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

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

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 >

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

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