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Evaluating the Safety of Flu Vaccination in Pregnancy

September 18, 2017 Leave a comment

The decision to get a flu vaccination in pregnancy is one that should be based on a complete evaluation of the scientific evidence that is available.  Flu shots have been safely administered to millions of pregnant women over many years, so how should expectant parents respond to a recent study that implies a connection between multiple flu vaccinations and the incidence of miscarriage in early pregnancy?  

To properly evaluate the significance of the latest data, we must consider the findings of this one report alongside the abundance of other science-based information we have, such as: 

  1. Why the Advisory Committee on Immunization Practices (ACIP) currently recommends flu vaccination among pregnant women.
  2. Data from the numerous studies that support the safety of the ACIP’s current recommendation of flu vaccine for pregnant women.
  3. Details of the “case-control” study in question and an examination of the study methods, findings and limitations.

Why the ACIP recommends flu vaccination among pregnant women.  

Currently the CDC’s Advisory Committee on Immunization Practices (ACIP) recommends that pregnant women get a flu vaccine during any trimester of pregnancy to help protect them and their newborns from the dangers of influenza.  Due to changes in the immune system, heart and lungs during pregnancy, expectant women are more prone to severe illness from flu, which has been known to result in premature delivery, low birth weight babies, miscarriage, hospitalization or even death.

Flu vaccination in pregnancy doesn’t just help protect the expectant mother from influenza, it is also the most effective way to pass critical immunity on to the baby during pregnancy.  This passive immunity can then protect the infant child from the dangers of influenza in the time before they are old enough to receive their own flu vaccination at six months of age.

The ACIP recommendation for flu vaccination during pregnancy is supported by other organizations as well, to include The American College of Obstetricians and Gynecologists (ACOG) and the American College of Nurse-Midwives (ACNM).

The studies that support the safety of flu vaccination in pregnancy. 

The ACIP is a committee which consists of 15 voting members who have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and preventive medicine.  The Committee meets in person three times a year and subcommittees meet regularly throughout the year via conference call to discuss vaccine research and scientific data related to vaccine effectiveness and safety.

The current ACIP recommendation for flu vaccination during pregnancy is based on a thorough review of the evidence compiled from numerous studies, which include the following:

    • A review of reports to the Vaccine Adverse Reporting System (VAERS), a national vaccine safety surveillance program run by CDC and the Food and Drug Administration (FDA), (Moro et al, 2011) which found no unusual or unexpected patterns of reporting for pregnancy complications or adverse fetal outcomes among pregnant women and flu shots.
    • A study using Vaccine Safety Datalink (VSD) data (Irving et al, 2013) which found no increased risk of miscarriage among pregnant women who received flu vaccines in the 2005-06 or 2006-07 flu seasons. (The VSD is a collaborative program that monitors the safety of vaccines and conducts studies about rare and serious adverse events following immunization.)
    • A large study using VSD data (Kharbanda et al, 2013) which found no increased risk for adverse obstetric events (like chorioamnionitis, pre-eclampsia, or gestational hypertension) for pregnant women who received the flu vaccine from 2002 to 2009 compared to pregnant woman who were not vaccinated.
    • A VSD study (Nordin et al, 2014) which compared pregnant women who received the flu shot with an equal number of pregnant women who did not receive the flu shot during the 2004-05 and 2008-09 flu seasons. The study found no differences between the two groups in the rates of premature delivery or small for gestational age infants.
    • A large August 2017 study using VSD data which found that the babies of women who received the flu shot during their first trimester had no increased risk of having children with major birth defects.

The examination of vaccine safety is an ongoing process.  Before being approved for administration, vaccines undergo rigorous testing by their manufacturers, the FDA, and the FDA’s Center for Biologics Evaluation and Research. Clinical trials are performed before the vaccine is made available to the public, to confirm the vaccine’s safety and efficacy. Even after the vaccine receives FDA-approval, post-licensure studies are conducted on an ongoing basis to continually monitor the vaccine’s safety and to detect and respond to any rare adverse events.

While the studies conducted to date have not signaled any safety concerns, the ACIP and the CDC are committed to the continuous evaluation of the safety of all vaccines, to include those recommended for pregnant women.

