![]() ![]() It also explores the potential need for complementary, input capacity-enhancing policies in the face of highly fragmented, cross-border COVID-19 vaccine supply chains. It also examines the emergence of input shortages and assesses whether both the price constraints implicit in the 2020 DPA contracts and business decisions made to quicken the process of bringing new vaccine plants online globally inadvertently exacerbated them. The paper investigates the tradeoffs US policymakers faced in early 2021 - once much of the initial uncertainty about the safety and effectiveness of many COVID-19 vaccines had been resolved - about whether to recalibrate contracts to expand production capacity to help meet global, instead of US, vaccine demand. However, a puzzle soon emerged, as the scale of US vaccine production was shortly thereafter overtaken by plants in the European Union and India. With a very large domestic market primarily for biogenerics and vaccines, China now ranks fifth worldwide in total capacity. But China, which ranks second, has 209 facilities, with about half the US average capacity/facility. This paper begins by describing the Defense Production Act (DPA) of 1950 and the initial "priority-rated" contracts agreed to under Operation Warp Speed in 2020 to expedite manufacturing and achieve scale, which succeeded in producing hundreds of millions of doses of COVID-19 vaccines by early 2021. Much of India’s well-established biomanufacturing expertise and capacity is in vaccines production. In response to the COVID-19 pandemic, the US government used novel policies to accelerate research, development, and production of a diversified portfolio of new vaccines. The Agency provides guidance and advice on the evidence required to support and expedite applications to add new sites or increase the capacity of existing sites for the manufacture of high-quality COVID-19 vaccines.Discussion paper DP17388 COVID-19 vaccine supply chains and the Defense Production Act These recommendations do not require a European Commission decision and the sites can become operational immediately.ĮMA is in continuous dialogue with all marketing authorisation holders of COVID-19 vaccines as they seek to expand their production capacity for the supply of vaccines in the EU. All together, these changes are estimated to allow the production of 40 million additional doses of Spikevax to supply the EU market in the third quarter of 2021. On 30 July 2021, CHMP already approved a scale-up of the active substance manufacturing process at two sites in the US (Moderna TX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire). In addition to the new manufacturing facility for this vaccine, CHMP has also approved several alternative sites responsible for batch control/testing and packaging of the finished product manufactured by Catalent. The site will perform finished product manufacturing. The site, located in Bloomington, Indiana, United States (US), is operated by Catalent. Additional manufacturing site for SpikevaxĬHMP has also approved an additional manufacturing site for the production of Spikevax, the COVID-19 vaccine developed by Moderna. The site will allow to provide approximately up to 51 million additional doses in 2021.ĮMA has also approved a new manufacturing line at BioNTech’s manufacturing site in Marburg, Germany which increases the active substance manufacturing capacity by approximately 410 million doses in 2021. The site, located in Saint Rémy sur Avre, France, is operated by Delpharm and will manufacture finished product. Additional manufacturing site and scaled-up process for ComirnatyĬHMP has approved an additional manufacturing site for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. This allowed researchers from across the globe to analyze the virus and better understand how it causes disease. This sequence was quickly shared with other researchers. EMA’s human medicines committee ( CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. Early in the COVID-19 pandemic, researchers used state-of-the-art genomic sequencers to quickly sequence the SARS-CoV-2 virus. ![]()
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