Businesses and schools can mandate the use of Covid-19 vaccines under EUAs, DOJ says
As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.
Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.
DOJ says that, consistent with the FDA’s interpretation of section 564 of the Food, Drug, and Cosmetic Act, only certain information needs to be provided to potential vaccine recipients, such as the fact that FDA “has authorized the emergency use of the product,” “the significant known and potential benefits and risks of such use,” and “the extent to which such benefits and risks are unknown.” But it does not prohibit imposing mandates, DOJ says, adding:
Some have questioned whether such entities can lawfully impose such requirements in light of the fact that section 564 instructs that potential vaccine recipients are to be informed that they have the ‘option to accept or refuse’ receipt of the vaccine. In the past few months, several lawsuits have also been filed challenging various entities’ vaccination requirements on the same theory. The only judicial decision to have addressed this issue so far summarily rejected the challenge.
In one such example, an employee of the Durham County Sheriff’s Office in North Carolina sued his former employer in April after he was fired for declining to receive a Covid-19 vaccine. He argued that he was “being forced to take an experimental, unapproved vaccine against his will.” Late last month, the employee dropped his lawsuit.
In Texas, Houston Methodist was one of the nation’s first health systems to impose a coronavirus vaccine mandate in April, leading to Jennifer Bridges and 116 other employees to file suit, arguing they’re being coerced into taking an unapproved vaccine.
“This is not coercion,” District court judge Lynn Hughes wrote in his opinion on June 12. “Methodist is trying to do their business of saving lives without giving them the Covid-19 virus. It is a choice made to keep staff, patients, and their families safer. Bridges can freely choose to accept or refuse a Covid-19 vaccine; however, if she refuses, she will simply need to work somewhere else.”
A federal judge similarly upheld the University of Indiana’s vaccine mandate last week, and other colleges and universities’ vaccination mandates are likely coming soon.
The US Department of Veterans Affairs on Monday became the first federal agency to mandate the use of the vaccines.
“We’re mandating vaccines for Title 38 employees because it’s the best way to keep Veterans safe, especially as the Delta variant spreads across the country,” VA Secretary Denis McDonough said in a statement.
Efforts have trickled down to states and cities now too. In California starting in August, state employees and health care workers must show proof of vaccination or get tested regularly. New York City in September will turn to a similar policy. Meanwhile, more than 50 medical groups also called for mandatory vaccinations of all health care workers, the Washington Post reported.
And per the DOJ, the mandates are entirely legal:
Indeed, if Congress had intended to restrict entities from imposing EUA vaccination requirements, it chose a strangely oblique way to do so, embedding the restriction in a provision that on its face requires only that individuals be provided with certain information (and grouping that requirement with other conditions that are likewise informational in nature). Congress could have created such a restriction by simply stating that persons (or certain categories of persons) may not require others to use an EUA product.