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Posts Tagged ‘Advisory Committee on Immunization Practices’

Evaluating the Safety of Flu Vaccination in Pregnancy

September 18, 2017 Leave a comment

The decision to get a flu vaccination in pregnancy is one that should be based on a complete evaluation of the scientific evidence that is available.  Flu shots have been safely administered to millions of pregnant women over many years, so how should expectant parents respond to a recent study that implies a connection between multiple flu vaccinations and the incidence of miscarriage in early pregnancy?  

To properly evaluate the significance of the latest data, we must consider the findings of this one report alongside the abundance of other science-based information we have, such as: 

  1. Why the Advisory Committee on Immunization Practices (ACIP) currently recommends flu vaccination among pregnant women.
  2. Data from the numerous studies that support the safety of the ACIP’s current recommendation of flu vaccine for pregnant women.
  3. Details of the “case-control” study in question and an examination of the study methods, findings and limitations.

Why the ACIP recommends flu vaccination among pregnant women.  

Currently the CDC’s Advisory Committee on Immunization Practices (ACIP) recommends that pregnant women get a flu vaccine during any trimester of pregnancy to help protect them and their newborns from the dangers of influenza.  Due to changes in the immune system, heart and lungs during pregnancy, expectant women are more prone to severe illness from flu, which has been known to result in premature delivery, low birth weight babies, miscarriage, hospitalization or even death.

Flu vaccination in pregnancy doesn’t just help protect the expectant mother from influenza, it is also the most effective way to pass critical immunity on to the baby during pregnancy.  This passive immunity can then protect the infant child from the dangers of influenza in the time before they are old enough to receive their own flu vaccination at six months of age.

The ACIP recommendation for flu vaccination during pregnancy is supported by other organizations as well, to include The American College of Obstetricians and Gynecologists (ACOG) and the American College of Nurse-Midwives (ACNM).

The studies that support the safety of flu vaccination in pregnancy. 

The ACIP is a committee which consists of 15 voting members who have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and preventive medicine.  The Committee meets in person three times a year and subcommittees meet regularly throughout the year via conference call to discuss vaccine research and scientific data related to vaccine effectiveness and safety.

The current ACIP recommendation for flu vaccination during pregnancy is based on a thorough review of the evidence compiled from numerous studies, which include the following:

    • A review of reports to the Vaccine Adverse Reporting System (VAERS), a national vaccine safety surveillance program run by CDC and the Food and Drug Administration (FDA), (Moro et al, 2011) which found no unusual or unexpected patterns of reporting for pregnancy complications or adverse fetal outcomes among pregnant women and flu shots.
    • A study using Vaccine Safety Datalink (VSD) data (Irving et al, 2013) which found no increased risk of miscarriage among pregnant women who received flu vaccines in the 2005-06 or 2006-07 flu seasons. (The VSD is a collaborative program that monitors the safety of vaccines and conducts studies about rare and serious adverse events following immunization.)
    • A large study using VSD data (Kharbanda et al, 2013) which found no increased risk for adverse obstetric events (like chorioamnionitis, pre-eclampsia, or gestational hypertension) for pregnant women who received the flu vaccine from 2002 to 2009 compared to pregnant woman who were not vaccinated.
    • A VSD study (Nordin et al, 2014) which compared pregnant women who received the flu shot with an equal number of pregnant women who did not receive the flu shot during the 2004-05 and 2008-09 flu seasons. The study found no differences between the two groups in the rates of premature delivery or small for gestational age infants.
    • A large August 2017 study using VSD data which found that the babies of women who received the flu shot during their first trimester had no increased risk of having children with major birth defects.

The examination of vaccine safety is an ongoing process.  Before being approved for administration, vaccines undergo rigorous testing by their manufacturers, the FDA, and the FDA’s Center for Biologics Evaluation and Research. Clinical trials are performed before the vaccine is made available to the public, to confirm the vaccine’s safety and efficacy. Even after the vaccine receives FDA-approval, post-licensure studies are conducted on an ongoing basis to continually monitor the vaccine’s safety and to detect and respond to any rare adverse events.

While the studies conducted to date have not signaled any safety concerns, the ACIP and the CDC are committed to the continuous evaluation of the safety of all vaccines, to include those recommended for pregnant women.

