Federal COVID-19 Vaccine Mandate Issued for Private Employers, Health Care Facilities

With COVID-19 vaccines now available for ages 5 and above in the United States, the White House is rolling out new vaccination mandates for employers with more than 100 employees, as well as health care workers at facilities that receive Medicare and Medicaid Benefits.

Vaccine mandates have already been adopted by a number of companies and organizations across the United States. More than 70% of Americans are fully vaccinated with two doses of the Moderna or Pfizer/BioNTech vaccine, or the single-dose Johnson & Johnson. Boosters for each of these vaccines have rolled out in the past few weeks and pediatric patients are beginning to receive their first doses of the Pfizer vaccine following the granting of Emergency Use Authorization by the U.S. Food and Drug Administration last week.

Vaccinations will be required by January 4 under the new White House plan. The mandates have been expected for some time and are sure to fuel the simmering political divide over the preventative measures. The mandate comes about a week after the world marked a grim milestone of more than 5 million deaths from COVID-19, which includes more than 750,000 deaths in the United States.

This morning, the Department of Labor’s Occupational Safety and Health Administration (OSHA) announced the requirement for employers who have 100 or more employees to mandate vaccinations or weekly tests for COVID-19 infections. In addition to the vaccination requirement, the OSHA rule calls for employers to receive paid time off to get vaccinations.

The mandate will cover about 84 million employees, the White House said. The OSHA rule requires those employees who decline a vaccination in favor of weekly testing to wear face masks to prevent any spread. Masking and weekly testing will begin December 5, the government said.

The mandate for health care workers in facilities will apply to more than 17 million employees at approximately 76,000 health care facilities, including hospitals and long-term care facilities. The ruling is for those facilities that receive federal funding from Medicare and Medicaid. It applies to employees regardless of whether their positions are clinical or non-clinical and includes employees, students, trainees and volunteers who work at these sites. This mandate was guided by the U.S. Centers for Medicare & Medicaid Services (CMS) at the Department of Health and Human Services.

In a brief statement, President Biden said vaccination is the “single best pathway” out of the pandemic.

“For our country, the choice is simple: get more people vaccinated, or prolong this pandemic and its impact on our country. The virus will not go away by itself, or because we wish it away: we have to act. And while I would have much preferred that requirements not become necessary, too many people remain unvaccinated for us to get out of this pandemic for good,” Biden said.

The president added that vaccination requirements are positive for the U.S. economy. He said increased inoculation will allow more people, about 5 million, to return to work. He said vaccines “make our economy more resilient in the face of COVID and keep our businesses open.”

Failure to comply with the mandates will result in financial penalties that can run into the tens of thousands of dollars, or in the case of health care facilities, potentially lose federal funding. The White House noted that the new mandates will supersede any state or local laws that ban or limit an employer’s authority to require vaccination, masks or testing.

There will certainly be a significant amount of support and criticism aimed at the latest mandate. A recent BioSpace survey of employees within the pharmaceutical industry reveals that there are many questions considered unanswered about vaccine mandates. Some of the concerns noted in the survey include questions about natural immunity following an infection from COVID-19, as well as questions regarding potential exemptions from vaccination due to medical status or religious beliefs. For more insight on the viewpoint of industry employers and employees, please see here.

A number of biopharmaceutical companies including Novartis, Gilead Sciences, Genentech and Pfizer, had already implemented stringent vaccination requirements for employees wishing to work onsite. 

Although the ink on the latest mandate is barely dry, the limits will likely be tested in court filings that are sure to come today or later this week.

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