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
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
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
Nine months ago, we discussed several issues that had been raised by COVID-19 face mask-related litigation. Soon after, COVID-19 infection rates spiked to unprecedented levels. But with the emergency use authorization of...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: Secretary of State Antony Blinken on Friday called for the World Health Assembly (WHA), a decision-making body of the World Health Organization (WHO), to allow Taiwan to participate as an observer in its...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
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
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
In Washington: Welcome back and to the new 117th Congress. The House of Representatives met Sunday to swear in new members of Congress and elect Nancy Pelosi (D-CA) to be the Speaker of the House for the fourth time...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
In Washington: With only hours to spare, House and Senate lawmakers were forced to pass a last-minute short-term extension of government funding (H.J. Res. 107) to stave off a government shutdown while congressional...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
The biopharmaceutical industry is at the forefront of COVID-19 news due to major advances in vaccine development. Now, more than a year since the first case of COVID-19 and nearing a year since daily life has been upended by...more
In Tuesday's Report: a panel discussion on the U.S. election, Americans warned of COVID-19 surge, Moderna files for FDA EUA, Hong Kong proposes corporate rescue bill, new Foreign Direct Investment rules in Spain, the EU moves...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
As the world continues to grapple with the COVID-19 pandemic that has taken the lives of over 250,000 Americans, and worldwide over 1 million people, this year, an effective vaccine has emerged as our silver bullet – a way...more