This has led to the “case-control” study of flu vaccination and possible miscarriage which was recently published in the journal Vaccine on September 12, 2017 and reported on by The Washington Post, the Associated Press, and various other media outlets.  The study showed that women in early pregnancy who received two consecutive annual vaccines during 2010-11 and 2011-12, both of which included a 2009 pandemic H1N1 (H1N1pdm09) component, had an increased risk of spontaneous abortion (miscarriage) in the 28 days after receiving the second vaccine.

Details of the recently published study of women who had miscarriage following flu vaccination. 

Read more…

Updates from June 2017 Meeting of the Advisory Committee on Immunization Practices

July 13, 2017 2 comments

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Recently, the Advisory Committee on Immunization Practices (ACIP) met to discuss several important developments concerning vaccines. As you may be aware, this impartial group of experts advises the U.S. Centers for Disease Control and Prevention (CDC) on all matters related to vaccine recommendations. In the coming years, the ability of the CDC and public health departments to implement the recommendations of this group may be under threat from proposed provisions within the health care reform bills and congressional budget cuts.

The activities of the ACIP are supported by staff at the CDC, which receives annual appropriations from the federal government to fulfill its duties.  This federal immunization funding is at risk of being drastically cut if the Prevention and Public Health Fund (PPHF) is eliminated. (Click here to see a breakdown of the impact of the elimination of the PPHF funds by state.) If Congress follows the recommendation of the President, funding will be reduced by another 14% beginning in Fiscal Year (FY) 2018.

The result is that CDC may no longer be able to fully support its immunization functions including:

  • ACIP staffing;
  • Vaccine purchase and supply management;
  • Vaccine safety monitoring;
  • Education initiatives;
  • Disease surveillance;
  • Outbreak response; and
  • Funding support for state, territory, and city immunization programs.

An example of the critical activities conducted by the CDC includes support for the ACIP.  This committee of experts from diverse fields such as vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and\preventive medicine meets three times a year to review and discuss vaccine research and scientific data related to vaccine effectiveness and safety, clinical trial results, outbreaks of vaccine-preventable disease or changes in vaccine supply.

There are 15 voting members, 8 ex officio members who represent other federal agencies with responsibility for immunization programs in the United States, and 30 non-voting representatives of liaison organizations that bring related immunization expertise. All members volunteer their time and come from many leading professional and public organizations such as the American Academy of Pediatrics, the National Foundation for Infectious Diseases, and the American Geriatrics Society. This is the only meeting to gather such a comprehensive group of experts whose aim it is to protect individual and public health.

The current health care reform discussions that are happening in Congress may have a direct impact on this Committee. Please continue to reach out to your Representatives and Senators to let them know the importance of keeping PPHF and CDC fully funded. (You can find your Members of Congress at http://whoismyrepresentative.com/ and some suggestive language to share here.) 

The value of the ACIP can not be overstated. During their most recent committee meeting in June, members discussed several important issues recapped in the summary below.

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.

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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…

Meningococcal Disease Killed My Child, But a New Vaccine Means it Doesn’t Have to Kill Yours

August 2, 2016 2 comments

Me head and shoulderThis guest post was written by Neal Raisman, PhD, to highlight the threat of meningococcal disease in the U.S. as part of Vaccinate Your Family’s “State of the ImmUnion” campaign.

My son Isaac was a very healthy 26-year-old who worked out every day and took great pride in how and what he ate. On September 24, 2005 he called home from college to tell his mother he had a terrible headache and felt lousy. Since he complained of chills and a fever, my wife and I thought he was suffering with the flu and told him to get some sleep and drink lots of fluids. He called again to report that the headache was even worse and he felt even sicker. Again, his mother re-assured him that it was probably the flu.

IsaacLittle did we know at that time, but Isaac did not have the flu.

What he had was serogroup type B meningitis and it was quickly eating at his body and brain.

He died soon after that call with his mother. It wasn’t until later that night that I was able to get into his apartment where I found his body. This is the last photo that was ever taken of our son.

Isaac had received a meningitis vaccine before college, but back in 2005, the only meningococcal vaccine available was one that covered the serogroup strains of A, C, W and Y.  At that time there was no vaccine to prevent the B strain that killed our son.

But there is now.

I’m sharing our story today so that every mother and father will know that serogroup B meningococcal disease kills and maims without mercy.

Not every person infected will die like Isaac.  Sometimes victims will live in a brain-dead coma.  Some will lose limbs.  Now that I know how quick and devastating this disease is, I must caution parents to do everything they can to protect their children before it is too late.

