COVID-19: FDA Authorization of ModernaTX,Inc. Vaccine December 18, 2020

#COVID-19, #Moderna, #modernavaccine

FDA Emergency Use Authorization—Another milestone to combat the COVID-19 pandemic: FDA gave the green light by granting an Emergency Use Authorization (EUA) to ModernaTX, Inc. (Moderna) for its vaccine. Here is the link to the official FDA Press release:

Letter of Authorization:

Why Emergency Use? This is because of the declaration under the PREP Act, which back in the winter of 2020, Health and Human Secretary Alex Azar II officially declared the COVID-19 a pandemic. The FDA grant of emergency use is critical because it allows the use of the unapproved yet authorized vaccine to travel in interstate commerce in essence as an unapproved drug.

Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 Health and Human Secretary Azar declared a public health emergency pursuant to section 319 of the PHS Act,  for the entire United States to aid in the nation’s health care community response to the COVID-19 outbreak. Azar issued a Declaration pursuant to section 319F-3 of the Public Health Service Act (codified above) to provide liability immunity for activities related to medical countermeasures against COVID-19. See 85 FR 15198 (March 17, 2020) retroactive and renewed effective date Oct. 23, 2020. (U.S.Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020).

This is the second vaccine (Pfizer BioNTech the first) authorized for the prevention of COVID-19, which is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

Vaccine Adverse Event Reporting System (VAERS) for Moderna COVID-19 Vaccine: According to FDA Moderna is required to report serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.


Does public safety justify mandatory vaccination?

Over 100 years ago, in the early 1900s the United States Supreme Court was faced with the issue of “police power” or the power of state government to protect public health and the Constitution’s protection of personal liberty. In the United States Supreme Court case of Jacobson v Massachusetts 197 US 11 (1905), the Supreme Court upheld the Cambridge Massachusetts Board of Health authority to require vaccination of healthy adults against smallpox due to the epidemic which could compromise the community. The plaintiff, Henning Jacobson, had refused the vaccination and was fined $5.00.

Unlike today, where chronic diseases account for most deaths, at that time, infectious disease was the leading cause of death and states administered public health initiatives. The FDA did not even exist at that time. Yet today, globalization, has essentially required immunizations from infectious diseases. COVID-19 is an example of a pandemic perhaps reminiscent of earlier time periods in history.

COVID-19: Critical Issues Facing the United States and the World

January 28, 2021 | Live@ Noon EST / 9:00am PST / 16:00 GMT / 17:00 CET  
Online Live 

WEBINAR: COVID-19: A must for anyone in the regulatory field both in industry and local, state and federal government. #FDA#FDAlaw#covid#webinar#cfpatraining

Webinar presented by: Roseann Termini COVID-19: Critical Issues Facing the United States and the World

COVID-19: Critical Issues Facing the United States and the World

This 60-minute accredited webinar will cover the following:
– Overview of Key Terminology-impact of COVID-19 
– Numbers Surge and Direction from the Federal Government
– Update on Diagnostics
– Controversy over Telethermographic Systems (Body Temperature Assessment)
– Science vs. Politics
– EUA Recent and Horizon
– Efficacy
– COVID-19 Approval
– Immunity
– Tracing, Tracking
– Impact of the Executive Order regarding Slaughterhouses
– Lessons Learned Globally
– Known and Unknowns
– Solutions

In-Person Course

Who Should Attend?
This course is a must for anyone in the regulatory field both in industry and local, state and federal government: 
– Regulatory affairs
– Quality assurance and control
– Drug representatives
– Managers
– Sales personnel
– Manufacturers
– Physicians
– Pharmacists
– Health care providers and practitioners
– Attorneys, In house counsel
– Risk managers; enforcement personnel; and compliance teams 

COVID-19 Impact on the Regulated Industry and Regulators

COVID-19-Impact on the Regulated Industry

COVID-19-Impact on the Regulated Industry
Date: November 18, 2020 
Time: Live 12:00pm (EST) / 9:00am (PST) / 17:00 (GMT) / 18:00 (CET)
Location: Webinar/Online

Join us for a unique opportunity to find out more about the COVID-19 pandemic in this nearly daily changing landscape. What you think applies today might change drastically tomorrow. This webinar will explore recent FDA activity regarding COVID-19 including an upcoming program discussion on inspections and other enforcement methods in the COVID-19 ERA. This is a Free CfPA Exclusive FREE Webinar.

Can’t make the LIVE webinar? Register now and we’ll send you a copy of the recording.

Registration Link:

Presented by: Roseann B. Termini, B.S., Ed. M., J.D. 
Ms. Termini has extensive experience in food, drug, medical devices, personal care, dietary supplement, tobacco and veterinary products regulation. Ms. Termini recently published a new comprehensive edition, both in print and E-book formats, of Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products (2019). Ms. Termini is also a featured speaker at international and national conferences and webinars.

FDA COVID-19 Treatment Approval

First FDA Approval for COVID-19: Veklury (remdesivir), an antiviral drug, manufactured by Gilead. It is for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. 

The FDA granted Gilead’s application Fast Track and Priority Review designations. Further FDA granted this application a  Material Threat Medical Countermeasure Priority Review Voucher. This means additional incentives because COVID-19 falls within this category; that is, medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats. It is important to mention that this approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) (issued on May 1, 2020). 

NOTE—FDA had granted Gilead Sciences Orphan Drug status for remdesivir and orphan designation for the “Treatment of coronavirus disease 2019 (COVID-19)” (March 23, 2020) which means tax advantages and exclusivity; however, in an unusual twist,  Gilead requested on March 25, 2020 that FDA rescind orphan drug designation.


This week, on Wednesday October 21, from 1-4pm, the FDLA, Delaware Law will be virtually hosting its “All Matters FDA” Symposium which will host a variety of speakers from professors, to judges, to other professionals in the field to discuss a range of topics such as: opioids and pharmaceuticals, COVID-19, vaping, cannabis law, and pet products. Just follow the link below to register. Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.

The Symposium will be hosted over zoom, and a link will be sent out beforehand.

Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.