The race to develop vaccines for COVID-19 has edged closer to its finishing line with at least three candidates announcing positive results from their vaccine trials. While this may appear to be the light at the end of the tunnel, the focus now shifts towards equally challenging issues of availability, accessibility, and affordability of vaccines. In this post, I discuss the vaccines developed by Moderna, Pfizer-BioNTech and AstraZeneca-Oxford, the complex ownership status of their intellectual property, the bilateral pre-purchase deals struck with higher-income countries and their implications on the Global South.
[Long Post Ahead]
The Leading Candidates
On 9th November, US Pharma giant Pfizer and German biotech firm BioNTech became the first to announce that ‘BNT162b2,’ the vaccine developed through their collaborative efforts, had shown over 90% effectiveness after the conclusion of Phase III trials. They will be supplying 50 million doses of one of the first ever messenger RNA-based vaccines by the end of 2020 and 1.3 billion doses by 2021. While no safety hazards have been noted, the vaccines will require ultra-cold storage at below -70 degree Celsius temperature and will only survive for 24 hours at refrigerator temperature (2-8 degrees Celsius). It is priced at a hefty price of $39 (nearly INR 3000). Today, UK gave an emergency approval to this vaccine.
A week later, US-based Moderna declared that its mRNA-1273, another mRNA-based vaccine, had shown 95% effectiveness. It is set to be priced at $25-37 (approx. INR 1900-2800) per dose depending on quantities purchased. Similar to Pfizer-BioNTech, this vaccine will have to be stored frozen at -20 degrees Celsius. However, it may be kept at refrigerator temperature for a month making downstream transportation relatively easier.
The highly anticipated AstraZeneca-Oxford vaccine, AZD1222, claims 70% efficacy as per interim data, a figure that is estimated to increase to 90% if the dosage is altered. Unlike the other two vaccines, this one utilizes a genetically modified common-cold virus. What makes the Oxford vaccine an attractive candidate is its price, which, following a no-profit pledge by AstraZeneca, is to be capped at $3 (approx. INR 222) per dose. It is also capable of storage at normal refrigerator temperature giving it a logistical edge over the other two.
A few other candidates are Russia’s Sputnik V and vaccines being developed by Sanofi-GlaxoSmithKlien, J&J, and Novavax.
This will go down in history as one of science and medical research’s greatest achievements. Perhaps the most impressive.
I put together a preliminary timeline of some key milestones to show how several years of work were compressed into months. pic.twitter.com/BPcaZwDFkl
— Eric Topol (@EricTopol) November 28, 2020
Public Funding and the Complex Web of Patent Ownership
Previous experiences such as the HIV epidemic in Africa have shown that patent ownership can drastically influence global access to healthcare. Since the beginning of the COVID-19 pandemic, concerns have been raised regarding the implications of enforcement of patents held over potential COVID-19 treatments. This has brought the patent landscape of the vaccine-manufacturing companies under scrutiny.
Public Citizen has identified 13 patents claimed by BioNTech on its vaccine technology. However, the status of rights over the vaccine is complicated. While the development of most vaccines has been significantly funded by governments, Pfizer has claimed that they have taken no money, neither from the US government nor from anyone else (perhaps as an explanation behind why it has not made any no-profit or non-patent enforcement pledges like other developers). Although this is true on the face of it, it is not to be forgotten that their Mainz-based partner BioNTech, who supplied the mRNA technology, received EUR 375 million from the German government and another EUR 100 million in loan from the European Investment Bank. More importantly, BNT162b2 was created using ‘spike protein technology,’ reportedly developed by scientists from the US government’s National Institute of Health (NIH). US Vice President Mike Pence went so far as to call the vaccine a ‘public-private partnership.’ If this is correct, in future, the ‘March-in rights’ under the Bayh-Dole Act could technically allow the US government to stake claim on what is being called taxpayer-funded technology (see the licensing arrangements here). Aside from this, Pfizer and BioNTech have been sued for patent infringement by San Diego-based Allele Biotech for using the latter’s mNeonGreen fluorescent protein in developing the vaccine. As the companies stand poised to make $13 billion from their vaccine by next year, these multiple claims over the ownership of the technology can lead to complicated battles between the public and private players involved. (Knowledge Ecology International maintains this page containing copies of the US government’s contracts with pharmaceutical companies for COVID-19 related technologies.)
