Category: COVID-19

Green Light Ahead-Novavax COVID-19 VACCINE

Vaccines and Related Biological Products Advisory Committee Meeting June 7, 2022 FDA Briefing Document Novavax COVID-19 Vaccine Link https://www.fda.gov/media/158912/download

The Vaccines and Related Biological Products Advisory Committee unanimously (one member abstained) voted to grant Emergency Use Authorization to Novavax (the Sponsor) for emergency use authorization (EUA) of the Novavax COVID-19 Vaccine for the treatment in people over the age of 18.

According to Peter Marks, MD, Director of FDA’s Center for Biologics Evaluation and Research: “We do have a problem with vaccine uptake that is very serious in the United States,”. “And anything we can do to get people more comfortable with these potentially life-saving medical products is something that we feel we are compelled to do.” This acknowledgment is a step in the right direction.

Next Steps- FDA will then determine whether to grant the EUA which will most definitely happen. Stay tuned.

#Vaccines, #Vaccination and a Tribute to a Historic Carousel

Photos of The Carousel at Pottstown, Pennsylvania

Did you know that Pottstown Pennsylvania boasts the 2nd oldest working carousel in the United States?  Read on to see the link to vaccines. 

Vaccines are far from a new phenomenon. Over two centuries ago, Edward Jenner was credited with inventing a vaccine to prevent smallpox. Other notable vaccines include Pertussis (1914) Diphtheria (1926), Tetanus (1938) combined at DTP in 1948. The licensing of the polio vaccine in 1955 was cause for celebration. Fast forward to early 2020, the dire necessity for a vaccine to combat COVID-19 became apparent as an unprecedented pandemic infiltrated the United States.  

The #COVID-19 pandemic has thrust vaccines in the forefront and unfortunately the United States passed one million deaths from COVID-19. Yet from the time the COVID-19 pandemic occurred, the United States has been a frontrunner in terms of prevention, vaccine licensure, authorizations and approved treatments not to mention the hundreds of diagnostic tests. 

What is the connection with the Carousel in Pottstown, Pennsylvania? Quite simply the answer is vaccines. Sadly, young Derek Saylor died from bacterial meningitis back in the 1990s. Eventually, the Pottstown community conceived the idea to revive the town with the Carousel. The significance is that the revitalization project was a success due to the generosity of Derek’s family. The family wanted to keep Derek’s memory alive and made a generous contribution to bring the carousel to fruition.  Finally, the Carousel is a fantastic venue and really brings home the strides the United States has made in vaccines to protect the public.

Useful Links: https://pubmed.ncbi.nlm.nih.gov/23444589/

www.carouselatpottstown.org

All Matters FDA March 31 Virtual Symposium

Food and Drug Law books  published 2022 new editions —Full Print and 12 Subject specific E-Books and a full print E-Book.  Please pass on to colleagues and anyone  you think would benefit.
https://fortipublications.com print and subject specific E-book links

1pm-5pm Virtual

Registration NOW OPEN >

all-matters-fda-2022Download PDF

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace. 

Moderator:

■   Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

■   Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas   —   Ethics and Professional Conduct

■   Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.   —   Food Law Cases

■   Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration   —   Enforcement

■   George D. Lapsley  —   Food Safety Expert  —   Court Appointed Expert – Miller’s Organic Farm 

■   Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration   —  
COVID-19 Vaccines

■   Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance   —   Enforcement

■   Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY    —   Pet Product Safety

■   Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School   —  
Symposium Director   —   Year in Review

■   Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration   —   FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

REGISTRATION NOW OPEN! All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Registration NOW OPEN >

all-matters-fda-2022Download PDF

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

■   Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

■   Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas   —   Ethics and Professional Conduct

■   Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.   —   Food Law Cases

■   Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration   —   Enforcement

■   George D. Lapsley  —   Food Safety Expert  —   Court Appointed Expert – Miller’s Organic Farm 

■   Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration   —  
COVID-19 Vaccines

■   Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance   —   Enforcement

■   Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY    —   Pet Product Safety

■   Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School   —  
Symposium Director   —   Year in Review

■   Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration   —   FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

UPDATE! All Matters FDA March 31 Virtual

UPDATE!

