12/27/2023 0 Comments Vaccine production capacity us![]() – having regard to the statement of US Trade Representative of affirming support for a temporary TRIPS waiver, ![]() – having regard to the open letter from 243 civil society organisations to the WTO Director-General of 13 April 2021 on addressing the global challenges of inadequate supply and inequitable access to COVID-19 medical products, especially vaccines, – having regard to the revised proposal for a waiver of the TRIPS provisions as communicated on by 62 WTO Members, – having regard to the communication from India and South Africa of 2 October 2020 requesting a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19, co-sponsored by Eswatini, Kenya, Mozambique and Pakistan, and supported by 100 other countries, – having regard to the decision of the WTO’s Council for Trade-Related Aspects of Intellectual Property Rights of 6 November 2015 on the extension of the exemption for least developed country (LDC) WTO members to implement provisions of the TRIPS Agreement related to pharmaceutical products, – having regard to the Doha Declaration of 14 November 2001 on the TRIPS Agreement and Public Health, – having regard to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), notably Article 31bis thereof, 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.Meeting the Global Covid-19 challenge: effects of waiver of the WTO TRIPS agreement on Covid-19 vaccines, treatment, equipment and increasing production and manufacturing capacity in developing countriesĮuropean Parliament resolution of 10 June 2021 on meeting the global COVID-19 challenge: effects of the waiver of the WTO TRIPS Agreement on COVID-19 vaccines, treatment, equipment and increasing production and manufacturing capacity in developing countries ( 2021/2692(RSP)) 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. EMA’s human medicines committee ( CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. ![]()
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