Archive

Posts Tagged ‘vaccines in pregnancy’

Evaluating the Safety of Flu Vaccination in Pregnancy

September 18, 2017 2 comments

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.   

SOTI-PregnancyCoverFB

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…

Protecting Your Baby’s Health Starts with Vaccines in Pregnancy

August 8, 2016 2 comments

National Immunization Awareness Month is a reminder that we all need vaccines throughout our lives.  This week we are focusing on the importance of vaccines during pregnancy.  These vaccines help protect expectant mothers while also passing immunity to babies that can help protect them from disease before they are old enough to receive their own vaccines.  

fb_timeline_baby.jpg

From the moment you found out you were pregnant, you started protecting your developing baby. You might have changed the way you eat, started taking a prenatal vitamin, or researching the kind of car seat you’ll buy. But did you know that one of the best ways to start protecting your developing baby against serious diseases is by making sure you get the whooping cough (Tdap) and flu vaccines while you are pregnant?

The vaccines you get during your pregnancy will provide your developing baby with some disease protection (immunity) that will last the first months of life after birth. By getting vaccinated during pregnancy, you can pass antibodies to your baby that may help protect against diseases.  This early protection is critical for diseases like the flu and whooping cough because babies in the first several months of life are at the greatest risk of severe illness from these diseases. However, they are too young to be vaccinated themselves. Passing maternal antibodies on to them is the only way to help directly protect them.

In cases when doctors are able to determine who spread whooping cough to an infant, the mother was often the source. Once you have protection from the Tdap shot, you are less likely to give whooping cough to your newborn while caring for him or her.

Headphones on stomachWhen it comes to flu, even if you are generally healthy, changes in immune, heart, and lung functions during pregnancy make you more likely to have a severe case of the flu if you catch it. If you catch the flu when you are pregnant, you also have a higher chance of experiencing pregnancy complications, such as premature labor and delivery. Getting a flu shot will help protect you and your baby while you are pregnant.

You also can rest assured that these vaccines are very safe for you and your developing baby. Millions of pregnant women have safely received flu shots for many years, and the CDC continues to monitor safety data on flu vaccine in pregnant women.

antoniobirthThe whooping cough vaccine also is very safe for you and your developing baby. Doctors and midwives who specialize in caring for pregnant women agree that the whooping cough vaccine is important to get during the third trimester of each pregnancy. Getting the vaccine during your pregnancy will not put you at increased risk for pregnancy complications.

You should get your whooping cough vaccine between your 27th and 36th week of pregnancy. You can get a flu shot during any trimester. You can get whooping cough and flu vaccines at the same time during your pregnancy or at different visits. If you are pregnant during the flu season, you should get a flu vaccine soon after vaccine is available.

If you want to learn more about pregnancy and vaccines, talk to you ob-gyn or midwife, and visit the pregnancy pages at Vaccinate Your Family and the Centers for Disease Control and Prevention (CDC).

Highlights from June Meeting of Advisory Committee on Immunization Practices

June 30, 2016 1 comment

Original Title: BLDG21_0023.jpg

Three times a year a specialized group of medical and public health experts meet to review scientific data related to vaccine safety and effectiveness. This group, known as the Advisory Committee on Immunization Practices (ACIP), has an enormous responsibility.  They establish, update and continually evaluate all the vaccine recommendations that are made in the United States for infants, adolescents and adults. Health insurance coverage of vaccines is based on these recommendations and the ACIP guidelines are considered the gold standard among healthcare providers.

Last week, in their second meeting of 2016, the ACIP discussed cholera, meningococcal, hepatitis, influenza, RSV and HPV vaccines, as well as the safety of maternal Tdap immunization and the laboratory containment of Poliovirus Type 2.  

Below you will find a recap of the highlights of the June 2016 ACIP meeting to help keep you informed of the latest ACIP recommendations and considerations. 

