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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
The Summer Beach Read You’ve Been Missing: Dr. Offit’s latest book, “Bad Advice”
By: Erica DeWald, Director, Advocacy Every Child By Two
Looking for your final summer beach read but tired of the same old thrillers, political exposés and romance novels? Look no further than the latest offering from Dr. Paul Offit, Bad Advice: Or Why Celebrities, Politicians, and Activists Aren’t Your Best Source of Health Information.
photo by Nicholas Pisani
You may be asking yourself, “Nonfiction? About health advice? I just want something fun and entertaining.” Think of Dr. Offit as that one teacher who always made learning fun. In fact, he’s been described by some as the Neil deGrasse Tyson of medicine. Offit’s quick wit will keep you laughing as he also manages to break down complex scientific and medical concepts.
Throughout the book, Dr. Offit takes us on his personal journey as he transitioned from a guy in a lab, trying to create a vaccine that could eventually save over 200,000 lives a year, to one of the world’s most renown speakers on vaccines. He has done so while facing some of the toughest interviewers and government panels. His secret to success? Trial and error. Not every speech he’s given has been a rousing success, nor has he always managed to convince his audience that the science is right. He has gathered these anecdotes into a series of lessons so others can learn from his mistakes.
His topic is particularly timely given the current conversation around what constitutes “fake news” and who we should view as experts. Social media has given celebrities outsized platforms beyond the usual movie or album release. While many of these individuals are well-meaning, they often base their opinions on the same unsubstantiated information you or I read online.
Which brings us to the topic of activists. In today’s interconnected world, it’s much easier to find individuals who are passionate about the same causes as you, whether it’s vaccines, GMOs, or plastic straws. Individual activists can quickly become seen as leaders, but does that make them experts? Too often their expertise is based on research they’ve conducted online or they are even influenced by monetary interests. Dr. Offit reminds us to always consider what an activist’s motivations may be, and whether they truly rank among the experts in their fields.
In all, Bad Advice is a quick read that will give you some faith that, ultimately, science and facts will win the day if we just communicate it in the right way. And it’ll give you hope that you can ultimately recover from that really awkward comment you just made.
Bad Advice is currently for sale on Amazon.com and at all major book retailers, along with other fascinating books by Dr. Offit.
If you buy the book at Amazon Smile, please consider selecting Every Child By Two as your charity of choice. This will ensure that 0.5% of the purchase price of all your purchases will be given to support our ongoing efforts to educate the public about the life-saving value of vaccines.
Supercharge Your Kid’s Cancer Fighting Power
By: Jennifer Zavolinsky, Director, Outreach Initiatives, ECBT
It’s hard to believe how quickly the summer is rushing by. The July 4th holiday is in the rearview mirror and stores are already putting their summer clothes on clearance. So now is a good time to start thinking about what you need to do to prepare your kids to go back to school.
Are You the Parent of an 11- or 12-Year-Old? 
Make sure your preteen gets the three vaccines that protect against whooping cough (Tdap), meningococcal disease (MenACWY) and HPV cancers (HPV).
We can reduce the risk of our children getting certain cancers later in life by helping them make healthy choices now, including eating a healthy diet, staying away from tobacco, wearing sunscreen and being physically active. We can also help prevent most HPV cancers with just two shots of the HPV vaccine.
HPV vaccination helps prevent six types of cancers caused by the human papillomavirus (HPV) in both men and women including cervical, vaginal, vulvar, anal, penis and throat cancers. Every year in the United States, HPV causes approximately 32,000 cancers in men and women, and HPV vaccination can prevent most of the cancers from ever developing.
HPV is a Common Virus that Infects Teens and Adults
HPV is so common that most people will get the virus at some point in their lives. About 14 million people in the U.S., including teens, become infected with HPV each year. HPV is passed during intimate sexual contact. You can get HPV by having vaginal, anal or oral sex with a person who has the virus. And the virus can be passed even when an infected person has no signs or symptoms. Most HPV infections go away on their own without lasting health problems. However, there is no way to know which infections will turn into cancer. That is why it is important that all children get vaccinated against HPV.
