Category: mRNA-1273

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

Clinical Trials, COVID-19, Covid-19 Vaccine, KidCOVE Study, Moderna, mRNA-1273, P-II/III / October 26, 2021 October 26, 2021

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

Against, COVID-19, EUA, Moderna, mRNA-1273, receives, regulatory, US, Us FDA / December 21, 2020 December 21, 2020

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

2M, Additional, Against, Agreement, Amends, Biotech, COVID-19, doses, Government, Moderna, mRNA, mRNA-1273, UK, Vaccine / November 30, 2020 November 30, 2020

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

Clinical Trials, COVE Study, COVID-19, Interim Analysis, Moderna, mRNA-1273, P-lll, reports, results / November 17, 2020 November 17, 2020

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 does one better than Pfizer/BioNTech; touts 94.5% efficacy for its Covid vaccine

BioNTech, BioPharma, biopharma nl, CDC, coronavirus, COVID-19, Daily, Diagnostics, FDA, Moderna, Moderna Therapeutics, mRNA-1273, News, Pfizer, Pharma, SYN, Top Story / November 16, 2020 November 16, 2020

The company is the second this month to report promising results for a Covid-19 vaccine even as the virus rages across the U.S.

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

Biotech, Clinical Trials, COVID-19, Moderna, mRNA-1273, P-l study / October 1, 2020 October 1, 2020

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

BioPharma, biopharma nl, Cambridge, coronavirus, COVID-19, Daily, Massachusetts, Moderna, mRNA-1273, SARS-CoV-2, SYN, Top Story / September 30, 2020 September 30, 2020

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 to supply up to 160M doses of Covid-19 vaccine to Europe

BioPharma, biopharma nl, Cambridge, coronavirus, COVID-19, Daily, European Commission, Massachusetts, Moderna, mRNA-1273, Policy, SARS-CoV-2, SYN, Top Story, Vaccines / August 25, 2020 August 25, 2020

The biotech company reached a deal with the European Commission to supply an initial 80 million doses, while European Union member states will have the option to purchase 80 million more.

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

BioPharma, biopharma nl, Cambridge, coronavirus, COVID-19, Daily, Massachusetts, Moderna, mRNA-1273, Policy, SARS-CoV-2, SYN, Top Story, Vaccines / August 12, 2020 August 12, 2020

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

BARDA, BioPharma, biopharma nl, Cambridge, coronavirus, COVID-19, Daily, Massachusetts, Moderna, mRNA-1273, Policy, SARS-CoV-2, SYN, Top Story / July 27, 2020 July 27, 2020

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

BioPharma, biopharma nl, Cambridge, coronavirus, COVID-19, Daily, Massachusetts, Moderna, mRNA-1273, SARS-CoV-2, SYN, Top Story, Vaccines / July 15, 2020 July 15, 2020

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.

Moderna completes enrollment in Phase II Covid-19 vaccine trial

BioPharma, biopharma nl, Cambridge, coronavirus, COVID-19, Massachusetts, Moderna, mRNA-1273, SARS-CoV-2, SYN, Top Story / July 9, 2020 July 9, 2020

The company said it is on track to start its 30,000-participant Phase III trial this month and has finished manufacturing enough supplies of the vaccine to do so.