Archive
Eliminating HPV in Celebration of International Day of the Girl
Today, October 11, is International Day of the Girl. This year the World Health Organization Regional Office for Europe (WHO/Europe) aims to increase awareness of the devastation caused by human papillomavirus (HPV) and to increase the number of countries offering life-saving HPV vaccines.
Cervical cancer profoundly changes a women’s life and her future. Over 28,000 women die every year in the WHO European Region of cervical cancer, and many more suffer long-term health consequences. In the U.S., even with screening, HPV causes 10,800 cases of cancer every year. HPV vaccination plays an essential role in stopping cervical cancer and other cancers that affect women including vulvar and vaginal cancer, anal cancer and oropharyngeal cancer, thereby protecting girls’ lives and their full future potential
Download the CDC’s HPV infographic
The HPV vaccine represents a tremendous public health breakthrough. According to the Centers for Disease Control and Prevention (CDC), over 90% of HPV-related cancers could be prevented through HPV vaccination. WHO recommends that all girls between 9 and 14 years old receive 2 doses of the vaccine. The U.S. recommends that all children – boys and girls – receive 2 doses of HPV starting at age 11-12.
According to WHO, over 270 million doses of HPV vaccine have been administered worldwide so far, and the vaccine programs have resulted in enormous reductions of up to 90% in HPV infections and genital warts in teenage girls and young women have been demonstrated by studies conducted in Belgium, Germany, New Zealand, Sweden, the United Kingdom, the United States and Australia.
In fact, Australia is set to become the first country in the world to wipe out cervical cancer, thanks to free HPV vaccination programs implemented in schools nationwide as well as screening programs. The Lancet Public Health forecasts fewer than six new cases per 100,000 Australian women by 2022, and fewer than four new cases per 100,000 women by 2035. Australian public health officials have set an elimination goal within the next 20 years.
According to the International Papillomavirus Society, the Australian federal government began offering the vaccine to girls aged 12-13 in 2007, and in 2013 it was made available to boys, too. Those under 19 years old are also being offered two free doses of the HPV vaccine.
Between 2005 and 2015, the percentage of Australian women between 18 and 24 years old who had HPV dropped from 22.7 percent to just 1.1 percent. “Immunization rates have increased further since 2015, contributing to what’s being described as a herd protection effect.” Vaccination rates in Australia are at 79% for girls at age 15 and 73% for boys.
Free vaccines seem to have made the difference in Australia. In the U.S., HPV vaccine is only free to those who are eligible under the Vaccines for Children Program (VFC). VFC provides free vaccines to children and teens younger than 19 years of age, who are either Medicaid-eligible, American Indian or Alaska Native, or uninsured. Although most health plans now cover the costs of the vaccine, it can cost as much as US$450 for the full recommended series of HPV vaccination. Only half of U.S. adolescents are up-to-date on the HPV vaccine, and only 66 percent of adolescents between 13 and 17 years old received the first dose to start the vaccine series.
WHO/Europe is hopeful that efforts to encourage more countries to vaccinate will save the lives of future generations.
To date, 37 of the 53 countries in the European Region have introduced the HPV vaccine into their national routine immunization schedules. Vaccinating all girls against cervical cancer will also indirectly prevent most boys from contracting the virus. However, several countries also offer the vaccine to boys to ensure their direct and immediate protection from genital warts and forms of HPV-related cancer that affect both men and women.
Learn more about HPV and the importance of HPV vaccination on Vaccinate Your Family’s website or read our previous blog post – Supercharge Your Kid’s Cancer Fighting Power.
Meningococcal Disease: How to Be Sure Your Teens Are Fully Protected
Guest Post By Lynn Bozof, President, the National Meningitis Association
This post was written by an extraordinary woman who passed away only days ago. Lynn spent the last phase of her life fighting to ensure that mothers, fathers, siblings and family members would never suffer the devastation of losing a child to a disease called meningitis. Many parents are now aware of this disease, and that is in large part due to the tireless advocacy and educational efforts of Lynn, and the many families who support the work of the National Meningitis Association. The entire vaccine community will miss you dearly Lynn. Every Child By Two promises to remain steadfast in our shared goal to save others from this terrible disease.
