FDA fast-tracks Moderna’s mRNA vaccine against coronavirus

The FDA has fast-tracked Moderna’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).

“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, Chief Medical Officer at Moderna.

“As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”

Moderna previously received Fast Track designation for its investigational Zika vaccine (mRNA-1893) and its methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927) programs.

Earlier this month, the FDA completed its review of the Company’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020.

Funding from the Biomedical Advanced Research and Development Authority supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the company’s facilities and that of its strategic collaborator, Lonza.

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

Novavax expands large-scale manufacturing capacity

Novavax, a late-stage biotech developing next-gen vaccines for serious infectious diseases, has expanded its large-scale manufacturing capacity with the $167 million acquisition of Praha...

Gilead & Arcus partner to develop next-gen cancer immunotherapies

Gilead Sciences and Arcus Biosciences, an oncology-focused biopharma working to create best-in-class cancer therapeutics, have entered into a ten-year partnership to co-develop and co-commercialise...

Atomwise announces partnerships to tackle COVID-19

Atomwise, a San Fran company using AI for small molecule drug discovery, has announced it has fifteen research collaborations underway with leading global universities...

GSK secures additional biopharma capacity via Samsung Biologics partnership

GlaxoSmithKline (GSK) has secured additional manufacturing capacity for its biopharmaceutical portfolio by partnering with South Korea’s Samsung Biologics. As per the agreement, Samsung Biologics will...

Sinovac secures $15m to accelerate COVID-19 vaccine development

Sinovac Biotech, a Chinese biopharma product provider, has secured $15 million to accelerate the development of a COVID-19 vaccine. The funds were invested by Advantech...

Related news

AbCellera raises $105m to advance antibody drug discovery platform

AbCellera has closed a $105 million Series B financing to further advance its antibody drug discovery platform. The financing was led by OrbiMed and current...

Novavax expands large-scale manufacturing capacity

Novavax, a late-stage biotech developing next-gen vaccines for serious infectious diseases, has expanded its large-scale manufacturing capacity with the $167 million acquisition of Praha...

Gilead & Arcus partner to develop next-gen cancer immunotherapies

Gilead Sciences and Arcus Biosciences, an oncology-focused biopharma working to create best-in-class cancer therapeutics, have entered into a ten-year partnership to co-develop and co-commercialise...

Atomwise announces partnerships to tackle COVID-19

Atomwise, a San Fran company using AI for small molecule drug discovery, has announced it has fifteen research collaborations underway with leading global universities...