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Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November

Company will seek emergency use authorisation for experimental vaccine

Moderna’s chief executive officer Stéphane Bancel (pictured above) 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.

If its BLA is approved, Moderna will be able to launch its vaccine within the general population, meaning the shot will be available for wide-scale use.

"25 November is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA, assuming that the safety data is good, ie, a vaccine is deemed to be safe," said Bancel, according to the Financial Times.

"The EUA, we think, will be an important medical tool to start addressing people at very high risk, like healthcare worker[s], like the elderly," he added, according to CNN.

In July, Moderna’s COVID-19 vaccine mRNA-1273 entered a late-stage phase 3 clinical trial, evaluating the shot on 30,000 study participants.

Interim analysis from the phase 1 study of mRNA-1273 was published in early July, demonstrating that the vaccine produced rapid and strong immune responses against SARS-CoV-2 in all participants tested.

Following two doses with the vaccine, neutralising antibody levels among participants were similar to those seen in individuals who had tested positive and recovered from COVID-19.

Last month, Moderna also revealed results from the phase 1 study, which showed promise in older adults, with adults aged 56-70 and aged 71 years and older exhibiting a strong immune response and similar levels of neutralising antibodies compared to younger participants.

Bancel previously told Business Insider that the company would most likely know in November whether or not its COVID-19 vaccine works, supporting the most recent timeline projection.

Article by
Lucy Parsons

5th October 2020

From: Regulatory

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