As a parent, it’s no surprise that the busy lives of teenagers can leave little wiggle room between school schedules, homework, and numerous extra-curricular activities. It’s hard to believe we’re already only a few weeks away from Thanksgiving break. Those off days from school are the perfect time to check in with your child’s healthcare provider to make sure they’ve received all recommended vaccines to prevent against deadly diseases – including meningococcal disease.
In 1998, I lost my son Evan Bozof to meningococcal disease – commonly referred to as bacterial meningitis. Evan was a vibrant, healthy teenage athlete, but within a month my husband and I watched this terrible disease attack every part of Evan’s body and ultimately take his life. No one had ever told me that there was a vaccine available that might have prevented it.
Ever since then, I’ve made it my mission to spread awareness of bacterial meningitis and encourage parents to get their children vaccinated. As we head into the colder months, here is everything you should know about this disease and the vaccines available to prevent it.
What is Meningococcal Disease?
Meningococcal disease is a rare but potentially deadly bacterial infection involving the inflammation of the membranes (meninges) surrounding the brain and spinal cord. The disease strikes quickly and can lead to devastating complications if your teen has not been fully vaccinated.
Of those who contract meningococcal disease, 10 to 15 percent die from it. Among those who survive, as many as 20 percent live with permanent disabilities, such as brain damage, hearing loss, loss of kidney function or limb amputations. Vaccinations offer the best protection against meningococcal disease.
Symptoms and Progression: What is Important to Know
Meningococcal disease is often misdiagnosed, as early symptoms resemble those of other illnesses such as the flu. They may include sudden high fever, headache, nausea, vomiting and exhaustion, and can progress into sensitivity to light, abnormal skin color or rash, with the most extreme symptoms being confusion, delirium or loss of consciousness.
Symptoms of meningitis advance incredibly quickly. Within 24 hours, patients can go from being entirely healthy to near death.
What You Should Know About Vaccination Options
There are two vaccines available to prevent against the five major strains of bacteria (A, C, W, Y and B)that cause meningococcal disease. The MenACWY vaccine protects against four strains, while the MenB vaccine protects against the fifth.
The Centers for Disease Control and Prevention (CDC) recommends the MenACWY vaccine to all adolescents at age 11-12, with a booster at age 16.
The MenB vaccine was recommended for permissive (aka Category B) use among those age 16-23 – with preferred vaccination between 16 and 18 – by the CDC in 2015. Older adolescents and young adults can decide, in collaboration with their doctors, whether they’d like to receive the MenB vaccine. Nearly 
every insurance plan covers the MenACWY and MenB vaccines, and adolescents without insurance can get vaccinated at little to no cost.
The NMA believes that all adolescents should be vaccinated against meningitis B, as it is the strain most commonly linked to outbreaks on college campuses. Vaccination is always the best method of meningitis prevention.
For a full list of those recommended by the CDC for meningococcal vaccination, please visit the CDC website.
Why Teens Are Most at Risk
Meningitis is a rare disease, but once it strikes it can prove deadly within a matter of hours. Teens and young adults are the group most at risk because they often live in close quarters – like a dormitory – and tend to share beverages more often than adults or young children.
In the winter of 2016, three cases of meningitis occurred at the University of Santa Clara. The year before, the University of Oregon experienced a six-month meningitis outbreak that infected seven students and left one dead.
Increasingly, colleges have begun mandating that students receive the second dose of the MenACWY vaccine – as well as the MenB vaccine – prior to matriculation. The NMA fully supports these efforts and believes that the best path to meningococcal prevention is complete vaccination.