Influenza Vaccine

The most significant and somewhat surprising decision that occurred during last week’s ACIP meeting was that the Committee voted in favor of an interim recommendation that live attenuated influenza vaccine (LAIV), also known as the nasal spray flu vaccine, should not be used during the 2016-2017 flu season. 

The vote followed an extensive review of data investigating the effectiveness of the nasal spray flu vaccine over the past three flu seasons.  The data showed vaccine effectiveness for nasal spray vaccine among children 2 through 17 years during 2015-2016 was only 3% effective (with a 95% Confidence Interval of -49-37%). In comparison, flu shots had a vaccine effectiveness estimate of 63% against any flu virus among children 2 through 17 years (with a 95% Confidence Interval of 52-72%). This estimate clearly indicates that while no protective benefit could be measured from the nasal spray vaccine in this past season, flu shots provided measurable protection in comparison.

The disappointing vaccine effectiveness data for the nasal spray vaccine during the 2015-2016 season follows two previous seasons (2013-2014 and 2014-2015) that also showed poor and/or lower than expected vaccine effectiveness for LAIV.  (More information about past LAIV VE data is available here.)

child_h1n1_flu_shotWhile it’s disheartening to see data suggesting that the nasal spray flu vaccine did not work as well as expected, the data did suggest that flu shots did perform well and offered substantial protection against influenza this past season. Some patients prefer the nasal spray flu vaccine due to an aversion to needles and may be disappointed in this vote. However, the action taken by the ACIP  emphasizes the important role they fill in continually measuring and evaluating vaccine effectiveness.  Only after a thorough review of the latest scientific data and discussion among the Committee do they decide to alter vaccine recommendations to ensure that they are in the best interest of the public’s health.

ACIP continues to recommend annual flu vaccination, with either the inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV) for everyone 6 months and older and the CDC expects that there should be no shortage of injectable vaccines.  However, it should be noted that with the ACIP vote the nasal spray flu vaccine should not be used during the 2016-2017 season and therefore should not be offered by providers or clinics and will not be covered under the Vaccines For Children (VFC) program.

Cholera Vaccine

A vote was taken to recommend the vaccine for people traveling to high risk areas. 

For more information about cholera visit the CDC travel page here and for up-to-date travel alerts that address various destinations and diseases, we recommend visiting Passport Health’s travel alerts here.

Meningococcal Vaccine

The first part of the discussion of meningococcal vaccines was a consideration of the data on the serogroup B vaccine Trumenba.  This particular vaccine is currently administered on a three dose schedule, however Pfizer’s Dr. Laura York indicated during her presentation that the FDA has approved both a 2 and 3 dose schedule based on the data showing both schedules to be considered safe and effective.  While immunity data suggests that the 3 dose schedule may confer slightly greater immunity over longer periods of time, the 2 dose schedule would be considered optimal in the case of an outbreak or when it is important to confer rapid immunity.   The committee will be reviewing more data on the duration of immunity and the safety of a 2 dose versus 3 dose schedule at the October meeting, before a formal recommendation is made for persons at increased risk, for use during outbreaks or for all healthy adolescents. Read more…

Preventing Childhood Diseases Requires a Community Commitment

April 20, 2016 52 comments
This post is part of a blog relay sponsored by the Centers for Disease Control and Prevention (CDC) in recognition of National Infant Immunization Week (NIIW).  You can follow the conversation on social media using hashtag #NIIW and join the #VaxQA Twitter Chat Wednesday, April 20th at 4 p.m. ET

 

niiw_web-banner_468x60_english

 

Protecting kids from disease requires more than just getting them their recommended childhood vaccinations.  It requires the commitment of an entire community.  

Thanks to an abundance of evidence based research, we’re constantly learning new and improved ways to protect our children; from safer rear-facing car seats with five-point harnesses, to wearing bike helmets and recommending that babies sleep on their backs.  Thankfully, advancements in medical science have also led to safe and effective vaccines that can protect today’s children from as many as 14 potentially deadly diseases.

eBookImageNAPNAP

This commitment to scientific research has provided us with the safest, most effective vaccine supply in history.   Today’s vaccines not only contain less antigens than they did years ago, but they have fewer side effects. There is even a system in place to continually evaluate vaccine safety and a process to update and improve vaccine recommendations as new information and science becomes available.