Vaccines are for Prevention, Not Treatment
Since vaccines are for prevention, not treatment, they only work if given BEFORE coming in contact with a virus. That’s why you want to get your child vaccinated against HPV at 11 or 12 years old. In addition, scientific studies have shown that children have the best immune response to the vaccine at these ages. The HPV vaccine is given as a series of two shots, and the series should be completed by age 13.
HPV Vaccines Are Continuously Monitored for Safety
Like all vaccines recommended in the U.S., HPV vaccines are monitored on an ongoing basis to make sure they remain safe and effective. With approximately 100 million doses of HPV vaccine distributed so far in the U.S., data continues to show that HPV vaccines are safe, effective and give long-lasting protection.
Make sure to ask your preteen’s health care provider about the HPV vaccine at his/her next appointment.
Commonly-Asked Questions
Are HPV vaccines safe?
Yes, numerous research studies have been conducted to make sure HPV vaccines are safe, both before and after the vaccines were licensed. Before the three HPV vaccines were licensed for use in the U.S. by the FDA, each went through years of testing in thousands of people through clinical trials. After being licensed, the CDC and FDA have continued to monitor the safety of the HPV vaccines through the three surveillance systems in the U.S. Over 100 million doses of HPV vaccines have been distributed in the U.S. so far and HPV vaccines continue to have a good safety record.
Like any vaccine or medicine, HPV vaccines can cause side effects, but the most common side effects are mild. They include pain, redness or swelling in the arm where the shot was given; dizziness; fainting; nausea; and headache. The benefits of HPV vaccination far outweigh any potential risk of side effects.
Does the HPV vaccine contain dangerous ingredients?
No, the HPV vaccine does NOT contain harmful ingredients. While HPV vaccines, like some other vaccines, do contain a small amount of aluminum in order to boost the body’s immune response to the vaccine, it’s important to realize that people are actually exposed to aluminum every day. Aluminum is commonly found in numerous food and beverages, water, infant formula and even breast milk. Aluminum-containing vaccines have been used for decades and have been given to more than 1 billion people without problems. The quantities of aluminum present in vaccines are low and are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER). Learn more about the use of aluminum and other ingredients in vaccines.
If I vaccinate my preteen now, won’t the vaccine wear off by the time he/she goes to college?
No, if you vaccinate your child at age 11 or 12, he or she should continue to be protected against HPV through college. Studies continue to monitor how long the vaccine protects against HPV infections, and protection has been shown to last at least 10 years with no signs of the protection weakening.
If I give my preteen the HPV vaccine, won’t it be like giving them permission to start having sex?
No, there have actually been scientific studies that have looked at this issue, and they show that there is no correlation between receiving the HPV vaccine and increased rates of, or earlier engagement in, sexual activity.
My child is not sexually active. Why should I vaccinate him/her against HPV now?
Preteens should receive all recommended doses of the HPV vaccine series long before they begin any type of sexual activity. Even if your child delays sexual activity until marriage, or only has one partner in the future, he or she could still be exposed to HPV if his/her partner has been exposed to HPV. Studies have shown that the HPV vaccine is most effective in preventing the virus, and therefore HPV cancers, when given at age 11 or 12.
Can HPV vaccination cause infertility?
No, there is no evidence that HPV vaccination causes fertility or reproductive problems. In fact, getting HPV vaccine, which protects against cervical cancer, can help ensure a woman’s ability to get pregnant and have healthy babies. For example, a woman who develops cervical cancer later in life due to HPV infection may require serious treatments that could leave her unable to have children. It’s also possible that treatment for cervical pre-cancer could put a woman at risk for problems with her cervix, which could cause preterm delivery or other problems. HPV vaccination can help prevent these complications.
Learn more about HPV vaccination at vaccinateyourfamily.org
Remembering Nadja, another precious child lost to measles
By Erica DeWald
Europe has been in the midst of a measles outbreak since 2016 which, so far, has resulted in 48 deaths. Unfortunately, many people are at risk, including children who are not yet old enough to receive the vaccine and those with compromised immune systems.
One mother in Serbia has chosen to share the story of losing her young daughter, Nadja, in the hopes that it will encourage other parents to vaccinate their children against measles and other vaccine-preventable diseases.
