#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

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 First COVID-19 Vaccine Approval Comirnaty August 23, 2021

Link: https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

Approval Letter

Package Insert

FAQ for Comirnaty (COVID-19 Vaccine mRNA)

Press Release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Indication and Approval: The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

According to FDA “Comirnaty contains messenger RNA (mRNA), a kind of genetic material, used by the body to make a mimic of one of the proteins in the virus that causes COVID-19.” “The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material.” Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. 

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”