, in light of recent disclosures that in at least one agreement, signed between the company and Brazil’s Fiocruz Institute, AstraZeneca had reserved the right to declare an “end” to the pandemic as early as July 2021.

In terms of production volumes, AstraZeneca’s deals with the Serum Institute and other partners should allow for the production of some 2.9 billion vaccine doses in total, in 2021. However, expected global demand would likely still be 7-8 times that - so that needs will far outstrip supply.

Significantly, AstraZeneca has only channelled about 300 million doses to the WHO co-sponsored global Covax pool, while the lion’s share of its supply would go directly to the countries hosting production, like India and Brazil. High-income countries have also placed orders, including the United Kingdom, the European Commission (400 million doses), along with middle-income countries too. Ditto for the more expensive vaccines to be produced by Moderna and Pfizer, where high income countries have already snapped up options to purchase the lions share of doses likely to become available next year.

While still more vaccines are yet to come online, in the absence of more big pharma commitments to sell vaccines to the Covax pool, and donor commitments to pay for them, other low-income countries outside of Astra Zeneca’s current production loop could wind up heavily reliant upon whatever lower-cost vaccines Russia as well as China do produce – if they want to get vaccines at all.

India First strategy. 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 his vaccines produced there would go to the domestic Indian market, as well as neighboring Bangladesh, as part of the company’s national and regional commitments.

The Serum Institute would thus be positioned to have only a “few hundred million” vaccine doses to offer to Covax by July or August of 2021, he said. But 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.”

But Poonawala is also optimistic that costs will come down as more vaccines emerge to compete with the boutique vaccine prices offered by developed countries:

“If we are talking about a $10-$20 dollar vaccine, you will need a budget of $60-$70-$100bn, which the world doesn’t have for vaccinating everyone.

“Indian vaccine prices will always be probably half or less than what we are seeing in the West with $20 and $30 dollar pricing that Pfizer and Moderna have publicly announced….

“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.

‘Vaccine nationalism’ in low- and middle-income countries. In fact, as a close examination of the publicly available data on vaccine pre-purchase deals reveals, many other LMICs are not waiting around for Covax either, but are directly pre-ordering vaccine stores from any source that they can afford, said Suerie Moon, co-director of the Global Health Centre of the Geneva Graduate Institute, and an expert on medicines access.

“The picture is complicated,” Moon said, “Many middle-income countries have secured their own sources of supply through bilateral deals. Says Moon:

“Many MICs are not sitting back and relying only on Covax. Some of the smallest and lowest-income countries will indeed be at the back of the line unless Covax can deliver for them. But for some countries in sub-saharan Africa (for example) there are lots of other health challenges to deal with, and spending massive resources on population immunization for Covid-19 may not be at the top of the list.

“In my view, overall the news on the Oxford/AstraZeneca vaccine is very good because it is much lower-priced, easier to use, and will be made available at much larger volumes globally than most of the others. And I think the investment being asked of G20 countries into Covax and the ACT-Accelerator more broadly is a drop in the bucket, compared to the massive economic costs of this pandemic. But the final situation with access to Covid-19 vaccines is going to be complicated, I think, neither as rosy nor as disastrous as some of the current predictions hold.”