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According to a new report from the Kaiser Family Foundation (KFF), it is not clear that employers have the legal right to require employees to be vaccinated with a vaccine that only has a permit. US Food and Drug Administration emergency use (EUA).
All three COVID-19 vaccines available in the United States have EUAs, but none have yet received full FDA approval. Pfizer-BioNTech, however, recently announced that it has enough test data to seek full approval, according to FiercePharma.
Whether employers can force COVID-19 vaccinations on their workers is important, not only for workers, but also for the drive to vaccinate enough of the American population to create herd immunity. A significant fraction of the population is still reluctant to be vaccinated or refuses to be vaccinated against COVID-19.
This resistant cohort includes many employees of health care organizations. According to a recent survey, nearly half of frontline health workers had not been vaccinated by early March. Twelve percent of respondents had not decided whether or not to get the vaccine, and 18% said they did not intend to receive a COVID-19 vaccine.
To date, most healthcare organizations have not made the vaccination of their workers mandatory. And if the KFF report is correct, the small number of health systems and post-acute care facilities that require vaccination may not have a solid legal foundation.
Until recently, all employer immunization mandates, such as flu shots for healthcare workers, were for fully approved vaccines, the report said.
The post 9/11 statute which established the EUA process states that individuals must be informed “of the possibility of accepting or refusing the administration of the EUA. [EUA-approved] product, the consequences, if any, of refusing to administer the product, and the alternatives to the product available and their benefits and risks. “
Legal experts are divided over what this directive means for the legality of requiring vaccination with a vaccine authorized for emergency use, the report notes. The courts have not yet interpreted this provision of the law.
Employers who require vaccination must comply with the December 2020 guidelines of the Equal Employment Opportunities Commission (EEOC), which does not directly address EUA status but indicates that a person’s disability is employee should be considered when an employer inquires about their immunization status. .
The employer must also offer “reasonable accommodation” to employees who say they cannot get vaccinated because of their disability, the report said.
Employers’ vaccination mandates are also subject to religious accommodation under Title VII of the Civil Rights Act, according to the report, although courts have held that state vaccination mandates are not constitutionally required to provide for religious exemptions.
Not all observers agree with the KFF report’s position on the legality of COVID-19 vaccine mandates while vaccines are under EUA. For example, a
April 7 JAMA The perspective of three academic experts refers to recent EEOC guidelines on COVID-19 vaccinations. Experts noted that the guidelines apply to any vaccine “approved or authorized by the Food and Drug Administration,” suggesting that employers may require vaccinations as part of an EUA.
Real world experience
This is also the view of Houston Methodist, one of the few healthcare organizations to have mandated its employees to receive COVID-19 vaccines. In an interview with Medscape Medical News, Marc Boom, MD, president and CEO of Houston Methodist, said the healthcare system’s legal counsel informed the organization that it has a solid legal foundation in requiring its staff to be vaccinated as a condition of ’employment.
This mandate is fairly recent. Houston Methodist has aggressively vaccinated its employees since January and offered them bonuses of $ 500 to get vaccinated by mid-March, Boom noted. To date, 84% of employees have been vaccinated and the number continues to increase. But most of those who still haven’t received the vaccine are “hesitant or reluctant to get the vaccine,” he said.
Explaining why the Houston Methodists ultimately demanded that the resistance be vaccinated, Boom said, “Our sacred duty and obligation is to care for and care for our patients in the safest way possible. of that is to make sure our team is protected. and that we minimize the risk of giving a patient COVID. It’s about having patients at the center of everything we do. “
The KFF report also noted that there have been discussions about the ethics of requiring employees to obtain vaccines that are not fully approved by the FDA. Boom did not dismiss this concern, but said it was now moot that COVID-19 vaccines had been widely accepted across the country.
“There have been 170 million vaccines administered in the United States alone,” he noted. “This is a massive real-world experience in addition to extensive, large-scale clinical trials. [EUA] the process was speeded up, but the studies were no different than they normally would be. “
Legality of vaccination mandates
The KFF report also addressed the broader question of whether COVID-19 vaccination mandates are legal and which entities can require people to be vaccinated.
The federal government’s power to impose vaccinations of any kind is limited, the researchers concluded. The Public Health Service Act authorizes the Secretary of Health and Human Services to adopt quarantine and isolation measures to stop the spread of the disease between states, but does not mention vaccination warrants. “General immunization mandates… are generally the purview of state and local governments… with the federal government playing a supporting role.”
The United States Supreme Court upheld a state’s immunization mandate over a century ago, based on state policing power, the report notes. In this case, a local law required that all adults be vaccinated against smallpox during an epidemic. All states now require vaccinations for school attendance, and the Supreme Court has also approved these laws.
Some states also require adults to be vaccinated, but those laws are very limited, according to the report. “Current adult immunization laws focus on healthcare workers and patients in healthcare facilities, rather than the general population.”
These state mandates generally require healthcare workers to be offered certain vaccines, and some require documentation of employee immunization status. But the report doesn’t say states are requiring these workers to be vaccinated.
Some private employers require their workers to receive vaccines, such as flu shots, at health facilities. But states can ban vaccination warrants as a condition of employment and instead require employees to have the option to opt out, according to the report.
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