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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…

Every Child By Two Co-founder and President Rosalynn Carter Celebrates 90th Birthday

August 18, 2017 1 comment
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Every Child By Two Co-founders Rosalynn Carter (right) and Betty Bumpers (left).

Every Child By Two’s beloved co-founder and President, Rosalynn Carter, is celebrating her 90th birthday today.  

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Mrs. Carter continues to inspire all who know her through her persistent commitment to the health and well-being of people throughout the world. Her compassion for those in need is the motivating force that drives the Every Child By Two (ECBT) staff to ensure that everyone, at every age, is protected against vaccine-preventable diseases.
Many of our fellow advocates have had the pleasure of meeting Mrs. Carter over the past forty years as she traveled to every state in our great nation alongside her good friend and fellow Every Child By Two Co-founder Betty Bumpers.

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In each town they visited, she and Mrs. Bumpers met with public health and community leaders.Together they discussed immunization challenges and helped to build immunization coalitions across the nation.  Many of these coalitions still exist today and continue the important work of ensuring that the public and healthcare providers are educated about infectious diseases and the vaccines that prevent them.

Through her work at the Carter Center and the Rosalynn Carter Institute For Caregiving, she continues to advocate for mental health, caregiving, global health, human rights, and conflict resolution.

Over the past twenty-six years, Mrs. Carter has unfailingly supported the staff and board in our efforts to fulfill the critical mission of Every Child By Two and the Vaccinate Your Family program.  

Thank you Mrs. Carter for all that you have done, and continue to do, to help people throughout the world.

You mean the world to all of us!

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If you would like to join Every Child By Two in our efforts to ensure that all children and their families receive timely immunizations consider

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!

Every Child By Two Delivers Critical Message to Legislators

June 27, 2017 2 comments

Every Child By Two will also be making a special presentation on Capitol Hill today, alongside experts from the CDC, AAP and Children’s National Health System.

The panelists will discuss concerns regarding the vaccine-preventable diseases that continue to infect American children and debunk misinformation about vaccine safety.   Every Child By Two’s Executive Director, Amy Pisani, will explain the impact that proposed cuts in vaccine funding and changes to the healthcare replacement bills will have on efforts to protect the American public from deadly preventable diseases.

Please contact your legislators and suggest they attend this special Childhood Immunization Presentation at 2322 Rayburn House Office Building between 3-4 pm today, June 27th.  (You can also tune into Facebook Live by following the Vaccinate Your Family Facebook page where we have provided live feed coverage of the meeting).  

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Given the continuing discussions on health care reform, Every Child By Two believes it is more important than ever to re-circulate their State of the ImmUnion report to our nation’s legislators.  This report details our country’s current abilities to control and respond to vaccine-preventable diseases.

It’s important that legislators understand that preserving funds for the Vaccines For Children (VFC) program was an important first step in protecting the nation against deadly infectious diseases, but it’s not enough. Proposed funding cuts to Medicaid, the Prevention and Public Health Fund (PPHF), and the Centers for Disease Control and Prevention (CDC) would:

  • Directly cause the understaffing and potential closure of health clinics across the country.
  • Prevent pregnant women from accessing crucial vaccines to prevent whooping cough and flu in their newborns. About half of babies younger than one year of age who contract whooping cough need care in the hospital, and 1 out of 100 babies who get treatment in the hospital die.  Additionally, in the 2016-2017 influenza season, 101 children died as a result of the flu.
  • Place adults at risk of vaccine-preventable disease. Influenza and pneumonia, both of which are vaccine-preventable, are currently the eighth most common cause of death among adults in the U.S. Treatment of adults for influenza, pneumonia, pertussis and influenza costs the U.S. $27 billion annually in unnecessary healthcare costs.
  • Reduce the management of the $4.3 billion investment in government-purchased vaccines for children. Administration of the VFC program is funded by Section 317 dollars which are subject to significant cuts in funding.

Ongoing outbreaks of measles, whooping cough, and flu are stark reminders that even small drops in vaccination rates can have devastating consequences.

This is why Every Child By Two is taking steps to encourage federal legislators to put the health of our nation first by fully funding CDC, replacing the PPHF, and maintaining a strong safety net through the preservation of Medicaid.  

 

 

101 Empty Chairs

June 23, 2017 1 comment

By Serese Marotta, Chief Operating Officer, Families Fighting Flu

Sadly, the Centers for Disease Control and Prevention (CDC) have reported that the 2016/2017 flu season has now claimed the lives of more than 100 children. 101 to be exact.  This statistic is hauntingly familiar – three of the past five flu seasons also claimed the lives of more than 100 children.

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Sometimes we forget what these numbers really mean.

It means that 101 families had to bury their beloved children; 101 families have to listen to the deafening sound of silence left by their lost loved ones; and 101 families now have empty chairs at their dinner tables every night.

