潜台词是美国FDA要求比较高,所以要最后申请吗
We have made significant progress in mobilizing a global manufacturing network over the past 18 months with sites that are now routinely producing high-quality product at commercial scale at multiple sites across the world. Our global supply chain is expected to achieve a capacity of 150 million doses per month by the end of the fourth quarter through:
Partnership with the Serum Institute of India (SII), the world’s largest vaccine manufacturerA state-of-the-art, wholly owned manufacturing site in the Czech RepublicManufacturing at established vaccine makers including SK bioscience in South Korea and Takeda in JapanAdditional manufacturing arrangements around the worldWe expect to complete multiple ongoing rolling regulatory submissions within the next couple of weeks in key markets, including the United Kingdom, Europe, Canada, Australia and New Zealand. We, along with SII, have already filed for authorization in India, Indonesia and The Philippines, as well as for Emergency Use Listing (EUL) with the World Health Organization (WHO). The WHO EUL will allow Novavax and SII to deliver on our combined commitment to the COVAX Facility for a cumulative 1.1 billion doses of our vaccine, around which we maintain ongoing conversations with CEPI, Gavi and UNICEF. Additionally, we expect to file for Emergency Use Authorization in the U.S. before the end of 2021.
"We are confident that our vaccine will soon play a significant role in the global COVID-19 vaccine arsenal, differentiated by its potential to help address two major issues slowing the world’s ability to end the pandemic: global distribution challenges and vaccine hesitancy," said Stanley C. Erck, President & Chief Executive Officer, Novavax.
Novavax would like to thank the hardworking Novavax employees, manufacturing and other partners, and clinical community who are working diligently every day to deliver the first COVID-19 protein-based vaccine with Phase 3 data showing a robust safety profile, strong immunogenicity, and high efficacy against multiple strains of the coronavirus. The company also extends its deepest appreciation to the clinical trial participants who made a vital contribution during a global pandemic.
潜台词是美国FDA要求比较高,所以要最后申请吗
"We expect to complete multiple ongoing rolling regulatory submissions within the next couple of weeks in key markets, including the United Kingdom, Europe, Canada, Australia and New Zealand. We, along with SII, have already filed for authorization in India, Indonesia and The Philippines, as well as for Emergency Use Listing (EUL) with the World Health Organization (WHO). The WHO EUL will allow Novavax and SII to deliver on our combined commitment to the COVAX Facility for a cumulative 1.1 billion doses of our vaccine, around which we maintain ongoing conversations with CEPI, Gavi and UNICEF. Additionally, we expect to file for Emergency Use Authorization in the U.S. before the end of 2021." 就这两周就知道了,再推迟就没救了[好失望]
无非就是义正严辞的辟谣 重申一切按照计划进展
啥