Moderna, which has received huge sums from the US government, has so far published seven US patents it claims protect its vaccine. In October, Moderna pledged to not enforce its COVID-19 vaccine patents while the pandemic lasts, and to willingly license the same afterwards. While this is a responsible step indeed, Moderna is embroiled in its own set of patent-ownership controversies. The company has been accused of failing to disclose vast amount of funds received from US Defense Advanced Research Projects Agency (DARPA) for its vaccine patent filings. Moreover, Moderna too has utilized US government’s NIH protein in its vaccine. It is also presently embroiled in patent disputes with other third parties such as Arbutus Biopharma over the sub-licensing of platform technology which has been utilized to develop the new vaccine. The company though, has emphatically declared that it is not aware of ‘any significant intellectual property impediments’, in commercializing mRNA-1273 with regard to Arbutus.
The developers of the Oxford vaccine, which has relied on the UK government’s funds and other donations, had been lauded initially for suggesting a possible open licensing framework. In April, Oxford entered into an exclusive licensing agreement with AstraZeneca. While they too have pledged to sell the vaccine at cost price till the pandemic lasts, AstraZeneca’s definition of “pandemic” has recently been called into question (see below).
Issues of Transparency
Several of the dealings relating to these vaccines have been shrouded in secrecy. The Oxford vaccine, which has received millions of dollars worth funding from the US and UK governments (see breakdown here), had originally disclosed little of its licensing agreement with AstraZeneca. It wasn’t until multiple civil society groups wrote to the developers urging them to observe greater transparency that it was revealed, among other details, that the license was exclusive. A major part of the deal still remains unknown to public. A recent Financial Times article also reveals that AstraZeneca has retained with itself the power to declare the pandemic over as early as July 2021. This means that the no-profit pledge is rather misleading as the widely celebrated price of $3 can expire long before the promised 3 billion doses are delivered by the end 2021. Further, the terms allowing the company to add up to 20% of manufacturing costs to cover additional expenses incurred had also been kept secret till October.
Oxford’s vaccine has also given rise to confusion over its clinical trial data. The study consists of two groups with the first group administered two full doses, and the second, one full and another half dose. The results show 62% and 90% effectiveness respectively, an aggregate of which clocks the figure at 70%. Oxford has clarified that the second group trial began as an error in measuring doses but they subsequently decided to continue with the two different sets. Not only is this process strange, the results themselves have raised eyebrows on multiple accounts. The fact that a lower dosage showed better results is seen as puzzling. Data has also shown that the more successful group was a much smaller one and consisted only of people below 55 years of age, leaving space for the possibility of a naturally stronger immune system response to coronavirus in younger people. Experts have also questioned the 70% figure obtained from two groups administered separate dosage.
Lack of transparency in the time of pandemic can be extremely harmful as it shakes public faith over the vaccines. Without adequate information on companies’ dealings or clinical trial data, it becomes very hard for the public, healthcare providers, and governments, especially those in the lower and middle income countries with limited resources, to make effective purchase decisions.
No Vaccines for the Global South?
The equitable distribution of vaccines depends largely on the availability of vaccines in sufficient quantities. The past few months have seen frenzied attempts at vaccine stockpiling by higher-income countries through numerous bilateral pre-purchase agreements. According to Global Justice Now, 82% of the Pfizer’s 1.35 billion vaccine stocks to be made available till the end of 2021 have been pre-booked by the UK (40 million), US (100 + 500 million), EU (200 million), Japan, and Canada, which represent only 14% of world population. Moderna is not far behind, with 78% of its vaccines sold to (largely the same) countries representing 12% of the people. AstraZeneca too has committed 100 million doses to the UK. This aggressive buyout strategy triggered by ‘vaccine nationalism’ is propelling the world towards exactly the kind of medicine trade war that experts feared when US bought up nearly all of the world’s Remdesivir supply earlier this year (discussed here). High efficacy rates and no-patent enforcement pledges would be of no benefit to countries in the Global South if they are forced to scramble over leftover supplies after rich countries have hoarded up their buffer stocks.
