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CA Medical Board Takes Action to Protect Children’s Health: Dr. Bob Sears Placed on Probation

By Amy Pisani,  Executive Director, ECBT (mother of two fully vaccinated teenage boys)

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Last week, the Medical Board of California ordered a 35-month probation for Dr. Bob Sears, an Orange County pediatrician who is best known for hawking an “alternative” vaccination schedule for young children, promoting the unproven theory that vaccines cause autism, and being a champion for parents who seek to claim exemptions from school vaccination requirements.

The revocation of Dr. Sears’ medical license was stayed by the Medical Board, which allows him to continue practicing medicine, as long as he follows certain requirements of his probation including taking Board-approved medical education and ethics classes, and allowing a Board-approved monitor to watch and report on his medical practices. Through this disciplinary order, the Medical Board is providing Sears with a clear warning against future misconduct.

The overall charges against Sears include gross negligence and repeated negligence in his care and treatment of a patient (a child called J.G), and failure to maintain adequate and accurate records. The formal accusation brought by the Executive Director of the Medical Board of California Kimberly Kirchmeyer provides specific examples of Sears’ departures from the medical standard of care, “which require that a physician who is evaluating a patient for possible reaction to vaccines obtain a detailed history of the vaccines previously received as well as the reaction that occurred. Based on that information the physician should provide an evidence-based recommendation for future immunizations.” The accusation continues “the respondent was grossly negligent and departed from the standard of care in that he did not obtain the basic information necessary for decision making prior to determining to exclude the possibility of future vaccines leaving both the patient, the patient’s mother, and his future contacts at risk for preventable and communicable diseases.”

Forbes’ contributor Tara Haelle, who has been following this case against Dr. Bob Sears since last year, noted that:

“the charges involve much more than writing a vaccine exemption letter. According to the accusation, Sears failed to test the same toddler for neurological problems after the child was hit on the head with a hammer and failed to investigate alleged vaccine reactions that, if they did occur, would have been life-threatening. He also prescribed garlic for the child’s ear infection despite there being no evidence of its effectiveness. Such departures from the medical standard of care prompt questions about what other ways Sears might be practicing negligently beyond this complaint.”

Ms. Haelle’s latest Forbes article offers insight into Dr. Sears’ extensive history of anti-vaccination practices and advocacy efforts:

“When physicians practice this type of substandard care, it places children’s lives at risk. Dr. Sears’ bias against vaccines flies in the face of overwhelming evidence of the safety and necessity of timely vaccinations,” Amy Pisani, MS, executive director of Every Child By Two told me.

“With notoriety comes great responsibility. Dr. Sears’ promotion of his ‘alternative vaccine schedule’ has helped perpetuate the myth that vaccines are not safe for children, which is shameful,” Pisani said. “This ruling should send a strong message to providers that the practice of medicine must be based on evidence, not anecdote, and signing vaccine waivers without medical necessity is not an acceptable practice.”

Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law, details the legal ramifications of Sears’ probation and offers insight into Sears’ past actions in a recent Skeptical Raptor post 

Like many moms, I was an avid follower of the advice of Dr. Bill Sears, the father or Dr. Bob Spears and the well-known pediatrician who offered advice to parents on child rearing and attachment parenting. Over the last decade, it has been very disturbing to see Dr. Bob using his father’s name and the Sears Parenting Library to sell his books, which contain inaccurate vaccination information and fuel parents’ fears about vaccines. Dr. Bob Sears’ “alternative” vaccination schedule, which encourages parents to either skip or delay recommended vaccines for their children, is dangerous and ignores the importance of following the Centers for Disease Control and Prevention’s (CDC’s) recommended schedule.

The CDC sets the U.S. immunization schedules for children, teens and adults based on recommendations from the Advisory Committee on Immunization Practices (ACIP). The ACIP, which is made up of medical and public health experts, carefully considers many factors, including the safety and effectiveness of vaccines, before recommending a vaccine for use. As a result, the CDC’s recommended childhood immunization schedule (from birth to 18 years old) is the ONLY vaccination schedule for children and teens that is rigorously tested for safety and effectiveness. No “alternative” or “non-standard” schedule has ever been tested. The CDC’s recommended schedule is also endorsed by the leading medical groups including the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP). The vaccines in the schedule are carefully timed to provide protection to children when they are most vulnerable to diseases, and when the vaccines will produce the strongest response from their immune system.

Learn more about how the vaccine schedule is determined and why it is never okay to delay a child’s vaccines.

 

Advisory Committee on Immunization Practices June 2018 Meeting Update

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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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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…

Evaluating the Safety of Flu Vaccination in Pregnancy

September 18, 2017 2 comments

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…