Legally Qualified: Can Employers Require Vaccines?
Can Employers Require COVID-19 Vaccinations?
Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more
Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance...more
In early 2023, the Biden administration announced and set into motion its plans to wind down a number of pandemic-related programs and allow the COVID-19 public health emergency (PHE) declaration, which has been in effect...more
On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...more
On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies...more
If you’re an employer contemplating implementing a mandatory COVID-19 vaccination policy for your workforce, you aren’t alone. With COVID-19 cases surging around the country and leading to new Centers for Disease Control and...more
As we enter our seventeenth month of the COVID-19 pandemic, fears that the pandemic is once again getting out of control continue to rise. With COVID-19 cases increasing across the country, due in part to the contagiousness...more
In a memo dated July 6, 2021, the DOJ’s Office of Legal Counsel concluded that the COVID-19 vaccines’ status as products authorized for emergency use does not prohibit public and private entities from requiring them as a...more
Yesterday, on July 27, 2021, the U.S. Center for Disease Control (CDC) issued new COVID-19 guidance, including recommending face masks even for vaccinated people when they are in indoor public settings in geographic areas...more
In its latest update to informal guidance on COVID-19 vaccination issues, the Equal Employment Opportunity Commission (EEOC) addressed vaccination mandates, incentives, and confidentiality, among other topics...more
An Emergency Use Authorization (EUA) is a mechanism used to enable the accessibility and use of medical countermeasures, including vaccines, during public health emergencies. Under an EUA, FDA may allow the use of unapproved...more
As noted, here’s a brief update pertaining to the new and updated guidance for developers of therapeutics, vaccines, and tests for COVID-19. These guidance outline FDA’s vision of a forward-looking, and flexible approach to...more
At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
Based on welcome news that the COVID-19 vaccine may be available to the public in the coming months, many employers are beginning to consider whether mandatory vaccinations can be incorporated into existing strategies to...more
As the first trucks of COVID-19 vaccines start their way around the United States, many employers are eager to return to work. The first reaction many employers have to news of FDA approvals for COVID-19 vaccines is whether...more
And employers will like it. NOTE FROM ROBIN: This is the text of a Legal Bulletin that we sent out today. I am posting it here for those of you who don't subscribe to our bulletins. The U.S. Equal Employment Opportunity...more
As the COVID-19 pandemic continues, and with an incoming Biden administration that is expected to step up efforts to control the spread of the virus, use of personal protective equipment (“PPE”) and cleaning/disinfectant...more
On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more
As businesses prepare to re-open, many employers will be concerned about the risk of workplace transmission of the COVID-19 disease. Testing employees before allowing them to enter the workplace is one preventative measure...more
On May 12, the California Department of Consumer Affairs (DCA) issued an Order Waiving Restrictions on Pharmacists Ordering and Collecting Specimens for COVID-19 Tests, under the authority of California Governor Newsom’s...more