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Moderna gets funding from BARDA for coronavirus vaccine

Biotech company says phase 3 study could begin in autumn 2020

Moderna Therapeutics

Biotech company Moderna has been awarded funding from the US Biomedical Advanced Research and Development Authority (BARDA) to accelerate development of its coronavirus vaccine, in a deal worth up to $483m.

Moderna has been at the forefront of the race to find an effective coronavirus vaccine, having reached the clinical testing stage in record time – just 63 days after the genetic code of the virus was identified by Chinese scientists and shared on 11 January.

Last month, the first patients were dosed with the company’s most promising candidate, an mRNA-based vaccine called mRNA-1273. The phase 1 study is being conducted by the US National Institutes of Health (NIH) at Kaiser Permanente Washington Health Research Institute in Seattle.

This study has now completed the initial enrolment of 45 adult volunteers between the ages of 18 and 55, split into three dose cohorts. The NIH recently amended the study protocol to include six additional cohorts, including three cohorts of older adults between the ages of 56-70 and three cohorts of elderly adults, aged 71 and over, with enrolment ongoing for these groups.

Under the terms of the agreement, BARDA is set to fund the advancement of mRNA-1273 through clinical testing all the way to FDA licensure. In a statement released on Thursday, Moderna revealed that if safety data supports advancement of the vaccine, a phase 2 study is planned to begin in the second quarter of 2020.

If all goes to plan in both studies, the company added that a phase 3 study of mRNA-1273 could begin as early as autumn this year. This timescale is unprecedented for vaccine development, which typically takes several years.

The funding from BARDA will also go towards the scale-up of vaccine manufacture this year to enable wide-scale distribution, should mRNA-1273 prove effective against the novel coronavirus, also known as SARS-CoV-2.

“Time is of the essence to provide a vaccine against this pandemic virus,” said Stéphane Bancel, Moderna’s chief executive officer.

“By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic,” he added.

A number of other big pharma and biotech players are also searching for a coronavirus vaccine, including Sanofi and GlaxoSmithKline, who recently announced they are working together on a vaccine which they hope to make available in the second half of 2021.

Article by
PMGroup

17th April 2020

From: Research

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