About one in ten people carry meningococcal bacteria in their nose or throat without showing any signs or symptoms of the disease. These people can unknowingly transmit the bacteria to others.
Putting It into Perspective
It’s normal for kids and teens to think they’re invincible and not see the importance of getting vaccinated. Caitlin Brison was a high school senior when her doctor asked at her routine checkup if she wanted to receive the second meningitis vaccine. Not wanting another needle, Caitlin said no. That decision ultimately came back to haunt her.
In college, Caitlin contracted a severe case of bacterial meningitis that ultimately led to months of dialysis, as well as memory loss and physical therapy to re-learn how to walk. Several years later, she received a kidney transplant. Caitlin says she can still remember that day in the doctor’s office like it was yesterday. “My first question was ‘Do I have to have it?’’’ she says. “He said no, so then I said no, and that was a big, big mistake.”
Cases like Caitlin’s serve as a reminder to parents and adolescents to think about the big picture when it comes to vaccination. A small prick in the arm is nothing in comparison to kidney failure, loss of arms or legs, or any of the other debilitating after- effects that survivors of meningitis often must manage for the rest of their lives. Listening to survivors talk about their long and painful paths to recovery illustrates not only the horror of meningitis, but the importance of vaccines as prevention.
If I had known that there was a vaccine available to prevent against bacterial meningitis, my son might still be alive today. The NMA continues to advocate for the broadest possible vaccine recommendations from the CDC so that other families don’t have to experience the truly devastating impact of meningococcal disease.
Where Can I Find More Information?
Following are additional resources that provide more information about meningococcal disease and prevention methods, including vaccination:
- National Meningitis Association: http://www.nmaus.org
- Centers for Disease Control and Prevention: http://www.cdc.gov
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 2018 (7th) edition of The Vaccine Handbook: A Practical Guide for Clinicians.
Dr. Gary Marshall, professor of pediatrics and chief of the Division of Pediatric Infectious Diseases at the University of Louisville, first published what the vaccine community refers to as The Purple Book back 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 in 2016 and has been updated annually, contains content from the new 7th edition of the book and 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.
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.”
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 experiences 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.”
Dr. Marshall adds,
“I am particularly proud of this iteration of The Purple Book. First, it is dedicated to Dr. Stanley Plotkin, with whom I trained in the 1980s and who stands out as mentor and friend to generations of physicians and scientists. Second, the Foreword was written by the Pediatric Infectious Diseases Society, which was founded by Stanley exactly 40 years ago. Finally, PIDS was able, through unrestricted educational funding, to make the app available free of charge to anyone who wants it.”
Download it today and let us know what you think in the comments below.
Fifty and Fabulous, But NOT Fully Vaccinated
By Amy Pisani, Executive Director, Every Child By Two
As the 2018 National Immunization Awareness Month comes to an end, with a focus on adult vaccines this week, I look back on the three personal milestones I have reached over the summer and thought about how much my resolve to ensure that people are aware of the need to vaccinate at every stage in life has been strengthened. As many people are aware, vaccines are critical to ensuring the health of babies, and as our children grow older they continue to need booster doses of certain vaccines as well as other vaccines to protect them against different diseases. But did you know that vaccines are recommended for people of all ages?
Every year in the U.S., thousands of adults become seriously ill, and many even die, from vaccine-preventable diseases. Even if you received vaccines as a child, your immunity can wear off over time. You may also be at risk of different diseases depending on your age, job, lifestyle, travel, or chronic health conditions. As I am now in the midst of several life changes, my perspective on vaccines for adults of all ages has also naturally shifted.
Sending my fully vaccinated son off to college this past week was my most recent life-changing milestone.
I’m proud to say that while I was making sure my son was up-to-date on all his vaccines throughout his preteen and teen years, I was also encouraging dozens of my friends and family members to protect their children from influenza (flu) and cancer-causing HPV through immunizations. More recently, as my friends and I prepared to send our kids off to college, I urged them to make sure their children received both vaccines against meningococcal disease (MenACWY and MenB), a dangerous, and sometimes deadly, disease that has taken the lives of too many young adults, which we discussed at length in last week’s blog post.
