Up until now, I have been speaking up for a global response to the pandemic – a globally defined, equitable sharing of all the tools we can possibly find by working together. The Access to COVID-19 Tools Accelerator initiative that was launched by the WHO a year ago is the prime example of this approach. I have been especially enthusiastic about the COVAX Facility that was launched as a part of this initiative to bring countries together to pool available vaccines for a globally equitable distribution based on population. But the huge surge in India upends the formula for the equitable sharing of available vaccines. It may well be that the formula had already lost traction because of the rationale for dealing with the second and third waves of serious outbreaks in the US and Europe. For me, though, it is the Indian surge that has led me to question the whole business of how we can achieve vaccine equity. It has become far more than a question of the equitable distribution of an existing but limited supply of vaccines; it has also become a question of how to dramatically – and rapidly – expand the actual supply.
The IP Debate and Global Manufacturing Capacity
In this month of April showers, I have found it challenging to keep up with the rapid fire of daily news reports on the global aspects of this vaccine supply issue. (Check the illustrative list at the end of this commentary.) I think we all noticed how the media finally got around to reporting on a growing interest in the urgency of improving access to vaccines – various NGOs seeking to persuade countries with surplus doses to release them but also increasingly raising the urgent need to globally expand the manufacturing capacity, And this has meant growing media attention to the debate over the impact of intellectual property rights on manufacturing capacity, as illustrated by the closed door consultation convened on 14 April by the WTO Director-General Ngozi Okonjo-Iweala .- and Dr. Ngozi’s portrayal of the divisions over a possible waiver of IP rights.
Significantly, the new US Trade Representative (USTR) Katherine Tai stirred things up with publicly posting her remarks at this event on the USTR’s website – hinting at the possibility of WTO reform on this sensitive IP issue. It seems that the American pharmaceutical industry responded to her statement with alarm. On the very next day, 15 April, the US Secretary of State Tony Blinken avoided the IP issue completely at a major launch event for more funding for the COVAX Facility, Since then, a barrage of publicity has shown widespread agreement among thought leaders on the urgency of expanding vaccine production but a continuing division among them on whether to do this through COVAX and/or its supporters (and therefore within existing IP rules) or through a waiver of the IP protections at the WTO.
The Crisis in India
Then came the unexpected and sudden surge of cases in India – in a country that has been expanding vaccine production for the developing world (and for COVAX) but a country that is also one of the co-sponsors of the WTO proposal for an IP waiver. The numbers are daunting. In this second wave for India, the increases in cases were very sudden. The first wave there had passed its peak in September, when the daily case rate was just under 100,000. As the case numbers steadily came down to well below 20,000 in January and February, complacency set in among India’s leaders, many even imagining that the worst was over. Then, as Indian health experts started reporting new variants, while campaign rallies and the famous Kumbh Mela festival were attracting large crowds, the case numbers started growing. The shock of jumping from under 50,000 cases a day at the end of March to 200,000 daily cases in mid-April and now suddenly to globally record-breaking numbers over 330,000 has hit the country hard.
No one seemed quite ready for this. News media are now reporting severe shortages – of oxygen, of hospital beds, of vaccines, of therapeutics, of diagnostic tests, of personal protective equipment, of funeral pyres, of personnel, of everything. Even with diverting what Indian suppliers had previously shipped overseas, the world is being called upon, country by country, charity by charity, business by business, to deliver emergency supplies of one sort and another. (Check the list below for ways to contribute.) What does this mean for COVAX? And what does this mean for the WTO?
Implications for the Future of the COVAX Facility
In one sense, I can see this crisis as an exception – a learning experience once again about how difficult it is to control the global reach and unpredictability of this pandemic. Once it’s under control, the rationale may still be there for a global distribution of limited supplies through something like the COVAX Facility (or similar arrangements for diagnostics or treatments or the like.) We’ve all been wringing our hands in distress with all the “vaccine nationalism” that has been working against a global response like COVAX. And as both the US and European countries are finally accumulating more vaccines than they need for their own populations, we have eagerly awaited announcements for more doses from these rich countries to go to the COVAX Facility.
Alas, a different outcome has started to unfold – a movement toward “vaccine diplomacy”. It has been there all along, I suppose, and should come as no surprise. The American contributions to the COVAX Facility under President Biden were a welcome infusion of billions of dollars but did not include an offer to share the large stock of vaccine doses reserved for the American people. And when the President finally made his first sharing gesture, it was for a “loan” of surplus AstraZeneca vaccines to Mexico and Canada, not to the COVAX Facility.
I also note that France, probably the first to offer to share its own supply, let it be known that the priority was for African countries, even if its surplus might be channeled through the Covax Facility. The Quad deal (US, Japan, India and Australia) that I mentioned in my last commentary was to produce vaccines specifically for Asian countries, and we all know that the Chinese and the Russians have both been diplomatically targeting their own vaccines. So the use of vaccines for diplomatic purposes has already been competing with the more neutral approach of a global pooling of vaccines for equitable access through something like the COVAX Facility, But I sense that these gestures are about to be overwhelmed by a tsunami of bilateral delivery arrangements to deal with the crisis in India.
No one is likely to be channeling their emergency deliveries to India through COVAX. One could argue that emergencies are different from the global pool of an equitable share, but it is also the case that the COVAX Facility has had to hold back on its own distribution plans because of the suspension of exports from places like India’s Serum Institute. And so the COVAX Facility loses out as a channel for the crisis as well as for meeting its own already modest distribution targets.
