On 5 May, Katherine Tai, the United States Trade Representative, announced that the US would support waiving intellectual-property protections for COVID-19 vaccines. This was a significant breakthrough for negotiations at the World Trade Organisation, where developing countries led by India and South Africa have pushed for relaxations of the Trade-Related Aspects of Intellectual Property Rights, or TRIPS, rules for all COVID-19 technologies to improve access to them. After the US, the European Union, New Zealand and Canada have said they will consider the proposal. However, the extent of support from these countries for such a waiver will come down to the fine print of any agreement reached at the WTO. The Bill and Melinda Gates Foundation, which is a major funder for many global public-health and vaccine organisations with an outsize influence on global health policy, said it would support only a “narrow waiver” on COVID-19 vaccines.
While these talks have been on, COVID-19 vaccines have been unequally distributed around the world. Rich countries signed agreements to buy up the bulk when vaccines were still being developed. Many players are involved in the development and distribution of COVID-19 vaccines—countries and their governments; research institutions such as Oxford University; and pharmaceutical companies such as AstraZeneca, Johnson & Johnson, GlaxoSmithKline, Pfizer, Moderna, Novavax and the Serum Institute of India. Global alliances have also been participating in the process, such as GAVI, which is a global alliance facilitating vaccine production and distribution, the Coalition for Epidemic Preparedness Innovations or CEPI, and COVAX, an alliance specifically to coordinate distribution of COVID-19 vaccines that is led by GAVI ad CEPI. The Gates Foundation helped set up both GAVI and CEPI, and had contributed to funding COVAX.
On 4 May, Nileena MS, reporting fellow at The Caravan, spoke to Mohga Kamal-Yanni about the global politics behind vaccine distribution. Kamal-Yanni is a senior policy and technical advisor to UNAIDS and a global-health-policy advisor at The People’s Vaccine, a group of organisations campaigning for vaccine equity. She has worked for forty years in the field of access to medicines and healthcare. According to Kamal-Yanni, the players involved in vaccine development have themselves resisted mechanisms to ensure fair vaccine distribution. She detailed the many hurdles to equitable vaccine distribution, the main one being pressure from pharmaceutical companies.
Nileena MS: At present, over 1.24 billion people across the world have been vaccinated, more than 80 percent in high- and upper middle-income countries. How did this situation come about?
Mohga Kamal-Yanni: There are two reasons. First, from last year when universities and pharmaceutical companies started to research vaccines, it was clear that the majority of the population in the world must be vaccinated to reach herd immunity. That means, anybody could have calculated how many doses are needed and even if all the vaccines in the clinical trial succeeded, those companies would not be able to produce all these billions of doses that are needed. A simple calculation would have told you that. The world leaders should have thought about how to produce these many doses, allocate and distribute them. That did not happen.
What happened led to the second problem, which is that countries that had money hoarded the vaccine. So, a country like Israel [which is 56 percent fully vaccinated] made a deal with Pfizer to vaccinate across its population, went ahead by offering Pfizer some incentives in terms of money and paid up to get the number of doses they wanted. It is the same case with the UK and the US that used legal and other means to get all the potential vaccines, and then allocated millions of doses for their populations. The EU also tried to secure this. They actually didn't get it yet.
So we have a problem of lack of supply and then we have a problem of little supply that we have not distributed fairly. With these two problems, of course the people who suffer are people of developing countries.
Last year, at least, there was this excuse—even though it is not a valid one according to me—that they didn’t know which vaccines were going to work, But this year, we know which vaccines are working and how many people should be vaccinated. So, there is more data on that. We also know the virus can mutate and if it mutates it might make the vaccines less effective. So all the money and effort that was spent in rich countries would be just wasted. But we still face the same issues as last year [in production and distribution].
That is because of the fundamental problem that most countries are content to leave vital decisions in the hands of pharmaceutical companies. So the decision on how much to produce, by when and how to allocate the vaccines, distribute across countries are decided by these companies. The prices are also set by the companies. J&J and AstraZeneca said they are [selling at] not-for-profit prices—AstraZeneca, because it has an agreement of not-for-profit with the Oxford University. The others like Pfizer and Moderna are set to make profits and are not shy about that.
NMS: Public-health activists have been warning against the issue of pharma companies deciding vaccine policy right from the time these vaccines were being developed. They had constantly pointed out the issue of lack of transparency, and demanded to make the contracts public, especially raising the point that the majority of the funding came from governments and the public sector. What do we know about these contracts?
