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Posts Tagged ‘Vaccine Oversight’

Most Popular Posts of 2017 Address Flu, Vaccine Safety, Disease Outbreaks and Maternal Vaccines

December 27, 2017 Leave a comment

As we look back at the success of the Shot of Prevention blog this past year, we’re especially grateful to our blog readers, contributors and subscribers.

Whether you’ve shared a post, shared your story, or shared your expertise, we recognize that our growth and success would not have been possible without your support. Thanks to you, our posts are helping people to make important immunization decisions for themselves and their families.

In these final days of 2017, we hope that you will revisit the top ten posts from the past year and share them with others in your social networks.  

1)  3 Things I’ve Learned Since Losing My Son To Flu

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It’s been eight years since Serese Marotta of Families Fighting Flu lost her five-year-old son, Joseph, to the flu. She’s not the same person she was eight years ago. Today, she sees things through a different lens as a bereaved parent. Losing a child is devastating, but she feels a responsibility to pass on some of the lessons she’s learned through her personal tragedy, which she does in her article here.

 

2)  10 Things Parents Who Don’t Vaccinate Their Kids Should Know

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In some cases, children who have suffered with a preventable disease were unvaccinated.  This could be the result of parents who did not have access to certain vaccines, parents who willfully refused a particular vaccine, or it could because they were too young to be fully vaccinated. After Riley Hughes passed away in the arms of his parents when he was just 32 days old, his parents made it their mission to educate people about the dangers of whooping cough, and promote the need for vaccination. In a plea to parents who still choose not to vaccinate, Riley’s mom posted the following list of “things to know” here.

 

3)  Even With All Our Modern Medicine I Watched My Sister Die From Flu

lizaLiza was healthy and only 49 years old when she contracted flu. She sought medical care early. She was cared for at a good hospital in a major city.  She had no other infections. And she was unvaccinated. To say that her death was a surprise to her brother is an understatement.  And yet her brother, Dr. Michael Northrop is a pediatric intensive care physician. His story traces the clinical course of Liza’s illness, and expresses the grief he felt as he helplessly watched his sister  succumbs to an illness that even modern medicine can’t always save us from. To read his story, click here.

 

4) Take It From This Mom, The Flu Is No Joke

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After her four-year old daughter is rushed to the emergency room, she writes a warning to others.  “The words just the flu need to be eradicated from our lexicon. Because this? This is the flu. There’s no ‘just’ about this. It was terrifying. It was the most helpless I’ve ever felt as a mommy. And it was potentially deadly.  All because I was too busy to get our flu shots.” Read the full story here.

 

5) Flu Vaccine Benefits Go Beyond Effectiveness of One Strain

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Amid speculation about how effective the flu vaccine will be this year, Dr. LJ Tan addresses some of the public’s most prominent concerns. He starts with a basic explanation of flu and flu vaccines, discusses the factors that play into vaccine effectiveness, and addresses rumors about this year’s flu vaccines. To gain a better understanding, read more here.

 

6) How My Sister Helped Save My Daughter From Whooping Cough

As a Medical Director responsible for Community Health and Prevention at Intermountain Healthcare in Salt Lake City, Utah, Tamara Sheffield is a huge advocate for SOTI_Pertussis_FBimmunizations. She is especially appreciative of maternal immunizations, which she considers one of today’s most promising new preventive health strategies. But her reasons go beyond her professional understanding of how maternal flu and Tdap vaccines pass on protective antibodies to newborns. Her surprising story ends with a twist involving her own daughter who nearly died from whooping cough when she was just three weeks old. Read it here.

 

7) Multiple Vaccine Oversight Committees Ensure Our Public Safety

While 2017 brought a lot of uncertainty about health services in this country, Dr. Dorit Reiss, Professor of Law at the University of California Hastings College of Law, explains 178_NFID_Vaccine_Safety_infograms_2_FINALwhy the public should remain confident in vaccine safety. In this post she reviews the specific ways in which vaccine safety is regulated in the U.S., and the oversight committees that monitor vaccines pre and post licensure. Her scrutiny explains that it would be hard to hide a problem if one existed, and that when problems do occur, they are quickly discovered and addressed. To learn more about vaccine safety oversight, read the full post here.

 

8) Why Should Vaccinated Individuals Worry About Measles Outbreaks

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With various measles outbreaks reported across the U.S. and the world in 2017, it’s important to understand why vaccinated individuals should be concerned. Many people mistakenly think that vaccinated individuals are not at risk during outbreaks. However, when it comes to infectious diseases like measles, one person’s decision not to vaccinate can negatively impact the health of others and this post explains how.

