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Coronavirus: US FDA approves potential Moderna vaccine for phase 2 trial

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The US Food and Drug Administration (FDA) has cleared a potential vaccine for the novel coronavirus to enter a phase 2 trial, according to Boston-based biotech firm Moderna, adding that the vaccine might be “supply-constrained for quite some time.”

“The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021,” Moderna CEO Stéphane Bancel said in a statement.

“We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” Bancel added.

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Speaking to CNBC, Moderna’s chief executive said that should their potential vaccine prove to work effectively, it would work closely with the US government to determine who would receive the first doses as supplies would be limited at first.

“In the case of the US, we anticipate to work very closely with the government and with key medical officials to decide who gets the vaccine in the first batch. And then when you have the next batch to ship to the government, how do we allocate it between health-care workers, people who are high risk and different geographies where you have more cases,” Bancel told CNBC.

The race to develop a vaccine that would end the coronavirus pandemic is accelerating as several firms move to clinical trials – but the World Health Organization (WHO) has warned that it is unlikely we will have a vaccine before the end of 2021.

“I think end of next year is a very reasonable expectation,” said Fisher, who is the chair of the WHO’s Global Outbreak Alert and Response Network, during an interview with CNBC on Monday.

Al Arabiya English’s Tommy Hilton contributed to this report.