In 2014, nine years after we lost Isaac, the FDA approved the first vaccine to prevent the serogroup B strain of meningococcal disease.

In order to offer the most complete protection from all the preventable strains of meningococcal disease, this MenB vaccine needs to be administered in addition to the MenACWY vaccine that is already on the recommended immunization schedule.

While the current burden of disease appears to be low, there have been outbreaks of serogroup B meningococcal disease at U.S. colleges that have resulted in loss of limbs and loss of life.  Following FDA approval, it is customary for the Advisory Committee on Immunization Practices (ACIP) to evaluate the data and determine whether the vaccine should be added to the recommended schedule.   With FDA approval, the safety of the vaccine was not in question, however the ACIP felt it was necessary to continue to review data pertaining to vaccine effectiveness, duration of effectiveness and impact of the vaccine on carriage and herd immunity.  Therefore, the initial ACIP decision was to make a routine recommendation for individuals at highest risk of disease and in outbreak situations, while recommending that those in the 16-23 year age range “may be vaccinated to provide short term protection against the strain”. This is what is known as a “permissive” or “Category B” recommendation.

In the beginning, there was speculation that due to this “Category B” recommendation, that not all insurance companies would cover the cost of the vaccine.  However, as a condition of the Affordable Care Act (ACA), all health plans must start covering any recommended vaccine (even Category B) with no out-of-pocket costs when provided by an in-network healthcare provider.  Health plans have until one year after the effective date of the recommendation to comply, so it is possible that some patients won’t be covered until their plan renewal, which may occur more than a year after the October 2015 recommendation was made. However, public health partners nationwide continue to report that providers (including Vaccine For Children providers) are not universally stocking the vaccine, nor making strong recommendations for its use. In addition, although the majority of health plans are covering the cost, some may not be following ACA guidelines, which can be quite ambiguous. Some may be covering the cost of the vaccine for one category of recipients (i.e. high risk) but not those who “may” be vaccinated.

As a parent of a child who died from meningococcal disease, I still worry that this ambiguous recommendation is leaving our children unprotected.

A vaccine is now available to prevent the B strain that my son died of.  Yet this limited recommendation means that many doctors won’t be discussing the availability of the vaccine, and many parents won’t know that the vaccine is available.  Worse yet, many parents may wrongfully believe their child is fully protected from all the preventable meningococcal strains when their child receives the MenACWY, which is not accurate.

So now we are left wondering, what is the benefit of the serogroup B meningococcal vaccine if parents aren’t aware that it is available or believe they can’t afford it?  How many lives will be lost due to the current policy?  And what will it cost to stop letting young men and women be horribly maimed or die?

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…

Highlights of the Latest Meeting of the Advisory Committee On Immunization Practices

February 26, 2016 4 comments

Three times a year a specialized group of medical and public health experts meet in Atlanta to review scientific data related to vaccine safety and effectiveness. Although most people are probably unaware that these meetings occur, this is not some clandestine group.  Far from it actually.  Meeting dates and proposed agendas are available in advance, all meetings are open to the public and available via webcast, public comments are accepted, and past meeting notes and slide presentations are accessible online.

What amazes me is that the 15 voting members, 8 ex officio members and 30 non-voting representatives of this group participate voluntarily.  In addition to the three meetings per year, members serve in various work groups that are active all year long.  Work groups  review the latest studies on specific vaccines, as well as the safety and efficacy of those vaccines, in order to provide recommendations to the larger committee.

They work hard and take their responsibilities very seriously.  And they should, because 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.  These guidelines are considered the gold standard among healthcare providers and health insurance coverage of vaccines is based on these recommendations.

Original Title: BLDG21_0023.jpgIf you’ve ever attended a meeting or tuned in to a live webcast, you know how thorough they are in their investigation of the science that is the driving factor behind every recommendation they make.  Earlier this week, in their first meeting of 2016, ACIP members discussed a variety of vaccines to include HPV, meningococcal, influenza and Japanese encephalitis, as well as Zika virus. For those who were unable to attend the meeting or tune in via webcast, I would like to provide a brief recap of the major discussion items.

HPV Vaccination: 

The discussion focused on the ongoing review of data comparing the immunogenicity of human papillomavirus (HPV) vaccine after a 2 dose schedule versus a 3 dose schedule. 

