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Fifty and Fabulous, But NOT Fully Vaccinated

August 29, 2018 3 comments

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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.

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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. 

 

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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.shingles

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

 

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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!

 

 

 

 

How Do We Know Vaccines are Safe?

August 15, 2018 8 comments

Vaccinate Your Family_MomGrandmaLittleGirlToo 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:

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.

Advisory Committee on Immunization Practices June 2018 Meeting Update

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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.

 

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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%.

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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  pneumoacip062018

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. img_0681.pngDuring 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

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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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What You Don’t Know About Hepatitis Can Hurt You

More than four million Americans are living with viral hepatitis, but most don’t know they’re infected.

HepABCs-cubeMany people can live with hepatitis for decades without feeling sick or exhibiting any symptoms.  But left untreated, there are three different types of viral hepatitis which can cause serious health problems, including liver damage, liver failure, liver cancer or even cirrhosis, a condition that causes permanent scarring of the liver.

In honor of Hepatitis Awareness Month, learn how the different types of viral hepatitis are spread, as well as how they can be prevented or treated. 

Hepatitis A

Hepatitis A can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months.

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It is usually spread by contact with people who are infected or from contact with objects, food, water or drinks contaminated by the feces of an infected person, which can easily happen if someone doesn’t properly wash his or her hands after using the toilet. It’s important to know that not all people with hepatitis A have symptoms, but it’s more likely for adults to have symptoms than children. If symptoms develop, they usually appear two to six weeks after being infected and may include:

  • Fatigue
  • Nausea and vomiting
  • Loss of appetite
  • Fever
  • Dark urine
  • Gray-colored stools
  • Joint pain
  • Yellowing of the skin and eyes (jaundice)
  • Severe stomach pains and diarrhea (mainly in children)

The good news is that hepatitis A is easily prevented with a safe and effective vaccine. For the best protection, it is recommended that children receive two  doses of Hep A vaccine with the first dose being administered between 12 and 23 months of age, and a second dose administered 6 to 18 months after the first dose. Adults who have not been previously vaccinated, or who are at risk due to their work or travel. should also be vaccinated.  Since the introduction of the vaccine, cases of hepatitis A have plummeted across the country.  However, outbreaks still do occur. 

Currently, there are reported outbreaks in West Virginia, Kentucky and California in which hundreds of cases have been identified and several deaths have occurred. This is why all everyone should ensure they are protected against hepatitis A.

Hepatitis B

People who get infected with the hepatitis B virus, especially young children, can go on to develop a chronic or lifelong infection which can cause serious liver damage, liver failure, liver cancer or cirrhosis.

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Hepatitis B virus can be spread through contact with an infected person’s blood, semen, or other body fluids.  This may happen when someone has a cut or sore, when someone is bitten by another person (as in the case of children in daycare), through the sharing of a toothbrush or food has been chewed (like in the case of young children), from an infected mother to her baby during childbirth, through sexual contact, or by sharing needles, syringes, or other drug-injection equipment.

Not all people with hepatitis B have symptoms. However, if they occur, they usually appear about three months after infection and can range from mild to severe, including:

  • Dark urine
  • Fever
  • Joint, muscle and stomach pain
  • Loss of appetite
  • Nausea, diarrhea and vomiting
  • Fatigue
  • Yellowing of your skin and the whites of your eyes (jaundice)

The best way to prevent hepatitis B is by getting vaccinated. The vaccine is recommended for: 

  • All infants, starting with the first dose of hepatitis B vaccine within 24 hours of birth.  This shot acts as a safety net, reducing the risk of a child getting hepatitis B from moms or family members who may not know they are infected with the disease. Additional doses of the vaccine should be given between 1 and 2 months, and between 6 and 18 months of age.Newborns who become infected with hepatitis B virus have a 90% chance of developing chronic Hepatitis B, which can eventually lead to serious health problems, including liver damage, liver cancer, and even death. This is why the birth dose has been an extremely effective way of reducing the risk of chronic Hepatitis B infection. 
  • All children and adolescents younger than 19 years of age who have not been fully vaccinated against hepatitis B
  • Unvaccinated adults at risk for hepatitis, in addition to any adult who wants to be protected from hepatitis B.

Unfortunately, many people got infected before the hepatitis B vaccine was widely available. That’s why the CDC recommends that anyone born in areas where hepatitis B is common (such as Asia, the Pacific Islands or Africa), or whose parents were born in these regions, get tested for hepatitis B.