My second big milestone was becoming Fifty and Fabulous.
Turning 50 means that, in addition to my annual flu vaccine and my one-time Tdap vaccine, it’s now time to also protect myself against the shingles virus. As the big day approached I started noticing signs at the local pharmacies regarding a shortage of shingles vaccine (Shingrix®). I sent photos of the signs to my coworkers, joking that I didn’t know what I would do with myself on my birthday, knowing that I couldn’t pop into my doctor’s office or pharmacy to get vaccinated as I planned on my big 5-0 day.
In all seriousness, what does it mean to be offered protection against shingles at age 50, rather than having to wait until age 60, which was the starting age for the previously recommended shingles vaccine called Zostavax®? For starters, Zostavax®, while a good vaccine, only reduced the risk of shingles by about 50% and protected against long-term nerve damage (PHN) by about 67%. The newer vaccine, Shingrix®, which was approved by FDA in 2017, offers a 97% reduction in your chances of getting shingles and 91% reduction against long-term nerve damage. And, since the Shingrix® vaccine offers longer-lasting protection against shingles and its complications, it is now recommended by the CDC for all healthy adults age 50 and older (even if you got the Zostavax®, vaccine before).
So what is shingles and why am I among the 1 in 1,000 people in the U.S. who are at risk of getting this virus? Shingles is a painful rash of blister-like sores caused by the varicella zoster virus – the same virus that causes chickenpox. After you’ve had chickenpox, the virus lies inactive in nerve tissue near your spinal cord and brain. Years later, the virus may get reactivated causing shingles to develop. The most common complication of shingles is postherpetic neuralgia (PHN). People with PHN have severe pain in the areas where they had the shingles rash, after the rash clears up. The pain from PHN usually goes away in a few weeks or months; however, for some people, the pain from PHN can last for years.
Luckily, Millennials and future generations will be spared the misery of both chickenpox and shingles due to development of the chickenpox (varicella) vaccine, which was recommended for routine use in the U.S. in 1995. However, being a child of the late sixties, and one of five girls in my household, you bet I caught the chickenpox! While it is usually a mild disease in children, prior to the routine use of the chickenpox vaccine in the U.S., approximately 11,000 children were hospitalized and about 100-150 children died each year due to serious complications from chickenpox.
Back to my fifty, fabulous and fully vaccinated plan, AND my third milestone
Unfortunately, my plan to be fully vaccinated on my 50th birthday didn’t go as planned. The Shingrix® vaccine is still out of stock in both my doctor’s office and my pharmacy. But I plan to get it as soon as it becomes available again. While I know I should keep my anxiety at a minimum, I truly don’t want to end up as one of the four out of 1,000 people in my age cohort who thought she was invincible, waited to get vaccinated, and ended up with a debilitating, but preventable case of shingles. Practice what you preach definitely needs to be added to Every Child By Two’s official mission statement! Which brings me to my third exciting milestone this month – I celebrated over two decades as the Executive Director of Every Child by Two, which has by far been one of the greatest priveleges of my life (next to raising my wonderful boys).
Paying for the Shingles Vaccine Is Complicated
As a vaccine advocate, I am incredibly dismayed to know that not all adults will have as easy of a time paying for the shingles vaccine as I will. I am lucky that my current health plan will cover 100% of the cost of my vaccine, but others, including those on Medicare Part D may not be as fortunate. As I await the end of the shingles vaccine shortage, I have hardened my resolve to be an even louder advocate alongside partners such as the Adult Vaccine Access Coalition (AVAC), a group that strives to prevent the deaths of over 50,000 adults from vaccine-preventable disease (VPDs) every year in the U.S. AVAC also seeks to put an end to the enormous economic burden caused by treating adults who contract VPDs, and works to ensure fair and equitable vaccine coverage for older Americans (like me). Stay tuned for my personal shingles vaccination photo op, hopefully in the near future!
