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
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
In the first major patent infringement lawsuit in the mRNA space, on February 28, 2022, Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences GmbH (“Genevant”) sued Moderna, Inc. and ModernaTX, Inc. (collectively...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
Don’t doubt the central role that vaccines are playing in the battle against the coronavirus pandemic. Federal officials - even as the Delta-variant surge is easing - have dominated the news by approving yet more...more
As the summer’s deadly Delta variant surge slowly seems to be receding, questions are rising anew as to what further harms the coronavirus pandemic may inflict on a nation that already has suffered greatly. The infection...more
On Monday, the Food and Drug Administration gave permanent approval to Pfizer’s COVID-19 vaccine. Similar approval of the Moderna vaccine may be forthcoming, with eventual approval of the Johnson & Johnson one-shot...more
We have seen biopharmaceutical companies around the world working to tackle COVID-19 in vaccine development, treatment development, and diagnostics, including the creation of world-class vaccines in record time, rapid tests...more
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others...more
In Washington: The Centers for Disease Control and Prevention (CDC) said it is looking to let cruise lines resume trips in the U.S. by mid-July and changing some of the rules to allow the ships to sail. A spokeswoman for...more
In Washington: The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on Friday lifted the recommended pause on the use of Johnson & Johnson’s coronavirus vaccine, saying the benefits...more
Shortly after we posted about Moderna, Inc.’s October 2020 pledge not to enforce its COVID-19-related patents during the pandemic, the United States Food & Drug Administration (FDA) granted emergency regulatory approval for...more
In Washington: President Biden on Tuesday began what is expected to be a weeks-long sales pitch to tout the new coronavirus relief package. Biden visited Smith Flooring in Chester, Pennsylvania, a small business that received...more
The Centers for Disease Control and Prevention (CDC) reports that as of Jan. 8, 2021, about 6.7 million people have received at least one dose of a COVID-19 vaccine, far short of the prediction by the Trump Administration of...more
Happy New Year! As we move into 2021, we know that many of you are considering whether to require employees to get the COVID-19 vaccination. The current COVID-19 vaccines have received Emergency Use Authorization (“EUA”)...more
To date, two COVID-19 vaccines have been authorized for emergency use by the FDA. Produced by Pfizer and Moderna, the vaccines are in full distribution throughout the world; however they differ slightly in certain respects....more
What You Need to Know: On December 18, 2020, the Food and Drug Administration issued the second emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Under...more
With the FDA’s recent approval of Pfizer-BioNTech’s COVID-19 vaccine, the FDA’s Vaccines and Related Biological Products Advisory Committee’s Advisory Council’s scheduled vote of today on the use of Moderna’s COVID-19 vaccine...more
In Washington: The bipartisan “908 negotiators” unveiled summaries and text of their $908 billion coronavirus relief proposal that has now been divided into two sections to allow the House and Senate to vote on the...more
The COVID-19 pandemic has been particularly devasting to people with disabilities. Recent studies indicate that they are three times as likely to die from the virus as the general population. But as the pharmaceutical...more
The FDA could approve two COVID-19 vaccines within a matter of days. However, drug makers have tried to keep expectations in check about how much vaccine they can deliver immediately and over the next few months as they...more
On December 2, 2020, the U.K. became the first Western nation to approve the use of Pfizer/BioNTech’s COVID-19 (SARS-CoV-2) vaccine for mass inoculation. As pressure mounts on U.S. regulators to follow suit, the next 30 days...more
In Washington: On Sunday, White House Coronavirus Task Force coordinator Dr. Deborah Birx warned Americans to “assume that you’re infected” with COVID-19 if you traveled or gathered for Thanksgiving and advised being...more
INTRODUCTION - Following earlier announcements as to the efficacy of vaccine trials by pharmaceutical companies Pfizer, Inc. (Pfizer) and Moderna, Inc. on November 20, 2020, Pfizer and BioNTech submitted applications for...more
Since March 2020, and in some cases before, the U.S. government, Congress and external entities have worked to design plans to reduce the impact of COVID-19 and ultimately prepare for the development and distribution of a...more