You can learn more about who may be at increased risk of hepatitis B here. Fortunately, treatments are available that can delay or reduce the risk of developing liver cancer.

Hepatitis C

FACT: People born from 1945 - 1965 are 5 times more likely to be infected with Hepatitis C. Learn more: //www.cdc.gov/KnowMoreHepatitis/

For some people, hepatitis C is a short-term illness, but for 70%–85% of people who become infected, it becomes a long-term, chronic infection which can cause serious liver damage and even liver cancer over time. Unfortunately, the majority of infected people are not aware of their infection because they are not clinically ill.

In the past, hepatitis C was spread through blood transfusions and organ transplants. However, widespread screening of the blood supply began in 1990 and the hepatitis C virus was virtually eliminated from the blood supply by 1992. Today, most people become infected with hepatitis C by sharing needles, syringes, or any other equipment to inject drugs. For reasons that are not entirely understood, people born from 1945 to 1965 are five times more likely to have hepatitis C than other age groups.

Unfortunately, there is currently no vaccine to prevent hepatitis C. However, once diagnosed, most people can be treated and cured in just 8 to 12 weeks, reducing liver cancer risk by 75%. This is why awareness and testing is so critical.


The CDC has developed an online Hepatitis Risk Assessment to help people find out if they should get tested or vaccinated for viral hepatitis.

ARE YOU AT RISK? Millions of Americans have VIRAL HEPATITIS. Most don't know it. Take this online assessment to see if you're at risk. //www.cdc.gov/hepatitis/riskassessment/

The assessment, which takes only five minutes, will provide personalized testing and vaccination recommendations for hepatitis A, hepatitis B, and/or hepatitis C.  Take it today and protect yourself from these viruses that can so easily go undetected.  

Shingles Vaccine is the Silver Lining of Turning 50

April 19, 2018 9 comments

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Turning fifty is a milestone most people would rather avoid.  

Not me.  

After watching both my 73-year-old mother and my 18-year-old daughter suffer with shingles, I would do almost anything to avoid it. And last year, when a new and more effective shingles vaccines was licensed by the FDA, and recommended by the Advisory Committee on Immunization Practices (ACIP) for people age 50 and older, I began looking forward to my 50th birthday.

You see, now that I’ve witnessed shingles up close and personal, I am eager to prevent it and I feel compelled to encourage everyone to as well.  And here’s why…

Vaccination is the Only Way to Prevent Shingles

You can’t avoid shingles by washing your hands or avoiding sick individuals.  The only means of prevention is through vaccination.

That’s because shingles isn’t your typical contagion. It’s a virus, but not the kind that is spread from person to person through coughing or sneezing. It’s actually a virus (the herpes zoster virus), that is caused by another virus, (the varicella-zoster virus, more commonly known as chickenpox).

Over the past two years I’ve watched as both my mother and my daughter have suffered with shingles, and I’ve learned a few things along the way.   

Shingles Pain Is Excruciating, Debilitating and Can Be Long Lasting

ShinglesImageThe rash then developed into fluid-filled blisters that would break open, ooze out and eventually crust over.  She had to be careful to keep the rash covered and wash her hands frequently since she didn’t want to infect my newborn niece who was living in the same home at the time. Since my niece had not yet received her varicella vaccine, she was not immune to the virus and would be at risk of developing chickenpox.  As a premature infant, that could have been extremely dangerous for her.   Read more…

Updates from the Advisory Committee on Immunization Practices February Meeting

March 6, 2018 2 comments
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Photo Credit: James Gathany, Centers for Disease Control and Prevention

The Advisory Committee on Immunization Practices (ACIP) held its first meeting of 2018 on February 21st and 22nd.  The Committee consists of a panel of immunization experts that advise the Centers for Disease Control and Prevention (CDC).  Part of their charter is to continually evaluate new data and update or change vaccine recommendations as warranted. 

The agenda for the February 2018 meeting included presentations pertaining to several different diseases and vaccines, to include hepatitis, influenza, anthrax, HPV, pneumococcal, meningococcal and Japanese encephalitis.

A overview of the meeting is provided below, with details on presentations in the order they occurred: 

Hepatitis B

The committee voted unanimously to approve a non-preferential recommendation for a new Hepatitis B vaccine (Dynavax’s HEPISLAV-B™) to their list of recommended vaccines for adults 18 years and older against infections caused by all known subtypes of Hepatitis B.

This vote came following the presentation of data showing that the new two-dose vaccine generates a more rapid and higher antibody response than the standard 3 dose vaccine.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, and transmission is on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally and 850,000-2.2 million persons are estimated to be living with infection in the U.S.

