Moderna applies for regulatory authorisation for COVID-19 vaccine
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
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The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
After purchasing an additional two million doses of Moderna's COVID-19 vaccine, the UK will now receive a total of 357 million doses of vaccines from seven developers.
The European Commission and Moderna have agreed that the company will supply at least 80 million doses of mRNA-1273, the company's COVID-19 vaccine candidate.
The rolling review will shorten the approval timeframe by evaluating data on the safety, efficacy and quality of the mRNA-1273 vaccine as it becomes available.
The analysis reveals that mRNA-1273 was generally well tolerated and prevented COVID-19 with an efficacy of 94.5 percent in a Phase III study.
Takeda will import and distribute 50 million doses of the mRNA-1273 vaccine candidate under an agreement with Moderna and Government of Japan.
The experimental COVID-19 vaccine, mRNA-1273, was well-tolerated and elicited a strong immune response in older adults during a Phase I trial.
Moderna will supply the US with at least 100 million doses of mRNA-1273, its COVID-19 vaccine candidate currently in Phase III clinical trials.
The first patients have been dosed in Moderna's Phase III clinical trial of its mRNA vaccine candidate to protect against COVID-19.
Catalent's biologics facility will conduct large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate.
The US FDA has given Fast Track Designation to Moderna's mRNA vaccine candidate, mRNA-1273, designed to protect against COVID-19.
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The US Biomedical Advanced Research and Development Authority (BARDA) will fund Moderna’s COVID-19 vaccine candidate mRNA-1273 through Phase II and III clinical trials to FDA licensure.
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