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Moderna scrutinizes the end of the year

By The Editor - 21 october 2020

As at least ten countries, including France, Germany, Italy and Spain, hit record highs in average daily new Covid-19 cases, more health officials and medical experts fear an uncontrolled virus could lead to overwhelmed hospitals and ask for new steps to be taken. According to analysis of data from the Johns Hopkins University, in the U.S., cases are growing by at least 5 % in 35 states, with 16 states reporting record high averages in daily cases.

While the pandemic shows no sign of slowing down, health officials and medical experts fear an uncontrolled virus through the flu season could lead to overwhelmed hospitals and a sharp increase in deaths.

Meanwhile, news from drugmakers searching for vaccine candidates is rather mixed. According to the National Institute of Health (NIH), the US is very unlikely to have a vaccine authorized by the FDA before late November.

But still several companies are confident in getting an emergency use authorization before the end the year. It is the case with Moderna, whose CEO Stéphane Bancel's new estimated timeline for his Covid-19 vaccine puts his company on track to score an emergency use authorization (EUA) in December. The American biotech also expects interim results from its late-stage trial on the effectiveness of its coronavirus vaccine by next month. This is about the same timeline given by Pfizer, which also plans to submit for an emergency use authorization in the next four weeks.

Mid-October, Moderna also announced it had received written confirmation from the European Medicines Agency (EMA) that mRNA-1273, was eligible for submission of an application for a European Union Marketing Authorization under the agency's centralized procedure.

In terms of manufacturing, Moderna is scaling up global capacities to be able to deliver approximately "500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021." In August, Moderna signed a $1.5 billion contract with the federal government to produce 100 million doses of its vaccine candidate. In late June, Catalent teamed with Moderna to handle fill-finish duties for up to 100 million doses of Moderna's shot at the CDMO's Bloomington, Indiana facility. In Europe, the company is working with its strategic manufacturing partners, Lonza of Switzerland and Rovi of Spain, for manufacturing and fill-finish outside of the United States through a dedicated supply chain.

Others competitors are less lucky. AstraZeneca and Johnson & Johnson, for instance, have both had to pause their trials in the US due to safety concerns, which could delay their applications further. AstraZeneca's coronavirus vaccine trial could resume though as soon as this week, after the FDA finished its review of a serious illness. The company's late-stage trial for its Covid-19 vaccine, called AZD1222, had been on hold in the US since September 6 after one of the participants in the U.K. reported a serious adverse reaction.

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