Since there is no here is no cure for hepatitis B, vaccination is our best chance at preventing the disease. While about 90% of people are infected during infancy, in adults, hepatitis B is most often spread through contact with infected blood and through unprotected sex with an infected person. Some individuals who are especially susceptible include those who are immunosuppressed or living with diabetes. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.

The Working Group summary suggested that this new vaccine option is likely to improve vaccine series completion and result in earlier protection, which is especially beneficial in persons with anticipated low adherence such as injection drug users.  Additionally, the improved immunogenicity in populations with typically poor vaccine response such as the elderly, diabetics and those on dialysis, is promising.  The ACIP will continue to review post-marketing surveillance studies and additional data to ensure safety and cost-effectiveness considerations.

Hepatitis A

The committee voted unanimously to pass three recommendations pertaining to Hepatitis A.

  • Hepatitis A vaccines should be administered for post-exposure prophylaxis for all persons 12 months of age or older.
  • Hepatitis A vaccine or immune globulin (IG) may be administered to persons 40 years of age or older, depending on the providers’ risk assessment.
  • Hepatitis A vaccine should be administered to infants age 6-11 months of age traveling outside the US when protection against hepatitis A is recommended. This recommendation takes into consideration the fact that infants under 12 months who will be traveling internationally will typically also need an MMR vaccine.  Since Hepatitis A immune globulin and MMR vaccine should not be administered simultaneously, these children should receive a single dose of HepA vaccine. It’s important to note that infants should then complete the full, 2 doses of MMR and HepA vaccines at 12 months of age as recommended.

Influenza

The Committee heard five presentations specific to influenza.

The first two were reports of current season data; one detailing flu surveillance, the other providing early influenza vaccine effectiveness data.

According to the update, the majority of circulating flu strains are similar to those contained in the 2017-2018 vaccine.  The only virus clearly showing antigenic drift was the B/Victoria lineage viruses which represents less than 1% of circulating viruses.  So far this season, influenza A (H3N2) has been dominant, with influenza B activity starting to increase more recently. Activity has been the highest we’ve seen since 2009, and while final severity can’t be determined until the end of the season, hospitalization rates and mortality could be similar to or exceed those send during the severe 2014-2015 season.

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Based on data from 4,562 children and adults with acute respiratory illness enrolled during November 2, 2017–February 3, 2018, at five study sites, the overall estimated effectiveness of the 2017–18 seasonal influenza vaccine for preventing medically attended, laboratory-confirmed influenza virus infection was 36%. The percentage differs by age group and by virus.  A detailed report can be found here.

The most notable news out of the Committee last week was the vote to restore the live attenuated influenza virus (LAIV) vaccine as an option for the 2018-19 season. LAIV is commonly known as the nasal spray flu vaccine or by its brand name, FluMist This renewed ACIP recommendation offers FluMist as one of several vaccine options for non-pregnant people who are 2-49 years of age during the 2018-2019 season, but does not indicate any preference for FluMist over injectable flu vaccines.

While FluMist has not been recommended for the past two flu seasons due to reduced effectiveness against the H1N1 flu strain in children, the Committee heard three presentations specific to LAIV vaccine efficacy in children prior to taking a vote on future recommendations for LAIV.  The first reported on the efficacy of Fluarix Quadrivalent in children 6-35 month of age. Another presented the results of a randomized trial of a new H1N1 LAIV strain in U.S. children. The third was a review LAIV in children 2-17 years of age.  

The possible root cause of the poor effectiveness of LAIV against H1N1 was discussed and poor replication of the H1N1 selected strain was thought to be the likely problem. A new strain selection process is now in place in cooperation with the Food & Drug Administration (FDA) and it suggested that the antibody responses of the latest reformulated version of the quadrivalent vaccine, which includes the new 2017-18 post-pandemic 2009 H1N1 LAIV strain (A/Slovenia), will perform significantly better than what was previously observed when the vaccine included the 2015-16 post-pandemic LAIV strain (A/Bolivia).  Immunogenicity and viral shedding data in small trials supported this notion, but no efficacy data is available at this time.

The Committee was therefore forced to a vote using only the science available to date. There was a lively discussion among members who expressed various concerns. While flu vaccine effectiveness is a serious issue, some committee members expressed concern that they may be holding FluMist to a higher standard than other influenza vaccines, yet all have efficacy challenges from year to year.  Other members were concerned with how the vaccine may perform in an H1N1 dominated season. Until the vaccine is used, further effectiveness assessments are performed, and a prominent H1N1 year occurs, a certain level of uncertainty will remain.