This has led to the “case-control” study of flu vaccination and possible miscarriage which was recently published in the journal Vaccine on September 12, 2017 and reported on by The Washington Post, the Associated Press, and various other media outlets.  The study showed that women in early pregnancy who received two consecutive annual vaccines during 2010-11 and 2011-12, both of which included a 2009 pandemic H1N1 (H1N1pdm09) component, had an increased risk of spontaneous abortion (miscarriage) in the 28 days after receiving the second vaccine.

Details of the recently published study of women who had miscarriage following flu vaccination. 

Read more…

5 Things Expectant Parents Need to Know About Vaccines in Pregnancy

August 10, 2017 1 comment

The more we learn about fetal development, the more advice women seem to get on what to do, and what to avoid, while pregnant.  Of course, all this information can be overwhelming, especially when preparing for the arrival of your first child.  While well-meaning friends and family will provide a constant stream of advice, 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.   

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Here are 5 things these organizations say about the flu and Tdap vaccines routinely recommended during pregnancy:

1) Maternal vaccine recommendations serve a dual purpose.  

The first reason is to protect the mother.  Changes in a woman’s immune, heart, and lung functions during pregnancy make her more likely to get ill and suffer severe complications from illnesses as compared to non-pregnant women.  In fact, a pregnant woman is five times as likely to suffer complications or death from flu compared to non-pregnant women.  Additionally, if a woman should fall ill during pregnancy, she has a greater chance of hospitalization, spontaneous abortion or complications that can directly impact the health of her baby such as preterm labor and delivery, and low birth weight babies.

The second reason is to protect the baby.  If a woman becomes sick before, during, or even shortly after delivery, she can easily pass a disease on to her baby.  New moms spend a great deal of time in close proximity to their newborn babies, so it is understandable that they might share infections. But infections like flu and pertussis, also known as whooping cough, are not just a threat to a new mother.  They can also be extremely dangerous, and even deadly, to young children.

2) Vaccination timing is important.  

Getting vaccinated during each pregnancy (as opposed to before or after) enables a woman to pass on protective antibodies to her developing baby that can then provide short-term protection against flu and pertussis until the baby is old enough to get their own vaccines.  

The best time for a pregnant woman to get a Tdap vaccine is between 27 and 36 weeks of each pregnancy, with the earlier part of this time period being most preferable.  This preferred vaccination window is based on studies of the cord blood of babies whose mothers received Tdap vaccine in pregnancy and the associated levels of pertussis antibodies detected in that cord blood.  Often times, adults are unaware that they have a pertussis infection, which is why the infection can easily be passed on to babies.  Babies are especially vulnerable to the disease because they only begin getting their own DTaP vaccination to prevent pertussis at 2 months of age.  But even then, they need an additional four doses at 4 months, between 6-9 months, between 12-15 months and again between age 4-5 before they are fully immunized.  The antibodies they receive from their mother helps protect them in those early months after birth.

An inactivated flu shot is recommended for pregnant women at any trimester of each pregnancy.  However, the best time to get a flu vaccine is before the season begins, so that the mother, who herself is at great risk of flu complications, is fully protected before flu activity begins to elevate in her community.  . Since it takes about two weeks after vaccination for antibodies to develop in the body that protect against flu virus infection, it is best for pregnant women to get vaccinated by the end of October, if possible.  Unfortunately, flu vaccines are not recommended until a child is 6 months of age, which is why the protection a child gets from his or her mother is critical to keeping that child flu-free until they can receive their own vaccine.

3) Maternal vaccines protect against two serious illnesses; whooping cough and flu.

Read more…

Help Stop Devastating Cuts to Immunization Infrastructure

July 20, 2017 18 comments

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The House is moving forward on budget proposals for Fiscal Year 2018 (FY18) and has suggested a $50 million cut to immunization funding to the Centers for Disease Control and Prevention (CDC).

