Posts Tagged ‘serogroup B meningococcal vaccine’

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.


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…

October Updates from Advisory Committee on Immunization Practices

October 26, 2016 3 comments

10693.jpgLast week, the Advisory Committee on Immunization Practices (ACIP) held it’s third and final meeting of 2016.  The agenda included presentations pertaining to hepatitis B, pertussis, HPV, meningococcal, herpes zoster, pneumococcal and RSV vaccines, and surveillance updates on Zika and influenza viruses.

During the two-day meeting, the committee took nine votes on newly proposed vaccine recommendations that addressed vaccination timing, number of doses needed, and dosing intervals for hepatitis B, pertussis, HPV and meningococcal vaccines.  They also approved the child, adolescent and adult immunization schedules.

This post provides a recap of each agenda item in the order they occurred. 

Hepatitis B Vaccine

The recommended first dose of the three-series hepatitis B vaccine is often referred to as “birth dose” and is typically administered to infants in the hospital after birth.  At this meeting, the Hepatitis B Work Group asked that the Committee consider removal of the permissive language that appears at the end of the recommendation which allows for a delay of the birth dose until after hospital discharge.

When hepatitis B vaccine is administered within 24 hours of birth it can help prevent transmission of the hepatitis B virus from an infected mother to her child.  The intent of the birth dose is to provide an additional safety net to prevent transmission from HepB positive mothers that are not properly identified due to errors in maternal testing or reporting. In these instances, when the mother is not properly identified as HepB positive before birth, the HepB vaccine alone is 75% effective in preventing prenatal transmission, and 94% effective when used in conjunction with Hepatitis B immune globulin.

Since delaying hepatitis B vaccination can interfere with the prevention of Hepatitis B – especially in a child unknowingly born to a HepB positive mother – the HepB Work Group proposed that the reference to delaying vaccination be removed from the recommendation.  It had originally been added in 2005, but the data suggests that administering the birth dose in the hospital leads to timely completion of the series. The current birth dose coverage was stated to be 72.4% of children, which remains below the Healthy People 2020 goal of 84%.

The Committee voted to remove the permissive language as well as include new language to clarify that the first dose of vaccine should be administered within 24 hours of birth, which is more explicit than “before hospital discharge”.

The anticipated changes to the previous recommendation are indicated below, however the exact wording may differ once published by the CDC:

“For all medically stable infants weighing 2,000 grams or more at birth and born to HBsAg-negative mothers, the first dose of vaccine should be administered before hospital discharge within 24 hours of birth.  Only single antigen HepB vaccine should be used for the birth dose. On a case-by-case basis and only in rare circumstances, the first dose may be delayed until after hospital discharge for an infant who weighs 2,000 grams or more and whose mother is HBsAG-negative.

*It should be noted that for those infants with birth weight of less than 2,000 grams, the birth dose is not counted as part of the vaccine series.

There was some discussion concerning the removal of the option to delay vaccination and it was emphasized that having a clear recommendation from the ACIP is not a vaccine mandate.  Rather, practitioners, public health professionals and parents rely on the ACIP recommendations as expert guidance and best practice. The Hepatitis B “birth dose” has been a successful strategy to help eliminate hepatitis B virus transmission in the U.S., and the ACIP’s revised recommendations only emphasize the importance of vaccinating within the 24 hours timeframe that will help prevent further transmission.


Other key updates to the hepatitis B vaccine recommendations included:

  • Providing examples of chronic liver disease, including recommending HepB vaccine for persons with HCV infection.
  • Post vaccination serologic testing for infants who’s mother’s HBsAg status remains  unknown indefinitely.
  • Testing HBsAg-positive pregnant women for HBV DNA.