Broadening Signs of Vaccine Diplomacy
Meanwhile, two other recent developments, one involving the US and the other involving the EU, suggest that we are well on the way to vaccine diplomacy more broadly. Not only does this mean a sidelining of the globally focused COVAX Facility, but it also means a setback for the IP waiver proposal at the WTO. That is to say, the distribution of surplus vaccines for a country’s diplomatic interests is not likely to be isolated from the parallel diplomatic interests in mobilizing government resources to enable an expansion of manufacturing capacity, especially in developing countries and especially where improvements in regulatory oversight are also part of the effort.. The assumption here is, of course, that the pharmaceutical industry will end up saving their IP rights by cooperating with this governmental use of vaccine diplomacy.
Here is what I see happening in the US. President Biden has been reluctant to commit any surplus of vaccine doses, even of the AstraZeneca vaccine that has not yet received US domestic authorization, without being sure that he had enough to ensure full coverage in the US. Under pressure, he has recently acknowledged that there are some 60 million doses that could be sent elsewhere (above and beyond the “loans” that went to Canada and Mexico). But even on that matter, he has not designated the quantities for either the Indian crisis or for the COVAX Facility. In fact, in his first state of the union speech delivered just yesterday (28 April 2021 and available here), he announced, “As our own vaccine supply grows to meet our needs – and we are meeting them – we will become an arsenal of vaccines for other countries – just as America was the arsenal of democracy in World War 2.” This sounds like vaccine diplomacy to me.
It is no surprise, then, that a new proposal is now being circulated by a group of American leaders associated with the Duke University’s Global Health Innovation Center. (See the proposal here.). To be fair, the proposal does support fully funding the COVAX Facility for the minimal equitable distribution of up to 20 per cent of vaccine needs to eligible countries. Nonetheless, the main thrust of the proposal calls on the US and other G7 members to make their surplus vaccines available for sharing with others in need – but not necessarily through the COVAX Facility. Instead, these surpluses would conceivably be managed more effectively through direct contributions from the US (or other G7 member) to needy countries. The proposal also calls for an aggressive PEPFAR-like program of helping expand manufacturing capacity using the same arrangements of voluntary licensing and technology transfer as was done for HIV/AIDS.
I suspect this will be the model for the kind of vaccine diplomacy, rather than vaccine multilateralism, that President Biden is likely to embrace. It retains US control over deciding who gets what surplus from the US supply. And it supplements this with active governmental oversight for mobilizing American pharmaceutical companies to engage in limited technology transfer and voluntary licensing arrangements. There may be ongoing debates within factions of the Biden team in the White House on whether to waive the industry’s IP rights , but I think it is more likely that President Biden will weigh in on getting the industry to collaborate with the US government in expanding manufacturing capacity around the world.
Similarly, the second recent development has to do with reports that EU Commissioner President Ursula van der Leyen is about to sign a deal with Pfizer’s CEO Albert Bourla to purchase an additional 1.8 billion doses of the BioNTech/Pfizer vaccine, half of the order in 2021 and the other half over the course of 2022 and 2023. The justifications for this deal are that the EU will be able to cover any need for a booster shot in EU countries or for covering the younger population of these same EU countries – but also or for distribution elsewhere in the world if they aren’t needed domestically. It looks like the EU is preparing for its own version of vaccine diplomacy to take off.
One still hears from the NGOs like Oxfam or Christian Aid or Amnesty International, who have formed the Vaccine People’s Alliance, that the only way to get enough vaccines out to the world is through a waiver of the IP protections at the WTO. They even publicized three letters – one featuring close to 50 former heads or state and Nobel laureates (i.e. members of the Club of Madrid), another featuring 400 European parliamentarians and a third featuring over 150 religious leaders from around the world. Both the WHO Director-General and the UN Secretary-General also still call for an IP waiver. But I think the ammunition is being mobilized for a reinforcement of pharmaceutical industry interests to collaborate with US and EU resources – for the sake of rapidly expanding global manufacturing capacity, but also for the sake of protecting the intellectual property rights of the pharmaceutical companies.
I also think this will be the end of anything like the COVAX Facility other than as a modest gesture for the 20 per cent – if it will ever get to that level. I say this even though the COVAX Facility is premised on respecting the IP rights of vaccine manufacturers and on negotiating with them for a bargain price through its supposedly consolidated negotiating strength. And that is because I don’t think the COVAX Facility has the negotiating power to coordinate an expansion of manufacturing capacity through voluntary licensing or technology transfers involving individual pharmaceutical companies. But I think that the US has the clout (and perhaps also the EU does too,) and will use it only if it is applied with the same kind of PEPFAR-based model as worked for HIV/AIDS. I’m willing to be surprised because I still believe that we need a globally equitable framework for a globally devastating pandemic.
Notes on Recent Developments and Selected Forthcoming Events
14 April: “COVID-19 and Vaccine Equity: What Can the WTO Contribute?” See the WTO Director-General’s statement and wrap-up of this meeting (both available here).
14 April: USTR Katherine Tai’s Remarks at a WTO virtual conference on COVID-19 vaccine equity (on the USTR website here)
15 April: “Former heads of state and Nobel laureates call on President Biden to waive intellectual property rules for COVID vaccines” (posted by the Club of Madrid here)
21 April: Joint Appeal by Members of the European Parliament and of European National Parliaments Urging the EU and its Member States to Support a TRIPS Waiver (posted with Club of Madrid here)
26 April: World Economic Forum says “Private Sector can help accelerate a COVID-19 vaccine roll-out” (available here)
27 April: “Global faith leaders call for drug firms to vaccinate world against Covid” in support of an IP waiver, published by The Guardian here.
28 April: Jeremy Farrar with the Wellcome Trust in support of the COVAX Facility, “Political leaders must ensure Covid vaccines aren’t the preserve of the rich”., published by The Guardian here.
21 May: Global Health Summit hosted by European Commission and Italy, will include adoption of a “Rome Declaration of Principles”. Preliminary information here.
24 May – 1 June: 74th World Health Assembly (documents and agenda available here)