RESUMEN
This article provides an early analysis of the potential for creating future biosimilar competition for cell and gene therapies (CGTs) to lower prices and improve patient access, building on a unique set of interviews with relevant experts. Our discussion addressed regulatory, manufacturing, intellectual property, and market size challenges. Due to CGTs' complexity, meeting the regulatory requirement of 'high similarity with no clinically meaningful differences' will be difficult. Gene therapies are likely better candidates for biosimilar development than cell therapies. Biosimilarity should be met when gene therapy biosimilars contain the same genetic sequence as a reference product, and the variability in the vector meets the high similarity standard. Manufacturing challenges, including the lack of standardized platforms, high production costs, and complexity, pose significant obstacles. It may also be important to demonstrate biosimilarity within the manufacturing process. Intellectual property barriers, specifically patenting, trade secrecy, and regulatory exclusivity, could hinder biosimilars' ability to gain market share, although recent Supreme Court decisions limiting the breadth of patent claims could ease barriers to future CGT competition, including from biosimilars. Finally, inadequate market sizes might create hurdles, especially for curative treatments, as patient pools shrink following treatment by the reference CGT.
RESUMEN
The COVID-19 vaccination is a crucial public health intervention for controlling the spread and severity of the SARS-CoV2 virus. COVID-19 vaccines have been developed in record time, but their deployment has varied across countries, owing to differences in health system capacity, demand for the vaccine, and purchasing power of countries. The aim of this rapid review is to summarize and synthesize experiences on COVID-19 vaccine service delivery and integration to inform future COVID-19 vaccination programming and contribute to the knowledge base for future pandemic management. A systematic search was conducted in PubMed, Scopus, and Global Index Medicus databases. Twenty-five studies were included in the analysis. Included studies spanned nine countries where COVID-19 vaccines were delivered through mass, mobile, and fixed-post vaccination service delivery models. There was limited evidence of integrating COVID-19 vaccines into routine services for pregnant women, people who inject drugs, and leveraging existing health programs to deliver COVID-19 vaccines to the general population. Common challenges reported were vaccine skepticism, lack of adequate health workers, and linguistic barriers to access. Partnerships with a variety of stakeholders and the involvement of volunteers were vital in overcoming barriers and contributed to the efficient functioning of COVID-19 vaccination programs.