Moderna

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

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Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in the P-I/II study of TAK-919 in Japan The studies are designed to include 200 healthy Japanese adults followed by 12mos.… Read More »Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

FDA gives nod to Moderna vaccine for Covid-19

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The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

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Shots: The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy The US FDA’s committees… Read More »Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

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Shots: Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs The alliance follows US FDA’s… Read More »Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

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Shots: Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs The alliance follows US FDA’s… Read More »Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

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Shots: The P-III COVE study demonstrated 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19. The vaccine was well tolerated with no serious safety concerns identified to date Moderna plans to submit an EUA to the FDA & an application for CMA with the… Read More »Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

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

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

FDA guidance eases some Covid-19 vaccine concerns, but others remain

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Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.