A Patent-Free COVID-19 Vaccine

As biopharmaceutical companies worldwide rushed to develop treatment measures for COVID-19 following its outbreak in late 2019, market speculators invested in life sciences companies that utilize the mRNA technology for anticipated patent royalties.  Two U.S. companies, Moderna and Pfizer, dominated the race, and the patented mRNA vaccines have become widely available in developed countries.  In developing countries, in contrast, the vaccination rate has been much lower.

Many developing countries have faced surging infection rates due in part to difficulties in affording large-scale distribution of the patented vaccines, problems that are being exacerbated by the proliferation of new variants.  A stark global polarization in vaccination rates between the developed and developing worlds is evident in the maps provided by organizations that track worldwide vaccination data on a daily basis, such as the Data Futures Platform run by the United Nations Development Programme (UNDP), and The New York Times.  For example, at the end of January 2022, the full vaccination rate in the United States hovers at around 65% of the population, while the list of least vaccinated countries is dominated by developing states, such as the Democratic Republic of the Congo (0.2%) and Chad (0.7%).  For developing countries, patented COVID-19 vaccine imports are prohibitively expensive.

However, mass production of a new, patent-free vaccine known as CORBEVAX is set to launch this month in India.  Other developing countries are expected to follow suit as either manufacturers or importers of the public domain vaccine, which is free from restrictions that would otherwise be imposed under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).  CORBEVAX was developed at the Houston lab of Texas Children’s Hospital Center for Vaccine Development, led by two scientists with a lifelong commitment to advancing vaccines for poverty-related, neglected and emerging diseases.  In an interview, one of the co-directors of the lab stated his mission as making a difference by filling the accessibility gaps with his “people’s vaccine for the world.”

TRIPS Deadlock on Waiver versus Compulsory Licensing

Public health inequalities continue to acutely expand on a global scale in the midst of the ongoing pandemic.  For those vaccines still under patent protection, there are two proposals regarding intellectual property (IP) rights for COVID-19 vaccine patents that have been facing a deadlock for several months in the TRIPS Council.  One proposal is led by India and South Africa, originally submitted on October 2, 2020, revised on May 21, 2021, and currently supported by 65 co-sponsors, most of which are developing countries seeking a waiver from certain provisions of the TRIPS Agreement.  The EU countered on June 4, 2021, with a proposal to impose compulsory licensing via a Council declaration.  The EU’s proposal is backed by several developed countries including the UK, Canada, Australia, and some Scandinavian nations.  The factions have not yet reached a resolution.  The United States has not been taking an active role in the TRIPS negotiation, despite having reversed its initial opposition on May 5, 2021, when the U.S. Trade Representative announced support for waiving IP protections for COVID-19 vaccines, followed by the President’s supporting statement on November 26, 2021.  The U.S. government appears hesitant to accept the broader concept regarding the proposed duration for the TRIPS waiver in the revised proposal submitted by India and South Africa.

Although the world awaits the WTO’s response to the pandemic with respect to IP protection, there seems to be no common ground for consensus or concession, as fundamental differences persist over questions such as whether a waiver is the appropriate and most effective way to address the inequitable distribution of vaccines.  Of course, the questions themselves are not simple, as various stakeholders and other interests are fixated on procuring the advanced technology or licensing fees, respectively.  If the CORBEVAX vaccine proves medically effective, it will represent an example of civil society solving a problem that has deadlocked governments influenced by the pharmaceutical and biotechnology industries and bound by rigid treaty obligations.