Nadja was diagnosed with an autoimmune condition when she was a year old. Her hypoparathyroidism, due to hypoglycaemia and hypocalcaemia, meant she could not keep her calcium levels high enough through simple oral therapy. She needed regular IV injections at her local hospital. The condition also made it harder for Nadja to fight infections and placed her among the high-risk group of people who cannot be vaccinated. She instead relied on those around her to protect her from vaccine-preventable diseases.
In January of this year, Nadja was admitted to the hospital but there was no room in the isolation unit. She ended up sharing a room for three days with another li
ttle boy. Her mother, Dragana, later learned the boy had been diagnosed with measles. Dragana recounted,
“At the moment, my world collapsed, I knew that she would get it, but again in the depths of the soul I hoped she will not.”
Three days later, measles caused Nadja to develop a high fever and she fell into a coma from which she never awoke. Despite multiple attempts and two resuscitations over the course of three months to stabilize Nadja, she died on April 4 from heart failure.
Measles is not just a threat in Europe. Here in the United States we are seeing increasing outbreaks of the disease. In the past week health officials have reported confirmed or suspected cases in Oregon and Washington as well as New Jersey. Since 2014, over 1,000 cases of measles have occurred in the U.S. placing communities at serious risk. That’s because it’s one of the most easily spread viruses we know of, and as many as 1 out of every 20 children with measles will get pneumonia, and about 1 child in every 1,000 who get measles will develop encephalitis. As a result, the disease still kills hundreds of thousands of children each year around the world.
Dragana has begun a Facebook page to remember her daughter and to warn others of the deadly consequences of measles. Please take a moment to follow her page and share it with your friends and families in remembrance of Nadja.
Have questions about the dangers of measles or what you can do to stop the spread of outbreaks?
- Read the Centers for Disease Control and Prevention’s measles vaccination recommendations,
- Check out our previous blog posts on measles,
- Ask us your questions in the comments section.
CA Medical Board Takes Action to Protect Children’s Health: Dr. Bob Sears Placed on Probation
By Amy Pisani, Executive Director, ECBT (mother of two fully vaccinated teenage boys)
Last week, the Medical Board of California ordered a 35-month probation for Dr. Bob Sears, an Orange County pediatrician who is best known for hawking an “alternative” vaccination schedule for young children, promoting the unproven theory that vaccines cause autism, and being a champion for parents who seek to claim exemptions from school vaccination requirements.
The revocation of Dr. Sears’ medical license was stayed by the Medical Board, which allows him to continue practicing medicine, as long as he follows certain requirements of his probation including taking Board-approved medical education and ethics classes, and allowing a Board-approved monitor to watch and report on his medical practices. Through this disciplinary order, the Medical Board is providing Sears with a clear warning against future misconduct.
The overall charges against Sears include gross negligence and repeated negligence in his care and treatment of a patient (a child called J.G), and failure to maintain adequate and accurate records. The formal accusation brought by the Executive Director of the Medical Board of California Kimberly Kirchmeyer provides specific examples of Sears’ departures from the medical standard of care, “which require that a physician who is evaluating a patient for possible reaction to vaccines obtain a detailed history of the vaccines previously received as well as the reaction that occurred. Based on that information the physician should provide an evidence-based recommendation for future immunizations.” The accusation continues “the respondent was grossly negligent and departed from the standard of care in that he did not obtain the basic information necessary for decision making prior to determining to exclude the possibility of future vaccines leaving both the patient, the patient’s mother, and his future contacts at risk for preventable and communicable diseases.”
Forbes’ contributor Tara Haelle, who has been following this case against Dr. Bob Sears since last year, noted that:
“the charges involve much more than writing a vaccine exemption letter. According to the accusation, Sears failed to test the same toddler for neurological problems after the child was hit on the head with a hammer and failed to investigate alleged vaccine reactions that, if they did occur, would have been life-threatening. He also prescribed garlic for the child’s ear infection despite there being no evidence of its effectiveness. Such departures from the medical standard of care prompt questions about what other ways Sears might be practicing negligently beyond this complaint.”
Ms. Haelle’s latest Forbes article offers insight into Dr. Sears’ extensive history of anti-vaccination practices and advocacy efforts:
“When physicians practice this type of substandard care, it places children’s lives at risk. Dr. Sears’ bias against vaccines flies in the face of overwhelming evidence of the safety and necessity of timely vaccinations,” Amy Pisani, MS, executive director of Every Child By Two told me.
