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1 1 (November 23, 2020)

handle is hein.crs/govdctm0001 and id is 1 raw text is: SConr essional Research Servik Supply Chain Considerations for COVID-19 Vaccine Manufacturing November 23, 2020 The development of a vaccine for the Coronavirus Disease 2019 (COVID-19) pandemic has been of concern to Congress, as vaccination can be one of the most effective methods of preventing disease spread. On November 18, 2020, Pfizer/BioNTech announced that an interim analysis found its newly developed vaccine to be 95% effective against COVID-19 and has since filed for an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. On November 16, 2020, Moderna announced that its vaccine, tentatively evaluated as 94.5% effective, will also be submitted for an EUA. According to media reports, Moderna said it would have 20 million doses ready by the end of 2020; Pfizer said it would have about 50 million by then. Providing COVID-19 vaccines-complex, specially manufactured and distributed products-involves significant supply chain considerations. Needed supplies may be limited in quantity and face global competition. This Insight provides an overview of selected supplies required to manufacture vaccines and ancillary vaccination materials that may pose supply chain challenges and describes the federal government's role in this process. It does not cover particular contracts issued, or supplies potentially required for transportation, distribution, and administration of eventual vaccines. Federal Role in COVID-19 Vaccine Manufacturing Through Operation Warp Speed (OWS), a public-private partnership engaged in deploying countermeasures against COVID-19, the federal government has entered into contractual agreements with medical supply and pharmaceutical companies to procure necessary supplies for countermeasure manufacturing. OWS has also invested in manufacturers' production capabilities, partly by financing new factory construction. While investigational vaccines are still undergoing late-stage clinical trials, production of vaccination supplies has begun. Any shortages may hamper vaccine distribution efforts and delay the vaccination campaign timeline. Materials of concern include those used to contain the vaccine, inject it into the body, increase the body's immune response, and ensure vaccine safety. Vaccine manufacturers stated in a congressional hearing, we believe we have a path to be able to have all the necessary materials for a vaccine program, should we be successful. Yet, throughout the pandemic, transparent, up-to-date reporting on the medical supply chain to federal agencies has, in general, been an issue, particularly for drug ingredients or supplies required for manufacturing. Congressional Research Service https://crsreports.congress. gov IN11544 CRS INS GHT Prepared for Members and Cornmttees oi Conqres3------------------------------------------------------------------------------------

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