US biotech company Moderna has been given emergency use authorization from the Indian government for its Covid-19 Vaccine Moderna (mRNA-1273) in adults aged 18 years and older. In this connection, the company has been given a registration certificate from the government along with permission to import the vaccine to India for restricted use in an […]
Moderna has signed a manufacturing services and supply agreement with Samsung Biologics under which the latter will undertake large scale, commercial fill-finish manufacturing for the mRNA-1273 COVID-19 vaccine. According to Samsung Biologics, technology transfer will begin immediately at the company’s facilities in Incheon, South Korea. The South Korean CDMO will use a production line equipped […]
Moderna Covid-19 vaccine : The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for mRNA-1273, the messenger RNA (mRNA) Covid-19 vaccine candidate of Moderna. The FDA authorization is for the use of mRNA-1273 in individuals aged 18 years and more for the prevention of Covid-19 caused by severe acute respiratory syndrome […]
Research Centers of America (RCA), an independent research site in Broward County, Florida, said that it is currently holding COVID-19 vaccine trials, implemented under the US government’s Operation Warp Speed (OWS). The research site is enrolling volunteers to take part in the clinical trials, working with the US government and various pharma companies, which have developed […]
Moderna and Laboratorios Farmacéuticos Rovi have entered into a collaboration for large-scale, commercial fill-finish manufacturing of mRNA-1273, the former’s mRNA vaccine candidate against COVID-19, at the latter’s facility in Madrid, Spain. Under the agreement terms, ROVI will offer vial filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic […]
Moderna said that it has concluded enrollment for the two cohorts of the phase 2 study of its COVID-19 vaccine candidate mRNA-1273. According to the US biotech company, mRNA-1273 is its second messenger RNA (mRNA) vaccine for an infectious disease to have wrapped up enrollment of a phase 2 clinical trial, after its CMV Phase 2 […]
Moderna said that mRNA-1273, its novel coronavirus vaccine candidate, has delivered positive interim data in a phase 1 clinical trial by eliciting neutralizing antibody titer levels in all eight initial participants across the 25 µg and 100 µg dose cohorts. The early-stage clinical trial in humans was led by the US National Institute of Allergy […]
Coronavirus vaccine trial : US biotech company Moderna has dosed the first participant in the phase 1 study of mRNA-1273, its mRNA vaccine against the novel coronavirus (SARS-CoV-2). The phase 1 coronavirus clinical trial is being carried out under its own Investigational New Drug (IND) application by the National Institutes of Health (NIH). mRNA-1273 is […]