The impact of infant immunizations is monumental.  

20-year-infographicIt is estimated that vaccines administered to American children born between 1994-2013 will prevent an estimated 322 million illnesses, 21 million hospitalizations, and 732,000 deaths.  In looking at the incidence of specific diseases like measles, we can see how beneficial childhood vaccines have been.  For instance, before the U.S. measles vaccination program started in 1963, about 3–4 million people in the U.S. got measles each year.  In comparison, last year we had 189 cases and even that seemed like a lot.

While these successes are to be applauded, there’s still more that can be done to protect today’s children and future generations from dangerous diseases.

Timely childhood vaccinations are critical.

HepB112315

The recommended childhood vaccination schedule is specifically designed to provide immunity at a time when infants and young children are at the greatest risk of contracting potentially life-threatening diseases.

Take Hepatitis B for example.  If a child contracts this disease before the age of one, there is a 90% probability that they will develop chronic symptoms later in life.  However, only 30% of children who contract hepatitis B between the ages of one and five will go on to develop these chronic issues.

This is one reason why the birth dose of the HepB vaccine is so important. Since the U.S. started routine HepB vaccination, new cases have declined by more than 80%, and mostly among children.

 

 

But vaccinating babies isn’t enough to ensure children will grow to be healthy adults.

Keeping children safe from preventable disease requires community immunity.

Because widespread vaccination programs have been so effective in preventing diseases in the U.S., many parents don’t realize that diseases like polio and diphtheria still exist.  Some don’t consider diseases like whooping cough, varicella or measles to be a serious threat to their children.  This miscalculation of risk can lead to vaccine complacency or refusal.

But the fact is that vaccine-preventable diseases are still circulating in the U.S. and around the world.  Even when diseases are rare in the U.S., they can still be commonly transmitted in many parts of the world and brought into the country by unvaccinated individuals, putting entire communities at risk.

This explains the recent resurgence of measles cases in the U.S. , despite measles having been declared eliminated from the U.S. in 2000.  Today’s outbreaks are often the result of unvaccinated individuals who contract the disease oversees and then return to the states where they spread it to others.  But unvaccinated individuals don’t just put themselves at risk; their choices impact the health of our communities as a whole. Read more…

After Losing Babies to Pertussis Parents Make Plea for Prevention

January 28, 2016 17 comments

How is it that three families, who’ve never actually met one another, find themselves sharing words of consolation and encouragement at the same time each year?

How is it that these three families are forever bonded by their children, and the courage and compassion they have to share their stories?  

Carter, Callie and Brady were just infants when they had to say goodbye.  But during this week, back in 2010 and 2012, three babies lost their fight to pertussis, (more commonly known as whooping cough) and their families were forever changed.

In 2008, Every Child By Two (ECBT) launched a program called Vaccinate Your Baby, which was inspired in large part by the Romaguera family, who had contacted the organization several years earlier after having lost their baby Gabrielle to pertussis.

In the days and months following the death of Carter, Callie and Brady, the Dube, Van Tornhout and Alcaide families also reached out to Every Child By Two in hopes that they could turn their personal tragedies into a public health mission.

VYF_Full-InfographicToday, as Every Child By Two Parent Advocates, their commitment to pertussis prevention has undoubtedly helped bring about many positive and live-saving changes. They have not only raised awareness of the importance of adult Tdap boosters, but their efforts have helped alter the way in which the public is advised to protect newborns from pertussis.

Prior to the death of their children, none of these families were educated on the need for adult Tdap boosters.  They’ve since devoted a great amount of time to sharing their stories; in media interviews, in state legislative chambers,  on podiums at public health conferences, and in blogs and Facebook posts shared widely on social media.

