Will you need it? What can the government do for employers


Grace Hauck

| USA ma

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During an emergency review by the Food and Drug Administration with two coronavirus vaccines, the nation’s attention is focused on who and when will first receive the vaccine.

The big question remains: will they be required to get vaccinated from Americans?

For some, the short answer is yes, say public health and legal experts. But a mandate is probably not expected soon, and probably not from the federal government. Instead, employers and states can assume the return of or access to jobs, schools, and colleges after obtaining a vaccine and authorize it if the FDA issues full approval, possibly months later.

“It’s much more likely that a private organization or company will need a vaccine to make sure they have access to the sites,” said Arthur Caplan, a bioethics professor at the Grossman School of Medicine at NYU. “People are afraid the president, the governor, or the county leader will tell them what to do. I don’t think that’s going to happen.”

At the August City Hall organized by Healthline, Dr. Anthony Fauci, director of the National Institute of Allergic and Infectious Diseases, said vaccination will not be mandatory in the United States. “I don’t think he will ever see a vaccine, especially for the general public,” Fauci said. “If someone refuses to get vaccinated in the general public, they can’t do anything about it. You can’t force someone to get vaccinated.”

And on Friday, President-elect Joe Biden told reporters he would not make vaccinations mandatory. “But I will do everything in my power – just as I think masks should not be made nationally mandatory – as President of the United States, I will do everything I can to encourage people to do the right thing,” Biden said.

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Historically, states had the right to prescribe vaccinations. This authority was established by the Supreme Court in 1905, when smallpox spread in Massachusetts when it ruled in Jacobson v. Commonwealth of Massachusetts.

“Our constitution has a long history of enabling the state to take action for public health and safety, and that has always included vaccination,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. .

“But although they have power, I think it is very unlikely that this power will be exercised,” he said. “They would be afraid of being disadvantaged and politicizing the vaccination.”

It is more likely that vaccination requirements will play out as they have in the past. Once fully approved by the FDA, vaccinations may be needed for children in public and private schools and day care facilities, university and college students, and some health care workers and patients, Gostin said.

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In all 50 states and Washington DC, there are laws that require certain vaccinations for students, and exemptions vary from state to state. All states grant exemptions for children for medical reasons, 45 states grant religious exemptions, and 15 grant philosophical exemptions to those who protest against immunization because of their personal, moral, or other beliefs, says the National Conference of Legislators.

Healthcare institutions across the country are increasingly requiring healthcare workers to be vaccinated against various diseases, and the CDC says some facilities supplement these standards because of mandates set out in state laws and regulations.

For influenza, 24 states have influenza vaccination requirements for long-term care workers and 32 for long-term care patients, according to the CDC. As of 2016, influenza vaccination requirements applied to hospital healthcare workers in 18 states.

Other employers also require certain vaccinations.

“Will the population need it? It’s very unlikely. It’s not American tradition or culture,” said Peter Meyers, professor emeritus at George Washington University’s law school and former director of the school’s vaccination injury clinic.

“We recommend it. We’ll make it as easy as possible to get it. We’ll make it free. If enough people take it, we’ll have a stock-free.”

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But officials also allowed the vaccinations beyond the school and employment environment in the past. Following the outbreak of measles in 2019 in the Williamsburg neighborhood of Brooklyn, triggered by a growing movement against vaccinations, New York City has ordered mandatory measles vaccination in the area in four zip codes for everyone who lives, works, or goes to school.

The order required all unvaccinated people who may have been exposed to the virus to be vaccinated, including children over 6 months of age, unless they enjoy immune or medical immunity. The city first threatened civil and criminal consequences, but ended up fining $ 1,000. The Brooklyn judge upheld the order.

This order was for a vaccine that was fully FDA approved. The two coronavirus vaccines currently under review are “approved” by the agency based on early data, at the discretion of FDA scientists. The FDA only issued an emergency use permit, the EUA, once for a vaccine – the anthrax vaccine – in 2005.

If authorized, the EUA status of the coronavirus vaccine will complicate legal issues related to theoretical mandates in the near future. There are also logistics issues of supply and distribution. There are no data on how vaccine candidates affect children or pregnant people. And it is still unclear whether vaccines prevent the spread of the virus while preventing disease.

“Institutions may require individuals to take an FDA-approved vaccine or request an exemption. However, EUA products are still considered investigative in nature,” FDA Commissioner Stephen Hahn told the U.S. today.

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It is unclear whether schools or employers can legally authorize vaccination under the EUA, said Dorit Reiss, a professor at Hastings College of Law at the University of California. He submitted a comment to the FDA requesting that the agency’s EUA documentation provide guidance on the issue of mandates.

In the past, members of the FDA and the Center for Disease Prevention and Control have said employers cannot apply for vaccinations under the EUA, Reiss said. But the secretary of health and human services can determine the terms of the EUA under the Federal Food, Drug and Cosmetics Act, including whether people have the option to accept or reject a vaccine, and the consequences, if any.

“I am confident that in the short term, no government will demand anything as long as we operate under the EUA,” Caplan said. “It would be very strange to demand things that don’t have permission or approval. The military can certainly demand things, but not for civilians.”

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When the coronavirus vaccine is first approved and then approved by the FDA, it can take years for it to be a requirement for school children or anyone, said Dr. Howard Koh, a professor at Harvard’s TH Chan School of Public Health led by Barack Obama, the deputy health secretary.

“Each new vaccine takes a while to become familiar and generally accepted. Much of this involves ensuring the effectiveness of the long-term safety profile. There is a level of comfort that everyone must achieve – parents, families, employees. This process takes time. it will be full, “he said.

Some companies in industries where there is a high risk of transmitting the virus – such as restaurants, gyms, salons, meat packaging, professional sports and nursing homes – may also require vaccination for their employees, Caplan said. The Office of Occupational Safety and Health has previously said that employers have the right to give flu vaccines, but employees can request medical or religious exemption.

“You may face a situation where your income depends on getting the vaccine,” said Robert Field, a professor of law and public health at Drexel University.

If service industry employers require a vaccination for employees, if a vaccination is allowed, they would “have a strong argument that the termination would be objectively fair,” Field said. For the time being, Field expects it to expect employers to avoid the legal risks of licensing an unlicensed vaccine.

The best strategic approach to promoting the vaccine is to maximize communication and minimize barriers, said Ross Silverman, a professor at Richard M. Fairbanks School of Public Health and Robert H. McKinney Law School at Indiana University.

“What can we do to make it as easy as possible for people to say yes?” he said. “The best approach in the near future is to involve communities, answer questions, and make people aware of the benefits and risks, where they can get it, and that there are no costs to get the vaccine.”

For the time being, the question is not who should be vaccinated, but who who willsaid Michelle Mello, a professor at Stanford Law School.

“Most people will come, so I’m not even sure we’ll even have a discussion about assignments,” Mello said. “If in eight months our supply is sufficient and we’ve run through all the people who wanted to get the vaccine and we’re still not close to the immunity of the herd, it could be another conversation.”

Featuring Elizabeth Weise and Adrienne Dunn, USA today

Follow Grace Hauck on Twitter @grace_hauck.