Supreme Court Denies Student Request to Block University Vaccine Mandate

On August 12, the Supreme Court of the United States denied eight students’ request to block Indiana University’s requirement that students be vaccinated against the coronavirus. The students’ case, Klaassen v. Trustees of Indiana University, is the first test of a COVID-19 vaccine requirement in the context of an educational institution to arrive at the Supreme Court.

To read the full text of this Duane Morris Alert, please visit the firm website.

President-Elect Biden Announces Plan for Massive Federal Vaccination Effort, Asks Congress for $20 Billion in Vaccine Funding

As COVID-19 continues to surge across the United States and a more contagious variant of the virus threatens to further strain the U.S. healthcare system, President-Elect Joe Biden is calling for a massive federal government mobilization to speed distribution of approved COVID-19 vaccines. With his proposed national vaccination plan, Biden is seeking to administer 100 million COVID-19 vaccine doses in his administration’s first 100 days.

To read the full text of this Duane Morris Alert, please visit the firm website.

CDC Updates Interim COVID-19 Vaccine Allocation Recommendations

At an emergency meeting on December 20, 2020, the CDC’s Advisory Committee on Immunization Practices updated its COVID-19 vaccine allocation recommendations based on limited vaccine supply by specifying the populations for the second and third subphases of the initial vaccine rollout: Phase 1b and Phase 1c. The recommendations have been adopted by the CDC director and became official as of December 22, 2020.

To read the full text of this Duane Morris Alert, please visit the firm website.

COVID-19 Vaccination: Considerations for Seniors Housing Communities

More than nine months after start of the coronavirus pandemic, the beginning of the end finally appears to be within sight. Novel vaccines have shown tremendous promise in clinical trials, and the United States Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) to the first two COVID-19 vaccines—one developed by a collaboration between Pfizer and BioNTech SE and the other developed by Moderna. The first Americans received initial doses of the Pfizer-BioNTech vaccine on Monday, December 14, 2020—a remarkably quick turnaround from the initial identification of the SARS-CoV-2 virus at the end of 2019 to the delivery of the first doses of a vaccine one year later.

While the efforts to bring vaccines to long-term care communities will not begin in earnest until December 21 or December 28, residents of long-term care communities in a handful of states have begun to receive COVID-19 vaccines. To that end, although companies in the seniors housing industry are likely well on their way to preparing for the upcoming vaccinations in their communities, this Special Issue Brief provides some background on the COVID-19 vaccine approvals and an overview of some of the key issues operators should make sure to consider.

To read the full text of this article by Duane Morris attorney Alison T. Rosenblum, please visit the American Seniors Housing Association website.

EEOC Updates Guidance on Employer COVID-19 Vaccination Policies

In our December 15, 2020, Alert, we advised that the Equal Employment Opportunity Commission (EEOC) would provide updates to its COVID-19 guidance, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” to address employer rights and responsibilities related to COVID-19 vaccination policies. Right after our Alert was issued, on December 16, 2020, the EEOC updated its COVID-19 guidance with questions and answers for employers who seek to have their employees inoculated against this deadly virus.

To read the full text of this Duane Morris Alert, please visit the firm website.

The Upcoming Firestorm Facing Employers Regarding Vaccines

With the Pfizer-BioNTech COVID-19 vaccine approved for emergency use authorization by the Food and Drug Administration and the CDC and approval of the Moderna COVID-19 vaccine expected imminently, America is seeing light at the end of the very long tunnel that has been the pandemic. Accordingly, many employers have begun to consider whether they should have a mandatory COVID-19 vaccination policy to protect employees and return to some normalcy in the workplace. An employer’s decision to require employee COVID-19 inoculations as a condition of workplace entry raises a number of legal, evidentiary and practical issues.

Update: On December 16, 2020, the Equal Employment Opportunity Commission released guidance on COVID-19 vaccinations, including employer mandates for the vaccine. Duane Morris will cover this development in an Alert to be published soon.

To read the full text of this Duane Morris Alert, please visit the firm website.

Vaccines to Arrive in New Jersey on December 15: Who Will Receive Them First?

As the FDA-approved Pfizer COVID-19 vaccines begin to arrive in New Jersey on December 15, 2020, the burning question on some people’s minds is who will be getting inoculated first?

Per the New Jersey Health Commissioner, vaccines will be distributed to almost anyone who works in the healthcare field. The list of eligible recipients is intentionally broad.

To read the full text of this post by Duane Morris partner Brad Molotsky, please visit the Duane Morris Project Development/Infrastructure/P3 Blog.

 

FDA’s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements Revealed by New Guidance

In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

To read the full text of this Duane Morris Alert, please visit the firm website.