Meningitis B and Your College Student: Preventing the Call
This important post is being published to highlight Preteens & Teens Week during National Immunization Awareness Month. Please take the time to talk to your child’s healthcare provider to make sure he or she is up-to-date on all recommended vaccines. (A version of this post was originally published on Shot of Prevention on February 14, 2018.)
Emily and the Stillman family after her high school graduation.
Emily was a 19-year-old college student when she called home complaining of a headache. Thirty-six hours later, she passed away due to serogroup B meningococcal disease (also known as meningitis B). Emily was able to donate six of her organs, together with bones and tissue, to save the lives of five others.
Emily’s mother, Alicia Stillman, who graduated from Arizona State University, returned to Arizona after founding The Emily Stillman Foundation to honor her late daughter’s life. She shared the story of how Emily contracted meningitis B and her family decision to donate Emily’s organs. She also explained the work she is doing to help educate others about the availability of serogroup B meningococcal vaccines (MenB) in the United States and to encourage organ donation. She spoke with Debbie McCune Davis, Director of The Arizona Partnership for Immunization (TAPI), who is leading the effort to increase awareness of the approved vaccine and who is working with the universities in Arizona to promote the Off to College education campaign.
Together these two women share a message of hope, as they work to save lives and prevent serogroup B meningococcal disease by educating parents, students, educators and medical professionals across Arizona and the nation.
Alicia: I always felt I was living a blessed life. I enjoyed motherhood. I had three beautiful children, a wonderful husband, and a successful career. I believed I was doing everything right to raise healthy, independent children, as I sent each one off to college.
My middle daughter Emily had a fabulous first year away at a small liberal arts college in Kalamazoo, Michigan. In 2013, she was well into the second semester of her sophomore year when she called home one evening, complaining of a headache. Thinking it was from lack of sleep, I advised her to take some ibuprofen, and to touch base with me in the morning. Little did I know that was to be the last time I would ever hear my Emily’s voice.
The call the next morning wouldn’t come from my Emily, but rather from the Dean of the college. She told me my daughter had been admitted to the hospital during the night with bacterial meningitis, that she was very sick, and I needed to get there as soon as possible. I remember insisting that this was not possible because even at that time, I knew she had received “the meningitis shot”. In fact, I even remembered that before she left for college, she had received a meningitis booster. What I did not yet know at that time was that the vaccine she had received (MenACWY) only protected her against 4 of the 5 common serogroups of meningococcal disease. I had no idea that there was a strain (serogroup B) she was not protected against because a vaccine for that strain was not even available in the United States at that time.
Less than 36 hours later I said goodbye to my baby. My beautiful girl that I had promised to always protect and take care of was gone. As I said goodbye to her on that cold February morning, I told her that I would be ok…and that I would figure this out. I would make sure this could not happen to other people.
Debbie: Stories like Alicia’s couldn’t be prevented in the U.S. when Emily Stillman was infected with meningitis B and lost her life to the disease, but they are today. In October of 2014 and January of 2015, the FDA approved licensing for two different vaccinations to protect against serogroup B meningococcal disease. Soon after that, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that college students talk with their doctors about the meningitis B vaccine (MenB).
Off to College – TAPI’s campaign to educate college students and their parents about vaccinations needed before school.
In Arizona, our Board of Regents (the governing board of our state university system) took quick action to recommend all incoming freshmen get the vaccine. There had been outbreaks in the PAC 12 schools and Arizona wanted to promote healthy campuses. We, at TAPI, worked with the universities, their medical directors and all of our professional medical organizations including osteopaths, pharmacists, nurses, and pediatricians to put forth a unified message and raise awareness.
