(INDIANAPOLIS) – The three COVID vaccines approved in the U.S. have what’s called an emergency use authorization. That doesn’t mean they’re not safe.
Opponents of vaccines or vaccine requirements have increasingly emphasized the temporary nature of the authorization. A letter this week from 19 Indiana House Republicans to Governor Holcomb protesting Indiana University’s new vaccine requirement notes three times in four sentences that the vaccines “do not have full FDA approval.” 35 of the 39 Senate Republicans make the same point in their own letter to IU president Michael McRobbie urging him to rescind the requirement. And some critics have gone further, calling the vaccines “experimental.”
Dan Orenstein heads IUPUI’s Hall Center for Law and Health. He says describing the vaccines as experimental is simply false. The regulatory standard for emergency approval is written more loosely, requiring that the vaccine “may” prevent infection, but Orenstein says that’s the minimum standard. In practice, he says, the FDA’s review standards for safety and effectiveness are as strict as they would be for permanent approval.
The primary difference between the standard and emergency approval processes is that the final stage of clinical trials is shortened to two months of followup monitoring instead of six. Orenstein says there’s now far more data on the vaccines than the extra four months would have provided, with millions of Americans, including more than 2.4 million Hoosiers, fully vaccinated.
The emergency use authorization law is less than 20 years old, passed in the aftermath of the post-9/11 anthrax scare. Orenstein says it’s only been invoked a few times, and never for a vaccine administered on the scale of the COVID vaccines. That makes it hard to say when the emergency authorization will be replaced by full approval, but Orenstein predicts it will take “months, not years.”
While health professionals say the emergency authorization is no basis to question the vaccine’s safety, the emergency status does create a potential legal question for mandates like IU’s. The Senate Republican letter to McRobbie says people receiving a medical product under emergency authorization must be informed “of the option to accept or refuse” it. That law also requires patients to be informed “of the consequences, if any, of refusing.”
The Senate letter also notes the new Indiana law banning the state or local governments from requiring “vaccine passports.” That law applies to any COVID-19 vaccine, whether it has full FDA approval or not. The letter pointedly notes IU will receive $1.2 billion in the new state budget, and says taxpayers “have a vested interest in Indiana University and the consequences spawned by this overreach.”