New Recommendations Are Helping in the Fight Against Pertussis

Today, leading professional organizations such as the AAP, the American College of Nurse-Midwives (ACNM) and the American College of Obstetricians and Gynecologists (ACOG), all recommend that pregnant women receive Tdap boosters in the third trimester of each pregnancy. This not only helps to protect the expectant mom from contracting pertussis and passing it onto their newborn, it also provides passive immunity to the unborn baby.  This practice helps protect infants before they begin receiving their own pertussis immunizations through a series of five DTaP vaccine doses that begin at two months of age.

Before the DTaP shot was routinely administered to infants, about 8,000 people in the United States died each year from whooping cough. However, thanks to greater immunization coverage and greater public awareness, this number has dropped to fewer than 20 deaths per year. Unfortunately, because the bacteria is still widely circulating in our communities and not everyone is adequately protected, whooping cough still makes people very sick.  In 2014, as many as 30,000 people were diagnosed with pertussis and each year many are still hospitalized. The real danger is among children under 12 month of age.  About half of these infants who get whooping cough are hospitalized, and tragically approximately 1 out of 100 infants who are hospitalized will die.  So how can we better protect these babies?

Research Continues to Guide Vaccine Recommendations

Research indicates that family members are often the source of infection among infants, and most family members are passing on the infection without ever realizing they have  pertussis themselves. In one recent study, approximately 85% of infants with pertussis got if from a member of their immediate or extended family.  This is why Tdap boosters are now recommended for all family members and caregivers who spend time around babies.  In fact, families members should get their Tdap booster at least two weeks prior to the expected arrival of the baby, since it’s estimated that it takes that long to acquire immunity after getting the vaccine.

Most recently, the efforts and experiences of our Every Child By Two Parent Advocates have even helped inspire the expansion of the Vaccinate Your Baby program to the Vaccinate Your Family program.  When people of all ages are up-to-date on their recommended vaccines, they’re less likely to pass illness on to our vulnerable infant population.

We encourage everyone to visit the adult section of the Vaccinate Your Family website, where there are several resources that specifically help educate older individuals about the need for adult Tdap boosters, to include materials for grandparents who want to help protect their young grandbabies.

Please familiarize yourself with this Grandparent Toolkit and share these materials among your friends, family and colleagues.

Health & Safety Checklist

Tips for Soothing a Fussy Baby

Pledge for Family Members and Friends to Sign

Frequently Asked Questions

Questions to Ask Your Doctor About Vaccines

Every Child By Two stands with our Parent Advocates in our mission to ensure that no family should ever have to endure what they’ve been through.  This week, as we mark the anniversary of the passing of Carter, Callie and Brady, may we each share this video and the many resources on the Vaccinate Your Family website in an effort to educate the public about pertussis prevention. 

 

Pertussis Vaccine in Pregnancy Key to Preventing Disease in Infants

Pregnant women should be vaccinated against pertussis during each pregnancy to best protect babies from infection.

PertussisThe Global Pertussis Initiative (GPI), an expert scientific forum charged with addressing the global burden of pertussis, announced this recommendation earlier this week.  However, this isn’t the first time we’ve heard this suggestion.  The CDC’s Advisory Committee on Immunization Practices (ACIP) first recommended that women get a Tdap vaccine during pregnancy in October of 2011.  Then, in October of 2012, they updated the recommendation stating that women should get a Tdap vaccine during each pregnancy.

As the GPI decision explained in a recent Medscape article,

Vaccination of women with Tdap during pregnancy is expected to provide some protection to infants from pertussis until they are old enough to be vaccinated themselves. Tdap given to pregnant women will stimulate the development of maternal antipertussis antibodies, which will pass through the placenta, likely providing the newborn with protection against pertussis in early life, and will protect the mother from pertussis around the time of delivery, making her less likely to become infected and transmit pertussis to her infant.   

While this excerpt may suggest the basis behind the GPI’s recommendation, the ACIP’s decision was further referenced in a Morbidity and Mortality Weekly Report (MMWR) published in February, 2012, which explained, Read more…