| The U.S. Food and Drug Administration inspects a few thousand drug manufacturing plants every year to ensure their standards are up to par. Many of those inspections are required before a pharmaceutical company can gain approval of a new drug. They serve as a check on whether drugmakers can produce quality therapies.
But that won't be the case for Covid-19 vaccine developers that gain emergency authorization of a shot.
FDA regulations don't require what's known as a pre-approval inspection for products seeking emergency use, said Jerry Weir, director of the Division of Viral Products in the FDA's vaccines office. Weir spoke last week at a meeting of FDA advisers to discuss standards for Covid-19 vaccines.
Before approval, FDA inspections ensure compliance with regulations. Once a product is being made—as vaccines already are to get them out as quickly as possible—they can uncover quality breaches and assess whether pharmaceutical companies handled them correctly or are possibly downplaying or ignoring serious issues. Take Eli Lilly, for example. In less than a year, the FDA twice found questionable conditions in inspections of Lilly's New Jersey plant that's producing its experimental antibody treatment for Covid-19. Pfizer is the frontrunner in the race for a coronavirus vaccine, and Moderna is just behind. Moderna was founded in 2010, according to its website, and has yet to gain FDA clearance of a product. An FDA database shows the company has never been inspected by the agency.  Pfizer samples during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida. Photographer: Eva Marie Uzcategui/Bloomberg Both Moderna and Pfizer are using new technology called engineered messenger RNA to make their vaccines. Moderna will produce its vaccine at its Massachusetts plant and has struck a deal to use contract manufacturer Lonza Group's New Hampshire factory to increase capacity. Lonza, like Pfizer, is an established company, and its New Hampshire plant has been FDA-inspected multiple times.
FDA's Weir said vaccine developers seeking an emergency authorization will have to submit complete details of their manufacturing process and show they've established a quality control unit.
Luigi Notarangelo, chief of the National Institutes of Health's Laboratory of Clinical Immunology and Microbiology and a member of the FDA's vaccine advisory panel, said during the meeting that inspections are warranted, particularly given the vaccines' use of new technology.
"This is something that could be done," he said. "It would provide some additional trust into the process."—Anna Edney | 
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