This could mean serious reductions in our country’s and states’ abilities to:

  • Support the science that informs our national immunization policy;
  • Provide a safety net to uninsured, low-income adults by enabling vaccine purchases;
  • Monitor the safety of vaccines;
  • Educate healthcare providers;
  • Perform community outreach; and
  • Conduct surveillance, laboratory testing and epidemiology in response to disease outbreaks.
With the U.S. currently facing costly outbreaks of vaccine-preventable diseases such as measles and pertussis (also known as whooping cough), now is not the time to weaken the backbone of our nation’s public health infrastructure.
We are not asking for a funding increase, we are simply asking that Congress not reduce current levels of immunization funding.
States have already had to make tough decisions because of a $4 million cut in funds in the 2017 budget.

Please call your Representative today and tell him or her:

“Please reject the proposed $50 million cut to the CDC Immunization Program and maintain level funding for FY18. A funding reduction would have serious consequences for communities across the country at a time when outbreaks of vaccine-preventable diseases such as measles are on the rise.”

SOTI-Report_Cover.pngYou can also reference Every Child By Two’s State of the ImmUnion report to examine how strong our defenses truly are against vaccine-preventable diseases and what we can do, as public health advocates and legislators, to make our ImmUnion stronger and more resilient in the face of emerging health threats. You may even want to share this report with your Representative since it highlights the successes of vaccines, the economic and societal savings incurred from vaccines, challenges facing the public health system and key areas that we need to focus on to achieve optimal protection against vaccine-preventable diseases.

Please use Who Is My Representative? to quickly find your Member of Congress in the House.

Thank you for your continued support of immunizations and their critical role in protecting our health!

Updates from June 2017 Meeting of the Advisory Committee on Immunization Practices

July 13, 2017 2 comments

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Recently, the Advisory Committee on Immunization Practices (ACIP) met to discuss several important developments concerning vaccines. As you may be aware, this impartial group of experts advises the U.S. Centers for Disease Control and Prevention (CDC) on all matters related to vaccine recommendations. In the coming years, the ability of the CDC and public health departments to implement the recommendations of this group may be under threat from proposed provisions within the health care reform bills and congressional budget cuts.

The activities of the ACIP are supported by staff at the CDC, which receives annual appropriations from the federal government to fulfill its duties.  This federal immunization funding is at risk of being drastically cut if the Prevention and Public Health Fund (PPHF) is eliminated. (Click here to see a breakdown of the impact of the elimination of the PPHF funds by state.) If Congress follows the recommendation of the President, funding will be reduced by another 14% beginning in Fiscal Year (FY) 2018.

The result is that CDC may no longer be able to fully support its immunization functions including:

  • ACIP staffing;
  • Vaccine purchase and supply management;
  • Vaccine safety monitoring;
  • Education initiatives;
  • Disease surveillance;
  • Outbreak response; and
  • Funding support for state, territory, and city immunization programs.

An example of the critical activities conducted by the CDC includes support for the ACIP.  This committee of experts from diverse fields such as vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and\preventive medicine meets three times a year to review and discuss vaccine research and scientific data related to vaccine effectiveness and safety, clinical trial results, outbreaks of vaccine-preventable disease or changes in vaccine supply.

There are 15 voting members, 8 ex officio members who represent other federal agencies with responsibility for immunization programs in the United States, and 30 non-voting representatives of liaison organizations that bring related immunization expertise. All members volunteer their time and come from many leading professional and public organizations such as the American Academy of Pediatrics, the National Foundation for Infectious Diseases, and the American Geriatrics Society. This is the only meeting to gather such a comprehensive group of experts whose aim it is to protect individual and public health.

The current health care reform discussions that are happening in Congress may have a direct impact on this Committee. Please continue to reach out to your Representatives and Senators to let them know the importance of keeping PPHF and CDC fully funded. (You can find your Members of Congress at http://whoismyrepresentative.com/ and some suggestive language to share here.) 

The value of the ACIP can not be overstated. During their most recent committee meeting in June, members discussed several important issues recapped in the summary below.

Read more…

How My Sister Helped Save My Daughter From Whooping Cough 

June 19, 2017 20 comments

TamaraSheffieldHeadShotBy Tamara Sheffield, MD, MPA, MPH, Medical Director, Community Health and Prevention, Intermountain Healthcare

In my role as a medical director at Intermountain Healthcare in Salt Lake City, Utah, I am responsible for Community Health and Prevention.  You could say that I’m a professional advocate for immunizations, since they prevent many illnesses, hospitalizations and even deaths.  In fact, maternal immunizations are one of today’s most promising new preventive health strategies.

