US' Moderna filing for its COVID-19 vaccine authorization

ANKARA

US biotechnology firm Moderna on Monday said its vaccine efficacy against the novel coronavirus is 94.1% after the Phase 3 clinical trial, saying it is immediately filing for the Emergency Use Authorization for the vaccine.

The company said the primary efficacy analysis of the Phase 3 study of its vaccine candidate against the novel coronavirus has been conducted on 196 confirmed COVID-19 cases, of which 30 cases were severe.

The firm said it will apply later today to the Food and Drug Administration (FDA) for Emergency Use Authorization for the vaccine and conditional approval from the European Medicines Agency.

"The 196 COVID-19 cases included 33 older adults, ages 65 and more, and 42 participants identifying as being from diverse communities," it said in a statement.  

The company's vaccine candidate also has the ability to prevent severe COVID-19 disease, according to Moderna CEO Stephane Bancel.

"We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death," he added.  

Noting that Moderna is working with the US' Centers for Disease Control and the President Donald Trump administration's Operation Warp Speed, Bancel said some 20 million doses of its vaccine will be available in the US by the end of 2020, and the company plans to manufacture 500 million to 1 billion doses globally in 2021.

ANKARA

The firm said it will apply later today to the Food and Drug Administration (FDA) for Emergency Use Authorization for the vaccine and conditional approval from the European Medicines Agency.

"The 196 COVID-19 cases included 33 older adults, ages 65 and more, and 42 participants identifying as being from diverse communities," it said in a statement.  

The company's vaccine candidate also has the ability to prevent severe COVID-19 disease, according to Moderna CEO Stephane Bancel.

"We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death," he added.  