For more information as to why babies need a Hepatitis B vaccine at birth, read these Shot of Prevention blog posts here

Pertussis Vaccine

The Committee reviewed the history of Tdap vaccination in pregnant women and reviewed studies that found that maternal Tdap vaccination to both safe and effective at preventing infant pertussis. Read more…

Highlights from June Meeting of Advisory Committee on Immunization Practices

June 30, 2016 1 comment

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

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

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

Influenza Vaccine

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

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

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

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

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

Cholera Vaccine

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

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

Meningococcal Vaccine

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

Serogroup B Meningococcal Vaccine Approved But Awaiting CDC Recommendations

October 30, 2014 67 comments

This mMeningococcalonth another college student succumbed to a strain of meningitis that is not covered in the currently recommended meningococcal vaccine. In 2013 and 2014 outbreaks of serogroup B meningococcal disease occurred at Princeton University and University of California’s Santa Barbara (UCSB) campuses, prompting health officials to request special permission from the Food and Drug Administration to utilize a vaccine that is not currently licensed in the United States. More than 5,000 Princeton University students received the first dose of the MenB vaccine in December 2013, and more than 4,700 students received the second dose in February 2014. At UCSB, as many as 9,000 students received the first dose in February and March 2014 and more than 7,000 received the second dose in April 2014.

While some questioned the wisdom of using a vaccine that had yet to be licensed here in the U.S., clinical trials in other countries have shown that the same vaccine met safety and efficacy standards that cleared the way for licensure in the European Union, Canada, and Australia back in 2013. More than one million doses of the vaccine have since been distributed to over 30 countries where the vaccine was licensed, with little to no sign of serious adverse events. And, it has been determined that there have been no unusual patterns or occurrence of serious reactions reported among the students vaccinated here in the U.S.

Two different manufacturers (Pfizer and Novartis) have sought FDA approval of their MenB vaccines. Yesterday Pfizer received final approval and Novartis will be informed regarding the FDA’s decision in the next few months. In anticipation, the CDC’s Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that develop vaccine recommendations to help control diseases in the U.S., has been receiving reports from their meningococcal subcommittee. This subcommittee is tasked with investigating the epidemiology of this disease and the results of the clinical trials. These reports become critical in helping the ACIP to ultimately vote on whether the vaccines will be recommended to the public once approved and under what parameters.

Of course, this will be no easy job. It’s important to understand that there are five main serogroups (“strains”) of meningococcal bacteria: A, B, C, Y, and W. The most common ones that cause disease in the United States are B, C, and Y. Our current U.S. meningococcal vaccine covers the A,C, Y and W strains, but not serogroup B. The strain prevalence often varies by country. For instance, Australia and Europe see far more cases of serogroup B than we do here in the U.S. However, in 2012, there were about 500 total cases of meningococcal disease in the U.S, and 160 of those cases were caused by serogroup B. According to a presentation made at today’s ACIP meeting, in the years spanning from 1998-2012 there have been an average of 50 cases of serogroup B meningococcal disease per year in 18-24 year olds. When factoring in the recent outbreaks, serogroup B now causes 40% of all meningococcal disease cases among 11-24 year olds.

While statistically speaking, an average of 50 cases a year may not sound like a lot, how can one quantify the number of deaths, and life-long disabilities caused by meningococcal disease that is considered acceptable? Read more…

Fascinating Report on the Advisory Committee on Immunization Practices

October 28, 2014 2 comments

Time and again I hear people on social media criticizing our immunization practices here in the United States.  Often they make suggestions that vaccine recommendations are made arbitrarily and without careful consideration.  Some even go so far as to suggest that vaccine recommendations are made for the sole purpose of lining the pockets of pharmaceutical companies.

My purpose in contributing to this blog has always been to inform people about immunizations and the various professionals and non-profit organizations working to ensure that timely immunizations are available to protect U.S. citizens from serious and often debilitating diseases.  What I’ve learned is that many people fail to recognize the great efforts that are made by the Advisory Committee on Immunization Practices (ACIP)mmwrhead.  This committee consists of many dedicated immunization experts who are given the immense responsibility of providing external advice to the CDC and the Secretary of the U.S. Department of Health and Human Services (DHHS).

Recently I read a detailed and fascinating MMWR report, written by Jean Clare Smith, MD, Alan R Hinman, MD, and Larry K. Pickering, MD, which summarizes the evolution of the ACIP over the past 50 years. I felt it was rather timely, given the fact that later this week the ACIP will meet once again, to discuss a variety of immunization related items. Read more…