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Moderna's big moment arrives

Coronavirus Daily
Bloomberg

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Moderna's big moment arrives

Pfizer gained U.S. authorization for its Covid-19 vaccine last week. This week, it's Moderna's turn in front of the regulators. 

A multiday march toward a potential clearance will begin Tuesday, when a report from the staff of the Food and Drug Administration will give the most detailed look yet at Moderna's clinical-trial data. The company has said its immunization is 94.5% effective, but we're likely to learn much more about how well the vaccine works for different racial and ethnic groups, as well as people with pre-existing conditions who might be more prone to severe Covid-19. The FDA staff could also make a recommendation of their own as to whether the shot should be authorized.

First it was Pfizer. Now Moderna is ready for its close-up.

Photographer: Joel Saget/Getty Images

The data will then be turned over to the FDA's outside advisory panel, which will convene for a public meeting Thursday to weigh the vaccine's benefits against any potential risks. At the end of that meeting, scheduled to stretch over nine hours, the panel will vote on recommending a clearance. Last week, some advisers wanted more information about allergic reactions to Pfizer's shot, and others balked at the idea of allowing 16- and 17-year-olds to take it. Ultimately, however, the prospect of having a tool that could help end the pandemic was enough to override those concerns.

This week is also a momentous one for Moderna as a company. After first selling shares to the public in 2018, the Cambridge, Massachusetts-based biotech faced some investor skepticism over its lack of approved products. The company built its reputation largely on its work toward a personalized vaccine for cancer, but the coronavirus came and changed all of that, and now the once-obscure firm is a household name around the world. Since the start of the year, its shares have surged more than sevenfold.

Moderna's corporate identity is inextricably intertwined with the messenger RNA technology behind its shot. Its stock-market ticker symbol, after all, is MRNA. If the FDA authorizes its vaccine, born from an epic scientific footrace in the middle of a pandemic that has upended nearly every aspect of daily life, it will be the ultimate validation.—Tim Annett 

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