International Efforts and Next Steps to Advance COVID-19 Vaccines Research and Production in Low- and Middle-Income Countries

Abstract

Equitable and efficient distribution of COVID-19 vaccines continues to be a key issue in global health, and a targeted approach is needed to meet the World Health Organization’s world vaccination targets. Although some low- and middle-income countries (LMICs) are developing their own vaccines to address the distribution problem, legal and technical challenges have had a negative impact on productivity. This article explores relevant international legal instruments that can enable faster research and development of COVID-19 vaccines in LMICs, focusing on the role of biosafety standards, biological materials transfer, and key knowledge sharing. Our analysis has established that the potential of existing global health legal instruments has yet to be realized in order to close the productivity gap in LMICs and strengthen their vaccine manufacturing capacity. Additionally, mutual recognition of vaccine efficacy has become a new challenge for achieving global vaccination targets. We argue that the World Health Organization should continue its leading position by developing a more practical and targeted framework to help LMICs overcome challenges arising from technology transfer, knowledge sharing, and politics.

Exploring the role of R&D collaborations and non-patent IP policies in government technology transfer performance: Evidence from U.S. federal agencies (1999–2016)

“…For example, proposals based on expectations that blockchain technology may facilitate a practical approach to knowledge management of these forms of IP, and thereby enhance their commercialization potential, are being developed and disseminated [ 138 , 139 ]. In another example that is especially pertinent to the outbreak and aftermath of the coronavirus, there is renewed interest among national governments and transnational actors such as the World Health Organization to facilitate greater pooling of cohort data from clinical trials, foster more open sharing of biological materials, and encourage the voluntary waiving of certain IP rights to accelerate medical R&D for combating COVID-19 [ 140 – 142 ]. Hence, new forms of CRADAs and MTAs may emerge in the near future, which only underscores the importance of identifying valid and meaningful ways to measure technology transfer activities and performance over time.…”

Research on the Adjustment of Patent Protection Standards under Emergencies: Based on the TRIPs Agreement

“…As some scholars have feared, a patent exemption would be like offering developing countries a recipe that would be difficult to turn into a helpful dish due to a lack of quality raw materials and a large skilled workforce, as well as a lack of regulation of their production and distribution processes [30]. The problem is similar in the case of vaccine production, where developing countries lack a sufficiently rigorous regulatory framework for both production and distribution, some of which do not even meet minimum biosafety standards, and there are inevitable concerns about the safety of vaccines produced by such unregulated production lines and questions about the fairness of distribution [31][32].…”

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“…[36] According to some experts, global vaccine inequity is a strong reason why booster programs should be discouraged for the time being, because only about 1-5% of the population in resource limited countries has received the first/second doses of the vaccine, compared to the well developed countries with high vaccine coverage. [37,38] As a result, the current focus for vaccine supply should be on protecting those who have are yet to receive the initial dose of the vaccine. [39][40][41] This will minimize transmission, reduce the risk of new variants arising, and give us more time to evaluate the evidence to see if booster doses are needed in the future.…”

“…While interruptions to other immunization programs appear to be reducing, they remain a danger. [36,37] Despite the fact that immunization initiatives are gaining pace in many developed countries, there are still significant gaps in vaccine access around the world. So many countries are yet to receive the single dose of the vaccine.…”

“…• African countries must continue to expand the supply logistics and take immediate steps to improve vaccination campaign capability. [37] • Still, the African countries must develop and continue to develop local capacity for production of indigenous vaccine to augment the global demand. [51] • They must leverage on the mRNA technology transfer center established in South Africa this year (2022) by the WHO to assist vaccine makers on the continent.…”