As early as June 2014, the ACIP began reviewing data for 2 dose bivalent and quadrivalent HPV vaccines.  The World Health Organization has been recommending a 2 dose schedule since 2014 for children starting the series before age 15 and most other countries who primarily administer bivalent or quadrivalent HPV vaccines are already using a 2 dose schedule.  These 2 dose schedules are recommended in foreign countries for use with the bivalent and quadrivalent vaccines.  Here in the U.S. the ACIP began recommending the 9-valent HPV vaccine, which provides protection from additional strains of HPV in February, 2015.  Vaccination with 3 doses was recommended at that time.

In evaluating the possibility of reducing the number of doses from 2 to 3 here in the U.S., the ACIP reviewed data on the immunogenicity of a 2 dose versus 3 dose HPV vaccination schedule to determine whether a different schedule could provide similar, acceptable levels of protection in the months and years following vaccination as compared to what is expected with a 3 dose schedule. The Committee reviewed three studies comparing 2 doses versus 3 doses of the bivalent HPV vaccine, three studies comparing 2 doses versus 3 doses of quadrivalent vaccine (one from Canada, one from Mexico and a large trial from India), and preliminary findings from a ongoing study of 9-valent vaccine that is expected to continue for two more years.

Each study was conducted slightly differently and provided an extensive amount of data to consider. For instance, some studies differentiated between the timing of the doses, (such as 0, 6 month dosing and 0, 12 months dosing versus the 0, 6, 12 month interval that is currently recommended).  Some studies also accounted for differences in gender, ages of administration of doses (for instance, young girls versus older women and girls versus boys).  There was even data that differentiated between the seroconversion rates at different intervals after vaccination and among the antibody titers for the different HPV types.

The data appears to suggest that a 2 dose schedule may be a consideration moving forward.  However, the ACIP’s HPV Work Group still needs to evaluate all the data in greater detail before they can present their recommendations for further discussion and approval by the entire ACIP Committee at a future meeting.

The Committee still needs to consider that completion of a 2 dose regimen would be important since the effectiveness of a single dose is known to be lower.  Currently,  completion rates for the 3 dose regimen remains suboptimal and there would be even less flexibility in a 2 dose regimen.  Additionally, the duration of protection from a 2 dose 9-valent vaccine has not been determined, but is currently undergoing investigation.  This type of data will likely need to be evaluated in comparison to a 3 dose schedule before proceeding with a change of recommendation.

A study released earlier this week suggests that we may be witnessing a herd effect with HPV vaccine.  Despite only 40% of girls and 22% of boys being vaccinated, the rate of HPV infections among young women has plummeted by two-thirds since the introduction of the vaccine.  Before altering the current recommendations, the Committee may also want to consider the comparative herd effect in a 2 dose versus 3 dose schedule.

It was noted that  the vaccine manufacturer is seeking FDA approval of a 2 dose 9-valent HPV vaccine, which should be determined within the year.  In the meantime, if the ACIP were to recommend a 2 dose schedule before the FDA review is complete, the recommendation would be considered off label. Although some may question an off label recommendation, the ACIP has made other off label recommendations when sufficient evidence suggests it is reasonable to do so.

Meningococcal Vaccine: 

The ACIP reviewed several post-approval studies of meningococcal serogroup B vaccine  to further evaluate the vaccine’s safety and efficacy profile.  Additionally, the Committee was presented with data from a mass immunization campaign that occurred in response to a large meningococcal serogroup B outbreak in Quebec, Canada.  There was also discussion pertaining to a possible increased risk of meningococcal disease among HIV infected persons.

As background, it was noted that the ACIP issued a recommendation for meningococcal serogroup B vaccine in 2015 following FDA licensure.  Prior to the licensure of the vaccine, the FDA approved special use of the vaccine in response to outbreaks of the disease on various college campuses.   While both the ACIP and the FDA have previously reviewed the efficacy and safety data available from pre-licensure vaccine trials, and from the use of the vaccine in many countries that have licensed and administered the vaccine ahead of the U.S., the Committee will continue to review post-approval studies to ensure the vaccine’s safety and efficacy.

This week, the Committee reviewed four safety and immunogenicity studies, all of which demonstrated a high proportion of individuals who achieved a high consistency of response across the studies.  The safety profile seemed consistent with the safety data at licensure and phase three studies confirmed that the vaccine elicits bacterial responses that correlate to protection against the four most prevalent strains circulating in the U.S., as well as 10 additional strains.  The data continued to demonstrate broad protective response when used for both outbreak control and prevention of endemic disease.

