NEW YORK (June 29, 2021) – In a new article published in the journal Vaccine: X, public health experts from Columbia University Mailman School of Public Health, University of Oslo and Spark Street Advisors highlight actions to accelerate access to vaccines around the world. The paper reviews the vaccine research and development process and suggests areas where reforms could increase access, speed time to market, and reduce costs – from R&D to manufacturing and regulation. through the management of incentives such as patents and public funding.

The COVID-19 pandemic has highlighted the importance of vaccines as public health and pandemic preparedness tools and amplified the importance of issues ranging from equitable distribution to reliable supply of vaccines to quality and affordable. The time between the first dose in a high-income country and its full introduction in a low-income country can take years. These delays are due to several challenges, some of which are unique to the vaccine development ecosystem. The authors write that patenting and global intellectual property (IP) protection are complex, regulatory oversight is rigorous, manufacturing processes require technical support or know-how transfer from the innovator, and market dynamics create barriers to large-scale delivery. To address these challenges, the authors offer several opportunities to accelerate vaccine availability in low- and middle-income countries:

  1. Regulatory harmonization. Regulators around the world are increasingly recognizing the need to harmonize their approval process to enable efficiencies that save time and money, which is particularly important with respect to new technologies. For example, mRNA and DNA vaccines have the greatest potential to accelerate development processes and the recent approval of the COVID-19 mRNA vaccine promises to fully establish regulatory pathways for these innovations. Although mRNA vaccines pose certain challenges for low-income settings, particularly their requirement for ultra-cold storage, efforts are underway to attempt to address this problem, including the establishment of a technology transfer center to. COVID-19 mRNA vaccine.
  2. Strengthening of manufacturing capacities. For vaccines to be deployed quickly and on a large scale, the manufacturing capacity must be in place to allow sufficient scale-up when demand is high. Given the significant know-how required, access to the facilities is not enough; low-income countries and regions also need to have sufficient know-how on manufacturing processes. This will require the freedom to operate around patents and investments in technology transfer. To address the unprecedented need and opportunity for rapid and massive global availability of COVID-19 vaccines, new business models have emerged with agreements between parent companies and manufacturing companies operating in different environments. geographic and market.
  3. Simplified IP layouts. When it comes to intellectual property agreements, biopharmaceutical manufacturers and governments have used government compulsory licenses, patent oppositions, intellectual property pools and voluntary intellectual property licenses, and technology transfer to advance access to new technologies. Although this has been limited in the area of ​​vaccines, improving transparency and creating more streamlined intellectual property agreements could contribute to a greater diversity of suppliers, which will also help ease supply constraints. .

“The COVID-19 outbreak and the steps that have been taken to accelerate the time to market could serve as a catalyst for other vaccines,” said lead author Nina Schwalbe, MPH, assistant assistant professor in population and family health. “While still a work in progress, the progress demonstrated through COVID-19 vaccine R&D promises that many of the challenges of effective and equitable vaccine development can be successfully addressed with funding. adequate and political will. “

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Co-authors include Ole Kristian Aars, Spark Street Advisors and the University of Oslo; and Michael Clar, Spark Street Councilors. The research was funded in part by funding from the Medicines Patent Pool.

Columbia University Mailman School of Public Health

Founded in 1922, Columbia University Mailman School of Public Health pursues a program of research, education, and service to address critical and complex public health issues affecting New Yorkers, the nation, and the world. Columbia Mailman School is the seventh largest recipient of NIH grants among schools of public health. Its nearly 300 multidisciplinary faculty members work in more than 100 countries around the world, addressing issues such as infectious and chronic disease prevention, environmental health, maternal and child health, health policy, change climate and health, and public health preparedness. It is a leader in public health education with more than 1,300 graduate students from 55 countries pursuing a variety of master’s and doctoral programs. Columbia Mailman School is also home to many world-renowned research centers, including ICAP and the Center for Infection and Immunity. For more information, please visit http: // www.postman.Colombia.educate.

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