“With notoriety comes great responsibility. Dr. Sears’ promotion of his ‘alternative vaccine schedule’ has helped perpetuate the myth that vaccines are not safe for children, which is shameful,” Pisani said. “This ruling should send a strong message to providers that the practice of medicine must be based on evidence, not anecdote, and signing vaccine waivers without medical necessity is not an acceptable practice.”
Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law, details the legal ramifications of Sears’ probation and offers insight into Sears’ past actions in a recent Skeptical Raptor post
Like many moms, I was an avid follower of the advice of Dr. Bill Sears, the father or Dr. Bob Spears and the well-known pediatrician who offered advice to parents on child rearing and attachment parenting. Over the last decade, it has been very disturbing to see Dr. Bob using his father’s name and the Sears Parenting Library to sell his books, which contain inaccurate vaccination information and fuel parents’ fears about vaccines. Dr. Bob Sears’ “alternative” vaccination schedule, which encourages parents to either skip or delay recommended vaccines for their children, is dangerous and ignores the importance of following the Centers for Disease Control and Prevention’s (CDC’s) recommended schedule.
The CDC sets the U.S. immunization schedules for children, teens and adults based on recommendations from the Advisory Committee on Immunization Practices (ACIP). The ACIP, which is made up of medical and public health experts, carefully considers many factors, including the safety and effectiveness of vaccines, before recommending a vaccine for use. As a result, the CDC’s recommended childhood immunization schedule (from birth to 18 years old) is the ONLY vaccination schedule for children and teens that is rigorously tested for safety and effectiveness. No “alternative” or “non-standard” schedule has ever been tested. The CDC’s recommended schedule is also endorsed by the leading medical groups including the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP). The vaccines in the schedule are carefully timed to provide protection to children when they are most vulnerable to diseases, and when the vaccines will produce the strongest response from their immune system.
Learn more about how the vaccine schedule is determined and why it is never okay to delay a child’s vaccines.
Advisory Committee on Immunization Practices June 2018 Meeting Update
The Advisory Committee on Immunization Practices (ACIP) held their second of three annual meetings at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA last week. ECBT staff took advantage of the opportunity to view the meeting via webcast, and strongly encourage members of the public to take advantage of this technology in order to gain a better understanding of the deliberations that take place to ensure the ongoing safety and effectiveness of the vaccines licensed for use in the U.S.
The CDC sets the recommended immunization schedules for people of all ages in the U.S. based on recommendations from the ACIP. The ACIP establishes, updates and continually evaluates all the vaccine recommendations that are made in the United States for infants, adolescents and adults. These guidelines are considered the gold standard among healthcare providers. The ACIP consists of 15 voting members, 8 ex officio members and 30 non-voting representatives who participate voluntarily. In addition to the three meetings per year, which are open to the public, ACIP members serve on various work groups that are active throughout the year. Work groups review the latest studies on specific vaccines (including safety and efficacy reports), in order to provide recommendations to the larger committee.
Last week the ACIP voted on recommendations for influenza (flu) and anthrax vaccinations, and discussed HPV, mumps, shingles (herpes zoster), Japanese encephalitis, and pneumococcal vaccines. Votes and highlights from the discussions are detailed below.
Influenza (Flu) Vaccination Discussion and Vote
It will come as no surprise to our readers that the flu virus hit a brutal blow to people of all ages during the very severe 2017-18 flu season in the U.S., striking at nearly the same time nationwide.
Influenza A (H3N2) was the predominant circulating strain and this year the effectiveness of the vaccine against this strain was approximately 24% (similar to the previous flu season). Effectiveness against the influenza A (H1N1) strain was 65% and 49% against the influenza B (Yamagata) strain.
Now the good news – vaccination reduced flu-related visits to healthcare providers (outpatient) by 40% among all people ages 6 months and older. Among adults, the vaccine reduced outpatient visits and hospitalizations by 22%.
The ACIP listened to vaccine safety reports provided by representatives from the Food and Drug Administration (FDA), vaccine manufacturers, and the vaccine safety surveillance systems in the U.S. – the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD) which is a collaboration between CDC and nine healthcare organizations that began in 1990 and analyzes up to 10 million immunization records per year to ensure ongoing safety. After an extensive review of the safety of this season’s flu vaccines, the ACIP confirmed that there were no vaccine safety signals of concern including anaphylaxis, narcolepsy and Guillian-Barre Syndrome, each of which received increased scrutiny due to a number of news and anecdotal reports in recent years.
