Sen. Chuck Schumer is raising red flags about the shortage of GlaxoSmithKline’s ultrapopular Shingrix vaccine, blaming the government shutdown for making the situation worse. But the fact is, the shortage started before the government shutdown, and is likely to continue long after the government reopens.
Because of the shutdown, New Yorkers are “in the dark” about when they might be able to get Shingrix, GSK’s new shingles vaccine that has been flying off pharmacy shelves, Sen. Schumer said, calling on the FDA to declare the now-months-long shortage an "emergency."
GSK says the senator has it wrong. A spokesperson said the company has been working with officials on the shortage and that the cooperation "has not been affected by the current government shutdown." In fact, two weeks ago, the agency approved a request from the company to expand Shingrix capacity from an existing plant in France, he said.
Lamenting the shutdown's sapping of FDA resources, Schumer urged the agency to “step in more directly” as a conduit between GSK and others “to ensure locals know when new shipments will arrive, and how to best publicize the news.” GSK already has a "vaccine locator" web page where consumers can search for available Shingrix doses within a 100-mile radius.
Schumer also called on the agency to remove any regulatory hurdles preventing shipments; it's unclear whether any exist. The FDA should also prioritize shipments to highly populated states because the risk of spreading the chickenpox virus is higher there, he said.
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For months, GSK has been open about its Shingrix shortage. The vaccine’s high efficacy has sparked an “unprecedented” demand for shingles vaccines, the company has said. GSK is expanding manufacturing capacity to help meet demand, but it expects the shortage to continue through the year as it ramps up production. In the meantime, GSK has delayed shipments and limited orders to allocate its supply.
Sen. Schumer said the fact that the FDA is shut down during the shortage “is a worrisome thought and a problem that must be addressed.” He’s asking the agency to “go above and beyond, to do whatever it can, amidst this needless shutdown and pull out all the stops to step in and help remedy this shortage before it becomes a full-on crisis.”
Even if the FDA were to reopen, though, the agency couldn’t solve the root problem of the shortage: limited supply and high demand. None of Sen. Schumer’s proposals for the FDA would solve that issue. Agency representatives didn't immediately respond to a request for comment.