Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November
Moderna’s chief executive officer Stéphane Bancel (pictured below) said that he expects Moderna to be ready to submit its COVID-19 vaccine candidate to the US Food and Drug Administration (FDA) in November.
Bancel revealed the possible timelines for approval and availability of the company’s mRNA-based COVID-19 vaccine candidate at the US Pharma and Biotech Conference hosted by the Financial Times last week.
He added that he expects the Moderna vaccine will be ready for use in late March or early 2021, with the aim of submitting the candidate to the FDA for emergency use authorisation on 25 November 2020.
Beyond an emergency use authorisation, Bancel said that Moderna will not be ready to submit its vaccine to the FDA for a Biologics License Application (BLA) until at least late January 2021.
Read more: http://www.pmlive.com/pharma_news/moderna_ceo_says_covid-19_vaccine_will_be_ready_for_fda_submission_in_late_november_1352493
Bancel revealed the possible timelines for approval and availability of the company’s mRNA-based COVID-19 vaccine candidate at the US Pharma and Biotech Conference hosted by the Financial Times last week.
He added that he expects the Moderna vaccine will be ready for use in late March or early 2021, with the aim of submitting the candidate to the FDA for emergency use authorisation on 25 November 2020.
Beyond an emergency use authorisation, Bancel said that Moderna will not be ready to submit its vaccine to the FDA for a Biologics License Application (BLA) until at least late January 2021.
Read more: http://www.pmlive.com/pharma_news/moderna_ceo_says_covid-19_vaccine_will_be_ready_for_fda_submission_in_late_november_1352493