The ACIP approved the following influenza recommendations for the 2018-19 season:
Everyone 6 months of age and older should be vaccinated with any licensed, age-appropriate influenza vaccine (IIV, recombinant influenza vaccine [RIV], or LAIV), as indicated. No preference is given for any one vaccine over another. In its February meeting, the ACIP once again recommended LAIV (the nasal spray vaccine known as FluMist) for healthy, non-pregnant people 2 through 49 years old during the 2018-19 season. This recommendation was made after ACIP reviewed effectiveness data presented by the manufacturers of FluMist.
Of Note: The Redbook Committee of the American Academy of Pediatrics, who typically endorses the recommendations of the ACIP, have stated a preference for the flu shot (IIV or RIV) over the nasal spray vaccine (LAIV), recommending that pediatricians only give the nasal spray as a last resort. This decision by the AAP is not without controversy as it may lead to confusion among parents and their providers. ECBT Board Member Dr. Paul Offit recently created a Medscape video explaining why he agrees with the ACIP’s decision to recommend the use of FluMist in children based on the effectiveness data.
Pneumococcal Vaccination Discussion
Two pneumococcal vaccines are currently recommended for all adults over the age of 65 – one dose of pneumococcal conjugate vaccine (PCV13) with a booster dose of pneumococcal polysaccharide vaccine (PPSV). ACIP is re-examining whether PCV13 should be routinely recommended for otherwise healthy older adults. Some experts believe the childhood recommendations for routine vaccination with PCV13 is sufficiently lowering the disease burden in adults by reducing the circulation of the disease in communities. In data presented to the ACIP, however, it seems there are persistent disparities in the rate of pneumococcal disease and vaccine uptake 
among minority populations and those in poverty, which puts into question whether it would be wise to eliminate the vaccine recommendation for adults. The ACIP will continue to deliberate the data and have continued discussions into 2019.
Anthrax Vaccination Discussion and Vote
The anthrax vaccine is currently approved for use by the FDA for 18-65 year olds, and is usually given to select populations of adults (i.e. military). As the Department of Health and Human Services (HHS) and CDC review their plans for responding to an anthrax “mass event”, they have asked ACIP to offer guidance on how best to use the vaccine in the event of emergency. Specifically, they asked ACIP whether the anthrax vaccine would be equally effective and safe if they had to administer the vaccine in fewer or smaller doses to ensure there was enough vaccine for everyone affected. Also under consideration was the utilization of different types of needles to be used in the event of a needle shortage. The current vaccine is given subcutaneously, not intramuscularly, like typical vaccines. Intramuscular needles are therefore more readily available.
After reviewing the data, the ACIP agreed unanimously that reduced dosing would still save lives, as would offering the vaccine intramuscularly instead of subcutaneously. There was no data, however, on whether reduced doses given intramuscularly would be equally effective. The Committee also offered their recommendations on the duration of antimicrobial treatment following vaccination. There is a new intramuscular anthrax vaccine on the horizon which may help federal agencies better plan for a possible emergency situation.
The ACIP made the following recommendations:
The intramuscular route of administration may be used if the subcutaneous route presents clinical, operational, or logistical challenges that may delay or prevent effective vaccination.
- Should there be an inadequate supply of anthrax vaccine available for Post Exposure Prophylaxis (PEP), either 2 full doses or 3 half doses of AVA may be used to expand vaccine coverage.
- In immunocompetent individuals 18-65 years of age, antimicrobials given in conjunction with vaccine may be discontinued at 42 days after the first vaccine dose or 2 weeks after the last vaccine dose, whichever comes later.
Japanese Encephalitis Vaccination Discussion
The cell culture-derived Japanese encephalitis vaccine (JE-VC) is both safe and effective, but given how few U.S. travelers contract the disease, ACIP is re-evaluating their recommendations. They are in the midst of re-evaluating the cost effectiveness of the vaccine and whether their recommendations should be more targeted. ACIP will continue deliberations at a future meeting.
