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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…

Vaccines Can Not Only Prevent Cancer, But May Soon Be Able to Cure It

April 6, 2016 28 comments

HPV112315HPV is such a common virus that nearly all sexually active individuals will contract the virus at some point in their lives.

It’s estimated that 79 million people (about 1 in 4) are currently infected with human papillomavirus (HPV) and about 14 million people become newly infected each year in the U.S. alone.  Yet, there is no cure for HPV and in some cases the virus will develop into cancer years, or even decades, after initial exposure. This results in about 270,000 people who are diagnosed with HPV-related cancers in the U.S. each year to include cancers of the cervix, vulva, vagina, penis, anus or throat.

While the CDC currently recommends that parents get their sons and daughters the HPV vaccine series between the ages of 11-12 to prevent future cases of HPV and HPV-related cancers, the reality is that many people are already infected and are spreading the virus to others.

Good News For Those Already Infected

Mayumi Nakagawa, M.D., Ph.D. from the University of Arkansas for Medical Sciences (UAMS) is researching a new vaccine that is designed to cure HPV, cause pre-cancerous lesions to disappear, and provide future protection against HPV. Following the success of the vaccine’s phase I trials, Dr. Nakagawa is now continuing with stage II trials with the support of a $3.5 million grant by the National Institutes of Health (NIH), over the next five years. Read more…

Questioning Whether To Get Your Child the HPV Vaccine? Read This

January 21, 2016 7 comments

iStock_000039978628_Double.jpgIn June 2006, the first human papillomavirus (HPV) vaccine was licensed for use in the U.S.  Rather than celebrate the development of a vaccine to prevent a deadly form of cancer, many parents have instead been misguided by fear.  As a result of persistent internet stories and inaccurate myths that question the safety of HPV vaccines, parents continue to refuse or delay HPV vaccines for their children, and one of the most effective ways to prevent cancer is being grossly underutilized.

Although millions of doses of HPV vaccines have been administered in the past 10 years, some parents still fear what may happen if their child gets an HPV vaccine. 

What they should fear is what may happen if they don’t.

I offer the following information about HPV because everyone should understand where their fears ought to be directed: at the disease, not the vaccine designed to prevent it.

1)  It’s not about sex, it’s about cancer.

Regardless of what parents choose to teach (or not teach) their kids about sex, abstinence or contraception, the HPV vaccine is vital to the health of our children because it protects them from cancer.

By preventing people from contracting certain strains of a highly prevalent infection, we can then prevent the possibility of HPV infections turning into cancerous cells. An HPV infection is often contracted shortly after sexual debut, and can eventually lead to cancers of the cervix, vulva, vagina, penis, anus or throat. Since the majority of these cancers have no formal screening measures, they often go undetected until they are well advanced.

2)  Nearly all sexually-active individuals will contract HPV at some point in their lives. 

HPV is the most common sexually transmitted infection in the United States and is often referred to as the common cold of the genitals. HPV is not a new virus, but many people are unfamiliar with how dangerous and prevalent it is. Consider these staggering statistics:

Not only is HPV infection common, but most people rarely know they’re infected because it typically occurs without any symptoms.  Since it’s possible to develop symptoms years after first being infected, it’s especially difficult to diagnose exactly when a person first became infected.

In about 90% of cases, an HPV infection will eventually clear in about a year or two. However, during that time, those infected with HPV are often unknowingly spreading the infection to others.

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3)  As many as 10% of those infected will eventually develop cancer. 

While 90% of people may clear the infection, the other 10% end up developing cancerous cells years, or even decades, after initial exposure.  Since there is no way to determine which cases will clear and which will lead to cancer, universal vaccination is the most effective means of prevention.

The following data reveals just how many cancer cases are linked to HPV each year:

Cervical cancer: Almost all cervical cancer cases are caused by HPV and more than 11,000 women in the U.S. alone get cervical cancer each year.  When looking at the bigger picture, 528,000 new cases of cervical cancer were diagnosed worldwide in 2012.

Anal cancer: About 91% of anal cancers are caused by HPV and there are approximately 4,300 anal cancers diagnosed each year.

Oropharyngeal cancers(cancers of the head, neck, throat, mouth, tongue, and tonsils) About 72% are caused by HPV and an estimated 8,400 of these cancers are diagnosed each year.

Vaginal cancer: HPV causes about 75% of vaginal cancers and there are about 500 vaginal cancers diagnosed each year.

Vulvar Cancer: HPV causes about 50% of vulvar cancers and an estimated 2,100 vulvar cancers are diagnosed each year.

Penile Cancer: About 63% of penile cancers are linked to HPV and there are about 600 penile cancers diagnosed each year.

Genital Warts: There are more than 40 types of HPV that specifically affect the genital area. However, 90% of genital warts are caused by HPV types 6 or 11 and about 360,000 people in the U.S. get genital warts each year.

Since there is no test to check one’s overall HPV status, and no standard screening to detect HPV in the mouth or throat, getting an HPV vaccine is an effective way to prevent illness rather than leave people vulnerable to infections that can lead to cancer.

Some argue that since there is a test to screen for cervical cancer that this eliminates the need for vaccination among women.  While cervical cancer screenings are vitally important, they don’t prevent infection.  Instead, they help identify precancerous lesions. Once lesions are discovered, women may then need to endure various invasive and painful procedures.  These may include cone biopsies used to help diagnose precancerous or cancerous cells, and a loop electrosurgical excision procedure (LEEP) often used to burn off precancerous lesions.  Additionally, cervical cancer screenings don’t help identify other HPV related cancers or help screen of men or adolescents for HPV.  With the vaccine we can prevent cancers before they exist.

4)  Surprise…you don’t have to have sex to get HPV.

Read more…