 

9) Five Things I’ve Learned About Vaccines Through 21 Years of Parenting

HowHerdImmunityWorksWe’ve all received plenty of unsolicited advice about how to care for our children. However, when making health decision for our families we should rely on evidence based research and credible information from reputable sources. In this post, I share five of the most important things I’ve learned about vaccines through my journey as a parent and immunization blogger. Spoiler alert: it begins with science and it ends with action.

 

10) Five Things Expectant Parents Need to Know About Vaccines in Pregnancy

SOTI-PregnancyCoverFBWhile well-meaning friends and family will provide a constant stream of advice on what to do and what to avoid while pregnant, all this information can be overwhelming. Expectant couples should rely on credible medical sources such as the CDC, the American College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse Midwives. This blog post reviews the 5 things these trusted organizations say about the flu and Tdap vaccines routinely recommended during pregnancy. Learn more here.

 

We hope you have found our content to be engaging and informative.  We have exciting changes planned for Shot of Prevention in 2018 in hopes of engaging even more people in these important immunization conversations in the years to come.  

If you have suggestions for topics you would like us to address in 2018, or you would like to contribute a guest post for publication, please email shotofprevention@gmail.com.

Also, if you want to receive important immunization news and join in our online discussions, be sure to “Like” our Vaccinate Your Family Facebook page, follow our @ShotofPrev Twitter feed and subscribe to Shot of Prevention by clicking the link on the top right of this page.

Thanks again for your continued support and best wishes for a happy and healthy new year!

Multiple Vaccine Oversight Committees Ensure Our Public Safety

January 11, 2017 126 comments
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This guest post has been written by Dr. Dorit Reiss, Professor of Law at the University of California Hastings College of Law.  Dr. Reiss is a regular contributor to various blogs and law journals, where she utilizing her legal expertise to examine the social policies of immunization.

Regulating Vaccine Safety, by Dr. Dorit Reiss

According to yesterday’s news reports, long-time vaccine critic Robert F. Kennedy, Jr. met with President-elect Donald Trump. 

screen-shot-2017-02-15-at-8-56-35-pmFollowing their meeting Kennedy reported that an offer was made to lead a new commission on vaccine safety and scientific integrity. As one would imagine, this has caused concern for immunization advocates and elation among anti-vaccine activists. It is, at this point, unclear whether Kennedy’s statements are true, as a Trump spokesperson issued an email statement that Forbes reported as follows:

“The President-elect enjoyed his discussion with Robert Kennedy Jr. on a range of issues and appreciates his thoughts and ideas. The President-elect is exploring the possibility of forming a commission on Autism, which affects so many families; however no decisions have been made at this time. The President-elect looks forward to continuing the discussion about all aspects of Autism with many groups and individuals.”

While Trump’s intentions in meeting with Kennedy may still be unclear, this is a good opportunity for us to review the specific ways in which vaccine safety is regulated here in the U.S., and the oversight committees that monitor vaccines pre and post licensure.

To begin, it is safe to say that vaccine safety is heavily regulated in the United States, with multiple systems overseeing the vaccine enterprise.

It would be hard to hide a problem if one existed. Further scrutiny reveals that vaccines are very safe and that when problems occur, they are quickly discovered and addressed.  It is important to also note that many of the same vaccines used in the U.S. are also studied and used in other countries. Even if the U.S. apparatus was completely flawed, it would be hard to hide any dangers in this age of global communications, intra-government collaboration and oversight.

Vaccine Regulation in the United States

The U.S. is a regulatory state and vaccines are no exception. The vaccine licensing process goes through multiple stages of vaccine testing and approval, as depicted in the CDC infographic pictured at right.journey-of-child-vaccine_sm.png

However, before a vaccine can even begin the clinical trial phase in humans, a request must be submitted to the FDA in the form of an Investigational New Drug application, which requires toxicology and animal data. (For more details on this regulation, you can refer to the resource here.)

This is followed by clinical testing, which is also heavily regulated as can be seen in a review of these references here and here.

While the FDA is underfunded and understaffed, and may not have the ability to constantly monitor all trials, companies know that FDA monitoring is to be expected and they must assume their trials will be reviewed.

Furthermore, once the clinical trials are complete, there is an additional layer of review. The sponsor and FDA present the results of the clinical trials to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). Most members of this committee are not part of the FDA; instead the committee is comprised of consumer representatives, as well as experts in relevant fields, many of whom work in universities or hospitals.  The current roster for the Committee can be found here.  The committee is further governed by the Federal Advisory Committee Act (FACA), which requires pre-announced public meetings.

After the licensing process is complete, there are several monitoring systems in place.  Read more…