MKY: For example, AstraZeneca went ahead and signed a contract with the Serum Institute of India. We had the new director of the WTO [Ngozi Okonjo-Iweala] and the UK government praising this “wonderful agreement” and how companies like AstraZeneca are paving the way. But, what is in the agreement? We don’t know! We get to know what is the agreement by knowing the outcomes of the agreement in drips and drops. A few days ago we heard the head of SII [Adar Poonawalla] saying he will sell the vaccines at-cost price [currently Rs 150 or $2.03 ] to the Indian government and at profit prices [current rate is Rs 600 or $8.13] to the private sector. This is when we discovered that the contract allows Serum Institute to do this.
If you sell the vaccines, that means people who can afford it, whether they are priority or not, will buy it. That means, one or two doses are taken away from somebody who might be a priority but can’t afford it. Because this is not like aspirin. If you buy aspirin, you are not affecting me buying it or the availability of it in the market. Remember, there is a global shortage, so that is when countries should have said, “Here are the priority groups,” and you go through group by group until everybody is vaccinated.
The other dangerous problem when people are buying vaccines is it would be like any medicine in the market. Basically, you buy the doses according to how much money you have. So people might buy the first dose and not the second, or they buy the second when they have money, which could be months later. So there you have a public-health issue and a financial problem.
The second thing we discovered is about the price. When AstraZeneca says “not-for- profit” and is selling the vaccine under $3 in Europe, we accept that there is no profit because it is very wrong [to profit from this]. But, Serum Institute is selling it to South Africa and Brazil for $5.25. It is absurd! Brazil is buying the Oxford vaccine from Astrazeneca for about $3 and buying the same vaccine from Serum at $5. And then [the pharmaceutical companies give] some excuses like Brazil and South Africa are middle-income countries [and can afford higher prices]. As if Europe is not high-income. But, they are selling it to Uganda for $7 a dose, when Uganda is a low-income country by the definition of the World Bank. So, what was in the contract then? Neither AstraZeneca nor Serum Institute say anything about this.
We heard in the news in March that the vaccination in the UK might slow down because of delays in the arrival of a second shipment carrying five million doses from India. Then, we shockingly discovered that the contract says that AstraZeneca can prioritise [doses that Serum Institute makes]. When AstraZeneca cannot fulfill its commitments to allocate to a country like the UK, then Serum Institute is obliged to do that. So the Serum Institute actually sent five million doses and the second shipment of five million was delayed when the crisis hit India. So, I think it would be really embarrassing if the UK gets this five-million doses [now].
If India says “prioritise me,” then everybody would say, “Oh no! you can't do that.” But prioritising the UK is okay? Does that make any sense when the UK has vaccinated all the priority groups and it is now vaccinating non-priority groups? Does it make any sense to vaccinate these groups when you get the doses from India where they haven't [fully] vaccinated health workers?
NMS: The CEO of SII, Adar Poonawalla, recently told the media that SII was paying 50 percent royalty to AstraZeneca. This appears to be in contrast to the not-for-profit agreement made by Astrazeneca. This also not in line with the commitment made by the Oxford University to go royalty- and profit-free till the end of the pandemic?
MKY: What we know is that Oxford University—it is still on their website—was willing to license IP in a non-exclusive way. When they did the agreement with AstraZeneca, the UK government stuck their nose in it and engaged. So Oxford University insisted on non-profit and on providing the vaccine for low- and middle-income countries. Oxford University said they will not take royalties during the pandemic. I obviously think that is what forced AstraZeneca to go for a non-profit [model]. The contract is secret. After that, AstraZeneca went for their negotiations with Serum Institute with Gates. How they negotiated, what they negotiated—it's all secret. So we don’t know.
In their defense, if AstraZeneca says even with that the price is still not-for-profit, but maybe they can just do that. But if it means the price Serum Institute has to charge in order to cover its cost and pay the 50% will be $5 or $7, of course, that is not what AstraZeneca committed. But the thing is the CEO of SII himself said they are making a small profit. These contracts are shrouded in secrecy. An example of how dangerous bilateral contracts are.
