| Moderna's Covid-19 vaccine was cleared by U.S. regulators, the second vaccine to gain emergency authorization this month as a historic mass immunization effort ramps up across the country. The Food and Drug Administration's decision to grant the authorization on Friday for use by adults means that two of the six vaccine candidates identified by Operation Warp Speed are now available to the public, a feat accomplished in less than one year. It also means that a U.S. biotech and a darling of investors has come through in a big way. Developed with the National Institutes of Health, Moderna's shot, like the one produced by Pfizer and BioNTech that was cleared last week, is based on messenger RNA technology that previously hadn't been used in vaccines. For Moderna, whose stock-market ticker symbol is 'MRNA,' it is also the first product from the company to be cleared by regulators for use. An application for full approval is expected next year. Based in Cambridge, Massachusetts, Moderna became one of the most richly valued private biotechnology companies before selling shares to the public for the first time in Dec. 2018. Though it had been working to develop numerous vaccines from its early days, its work on a potential personalized cancer vaccine drew the most attention. Investors were initially skeptical, given the company had no portfolio of approved products from which to draw a reliable stream of revenue, and between its debut and the start of this year it had declined roughly 15%. But since the company began working on its vaccine, the shares have soared, leaping by more than eightfold. Operation Warp Speed, the Trump administration's effort to speed vaccine development, made more than $950 million available to Moderna to develop the vaccine. The U.S. has committed to purchasing 200 million doses, enough to immunize 100 million people, and has the option to purchase another 300 million. Now Moderna says it expects to produce 20 million doses for the U.S. by the end of the year, and another 85 million to 100 million doses in the U.S. in the first quarter. Overall, it and its manufacturing partner Lonza Group AG plan to produce 500 million to 1 billion total doses of its vaccine in 2021. The European Union, Canada and Japan also have large purchase agreements with the company, and the U.K. has secured 7 million doses. Moderna's vaccine is 94.1% effective at preventing symptomatic cases of Covid-19 and was able to prevent the most severe infections, according to the FDA's analysis of clinical trial results. Pfizer and BioNTech's vaccine is 95% effective. Both shots far exceed the minimum standard of 50% efficacy the FDA set for clearing any potential coronavirus vaccine. Like the Pfizer shot, Moderna's is administered in a two-dose regimen. However, it doesn't require special equipment to be kept cold. Pfizer's vaccine must be stored in ultracold freezers, but Moderna's can be kept in a standard freezer like those found in most home kitchens. That is expected to make it easier to distribute and for many pharmacies to handle. When it comes to rolling out a new product at enormous scale, Moderna, as a young company, is untested. However, it may account for half or more of the early U.S. vaccine inventory. It's been a huge gamble that, at least so far, has paid off.--Anna Edney and Robert Langreth | 
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