Open Source COVID-19 Vaccine Offers Potential Pathway for Vaccinating the World
Scientists from the Texas Children’s Hospital Center for Vaccine Development and Baylor College of Medicine have developed a new COVID-19 vaccine based on well-known, easy-to-use technology, cheap to produce and relatively easy to store. Drawing from just $7 million in investor funds over the past two years, Peter J. Hotez and Maria Elena Bottazzi began development on the vaccine, known as CORBEVAX, in 2020 and currently are awaiting the final results of Phase Three clinical trials to determine its efficacy rate with respect to the Omicron COVID-19 variant.
In sharp contrast to the four dominant vaccines globally, CORBEVAX is protected by no patents or other intellectual property protection. Drs. Hotez and Bottazzi began collaborating in 2020 with Biological E. Limited (BioE), an Indian pharmaceutical company, to undertake the requisite clinical trials and produce it at a massive scale beginning in February 2022. Other manufacturers in Indonesia and Bangladesh have also received licenses. While the recipe, know-how and technology are freely available for any manufacturer interested in deploying it, these licensing contracts also provide access to pre-clinical data, cell banks and reagents, among other useful inputs. The hope is that this vaccine will play a part in helping the world achieve herd immunity by the end of 2022 – a goal currently frustrated by extreme vaccine inequity.
The scientists behind CORBEVAX and their partners at BioE are not the only ones approaching vaccine innovation in a less conventional way. Firms in Cuba have developed several low-cost vaccines which are not patent protected, the technology for which they are eager to share with countries around the world. Two of their vaccines are in the process of requesting pre-qualification from the World Health Organization (WHO), which would allow them to donate additional doses through the COVID-19 Vaccines Global Access (COVAX), a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations and the WHO.
In the wake of clear evidence of unequal access to COVID-19 vaccines and political pressure from world leaders criticizing pharmaceutical companies and high-income countries for exacerbating “vaccine apartheid,” some firms are beginning to step up. Moderna, in particular, has set up a new vaccine manufacturing plant in Australia to expand supply and promised to donate one billion doses to low-income countries in 2022. BioNTech has partnered with firms in Rwanda and Senegal to begin manufacturing, while a number of other countries are building up native vaccine technology and manufacturing.
Pharmaceutical firm efforts, however, are far from meeting the total need, with additional public and private actors attempting to fill the gap. The WHO has partnered with Afrigen Biologics and Vaccines to reverse engineer Moderna’s jab as a part of the WHO’s South Africa-based technology transfer hub. Billionaire Patrick Soon-Shiong of Nant South Africa (NantSA) has launched an effort to increase local manufacturing in South Africa and across the continent. Meanwhile, China’s promise to donate another one billion vaccines to Africa in 2022, almost half of which will be produced on the continent, has been largely ignored in public discourse.
Some of these efforts seem focused on the current state of vaccine inequity, while others have a longer-term view. The current state of vaccine inequity is stark – exemplified by the fact that a higher percentage of people in advanced economies have received a booster shot than those who have received first doses in Africa. Experts and global public health officials agree that achieving equity in vaccine distribution is the key to reaching herd immunity – which is fundamental to ending the pandemic.
What is not agreed upon, however, is how to achieve it. Despite evidence to the contrary, dominant pharmaceutical companies and their home states are urging that continued reliance on intellectual property protection will incentivize innovation and facilitate more voluntary cooperation so vaccines can be more widely produced and distributed. India, South Africa and others, however, continue to push for a waiver of global intellectual property rules in the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) at the World Trade Organization. Other stakeholders have pushed for a greater commitment on the part of wealthy countries to increase donations, either bilaterally or through COVAX for countries in need, despite the inadequacy of these efforts so far.
However, equally important is the goal of building resilience for a more robust manufacturing response in future pandemics. Despite statements that the current vaccines could not be produced on the African continent and in other low-income countries, there is evidence that more than 100 firms world-wide stand poised to produce mRNA vaccines if given access to the relevant know-how and technology.
To be sure, in countries with the lowest vaccination rates, obstacles to vaccine access do not stop with supply. They often lack sufficient access to ultra-cold storage technology and equipment, delivery to rural areas is blocked by infrastructure weaknesses and as recent research has shown, vaccine hesitancy has slowed vaccination rates in some countries. In one well-documented instance, South Africa delayed delivery of a donation shipment close to its expiry date over concerns it would not be able to distribute and administer all the vaccines before they expired.
The development of vaccines like CORBEVAX begins to address some of these issues. As its recombinant protein vaccine technology is well-known and has been used in countries all over the world for decades in other vaccines, the learning curve for producing it will be almost non-existent. Moreover, its relatively low-tech storage requirements and low-cost production will decrease logistical supply and distribution obstacles, allowing it to be manufactured in a diverse set of countries, much closer to key distribution points. However, there is still more to learn and to do. Researchers have not yet published comprehensive studies on the effectiveness of the vaccine in Phase 3 trials, and its effectiveness against the Omicron variant is still unknown. While India has authorized the vaccine for emergency use, regulatory barriers remain in Indonesia, Bangladesh and South Africa, awaiting clinical trials by their country partners.
The work done on the CORBEVAX vaccine by Hotez and Bottazzi, as well as their international partners, took place without the participation of major US and EU pharmaceutical giants and without changes to global intellectual property rules. Nevertheless, it demonstrates what could have been done if equitable global vaccinations were viewed as a global public good, rather than voluntary acts of charity by large corporations or high-income countries. In 2022, countries must support efforts that result in this good, whether they be a comprehensive and effective TRIPS waiver with parallel domestic financing and incentives for technology transfer, investment in domestic manufacturing capacity in Africa and other developing regions, or investment in new vaccines, like CORBEVAX, that are more accessible to manufacturers all over the world.
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