Around 25% of the population of the world is under 15 years of age. With around 7.9 billion people on Earth, that means there are approx. 5.9 billion adults on this Blue Marble. Assuming all these adults are given a 2-shot Covid vaccine around 12 billion doses are required to vaccinate 75% of the World’s population. Although somewhere north of 8.6 billion doses have apparently been ordered there is an obvious imbalance in the distribution of vaccines.

This imbalance in vaccine distribution gave rise back in October last year to a proposal from India and South Africa for a waiver from certain Intellectual Property provisions of the TRIPS Agreement. In recent weeks the clamour for such a waiver to be approved has increased and is often presented as the solution to the problem “we’re not safe until we’re all safe”. In the last week, the US apparently reversed its long standing position against such waivers when Ambassador Katherine Tai announced that the US would support waiving intellectual property provisions for COVID-19 vaccines.

However, will such an IP waiver (also referred to in the press as a “patent waiver”) be the silver bullet solution to vaccine shortages that it’s being portrayed as?

It’s easy to forget just how quickly the vaccine response to Covid has come together. Just 12 months ago people regularly cautioned that there’d never been a successful coronavirus vaccine but now there are multiple vaccine candidates being administered to millions of people worldwide. Since multiple viable vaccines are now being rolled out it can perhaps be easy to forget just how challenging manufacturing these life saving drugs at scale can be. Each of the vaccines has its own challenges – mRNA vaccines (like those from Moderna and Pfizer) represent the first vaccines using such technology to be made at scale. Although making the mRNA itself may be relatively easy, the complete manufacturing process includes a step in which the mRNA is encapsulated into specialised lipid spheres. This step is especially challenging from a technological and also supply point of view. Adenovirus vector vaccines, such as those from Astrazeneca and J&J, are also relatively new and involve the growth of large quantities of human cells. Astrazeneca’s well publicised issues with delivery in Europe and the destruction of millions of doses of the J&J vaccine following a factory mix up show that the manufacture of such vaccines is also challenging. Vaccines based around protein subunits, such as the Novavax vaccine, are a more well-known type of vaccine but supply concerns around the adjuvant used to improve the effectiveness of the vaccine may represent a limiting factor for such vaccines.

The Covid-IP waiver proposed by South Africa and India would, in the form it was presented, release WTO Members from implementing or enforcing certain obligations of the TRIPS Agreement (namely, patents, copyright, industrial designs and trade secrets). If the waiver were to be approved this would not mean that patents, for example, would suddenly cease to have effect in all countries. Instead it would be up to the individual WTO Member concerned whether they would allow companies within their territory to use Covid-related IP without the threat of being sued.

On the face of it therefore it might appear that the Covid-IP waiver could lead to more vaccines being produced such that the vaccine distribution imbalance is addressed.

However, in my view the time, effort and attention being brought to bear on pushing for an IP waiver is a distraction that doesn’t really address the underlying problems in getting more vaccines into more arms.

IP isn’t the issue, or at least, it’s not the only issue that is preventing the manufacture of more vaccines. I would hazard that no company, in the midst of a pandemic, is going to assert its IP. Moderna has made public statements to that effect. And, the Chief Executive of the Serum Institute of India (SII), the India based manufacturer that has licensed production of the Astrazeneca vaccine (marketed locally as Covishield), has suggested that the patents that vaccine developers hold are not the issue.

There are however issues with the supply of raw materials which the IP waiver itself will not directly address. The Chief Executive of the Serum Institute has highlighted that the availability of critical items (bioreactor bags, filters and other materials) from the US is limiting the production of Coronavirus vaccines.  Although the US has recently apparently indicated that it will make an exception for the raw materials needed for the Covishield vaccine, the US restrictions may also be expected to impact other vaccines, e.g. the local manufacture of the Novavax vaccine. [Note: the US is not the only source of many of the raw materials but in many cases it may well be the major supplier.]

Another issue to consider is that making vaccines is a complex undertaking. There are numerous stages in the manufacture of vaccines and the supply chain that serves the various stages of the process often requires collaboration between multiple parties. Although the expertise necessary to make vaccines will exist in areas that are currently seeing vaccine shortages, it is not a trivial task to retrofit facilities (see, for example, this article that highlights the challenges of converting facilities to make vaccines), to scale up production on short timescales or to address the fact that, for each of the various vaccine candidates in circulation, there is probably a scarcity of people who possess the know how that can make the whole process easier.

It should also be noted that the proposed IP waiver is not likely to be agreed any time soon with the head of the WTO, Ngozi Okonjo-Iweala, stating that she would press members to agree the waiver no later than 3 December. Additionally, for the waiver to come into force all 164 Members of the WTO will need to agree (i) to move ahead with the waiver, and (ii) to agree the text of the waiver. On this point, the US, Europe, the UK and others have previously come out against the waiver and although the US appears to have now reversed its position, other countries have since restated their objection to the waiver. In Germany, for example Angela Merkel has spoken out against the waiver and at the European level there has also been push back (see here and here). The UK’s Trade Secretary released a statement supporting the US but, notably, not explicitly supporting the waiver. And in France, President Macron has said he’s both for and against the waiver…

As an aside, the reasons for the US change of position on this are interesting to consider. It may be that the administration does actually now fully support the idea of the waiver (though it is noted that the language in the US press release is narrower than the waiver text). Alternatively, the US’s actual aim might just be to use the threat of the IP waiver as a leverage tool to encourage vaccine IP owners to licence their IP more widely than at present (this option would have the beneficial side effect from the US point of view of drawing attention away from the US’s poor record of exporting vaccines or the barriers the Defense Production Act (which has been repeatedly invoked by both Presidents Trump and Biden) have had on the export of raw materials that are needed elsewhere for vaccine manufacture).

In summary, in my view, although IP might be responsible for some issues it seems unlikely that removing IP barriers will quickly translate into additional vaccines. The main issues to tackle seem to be the availability of raw materials, import/export difficulties, the conversion/retrofitting of potential sites and other general issues in standing up additional manufacturing capability in short time frames.

Rather than choosing to spend months wrestling with the exact wording of an IP waiver with WTO members, governments need, in my view, to work together and pour more time, resources and money at trying to expand the capacity of the entire vaccine supply chain. This might mean existing players in the market get to increase their own capacity, it might allow new players to enter the market if the risk of retro-fitting and scaling up manufacture is de-risked. Astrazeneca , Johnson & Johnson and Novavax have already gone a long way to involve manufacturers around the world. Any assistance required to expand this even further should be freely given. Patents might, whisper it, even be used to encourage further sharing of know how in cases where private firms are reliant on licensing of key government owned patents to produce their own vaccines.

Mark Richardson 11 May 2021