Alicia: I live my promise to my Emily every single day with my work at The Emily Stillman Foundation. Before the vaccine was approved in the U.S., I discovered the vaccine was available in Canada. We took busloads of families across the Detroit/Windsor border into Canada to get the MenB vaccine. We met with the Food and Drug Administration (FDA) and many members of Congress to urge the fast tracking of the licensing process. I testified at the CDC and encouraged ACIP to grant a firm recommendation to protect our adolescents and young adults. I set up vaccination clinics locally to provide the vaccine before medical practices were willing to hear about it. I speak nationally, working with colleges, medical practices, and parents to raise awareness to this hideous disease, its symptoms, and the vaccinations now available to prevent it. I won’t stop until the MenB vaccine is on the required list, and is available to all people. Only then will my promise to my Emily be fulfilled.
Debbie: Today, we at TAPI are taking it a step further…we don’t want kids to wait until they’ve moved into their dorms to receive their vaccination. We are working with high schools, parents groups, physicians, athletic departments and more to promote Vaccinate Before You Graduate here in Arizona. We want this to become part of the college prep routine—take your college entrance exams, turn in your transcripts, apply for scholarships, choose your school, order your cap and gown and vaccinate.
As mothers and as experts – one from a heart-breaking loss, and one as a professional who works tirelessly to prevent disease – we urge you to enjoy these moments with your child. However, as you are giving them that final send off, smoothing the bedding on their dorm bunk, stocking snacks and toiletries, telling them to study hard and have fun (but not too much fun), asking them to be safe, be sure to also give them the tools to stay healthy. Make sure they have their boosters, that they are up-to-date on all vaccination and be sure your health professional has given your child protection from all strains of meningitis, including meningitis B. If your child has already started that journey and is off to college, check with the student health services at their school for information about vaccine availability on campus. Do it for your child, do it for yourself and do it for Emily.
Watch this video from the Meningitis B Action Project to learn more about MenB in 90 seconds
Alicia Stillman lives in West Bloomfield, Michigan with her husband of 29 years, Michael. In addition to her angel daughter Emily, she has two live children – Karly, 25, and Zachary, 21. Alicia holds an MBA in Management Accounting, and is the Accounting Director for a multi-state law firm. She is the Co-Founder and Director of The Emily Stillman Foundation, founded in 2014 in memory of her late daughter Emily. The Foundation has a trifold mission to raise awareness for and encourage organ and tissue donation, to educate about meningococcal disease as well as all vaccine-preventable diseases, and to advocate globally for all health and wellness issues. Most recently, Alicia partnered with Patti Wukovits to co-found the Meningitis B Action Project. Alicia can be reached through the Foundation at emilystillmanfoundation@gmail.com.
Debbie McCune Davis has served as Director for The Arizona Partnership for Immunization, better known as TAPI, since February 1996. She was an elected member of the Arizona Legislature, serving from 1979 until 1994 and again from January 2003 until her retirement in January 2017, serving in both the House of Representatives and the Arizona State Senate. In her local community Debbie serves on numerous committees and task forces, working to improve the health status of women and children in Arizona. She has established a reputation for being a knowledgeable advocate for maternal and child health and childcare issues. In 2012 she was recognized for her advocacy by the Children’s Action Alliance in Phoenix and Every Child By Two in Washington, DC. Debbie also served on the Board of Directors of the American Immunization Registry Association and she volunteers her time as a member of the planning committee of the National Conference on Immunization and Health Coalitions. She is married to Glenn Davis and has a blended family of 5 children and 3 grandchildren. More information about TAPI may be found at www.whyimmunize.org.
Learn More
National Meningitis Association
Meningococcal Vaccination for Preteens and Teens: Information for Parents (CDC)
CDC’s Recommended Immunization Schedule for Preteens and Teens (En español)
How Do We Know Vaccines are Safe?
