Legally Qualified: Can Employers Require Vaccines?
Can Employers Require COVID-19 Vaccinations?
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
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 the wake of the Department of Health and Human Services’ (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023, the United States Food and Drug...more
One of the most amazing accomplishments in the field of biotechnology has been the development and distribution of a vaccine against SARS-CoV-2 (COVID 19). The numbers tell the story. The time from when the coronavirus’...more
Seyfarth Synopsis: Despite President Biden’s recent declaration that the COVID-19 pandemic is over, litigation concerning employer vaccine mandates continues as employers face hurdles to ensure workplace safety and compliance...more
The Novavax COVID-19 vaccine recently received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for individuals 18 and older, making Novavax the fourth COVID-19 vaccine to receive either...more
Seyfarth Synopsis: On July 13, 2022, the U.S. Food and Drug Administration (“FDA”) issued an emergency use authorization (“EUA”) for the Novavax COVID-19 Vaccine, Adjuvanted. Beyond adding another vaccination option in the...more
Updates on vaccines for young children and a massive study on the efficacy of mask-wearing in schools headline this week’s COVID-19 news....more
Two prominent vaccine manufacturers submitted requests for authorization of an additional COVID-19 booster dose this week. Meanwhile, as case rates rise in Europe and China, U.S. public health officials take stock of what to...more
A number of recent studies have sought to identify commonalities among COVID-19 patients under the age of 18 who have required hospitalization. In addition, many new studies have worked to measure the impact of the COVID-19...more
The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic....more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more
It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more
In the past two weeks, the Federal Trade Commission (FTC) has ordered major U.S. companies to provide information on their supply chain issues and solutions. The FDA issued an emergency use authorization (EUA) for a...more
As of December 6, 2021, all air passengers 2 years or older (regardless of vaccination or antibody status) with a flight departing to the United States from a foreign country are required to show a negative COVID-19 viral...more
A global vaccine tracker is unveiled as cases are on the rise for the first time in two months. With herd immunity unlikely at this point, researchers are developing the next generation of COVID-19 vaccines. COVID Cases...more
Even as the coronavirus batters parts of the country, notably the Mountain West, public health officials are pointing to key ways in which Americans could safely and effectively further quell the pandemic that has claimed...more
With the recent imposition of COVID-19 vaccine mandates (Mandates), some employees claim that the vaccine conflicts with their religion. So employers are being forced to ask themselves a similar question – whether their...more
Upcoming Hearings/Markups - October 26 - House Education and Labor Committee, Subcommittee on Workforce Protections and the Subcommittee on Civil Rights and Human Services Hearing: “Protecting Lives and Livelihoods:...more
Booster Shot Endorsements - Last week, the U.S. Food and Drug Administration (FDA) advisory committee endorsed one of the mRNA COVID-19 vaccines and the single-dose vaccine to be used as a booster shot. This week, FDA...more
In a Twitter announcement on October 15, the White House announced that the U.S. will introduce a new travel policy that will begin on November 8, permitting foreign nationals access to the United States provided they have...more
A new submission for a Food and Drug Administration (FDA) emergency use authorization (EUA), new guidance for travelers entering the U.S. and continued studies into the efficacy of booster shots headlined this week’s...more
Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs. The FDA provided information to the public about a database repository of gene variants and associated conditions....more
Seyfarth Synopsis: We previously discussed how to apply the HIPAA wellness rules to a premium differential based on a participant’s vaccination status in our Legal Update. At the time, we were left to interpret the existing...more