By vaccinating pregnant women against certain diseases – like whooping cough (pertussis) and influenza – we are reducing the amount of illness, hospitalization, miscarriage and pre-term labor these women experience as a result of these diseases.

Additionally, maternal vaccines enable pregnant women to pass on protective antibodies to their unborn babies.  These antibodies provide newborns with early, short-term protection against pertussis or flu, during the time when they are too young to receive their own vaccines to prevent these diseases.

For instance, children must be six months of age before they can receive their first flu vaccination, and the DTaP vaccine, which helps prevent whooping cough in children, is administered as a series of five shots (with doses at 2, 4, 6, 15-18 months, and 4-6 years of age). Sadly, there are about 100 pediatric deaths due to influenza each year, and 90% of all deaths associated with whooping cough are among infants, mostly because the thick mucus that accompanies the infection has a severe impact on a baby’s ability to breath.

For an expectant woman, changes in the immune system, heart and lungs during pregnancy make them more prone to illness.  When a pregnant women gets ill, it raises her risk of complications, such as premature labor and delivery.  But research shows that mothers can help protect themselves and their babies by getting vaccinated during pregnancy.

The flu vaccine is recommended at any trimester of each pregnancy. An adult Tdap booster vaccine is recommended during each pregnancy as well – and studies show that the best time for optimal transfer of protective antibodies is at 27-to-36 weeks gestation. The ongoing research continues to indicate that these maternal immunizations are effective at reducing the number of flu and whooping cough-related illnesses, hospitalizations and deaths among infants.

The abundance of scientific evidence on this matter is one reason I am a strong advocate for maternal vaccinations.  However, I have a very personal reason to advocate for maternal vaccinations as well.

You see, I know an amazing 25-year-old young woman who nearly died from whooping cough when she was just three weeks old. 

Alicia Outside ICU at Phoenix Childrens' Hospital

Like many infants who suffer with whooping cough, this beautiful baby girl contracted it from a family member.  During the weeks before delivery, her mother developed a persistent cough that went undiagnosed, and she unknowingly passed whooping cough on to her baby.  Three weeks later, after a couple of incidents where the baby stopped breathing and turned blue, her parents rushed her to the hospital. Read more…

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

It’s not uncommon for a parent who has lost a child to a vaccine preventable disease to try to spare other families from the same agonizing heartache. 

In some cases, these children may have suffered with a preventable disease because they 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 in the case of Riley Hughes, infants who were too young to be fully vaccinated.

Riley was a healthy baby boy born in Australia on February 13th, 2015.  At three weeks of age he started exhibiting cold-like symptoms with an occasional cough. When he was just 32 days old, Riley passed away in the arms of his parents.  

pertussis112315While in the hospital, Riley was diagnosed with pertussis, also known as whooping cough.  At that time, the U.S., the UK, Belgium and New Zealand, were already advising expectant women to get an adult Tdap vaccine at 28-32 weeks of pregnancy in order to transfer protective antibodies to their unborn babies.  This practice helps protect infants from pertussis at a time when they are most vulnerable to infection and subsequent complications.  It’s also the only way newborns can benefit from some protective antibodies before they are two months of age and begin receiving the first of five doses of DTaP vaccine to become fully vaccinated against pertussis.

Unfortunately, the Australian government hadn’t adopted this practice until shortly after Riley’s death. Since then, Riley’s parents have made it their mission to educate people about the dangers of whooping cough, and promote the need for vaccination so that no other family would have to suffer like they did.

Sadly, there are still some parents who choose not to vaccinate.  In a plea to these parents, Riley’s mom posted the following list of “things to know” on the Light for Riley Facebook page:

 


Ten things I want parents who don’t vaccinate their kids to know:

1. There are no cures for most of the diseases we vaccinate against.

2. Even if you choose not to vaccinate, please, please, please make yourselves aware of the symptoms of these potentially fatal diseases. Infections like meningococcal can kill within 24 hours, and every minute counts.