The fundamental issue is bilateral contracts between companies. These are commercial contracts between companies who are negotiating from a commercial point of view. We can’t say that this is wrong, that is how contracts are negotiated. What is wrong about it is that we are in the middle of a pandemic, and what we need is for somebody to negotiate with the companies on behalf of public health. In this case, it would not be a bilateral deal, but it should be one that allows non-exclusive licenses. Like what the Medicine Patent Pool is doing with HIV drugs. They negotiate the license with the originator company. The pool takes the license and then is free to sub-license, among the group companies. They can sign contracts with a hundred companies. That is what should happen and that is why we at the People's Vaccine have been promoting the COVID-19 Technology Access Pool.
NMS: The WHO launched the COVID-19 Technology Access Pool or C-TAP in April 2020, when the first vaccines were being developed. But it appears to have been sidelined soon after that. What happened to this project?
MKY: You have three actors working against this. The first group is pharmaceutical companies who see the vaccines now as a profit-making thing. They don’t want to lose the market even in developing countries. So, if those manufacturers in India or other countries start producing, then of course, they will eat [into] the developing countries market. That is just not okay with these big companies. So they want to keep the monopoly. Companies don’t change policies in general. They are always dragged kicking and screaming to do anything. They are not willing to join this pool unless they are pushed. What they are doing is they are lobbying against this, so they never get pushed.
The second group that opposes the pool are countries and governments themselves. Rich governments and some middle-income countries either worry about protecting the pharma [sector] and their profits or they are worried about not getting enough doses. Because of this shortage, for example, if the UK pushes for something that pharma doesn’t like, maybe AstraZeneca or Pfizer would then prioritise giving the doses to Europe or other countries. What we see is that no rich country including the US, Canada, the UK and the European Union, supported C-TAP—except Norway and Netherlands. They supported this at the time of the launch, but both these countries do not have pharmaceutical companies, so that might be the reason. But, it is also not like they are doing anything to make this work.
The third group is institutions that are influential like GAVI, CEPI and collectively COVAX. These three entities are basically against the pool. When you talk about the pool, they say IP doesn't have anything to do with vaccines. Firstly, this is a lie. Second thing is that we are also talking about pooling technology and not just IP. But they believe that bilateral deals like that of AstraZeneca can solve the problem.
Bill Gates clearly said the other day that no one believes that there is an issue in terms of the contracts not being transparent. Yes, he is a billionaire who did quite a lot for global health which we really recognise and appreciate. But that doesn’t give him the authority to decide what is needed for the world at this hour. Because of his money he has huge influence, so what he says matter.
Basically he wants to keep the solutions in his hands and the pharmaceutical companies. What they always needed was funding from rich countries and that he and the companies will sit together and solve these: “Let the rich countries just pour a few millions or billions into Covax and we will sort this out.” To start with, who are you to sort this out?
This triangle of negative influences, it is a big struggle for C-TAP to function. A year ago, when C-TAP was launched, it was rooted [for] by a number of countries including Costa Rica as well as the WHO. At that time, the authority of the WHO was severely challenged and undermined by Donald Trump. Trump’s policy towards the WHO was not just about money. All that he was saying against the WHO and partly against Tedros Adhanom, [the former director general] who had done a wonderful job during a difficult time, basically decreased the authority of the WHO. It made things very difficult for WHO to say, “Hey guys, let’s talk about CTAP.” I think they are just starting to talk about it. But it was just difficult last year.
NMS: COVAX was set up with the promise of rapid and equitable access to vaccines. How do you look at their functioning so far?
MKY: COVAX’s target was to provide vaccines for 20 percent of the population in low- and middle-income countries or LMICs, and that is not enough to reach herd immunity. The African Union had the plan to reach herd immunity by vaccinating a minimum 60 percent of Africans. Here in the UK, we have already vaccinated 60 percent of the population and we continue to vaccinate now. The same in the US, where they aim to vaccinate all adults by 4 July. The EU also targets vaccinating most people. So, by the end of year, everybody in rich countries are vaccinated but only less than a third of the population in developing countries would be vaccinated. If that is not apartheid, then what is?
COVAX is making deals with various vaccine manufacturers like J&J, Novavax and Pfizer [but] till now, the main supplier of COVAX is Serum Institute. There is also this South Korean company [SK Bioscience] that AstraZeneca had a deal with. If there is one problem with the AstraZeneca vaccine, like in South Africa where the vaccine is not effectiveagainst the South African variant, then we are stuck. You are relying on one vaccine only. That would work, for say measles when vaccination is on a definite number of vaccines or estimate that this year we will have say a million kids who have reached one year old. It can be calculated and produced accordingly and this had been done for years. But COVID-19 vaccines are new and needed on a huge scale.
