Secretary of Defense Lloyd Austin announced Monday that he intends to mandate all US military troops, civilian contractors, and employees to be vaccinated for COVID-19 by mid-September. But some military members — and several Republican lawmakers — say he can’t do that, at least not yet. The real answer appears to be: Well … it depends.
On Friday, Aug. 6, Rep. Mark Green of Tennessee and 15 other members of Congress wrote Lloyd a memo insisting that a mandate for any of the commercially available COVID-19 vaccines, which are all currently being used under an emergency use authorization from the Federal Drug Administration, would be illegal.
“The law of the United States is clear: Mandatory vaccination is illegal for military personnel prior to complete approval,” the memo reads. “As long as the vaccine is authorized under an Emergency Use Authorization, the Department of Defense does not have the authority to implement such an order.
“The Secretary of Defense is not above the law.”
The letter cites a case, Doe v. Rumsfeld, in which a federal district court sided with service members against involuntary anthrax vaccinations in 2003. The court said the Pentagon could not require military personnel or civilian contract employees to receive experimental drugs without a waiver signed by the president.
For the time being, all three COVID-19 vaccines circulating in the United States have received approval only for emergency use. An emergency use authorization, or EUA, is used for vaccines in the case of public health crises and require less — though still rigorous — safety testing than final approval, which may be granted after a drug undergoes what is known as a BLA, or biologics license application. Once a medicine or vaccine receives a biologics license, it is considered fully approved for all clinical uses intended.
In terms of the current COVID-19 vaccines, the two approvals vary in small but important ways:
- Both approvals require three phases of human testing, but an EUA can be issued with two months of safety data following phase 3 study participants’ completion of the vaccine regimen. A BLA requires at least six months of safety data following phase 3 study participants’ completion of the vaccine regimen.
- A manufacturer’s creation process and manufacturing facilities must all pass a full FDA inspection to receive BLA approval.
- An EUA product must be shown to be safe in clinical trials and that it “is reasonable to believe that the product may be effective.” The bar is higher for a BLA, in which a product must demonstrate through trials that it is clearly a potent remedy in its intended use (the COVID-19 vaccines available in the US all are considered extremely effective, even under an EUA).
Additionally, an EUA approval is automatically nullified if an emergency ends, whereas a biologics license, once issued, is indefinite. A drug with an EUA can only be used as specifically authorized. In contrast, doctors and patients can agree to “off-label” use of drugs that have a biologics license — with the COVID-19 vaccines, for instance, parents and doctors could decide to vaccinate children under 12, if the vaccines receive their biologics license.
However, the rules cited in the congressional letter could be subject to a presidential override, and full approval of the vaccines may come within weeks. And even if COVID-19 vaccines can’t be legally mandatory, that doesn’t mean refusing the vaccine would be without consequences.
A law professor with experience as both an Air Force officer and a military trial judge said that refusal to get vaccinated could leave military members without jobs.
University of New Mexico law professor Joshua Kastenberg spent 20 years as a lawyer and trial judge in the Air Force. Any case of vaccine refusal would likely turn on the military’s need for its members to travel the world, he said. And when a member’s capability to deploy is impaired or compromised, the military has little use for that person.
“The ability to serve in the military is predicated to mainly serve in a worldwide capability. They can send you to Germany, Iraq — anywhere in the world — tomorrow,” Kastenberg said. “But if you’re not capable of worldwide deployment you can be discharged from the military at any time. It’s an all or nothing thing.”
DOD personnel who refuse to get the vaccine and can no longer perform their necessary duties, including deployment, could face administrative separation. And that consequence has already met constitutional approval.
The individual could fight the vaccine requirement, Kastenberg said, but judges have traditionally sided with the government and military necessity on similar cases.
One thing is clear: If President Joe Biden signs a waiver for the mandate — or if the FDA grants the vaccines full biologics licensure — refusal to get the shot will be (outside of established issues) essentially indefensible.
“There will be an order that is presumed to be lawful, and to defy that would be at your own risk,” Kastenberg warned. Refusing a lawful order violates Article 92 of the Uniform Code of Military Justice. It typically results in a court-martial and carries a maximum penalty of a dishonorable discharge, forfeiture of all pay and allowances, as well as confinement for up to two years.