While members voted overwhelmingly (12-2) to reinstate LAIV on the immunization schedule, a second vote to give other flu vaccines a preferential recommendation over LAIV failed (11-3).  So, while the ACIP will not indicate a preference for any one type of flu vaccine over another, the public will ultimately determine whether there will be high uptake of this particular vaccine next season. Read more…

Is This Season’s Flu More Severe Than Usual or Just Highly Active?

January 13, 2018 10 comments

At this point in the flu season people often wonder if all the media hype is part of an orchestrated effort to panic people about flu, or if it is really signaling serious concern.

There are lots of flu stories in the news these days.  From reports of  74 Californian’s who’ve died from flu – five times the number seen at this point last year – to 13 school districts in TX closing due to the high number of flu cases among students, we’re left to wonder….

Is this year’s flu season more severe than usual or just highly active at the moment?

A recent CDC media briefing has helped clarify the following concerns regarding the latest flu activity in the U.S.: 

Right now, flu is widespread everywhere.  

One of the most notable differences between this season and others is in relation to the geographic spread of flu. This is the first time over the course of 13 years of surveillance data that the entire nation is experiencing widespread flu at the exact same time, as can be noted by the color of CDC’s flu surveillance map below.

FluWeeklyReportActivity is severe right now.

 

One of the ways the CDC tracks influenza activity is to record the number of lab confirmed cases of flu and hospitalizations by week. What they’ve noted is a very rapid increase in the number of people seeing their healthcare providers for flu diagnosis, along with a rapid rise in the numbers of people being hospitalized with lab confirmed flu. For instance, this week’s surveillance data indicates that there’s been 22.7 hospitalizations per 100,000 people in the U.S., which is up considerably from the 13.7 number recorded last week.

So far this season, influenza A (H3N2), has been the most prevalent strain in circulation. Unfortunately, historically it is often the strain linked to more severe illness, especially among children and older individuals above the age of 65. Interestingly enough, the current flu surveillance observations seem to be in line with two more previous H3N2 dominant seasons; the 2014-2015 and 2012-2013 seasons.WHOPHL02_small

Additionally the hospitalizations so far this season seem to be in line with other H3N2 predominant seasons, with the highest rates among those over the age of 65, those between 50-64, and children under 5 years of age.

Flu can cause mild disease in some, but severe disease and death in others.

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Sadly, there have been as many as 30 pediatric deaths so far this season. While children are at great risk, there are plenty of reports of otherwise healthy adults who have been hospitalized or died from flu this season.

Peak season may have started early, but there are many more weeks to go.

Speaking to the media on behalf of the CDC on Friday, Dr.  Jernigan explained,

“If we look at the timing of the season, even if we have hit the top of the curve or the peak of the seasonal activity, it still means we have a lot more flu to go.”

He went on to suggest that there will likely be at least 11 to 13 more weeks of elevated influenza activity this season, before activity begins to subside. Even though it can take about two weeks for protection from vaccination to set in, Dr. Jernigan explained that we still have a lot of flu season to get through and that vaccination efforts should continue as long as influenza viruses are circulating.

While we are seeing a lot of H3N2 circulating now, we are also seeing H1N1 show up in states that have already had H3N2 activity. And we know that B viruses also tend to show up later in the season. Each of these strains are covered in the vaccine, so flu vaccination now can still help to prevent, or lessen the severity of flu throughout the remainder of the season.

Vaccination is our best defense.  

While flu vaccination is far from perfect, it remains our best defense. Not only can it help prevent flu, but it can also help lessen the severity of symptoms if a vaccinated person does end up getting infected.  This can reduce the chances of an individual being hospitalized or dying from flu.

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In fact, a recent study showed that influenza vaccination reduced the risk of flu-associated death by 65% among healthy children and by 51% among children with underlying high-risk medical conditions. Another study indicated that many older adults benefit from repeated flu vaccination. When getting vaccinated in both the current and previous seasons, the study found flu vaccination was 74% effective in preventing ICU admissions in older individuals and 70% effective in preventing deaths among older adults.

Manufacturers are reporting that they’ve shipped more than 151 million doses of flu vaccine this season, so there shouldn’t be a problem finding a flu vaccine in your area.  Simply refer to the flu vaccine finder for assistance.

We won’t know preliminary flu vaccine effectiveness until February.  

Read more…