Additionally, there was a review of a mass immunization campaign following a significant outbreak in Quebec, Canada.  The data suggests direct protection during 18 months following vaccination with 100% vaccine effectiveness observed among the 47,115 vaccinated people and two cases among two unvaccinated adults.  There was additional data presented on the safety profile and observational evidence pertaining to adverse events such as pain and fever post injection.

The meningococcal vaccine discussion also suggested that there is a growing body of evidence that supports an increased risk of meningococcal disease among HIV-infected persons.  This is of particular interest since the ACIP doesn’t currently include HIV-infected persons on the list of people at high risk.  This is largely due to evidence that suggests that the meningococcal vaccine offers suboptimal vaccine response and duration of protection among this particular demographic of HIV-infected persons.  In contrast, the American Academy of Pediatrics does in fact recommend MenACWY vaccine for HIV infected persons ages 2 and up.  So, while the Meningococcal Work Group seems supportive of adding a recommendation to include HIV infected persons, they will continue to review additional data and will report back to the full Committee at a future meeting.

During the public comment period of the meeting, Lynn Bozof from the National Meningitis Association, raised the concern that the public is having difficulty locating MenB vaccine.  She provided anecdotal evidence that her member families seeking MenB vaccination for their children have had to make up to five calls to providers to gain access to the vaccine.  She feared that less motivated families would simply give up.  She asked that the ACIP consider the ramifications of their permissive Category B recommendation for MenB vaccination, which in her opinion does not carry the strength of a full Category A recommendation.

ACIP’s current recommendation as posted on the CDC website states that “Teens and young adults (16 through 23 year olds) may also be vaccinated with a serogroup B meningococcal vaccine (Bexsero® or Trumenba®), preferably at 16 through 18 years old. Two or three doses are needed depending on the brand.”  “Preteens, teens, and young adults should be vaccinated with a serogroup B meningococcal vaccine if they are identified as being at increased risk of meningococcal disease.”  This is quite different than the Category A recommendation for the vaccine to prevent the A,C,W and Y strains of meningococcal.  The recommendation states that “all 11 to 12 year olds should be vaccinated with a single dose of a quadrivalent (protects against serogroups A, C, W, and Y) meningococcal conjugate vaccine (Menactra® or Menveo®)”.   The small differences in recommendation types can make a big difference in the number of individuals who are offered the vaccine, have access to the vaccine and ultimately get vaccinated.

Influenza Vaccine: 

There were two significant discussions pertaining to influenza vaccine.  First, the CDC announced that based on interim vaccine effectiveness data it appears that getting a flu vaccine this season has helped reduced the risk of having to go to the doctor because of flu by 59%.  Additionally, data suggests that there is a very low rate of adverse reaction to flu vaccine in people who have egg allergy and that since the same reactions occur at the same rate in non-egg-allergic people, the ACIP will be removing egg allergy warnings for influenza vaccination. 

The influenza surveillance data from this season indicates that influenza activity in the U.S. has been lower this season than in the last three seasons, and that there is a good match between the most common circulating viruses (A (H1N1) and B) which may explain why the vaccine is offering significant protection this season.  It was also noted that there have been 13 pediatric deaths this season.

The Committee also learned that among the 73.7 million children in the U.S., 1.3% or approximately 958,100 children have some type of egg allergy.  Current flu vaccine recommendations for those with allergy to egg are quite extensive, including a long algorithm which must be considered by vaccine administrators.  The recommendation that children be monitored post vaccination or seek the advice of an allergist may result in parents avoiding influenza vaccine all together for their children.  However, this may no longer need to be the case.

In the review of 27 published studies involving flu vaccine and egg allergy, most studies included patients with history of severe anaphylaxis with egg ingestion. These patients tolerated the vaccine without any serious reactions such as respiratory distress or hypotension.  While there was a very low rate of minor reactions such as hives and mild wheezing, these reactions occurred in non-egg-allergic people at the same rate.  Similarly, there was a one in one million chance of anaphylactic reaction to flu vaccine among egg-allergic people, which is the same rate in response to flu and other vaccines in non-egg-allergic people.  The research suggests that there haven’t been serious reactions to flu vaccine in people with egg allergies because flu vaccines contain minimal egg ovalbumin and therefore are unlikely to cause a reaction in egg-allergic people.  In fact, it was demonstrated that the manufacturers have actually over-estimated the amount of egg ovalbumin contained in both the IIV (injected) and LAIV (live attenuated/nasal) vaccines.

