FDA Emergency Use Authorization

https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

FDA Press Release

For Immediate Release:February 27, 2021

On Feb. 27 the U.S. Food and Drug Administration issued an #emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”

FDA Evaluation of Available Safety Data

The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death. 

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

#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. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-janssen-biotech-incs

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.

https://vaers.hhs.gov

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.

COVID-19, CBD, VAPING, PET PRODUCTS SAFETY, OPIOID EPIDEMIC

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.

Prison Sentences- Peanut Corp.of America Salmonella Tainted Peanut Products

Update-Sentences Affirmed on January 23, 2018 Corp. Executive Liability Sentence Largest Ever in Food Safety History 

AFFIRMED:  See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018)  Click on the link for the appellate court decision. Court of Appeals Opinion

Former Peanut Corporation of America (PCA) President and Owner Stewart Parnell received a criminal prison sentence of 28 years in connection with the 2009 salmonella poisoning outbreak of 700 reported cases in 46 states. Expert evidence presented at trial detailed that there were nine deaths linked to PCAs tainted products. Parnell’s brother Michael received a 20 year prison sentence. The Quality Assurance employee received a 5 year sentence. They were sentenced based on their roles at PCA by shipping salmonella-positive peanut products and by falsifying microbiological test results.  A federal jury convicted the Parnell brothers in September 2014 on several counts of conspiracy, mail and wire fraud as well as selling misbranded food. Stewart Parnell was also convicted for introducing adulterated food into interstate commerce.  Stewart Parnell and Quality Assurance Manager Mary Wilkerson were also convicted of obstruction of justice. According to U. S. Justice Attorney Moore, “The sentence that was handed down today [Sept. 21, 2015] means that executives will no longer be able to hide behind the corporate veil”. The direct link to the sentences in the Parnell Salmonella Tainted Peanut Product case is below and court of appeals opinion above.

AFFIRMED:  See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018 (affirmed)). Click on the link Court of Appeals Opinion

http://www.justice.gov/opa/pr/former-peanut-company-president-receives-largest-criminal-sentence-food-safety-case-two