Shots: The US FDA has authorized EUA of mRNA-1273 vaccine against COVID-19 in individuals ≥18yrs. The delivery to the US govt. will begin imminently while Moderna will continue to gather additional data and plans to file BLA for full licensure in 2021 Allocation and distribution will be prioritized according to populations identified by the CDC’s […]Read More
Shots: Moderna amended its current supply agreement with the UK govt. for an additional 2M doses of mRNA-1273 against COVID-19. The UK govt. has now secured 7M doses of mRNA-1273 The agreement reflects Moderna’s commitment to making its vaccine available in multiple countries. Moderna ramp up its global manufacturing to be able to deliver ~500M […]Read More
Shots: The P-lll COVE study involves the assessing of mRNA-1273 (100 µg dose level) in 30,000 patients with COVID-19 in the ratio of (1:1) aged > 18 yrs. in the US The study met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5% in the first interim analysis […]Read More
Shots: The initiation of a rolling submission follows positive results from a preclinical viral challenge study of mRNA-1273 and the +ve interim analysis of the P-l study of mRNA-1273 in healthy adults (aged 18-55 yrs.) and older adults (aged 56-70 and 71+), published in the NEJM Moderna has become the third maker that initiates the […]Read More
Shots: Moderna reported the publication of the second interim analysis of the open-label P-I study of mRNA-1273 in the NEJM. The study evaluated a 2dose vaccination schedule of mRNA-1273 given 28 days apart in 40 adults across two dose levels (25/100µg) in two age cohorts (56-70/ 71+) and reports results @Day 57 (1mos. following the […]Read More
Shots: The P-III study will evaluate mRNA-1273 vs PBO in a ratio (1:1) and is expected to enroll ~30,000 patients in the US, to be conducted in collaboration with NIAID. The 1EP of P-III study will be the prevention of symptomatic COVID-19 while 2EP include prevention of severe COVID-19 The company has finalized 100 μg […]Read More
Shots: Immunogenicity data are available for the 25µg & 100µg dose level (aged 18-55yrs.) after two doses (day 43) and at the 25µg level after one dose (day 29). All the participants are seroconverted by day15 following a single dose, @43day 2wks. following the second dose, at the 25µg, levels of binding Abs were at […]Read More
Shots: The US FDA has granted the FT designation to the Moderna’s mRNA vaccine (mRNA-1273) candidate against COVID-19. FT designation is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need On May 06, 2020, the FDA has completed its review of mRNA-1273’s […]Read More
Shots: The company reported in its Q1 results that the US FDA has accepted its NDA of (mRNA-1273) and allow it to initiate P-II study evaluating the therapy in 600 patients divided into two cohorts, aged 18-55yrs. and another of people aged 55+ yrs., expected to begin shortly Moderna is finalizing the protocol for P-III […]Read More
Shots: :stohththShots: The companies intend to establish manufacturing suites at Lonza’s facilities in the US and Switzerland to manufacture mRNA-1273 at both sites. The collaboration will deploy Lonza’s global expertise in technology transfer and manufacturing while the technology transfer expected to begin in Jun’2020 The focus of the collaboration is to enable the manufacturing of […]Read More
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