Save the Date March 31, 2022

1pm-5pm Virtual

Pre Registration: https://bit.ly/all-matters-fda-2022

all-matters-fda-2022-save-the-date

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

■   Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

■   Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas   —   Ethics and Professional Conduct

■   Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.   —   Food Law Cases

■   Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration   —   Enforcement

■   George D. Lapsley  —   Food Safety Expert  —   Court Appointed Expert – Miller’s Organic Farm 

■   Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration   —  
COVID-19 Vaccines    and    Alzheimer’s Aduhelm® Approval

■   Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance   —   Enforcement

■   Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY    —   Pet Product Safety

■   Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School   —  
Symposium Director   —   Year in Review

■   Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration   —   FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Brook Duer, JD, Pennsylvania State Univ., Center for Agriculture Law

Michael Helbing, JD, Office of Chief Counsel, U.S. Food and Drug Administration

Peter Marks, MD, PhD, Director, Center for Biologics, U.S. Food and Drug Administration

Christopher Mondics, Moderator

Matthew Noonan and Lillian Hsu, FDA Preventive Controls (PC) experts in CFSAN Office of Compliance, U.S. Food and Drug Administration  

Jessica Sleater, Esq. Veterinary Medicine, Pet Products

Roseann B. Termini, Esq., Food and Drug Law Cutting Edge Issues including Vaping

Julia C.Tierney, JD, Chief of Staff, U.S. Food and Drug Administration

Further Info. Roseann Termini: rbtermini@widener.edu

COVID-19 Treatment— FDA Issued Emergency Use Authorization to Pfizer

FDA granted the first oral treatment on Dec. 22. The FDA authorized Pfizer’s, Inc.’s (Pfizer) request that the Food and Drug Administration (FDA or Agency) issue an Emergency Use Authorization (EUA) for PAXLOVID (nirmatrelvir co-packaged with ritonavir) for treatment of mild-to-moderate COVID-19 in some adults and pediatric patients under the official Section 564 of the Federal Food, Drug, and Cosmetic Act codified in 21 U.S.C. §360bbb-3).

Here is the direct link to the EUA letter. https://www.fda.gov/media/155049/download

In the press release, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research remarked:

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

Direct Link to press release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

CDC Recommends COVID-19 Vaccine for Pediatric Ages 5-11

CDC Director Rochelle P. Walensky, M.D., M.P.H., followed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that children ages 5 to 11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine. 

What this Means—Recommendation applies to about 28 million children in the United States in this age group

When—as soon as possible. 

https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html

Risk—Direct Link

https://www.cdc.gov/coronavirus/2019-ncov/faq.html#Children

FDA Advisory Committee Votes in Favor of COVID-19 Pfizer Vaccine for Ages 5-11

The FDA’s Vaccines and Related Biological Products Advisory Committee (FDA Vaccine Advisory Committee ) voted 17-0 (one abstention) to approve the use of the COVID-19 Pfizer Vaccine for Ages 5-11 using a risk/benefit approach. If authorized, the dosage would be a lower dose than for adults.

Next Steps- FDA would have to agree with the FDA Vaccine Advisory Committee recommendation. Next the Centers for Disease Control and Prevention’s (CDC) independent advisory committee (Advisory Committee) will meet in early November and vote on whether to recommend the vaccine for this age group. Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or perhaps amend the Advisory Committee’s recommendation.

Here are Direct Links for Review:

FDA Briefing Document and Meeting
EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age Vaccines and Related Biological Products Advisory Committee Meeting October 26, 2021 https://www.fda.gov/media/153447/download and https://www.youtube.com/watch?v=laaL0_xKmmA