Too often, we hear misinformation about vaccines and their safety. Some people claim that they are not tested for safety before being licensed and recommended for use in people in the United States. Others say that vaccines are not held to the same safety standards as drugs, when in fact they are held to a higher standard. And some others wrongly proclaim that vaccines are not monitored for safety after they are licensed by the U.S. Food and Drug Administration (FDA) and recommended for the public by the Centers for Disease Control and Prevention (CDC), as they are unaware of the strong vaccine surveillance systems we have in place in the U.S.
The United States has the safest, most effective vaccine supply in its history.
Below, we offer an overview of how vaccines are tested and monitored for safety and effectiveness:
Clinical trials
Vaccines are one of the most thoroughly tested medical products available in the U.S. Before a vaccine can be considered for approval by the FDA, a vaccine manufacturer must show it is safe and effective through clinical trials. Developing a new vaccine begins with exploratory stage and pre-clinical stage before advancing to three stages of clinical trials. Together, this scientific process can take over a decade and cost millions of dollars. The FDA then examines these studies and determines whether a vaccine is safe, effective, and ready to be licensed for use. The FDA only licenses vaccines that have data that shows that the vaccines’ benefits outweigh the potential risks. If there is any question about the data, or any holes in the data, the FDA will request further studies before approving the vaccine.
Four monitoring systems
After a vaccine is licensed for use in the U.S., there are four systems in place that work together to help scientists monitor the safety of vaccines and identify any rare side effects that may not have been found in clinical trials. Even large clinical trials may not be big enough to find very rare side effects. For example, some side effects may only happen in 1 in 100,000 or 1 in 500,000 people. Second, vaccine trials may not include certain populations like pregnant women or people with specific medical conditions who might have different types of side effects or who might have a higher risk of side effects than the volunteers who got the vaccine during clinical trials.
Vaccine Adverse Events Reporting System (VAERS)
VAERS is a passive reporting system. That means it relies on individuals to report vaccine reactions. Anyone can report a reaction or injury, including healthcare providers, patients and patients’ representatives, such as caregivers or attorneys. The system is co-managed by the FDA and the CDC. However, it is important to note that VAERS data alone can’t be used to answer the question, “Does a certain vaccine cause a certain side effect?” This is because adverse events reported to VAERS may or may not be caused by vaccines. There are reports in VAERS of common conditions that occur just by chance after vaccination. Further investigation may find no medical link between vaccination and these conditions. Instead, the purpose of VAERS is to see if unexpected or unusual patterns emerge, which may indicate a vaccine safety issue that needs to be researched further.
The Vaccine Safety Datalink (VSD)
Established in 1990, VSD is a collaboration between the CDC’s Immunization Safety Office and eight health care organizations across the country. It conducts studies based on questions or concerns raised from the medical literature and reports to VAERS. In addition, when new vaccines are recommended or if changes are made in how a vaccine is recommended, VSD will monitor the safety of these vaccines.
The Clinical Immunization Safety Assessment Project (CISA)
CISA, which was created in 2001, is a national network of vaccine safety experts from the CDC’s Immunization Safety Office, seven medical research centers and other partners. CISA addresses vaccine safety issues, conducts high quality clinical research and assesses complex clinical adverse events following vaccination. CISA also helps to connect clinicians with experts who can help consult on vaccine safety questions related to individual patients.
The Post-Licensure Rapid Immunization Safety Monitoring System (PRISM)
PRISM is a partnership between the FDA’s Center for Biologics Evaluation and Research and leading health insurance companies. It actively monitors and analyzes data from a representative subset of the general population. PRISM links data from health plans with data from state and city immunization information systems (IIS). PRISM has access to information for over 190 million people allowing it to identify and analyze rare health outcomes that would otherwise be difficult to assess.
These four post-licensure monitoring systems have been able to address several important issues related to vaccines and their safety, including:
- Finding no connection between the human papillomavirus (HPV) vaccine (Gardasil) and venous thromboembolism in females 9 to 26 years of age.
- Identifying a link between a rotavirus vaccine (RotaTeq®) and an increased risk of intussusception in infants, which led to its withdrawal from the market.
