mRNA-1273

Moderna Reports Results of COVID-19 Vaccine in P-II/III KidCOVE Study for the Treatment of COVID-19

Shots: The P-II/III KidCOVE study evaluated the safety, tolerability, reactogenicity & effectivity of mRNA-1273 in 4753 children aged 6-12yrs. with COVID-19, administered as 28 days apart The study met its primary immunogenicity EPs & interim analysis showed a robust neutralizing Ab response after two 50 μg doses of mRNA-1273. The therapy was well tolerated with …

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Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

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 …

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Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

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 …

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Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

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 …

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Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults

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 …

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Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data

The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.

Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine

The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.

Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial

The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.

Moderna publishes Phase 1 Covid-19 vaccine data showing robust immune responses

Evaluation of durability is still under evaluation, but the responses to mRNA-1273 show neutralizing antibody titers multiple times higher than those of recovered patients. Additionally, T-cell responses suggest potentially lower risk of enhanced respiratory disease.