Based on the Committee’s review of this data, the ACIP voted to remove the precautions about IIV and LAIV flu vaccine for people with a history of egg allergy.  The ACIP Influenza Work Group was tasked with developing the exact wording of the recommendation post-meeting, which will be approved for the 2016-2017 season.  Stay tuned for the exact recommendation changes.

Japanese encephalitis vaccine:

The ACIP reviewed data on the current recommendation for travelers to receive Japanese encephalitis vaccination.  Studies regarding the safety of the vaccine and duration were presented to the Committee and it was determined that there was insufficient data to spur the inclusion of a booster (2nd) dose of the vaccine.  The latest data will however be included in an upcoming MMWR and further considered at a future meeting.

Zika Virus:

The Committee was given an overview of the international efforts to quell outbreaks of the Zika virus and develop a potential vaccine to protect against future infections worldwide.  Collaboration among global experts was similar to the impressive response to the Ebola outbreaks and the conversation regarding the potential for a future vaccine was encouraging.

While this recap offers a glimpse into the type of considerations that the ACIP addresses and the extensive amount of research they regularly review, these highlights do not go into the length necessary to recount the entire meeting.  If you should be interested in seeing the slide presentations made to the Committee, simply check for the slides to be updated here within the next week or two.  If you should have questions, please let us know in the comments below and we will do our best to address them.  Additionally, by subscribing to this Shot of Prevention blog in the upper right corner of the page you can ensure that you will receive notice of ACIP updates and meeting recaps in the future.

Why My Kid Won’t Be Getting These New Vaccines Anytime Soon

September 11, 2015 7 comments

There’s a part of me that understands why some people are hesitant to get newly approved and recommended vaccines.

“I don’t want my child to be a pharmaceutical guinea pig.”

“The vaccine hasn’t been around long enough.  How can we really know the long-term side effects?”    

“I didn’t have half the vaccines that kids today get and I survived.  Why do we bother to give so many vaccines for diseases that aren’t even all that serious?”

These are the kind of comments I’ve heard in school, at the doctor’s office, on the playground with other parents, or posted as comments on social media. While I understand that people may be hesitant, and sometimes even fearful, of something new, I tend to address my concerns by learning more about whatever it is I’m afraid of.

Since I began contributing to this blog six years ago, I’ve tried to address some of the most popular immunization concerns I’ve heard from other parents.  In sharing what I’ve learned, It is my sincere hope that others will be better able to make informed immunization decisions based on the sound scientific evidence that I include in my posts.

However, the approval of two new vaccines (HPV9 and MenB) have actually caused me much concern and distress lately.

It’s not that I’m worried about the dangers of these new vaccines.  Quite the contrary.  

I’ve sat through enough presentations at immunization conferences and committee meetings to appreciate the extensive amount of data that is collected and analyzed by hundreds of scientists and doctors as a vaccine makes it’s way through the various phases of clinical trials.

img3I’ve become familiar with the elaborate process that leads to FDA approval, and I’ve witnessed discussions by the Advisory Committee on Immunization Practices (ACIP) when they’ve considered modifications or additions to the recommended vaccine schedule.  By the time a new vaccine is ever recommended for my child, the vaccine has already been administered to thousands of people in clinical trials and the vaccine’s efficacy and potential adverse effects have already been well documented.  In fact, many vaccines, are already being used in foreign countries for years prior to being approved here in the U.S.  This provides a considerable amount of safety and efficacy data for us to analyze prior to U.S. licensure and recommendations.

With all the available data that is scrutinized by so many experts, I’m not concerned at all about the vaccine’s safety.  What I am concerned about is how long it takes for the public to finally have access to these new vaccines after FDA approval and ACIP recommendation.

In the case of these two new vaccines (HPV9 and MenB) my personal experience has been far from ideal.  It’s been at least three months since the new ACIP recommendations and yet I’m still unable to locate a single dose of either vaccine within a 50 mile radius of my home.  To make matters worse, I’m hearing reports from parents who are getting inaccurate information about the availability of these vaccines. Read more…