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Moderna eyes COVID-19 vaccine approval in the US and the EU

Updated analysis demonstrates efficacy of 94.1%

Moderna is seeking regulatory approval in the US and the EU for its COVID-19 vaccine candidate after posting an updated primary efficacy analysis for the vaccine of 94.1%.

In November, Moderna announced initial data from an interim analysis of its phase 3 COVE study which suggested that its COVID-19 vaccine, mRNA-1273, is 94.5% effective.

The preliminary data was based on analysis of 95 confirmed COVID-19 cases within the study – 90 of which occurred in the placebo group and five within the vaccinated arm.

The updated data analysis is based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases in the mRNA-1273 group, reflecting a point estimate vaccine efficacy of 94.1%.

In addition, an analysis of severe cases of COVID-19 within the study found 30 severe cases – all of these cases occurred in the placebo group, with none observed in the mRNA-1273 vaccinated group.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, chief executive officer of Moderna.

“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, hospitalisations and death,” he added.

Following the new, positive data analysis, Moderna also announced that it has submitted an emergency use authorisation (EUA) application to the US Food and Drug Administration (FDA) for mRNA-1273.

An FDA panel of outside experts – the Vaccines and Related Biological Products Advisory Committee (VRBPAC) – is due to review the safety and efficacy data for mRNA-1273 on 17 December, Moderna added in a statement.

The company is also set to apply for a Conditional Marketing Authorisation (CMA) application with the European Medicines Agency (EMA), priming itself to score regulatory approval for the vaccine on both sides of the Atlantic.

If mRNA-1273 does score approval from the FDA this month, Moderna expects to have approximately 20 million doses of the vaccine available in the US by the end of 2020.

The US-based biotech is also ‘on track’ to manufacture 500 million to one billion doses globally in 2021.

Last week, Moderna announced that it had amended a supply agreement for mRNA-1273 with the UK for an additional two million doses, taking the total agreed dose supply to seven million – as the vaccine needs to be given in two doses, this would be enough for around 3.5 million people.

The European Commission has also secured up to 160 million doses of Moderna’s vaccine candidate, while the US Department of Health & Human Services has paid $1.5bn in funds to support large-scale manufacturing and delivery of mRNA-1273.

Under the terms of this agreement, the US government will own the resulting 100 million doses of mRNA-1273, and will have the option to acquire more doses in addition to that.

Article by
Lucy Parsons

1st December 2020

From: Regulatory



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