- Establishing the safety of thimerosal in vaccines.
- Establishing the safety of the childhood immunization schedule in the U.S.
- Demonstrating the safety of vaccines during pregnancy through fourteen separate studies.
The Department of Health and Human Services (HHS) and its agencies, health insurance companies, scientists, healthcare providers, and other public health and medical groups are all dedicated to ensuring people of all ages are protected against serious infectious diseases by a safe, effective supply of vaccines.
Protecting Myself and My Child against Vaccine-Preventable Diseases during Pregnancy
By Erica DeWald, Director, Advocacy, Every Child By Two
Here at Every Child By Two, we practice what we preach. That’s why I got both a Tdap and influenza vaccine when pregnant with my first child (who is fully up-to-date on his childhood vaccines). Now that I’m expecting my second baby, I didn’t hesitate to get vaccinated again.
Why do I choose to get vaccinated?
Vaccines during my pregnancy have the ability to protect not only me, but my child as well. Infections such as flu and whooping cough, also known as pertussis, are not just a threat to me. They can also be extremely dangerous, and even deadly, to newborns.
Why get vaccinated against whooping cough?
Whooping cough is a highly contagious respiratory disease that spreads easily from person-to-person through coughing and sneezing. Symptoms can be less severe in vaccinated people and older children and adults, so adolescents or adults may unknowingly pass the infection onto vulnerable infants.
In young children, the cough can be so severe that it can cause a child to gag, turn blue, vomit or pass out. A gasp for air after a coughing fit can sometimes produces a loud “whoop” sound, though it is not uncommon to have whooping cough without producing the “whoop” sound. This intense coughing phase can last as long as 10 weeks.
Half of all children who get whooping cough under a year of age end up in the hospital. Some will suffer lifelong complications and one of every 100 will die.
Why get vaccinated against flu?
Changes in my immune, heart, and lung functions during pregnancy make me more likely to get ill and suffer severe complications from illnesses as compared to non-pregnant women. In fact, as a pregnant woman, I am five times more likely to suffer complications or death from flu compared to non-pregnant women. Additionally, if I fall ill during pregnancy, I have a greater chance of hospitalization, spontaneous abortion or complications that can directly impact the health of my baby such as preterm labor and delivery, and low birth weight babies.
In children, the highest incidence of hospitalization due to influenza is among infants younger than 1 year, with those younger than 6 months at highest risk. On average, about 100 children die from flu each year in the U.S. and thousands more are hospitalized.
Getting vaccinated during pregnancy also provides my child with protection during his first weeks and months.
By getting my vaccines in pregnancy when recommended by the Centers for Disease Control and Prevention (CDC), the American College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse Midwives (ACNM), I can lessen my child’s chances of contracting these diseases when he is most vulnerable (and before he receives his own vaccines):
How do I know vaccines are safe for me and my child?
Experts carefully reviewed the safety data of the whooping cough vaccine before recommendation that women receive a Tdap vaccine during each pregnancy. They concluded that the vaccine was safe for both pregnant women and their babies and there is a long list of published safety studies that can be reviewed here.
Additionally, science supports the safety of flu vaccination for pregnant women and their babies, and the flu shot has been safely administered to millions of pregnant women over many years. While the scientific community will continue to gather data on this topic, various studies, such as those detailed below, already indicate that it is safe to administer the flu vaccine in pregnancy.
For now, I’m off to find a flu vaccine in order to give my child some protection against the disease before he’s born and flu season is in full swing!
Find more information on vaccines in pregnancy on these websites:
- Every Child By Two’s Vaccinate Your Family website
- CDC: Pregnancy and Vaccination
- The American College of Obstetricians and Gynecologist (ACOG); Immunization For Women
- The American College of Nurse Midwives; Immunization in Pregnancy
- World Health Organization; Safety of Immunizing During Pregnancy; A review of the evidence, From the Global Advisory Committee on Vaccine Safety
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