#COVID-19 Update: #FDA Advisory Committee Meeting for Possible #Emergency Authorization #Janssen Biotech Inc.’s COVID-19 Vaccine

FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)to consider request by Janssen Biotech Inc.’s division of J&J. According to Acting FDA Commissioner Janet Woodcock, M.D.

 “A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines. 


FEB. 26 VRBPAC meeting will be livestreamed on YouTube, Facebook and Twitter channels and webcast the FDA website

Stayed tuned for Federal Register Notice for comment submission.

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: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

Letter of Authorization: https://www.fda.gov/media/144636/download

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: http://ow.ly/yxKU50Cuzaq 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: https://www.cfpa.com/CourseDescription/CourseDescription/2011907OL2974L/2974?utm_source=Listrak&utm_medium=Email&utm_term=Register+Now_2974&utm_campaign=2947_Free_1

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.