The logistical challenge is an even greater one. Several countries across the Global South have ill-equipped healthcare systems that lack the level of electrification needed to sustain vaccine storage at ultra-cold temperatures. Also, cross-country cold storage transportation requires timely infusions of dry ice to maintain temperature, which is all the more difficult to ensure in tropical regions with torrid climates. This risks spoilage of expensive vaccines which are already limited in number.
The Need for Technology Sharing
As the physical procurement of vaccines clearly presents a multilayered challenge, an alternative way of ensuring wider, equitable distribution is by sharing technological know-how with local manufacturers across the world to pump up total supply. Earlier, an attempt by WHO to facilitate a COVID-19 Technology Access Pool for the sharing of know-how and IP in order to allow companies to manufacture vaccines and treatments had fizzled out with only 40 countries (excluding India) joining the Solidarity Call for Action – most of which were lower income countries. In October, when India and South Africa made a proposal to the WTO to allow the suspension of patents linked to Covid-19 treatment till global immunity is achieved (explained in detail by Praharsh here), this proposal was widely supported by other lower and middle income countries, WHO, and leading UN experts. At the same time, the higher income countries, which have reportedly already pre-booked 51% of the world’s vaccine supply, refused to concede. (Interestingly, Moderna’s non-enforcement pledge came merely days after this proposal, but what good is a time-barred pledge when the company does not share its technology?).
It is worth noting that AstraZeneca has signed local manufacturing agreements with some of the worst affected countries such as Mexico and Argentina, who shall be sharing the produced vaccines to other Latin American countries. Brazil too has its independent agreement with the company. Similarly, Serum Institute India (SII) has signed a licensing agreement with AstraZeneca to manufacture 1 billion doses of the latter’s vaccine for lower and middle income countries including India.
COVAX: A Solution?
Countries in the Global South are now looking to (or are only left with?) another initiative called COVAX, which is a global collaboration spearheaded by CEPI, GAVI and WHO. COVAX has developed a fair allocation mechanism that supports building of manufacturing capabilities and procurement of timely supply so that 2 billion doses can be fairly distributed across its 172 member countries by the end of 2021. This will be done by pooling participants’ buying power and investing in vaccine production at scale in order to subsidize costs for lower and middle income countries. There shall be a proportional allocation of vaccines till all countries have received enough to immunize 20% of their populations and end the acute phase of the pandemic. So far, COVAX has been successful in raising funds from UK, EU, Italy, Spain, France, India, South Korea, Canada as well as non-governmental donors such as the Gates Foundation. Sanofi-GSK has committed 200 million doses of its vaccine to COVAX, and AstraZeneca has promised another 300 million.
Despite immense promise shown by COVAX, their plan has flaws. To begin with, its vaccine allocation scheme aims at immunizing only 20% of national populations, followed by a need-based weighted approach (read more on this here). If successful, this will not alleviate national inequities but leave a large number of helpless people in lower income countries whose healthcare systems are much weaker. On the other hand, rich countries that are infrastructurally and financially better equipped to handle the crisis have the additional option of turning to supplies from bilateral deals.
COVAX is also heavily funded and controlled by the Gates Foundation, which has been criticized for constantly siding with Big Pharma in the IP rights suspension debate. This New York Times article explains how the Foundation played a role in Oxford backtracking from its non-exclusive, royalty-free vaccine license promise to join hands with AstraZeneca. The Foundation has also faced criticism for directing resources into pharma companies allowing corporate control over vaccine supply rather than strengthening fragile healthcare systems which would help governments handle the crisis better from the grassroots. While COVAX remains, as of now, the Global South’s best hope to combat COVID-19, this corporate-oriented approach casts doubts regarding COVAX’s ability to cater to the pressing needs of these countries in later stages of the pandemic.
With these concerns persisting, more and more countries are joining the call for suspension of patent rights which have not only allowed pharma companies to make profits by free-riding on largely public-funded vaccine research, but also pose a serious impediment in achieving the goal of equitable access.
Please click here to view other COVID-19 related posts on SpicyIP and leave a comment.