I paint this picture because I know how these families feel. They’re probably thinking the same thing I did after my son died from the flu – how did this happen and what could I have done to prevent it? 

Unfortunately, unless flu has personally touched your family like it has mine, chances are you’re not all that worried about flu.  You may even think it’s just a bad cold. Well, as the mother of a child who lost her five-year old son to flu, I’m here to tell you, “Not so“.

According to the CDC, flu kills more Americans every year – up to 56,000 people – than any other vaccine-preventable disease.  Since 2004, when the CDC started reporting pediatric flu deaths, 1,466 children – many of whom were otherwise healthy – have lost their lives to flu.

Flu is that infectious disease that seems to fly under the radar. While everyone is focused on the latest outbreak of measles, mumps, pertussis or meningitis, flu is that one disease that we know we will have an outbreak of each and every year.  As prevalent as flu is, it still manages to creep up like a quiet thief in the night, stealing our loved ones right out from under our noses.  And yet when it does, we wonder why we never saw it coming.  Flu has killed millions of people worldwide – and it will continue to do so for the foreseeable future.

So what can we do to protect ourselves and our loved ones from influenza each year?  Annual vaccination.

Studies show that flu vaccination can reduce the likelihood of death and hospitalization from flu in people of all ages.  Yet, less than half of Americans get their annual flu vaccine.   Read more…

Contact Your Senator to Prevent Devastating Cuts to Immunization Programs

June 15, 2017 2 comments

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Every Child By Two has a long history of advocating for immunization funding and strong immunization policies. As the Senate is now considering two crucial pieces of legislation — the American Health Care Act (AHCA) and the Fiscal Year (FY) 2018 budget — we are calling upon the public to speak out in support of #PreventionProtection. Both of these pieces of legislation could impact vaccine programs in a way that limits access for millions of Americans.

It is critical that we help Senators understand the impact of their legislation on public and individual health before they finalize the bill language. Time is of the essence, so we are encouraging everyone to take action this week.

Please call AND email your Senators TODAY with this critical message:

Call your Senators to say:

I am a constituent and am calling to urge Senator X to ensure CDC’s immunization programs continue to be fully funded, both through direct appropriations and through preservation of the Prevention and Public Health Fund.

It is also critical to preserve first dollar coverage in private health plans and Medicaid. Coverage for vaccines is critical to our nation’s health and integral to accessing cost-saving and potentially life-saving vaccines.

Please support public health funding and oppose any aspects of the American Health Care Act which would slash these critical investments.

To ensure your Senator is getting the message, follow-up with an email that reads:

Read more…

Why Should Vaccinated Individuals Worry About Measles Outbreaks?

The United States is well on our way to a record year for measles cases.  So far in 2017, we’re on track to see more cases this year than last year.

In the state of Minnesota alone, where a Somali-American community was encouraged to refuse MMR vaccine during visits from Andrew Wakefield and other vaccine critics, a drop in vaccination rates has resulted in a dangerous measles outbreak.  So far, the Minnesota Department of Health has identified 66 total cases spread among four counties, with many cases involving the hospitalization of children.

SOTI-MeaslesCasesIG As the number of measles cases in MN is expected to climb, health departments across the U.S. are beginning to identify other measles cases as well.

For instance, the Maryland Department of Health is investigating a potential outbreak after a patients was admitted to Children’s National Medical Center in the District.  The patient had previously sought medical treatment at Prince George’s Hospital Center in MD, exposing countless people in that area as well.  Meanwhile, a teenaged tourist staying in a NJ hotel contracted measles, and now the New Jersey State Health Department fear other people may have been exposed before the patient was treated at The Valley Hospital in Ridgewood, NJ.

With measles cases emerging across the U.S., and large-scale outbreaks of measles being reported by the World Health Organization in places like Romania and Italy, it’s important to ask if measles outbreaks should be a concern to those who are vaccinated.  

Aren’t vaccinated individuals protected during outbreaks?  And if so, why should we care if others remain unvaccinated?

When it comes to infectious diseases like measles, one person’s decision not to vaccinate can negatively impact the health of others.  There are plenty of unvaccinated individuals who rely on protection from the vaccinated, to include children under one year of age who are too young to be vaccinated for measles, individuals who have medical reasons that restrict them from being vaccinated, or people with compromised immune systems.  These individuals are all at great risk of contracting measles and suffering serious complications and the only protection they have comes from those who are vaccinated.

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In fact, in order to keep measles from spreading, about 92-95% of the population needs to be immune to the disease.  Unfortunately, in the case of measles, even small pockets of un-immunized individuals can threaten the herd immunity threshold.  This is exactly why we are seeing an outbreak in Minnesota.

What’s the big deal?  Is measles even that dangerous? Read more…