Mumps Vaccination Discussion
Mumps outbreaks continue to crop up throughout the nation. From late 2016 through 2017, there were 56 outbreaks, which included 3,914 cases, and in 2018, there have already been 30 outbreaks, including 1,415 cases. The ACIP previously recommended the use of a 3rd dose of mumps virus-containing vaccine (MMR) for people identified at increased risk during a mumps outbreak. 
During the June, 2018 ACIP meeting, the CDC provided guidance for public health officials to assist them on the use of a 3rd dose of MMR vaccine during an outbreak, including identifying groups of people at risk for acquiring mumps during an outbreak; assessing transmission in the settings to determine if groups are at increased risk; and how to implement a 3rd dose recommendation.
Shingles (Herpes Zoster) Vaccination Discussion
In October 2017, ACIP made recommendations for a new recombinant zoster vaccine (RZV) called Shingrix. The vaccine is recommended for the prevention of shingles and related complications for adults 50 years of age and older. It is also recommended for adults 50 and older who previously received zoster vaccine live (ZVL), and it is preferred over ZVL for the prevention of shingles and related complications.
GSK, the manufacturer of Shingrix, reported to the Committee that it is increasing the number of doses available due to high demand and shipping delays. They are also continuing to study the safety and effectiveness of the vaccine. The CDC also continues to monitor shingles vaccine coverage and vaccine supply. As it does with all vaccines, the CDC is using U.S. safety surveillance systems – VAERS and VSD – to monitor the shingles vaccine (RZV). VAERS is a passive system that is not designed to determine if a vaccine caused a health problem, but does help to detect unusual or unexpected patterns of adverse events that might indicate a possible safety problem with a vaccine. The CDC reported that were 680 reports to VAERS between October 20, 2017 and April 27, 2018, and the majority concerned females. There were no unusual patterns or unexpected adverse events. 48 (7%) of reports involved co-administration with 1 or more other vaccines, and the most commonly reported side effects from RZV were injection site pain and pyrexia (fever).
The CDC also reported to ACIP about VSD monitoring of the shingles vaccine. The staff of the VSD conducted vaccine safety studies based on questions and concerns raised from the medical literature and reports to VAERS. As of May 31, 2018, 37,303 total doses of RZV were administered at the participating VSD sites. The VSD monitoring for RZV includes high priority short-term outcomes (GBS, anaphylaxis, and acute myocardial infarction); lower priority short-term outcomes for descriptive analysis (gout, local and systematic reactions); and longer-term outcomes (potential immune-mediated diseases). Evidence of safety and effectiveness of shingles vaccine in immunocompromised is currently being reviewed.
The CDC has created a number of resources for RZV. For providers, the CDC developed a report published in MMWR on vaccine administrative errors, a Continuing Medical Education program (CME) called “You Call the Shots”, a Medscape video, web pages, webinars/conferences and fact sheets. For the public, the CDC created a vaccine information statement (VIS) on the RZV, web pages and a fact sheet.
Human Papillomavirus (HPV) Vaccination Discussion
In October 2018, the FDA is expected to complete a review of scientific studies to determine whether 9-valent HPV vaccine (GARDASIL®9) is safe and effective for use in adults ages 27 to 45. The vaccine will continue to serve as a prophylactic to prevent new infections, and is not expected to prevent progression of the disease among those who already have a HPV infection. The ACIP is also simultaneously reviewing the evidence that has been sent to the FDA and will determine whether to recommend the vaccine if and when the FDA approves the vaccine for use among mid-aged adults. Factoring into the ACIP decision will be the fact that the overall population-level benefit will be lower among mid-aged adults than among younger populations. This is due to the fact that this
population may have already been exposed to HPV and thus already have an infection, or have immunity against some strains of the disease. In addition they tend to have fewer new sex partners and have several other factors that will make the vaccine less beneficial (but not without merit) for this older group than for those ages 11-12, who can be vaccinated prior to exposure.
The ACIP’s HPV work group is also continuing to review data in consideration of “harmonizing” the schedule for males and females so that both populations would be recommended up to the age of 26 instead of up to age 21 for males and up to age 26 for females and will report back to the full ACIP at a future meeting.
ECBT will keep you informed on this and other deliberations of this important committee.
Learn more about each of these vaccines and the diseases they prevent on the Vaccinate Your Family website and Facebook page.
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