Even if all these companies double their capacity, that isn't enough and that is the problem. Even if COVAX gets all the money it needs and a bit more, what is it going to buy with this money? There aren’t enough doses in the market to buy and now Serum Institute is producing for India. Can anybody blame them or India for prioritising to vaccinate its people? I think rich countries are shutting up on that because they know that if it was the situation in these countries, they would do exactly the same. They would stop the exports and vaccinate their people first. That is what the US is doing by the way. The US, under the Defence Production Act, doesn’t export anything that is needed in the US. Anything that is made in the US—and they have Pfizer, J&J, various manufacturers for Moderna and others—all that production is not exported. In fact, only the people that exported their production are Europe—50 percent of what is produced—and similar is the case of India.
We are in a difficult position because do I want to prioritise a nurse in India or a nurse in Malawi? It should be both. Why should we be in a position where we have to choose? If there are enough doses, both the nurses will be vaccinated.
NMS: What do you think of the US’ recent decision to support a waiver of TRIPS for COVID-19 vaccines?
MKY: This a great decision from the US. Other countries should follow suit. The text negotiation should be rapid. Every delay means delay in vaccinating people in developing countries. It is a critical time and the US and G7 need to take urgent actions to publicly support C-TAP, and influence pharma companies and research institutions to share their technologies with C-TAP. Sharing technology, the waiver and funding for expanding manufacturing capacity in developing countries is the way to maximise production and secure supply to the billions awaiting a vaccine instead of waiting for the extra doses after vaccinating everyone in rich countries.
NMS: How far can this waiver help?
MKY: If you want to maximise the production capacity, you need three things: technology, you need to produce without worrying about IP rights, and money. For example, Merck is going to produce J&J vaccines. They have taken $150 million from the US government to basically upgrade or modify or whatever is required for the cost of production. What we don’t talk about is that the companies in developing countries also need this. Waiving IP rights will open the door for investment in production. A TRIPS waiver also means individual countries will separately issue compulsory licenses on a vaccine but then they have to talk about trade secrets. [There is] the question of whether compulsory licenses cover that or not. Then the companies might say it doesn't and the matter will go to court and will stay for maybe five years there.
A country doesn't even have to wait for this waiver. Basically any government can invoke emergency approval and it becomes a law. All these vaccines are approved on emergency authorisation and don’t have the full authorisation. So, if you can have emergency approval in the country, then you can start production. Technology and investment is critical.
The waiver would be beneficial to other things like PPE, filters for ventilators, diagnostics, treatment, medicines are going to be important particularly when we don’t have enough vaccines. In the case of a waiver for vaccines, may be some vaccines can be produced by some [new] companies. If there is a waiver, Russians and Chinese can make them. That is obviously why many don't want to do this.
NMS: In India, there is an increasing public demand to invoke compulsory licensing under the Indian Patent Act to allow more manufacturers to produce the vaccine quickly. There are even state-owned companies, such as HLL Biotech, that have the capacity to produce vaccines. Do you think the Indian government should do this to ramp up production?
MKY: I think, if India even threatens with a compulsory license, that is not a bad idea. That might force companies to go for voluntary licensing, which is going to C-TAP. They [pharma companies] need to know if they don’t come to the table, people will find other ways to do it.
My reading is that companies keep promising billions of doses by the end of the year, so it seems like there will be excess vaccine in the market. The rich countries are waiting, stalling at the WTO, because they are waiting until these vaccines are available. Then they can ask other countries, “Why do you want to wave IP and share technology? Here are the vaccines we are buying it for you via COVAX.”
It’s high time for developing countries learn their lesson. They are not realising that there is a security issue that is more important than world war. You have to secure your production, diversify the source so that you are not relying on one or two companies. We don’t have to depend on Serum Institute. There can be five other companies in Africa or others that can do it.
This is really critical moment for developing countries and they should maximise their benefits from this moment. There is no guarantee that there will be a fair distribution. You have got to protect yourself by diversifying the manufacturing by maximising the manufacturing capacity in developing countries.
This interview has been edited and condensed.