12244586_1518881475089295_4527321516860468835_o3. If you’re really worried about vaccine “toxins”, you don’t want to see what the toxins from Bordetella Pertussis (the bacteria responsible for whooping cough) can do. Trust me – I watched my newborn son die from it. Read more…

Comprehensive Vaccine App Available on iPhones and iPads

If you’re looking for a comprehensive source of vaccine information, look no further than The Vaccine Handbook App, now available for Apple iPhones and iPads.

This free downloadable App serves as an enhanced digital version of the new 2017 (6th) edition of The Vaccine Handbook: A Practical Guide for Clinicians (often referred to as “The Purple Book”).  

This book, written by Dr. Gary Marshall, professor of pediatrics and chief of the Division of Pediatric Infectious Diseases at the University of Louisville, was first published in 2004.  Each edition of The Vaccine Handbook compiles a wide variety of information on vaccine science, guidance, and practice into one easily accessible user-friendly resource.

The App, which was first released a little over a year ago, was updated in April 2017 to contain the new 6th edition of the book and the program has been enhanced in many new ways. The electronic version of The Purple Book is fully searchable, with functionality that includes bookmarking, highlighting, user annotation and active links to content on the Internet. There is also a resource section in the App that complements the book with links to vaccine websites, governmental organizations, manufacturers, and various advocacy groups, including Every Child By Two.

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Dr. Marshall elaborates on the intent of the project by saying,

“From the beginning, the purpose of The Purple Book was to distill down the complex world of vaccine science and practice into something that practitioners could use, not just for optimizing implementation, but for deepening their understanding as well. It’s not just a “how to” guide; it’s a “how to and here’s why” book.”

The Purple Book is ideal for pediatricians, family physicians, internists, obstetrician/gynecologists, nurses, nurse practitioners, physician’s assistants, and clinical staff. Additionally, Dr. Marshall believes the publication can also be used as the basis for a vaccine curriculum for students and residents.  It can even be a useful resource to parents and patients. He explains,

“The content is expansive but the language is plain, simple, and accessible. It covers the rationale behind authoritative immunization recommendations as well as the many contingencies encountered in everyday practice. Beyond this, it provides a readable foundation on how vaccines are developed, tested, and licensed; how vaccine policy is made; what constitutes the vaccine safety net; standards and regulations; billing; office logistics; and much more. It can be read cover-to-cover, or section-by-section.”

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The book is divided into two sections. 

The first section includes, among other things; 

  • basic principles of vaccine immunology;
  • background on vaccine development, infrastructure and policy;
  • vaccination standards;
  • general vaccine recommendations and implementation;
  • vaccination schedules;
  • vaccination in special circumstances;
  • and most importantly, tips on addressing concerns about vaccines.

The second section contains details about every vaccine currently licensed in the United States, as well as; 

  • the burden and epidemiology of the respective diseases,
  • history of the immunization program,
  • vaccine constituents,
  • vaccine efficacy,
  • vaccine safety,
  • and vaccine recommendations.

MaryBeth Koslap-Petraco, Pediatric Nurse Practitioner and Adjunct Clinical Assistant Professor at Stony Brook University School of Nursing, had this to share about her recent experience using the App:

 “The App is perfect for accessing vaccine information without having to carry around the book. I was preparing a lecture for school nurses about vaccine hesitancy and I used the app on my phone. It was incredibly quick and easy to locate the information I was looking for in the index and then scroll to the specific pages I needed.  Upon opening the App I found the section buttons right on the first page.  I then went directly to the “Addressing Concerns” section which included information on vaccine refusal, communicating risks and benefits, and other topics related to vaccine concerns.  All of the information I needed, along with a complete list of references, was right in one place. If you’re someone who wants to have a full array of vaccine information at your fingertips, than I highly recommend that you download this App.” 

VaccineHandbookDr. Marshall adds,

“There are many vaccine resources, but The Purple Book is unique. It is replete with scientific background but it is not an academic textbook—at the same time, it is much more than just a compilation of facts and recommendations.”

The most recent version of this free downloadable App is sponsored by the Immunization Action Coalition and can be found by searching the iTunes App Store for “The Vaccine Handbook App” or by clicking the link here.  Download it today and let us know what you think in the comments below.

For anyone still interested in a hard copy of the book, they can be ordered directly from the App, in bulk from the publisher, or from the Immunization Action Coalition website at a cost of $34.95 each.