Evaluating the Safety of Flu Vaccination in Pregnancy
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:
- Why the Advisory Committee on Immunization Practices (ACIP) currently recommends flu vaccination among pregnant women.
- Data from the numerous studies that support the safety of the ACIP’s current recommendation of flu vaccine for pregnant women.
- 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:
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- 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.
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- 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.)
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- 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.
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- 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.
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- 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.
Every Child By Two Co-founder and President Rosalynn Carter Celebrates 90th Birthday
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.
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!
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
Some Things You Outgrow as an Adult. Vaccines Aren’t One of Them.
Did you know that vaccines are recommended for people of all ages?
Even if you were fully vaccinated as a child, the protection from some vaccines you received can wear off over time and you may need a booster. There also are specific vaccines that you may need as you get older based on your age, job, lifestyle, travel, or other health conditions.
Below are 5 reasons adults need vaccines:
1) Every year, thousands of adults in the U.S. suffer serious health problems, are hospitalized, or even die from preventable diseases.
Much of this could be avoided if more adults received their recommended vaccines. While most adults recognize the need for childhood vaccinations, many adults simply don’t realize that vaccines are recommended to protect against diseases like whooping cough, hepatitis A and B, pneumococcal disease, shingles and influenza.
The latest data from the Centers for Disease Control and Prevention (CDC) shows that vaccination rates for adults are extremely low (National Health Interview Survey, 2014).
Higher vaccination rates could help avoid the many cases of vaccine preventable diseases that adults suffer with each year. For example, in 2015 there were about 27,000 cases of invasive pneumococcal disease and 3,300 deaths among adults. In 2016, there were more than 15,000 cases of whooping cough reported to the CDC. Additionally, there are about 1 million cases of shingles and millions of cases of influenza that occur each year in the U.S.
2) Certain health conditions can put adults at greater risk of complications if they do get sick.
As we go through life we’re often diagnosed with certain health conditions that put us at increased risk for complications from diseases such as pneumonia and influenza. This includes conditions such as heart disease, asthma, chronic obstructive pulmonary disease (COPD) and diabetes. Even if we feel we have those conditions under control, it is best to get vaccinated to prevent an illness that can complicate these conditions and cause severe illness, hospitalization or even death.
3) Adults are more likely to contract certain diseases.
As we age, we also become more likely to suffer with diseases such as shingles or pneumococcal disease. That is why adults 65 and older are recommended to receive one or more pneumococcal vaccines, and those 60 years and older should get a shingles vaccine.
5 Things Expectant Parents Need to Know About Vaccines in Pregnancy
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.
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.
Raising Awareness of Viral Hepatitis on World Hepatitis Day
Viral hepatitis is a major health problem and one of the leading causes of death globally. Approximately 1.34 million people die each year all around the world, and million others are infected, most of which do not even know. Since hepatitis is not limited to one location or one group of people, everyone around the world needs to understand the disease burden and the steps they can take for prevention, testing and treatment.
The ABC’s of Hepatitis
“Hepatitis” means “inflammation” of the liver and it can be caused by things such as bacterial and viral infections, toxins, certain drugs, some diseases, and heavy alcohol use. There are currently five hepatitis viruses that have been identified that specifically attack the liver and cause “viral hepatitis”. The most common types are A, B, and C, but there is also D and E.
All of the hepatitis viruses cause a new or “acute” infection, but only the hepatitis B and C viruses can result in a “chronic” infection that increases the risk of a person developing cirrhosis, liver failure or liver cancer.
Hepatitis A virus (HAV):
Hepatitis A virus can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months. It is highly contagious and usually transmitted when the virus is taken in by mouth from contact with objects, food, or drinks that are contaminated by the feces (or stool) of an infected person.
The best way to prevent an infection is by getting vaccinated with the 2-dose series of hepatitis which is routinely recommended for all children, travelers to certain countries, and persons at risk for the disease. Fortunately, the vaccine has helped reduce the incidence of hepatitis A, but there are still outbreaks in the U.S. every year. In 2014, there were an estimated 2,500 cases of acute hepatitis A infections in the United States. So far in 2017, there have been 275 cases in San Diego alone, resulting in 194 hospitalizations and 8 deaths.
Hepatitis B virus (HBV):
Hepatitis B virus can be transmitted through the body fluids of an infected person. This can happen through intimate contact, contact with the blood or open sore of an infected person, sharing needles, syringes, razors or toothbrushes, or from a mother to her baby at birth. Unlike hepatitis A, it is not routinely spread through food or water. However, it is possible to spread to babies when they receive pre-chewed food from an infected person. Surprisingly, hepatitis B virus can survive outside the body for as long as 7 days. During that time, the virus can still cause infection if it enters the body of a person who is not infected.
Many people with chronic hepatitis B virus infection do not know they are infected since they do not feel or look sick. It is believed that 90% of people living with hepatitis B are unaware of their infection status. Unfortunately, this means they are often unknowingly spreading it to others.
For some people, hepatitis B is an acute, or short-term, illness but for others, it can become a long-term, chronic infection. The younger a person is when infected, the greater their risk of developing chronic disease. For example, approximately 90% of infected infants become chronically infected, compared with 2%–6% of adults. This is why the birth dose of hepatitis B vaccine is so critical in preventing chronic infections that can lead to serious health issues, like cirrhosis or liver cancer. (To understand why babies need the vaccine at birth, see a guest post written by Carolyn Aldigé, President and Founder of the, Prevent Cancer Foundation here.)
In the U.S. an estimated 850,000-2.2 million persons have chronic hepatitis B. However, rates of acute hepatitis B in the U.S. have declined by approximately 82% since 1991, when the routine vaccination of children was implemented. Yet, in 2015, it was estimated that 257 million people are still living with hepatitis B infection worldwide.
Hepatitis C virus (HCV):
Help Stop Devastating Cuts to Immunization Infrastructure
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.
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.”
You 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
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.)
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