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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…

Immunization Funding is an Investment in Public Health that Saves Lives and Dollars

February 26, 2018 Leave a comment

ba3f8b28-e868-42b5-b217-1d8da24ffbd8For the past two decades, every President has proposed a fiscal budget that has underfunded immunization programming. Fortunately, over the years, Congress has been steadfast in approving higher amounts. As we approach another crossroad in our fiscal planning, we must, once again, call upon Congress to properly fund critical prevention programs.  

In the following Op Ed published in The Hill, Every Child By Two Executive Director, Amy Pisani, makes the case that Congress should support the CDC’s Immunization Program to the fullest extent possible. In order to truly effect change, the program requires $1.03 billion. While it may seem like a hefty sum, the argument in favor of full funding is that an investment in public health will save lives as well as future expense. 

 

Undercutting the Immunization Program

Puts Both Lives and Dollars at Risk

 

By Amy Pisani, executive director of Every Child By Two, a nonprofit organization committed to reducing the burden of vaccine-preventable diseases in families and individuals.

 

Earlier this month, President Trump released his proposed Fiscal Year 2019 budget. It notes an impressive achievement: For every $1 the Centers for Medicare and Medicaid Services (CMS) spends on preventing fraud and abuse, the agency saves $5.

Whenever you can spend money to save money in government, it’s a no brainer for policymakers. Unfortunately, that rationale seems to have escaped the President on the issue of vaccination.

For every $1 we spend on childhood vaccines, we save $10.10, which is nearly double the savings of preventing fraud. The vaccines given to children born over the past two decades will result in a savings of $360 billion in direct and nearly $1.65 trillion in societal costs.

The benefits don’t end with children. The U.S. still spends nearly $26.5 billion annually treating adults over the age of 50 for just four diseases that could be prevented by vaccines: influenza, pertussis, pneumococcal disease and shingles.

The majority of these avoidable costs are borne by federal health insurance programs. Yet for the second year in a row, the President has proposed gutting the Centers for Disease Control and Prevention’s (CDC’s) Immunization Program.

This is not just a discussion of dollars saved. It’s also a matter of lives saved. Over the past 23 years the Vaccines for Children program has prevented 381 million illnesses, 855,000 early deaths and 25 million hospitalizations, but we have much more work to do.

(Click here to read the full article on The Hill)

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For information pertaining to the preparedness of our nation, and for suggestions on what we can do as a nation to make our country stronger and more resilient in the face of emerging health threats, review Vaccinate Your Family’s second annual State of the ImmUnion report here.   

Congress Proposes Big Cuts to Prevention and Public Health Fund

February 6, 2018 1 comment
by Erica DeWald, Director of Advocacy, Every Child By Two

Congress is Proposing a $2.85B Cut to Prevention and Public Health Fund (PPHF) over 10 Years

Congress is once again developing a Continuing Resolution (CR) to keep the government from shutting down on Thursday, February 8. Every Child By Two (ECBT) is pleased to report that the proposed CR budget also includes critical funding for many public health programs including two years of funding for community health centers and the National Health Service Corps.

Unfortunately, it also includes a $2.85 billion cut over ten years to the nation’s Prevention and Public Health Fund (PPHF).

Here’s how it’s broken down (courtesy of Trust for America’s Health):

Fiscal Year Current Law Latest CR Net Cumulative Net
FY2018 $900M $900M 0 0
FY2019 $800M $900M +$100M +$100M
FY2020 $800M $1.0B +$200M +$300M
FY2021 $800M $1.0B +$200M +$500M
FY2022 $1.25B $1.1B -$150M +$350M
FY2023 $1.0B $1.1B +$100M +$450M
FY2024 $1.7B $1.1B -$600M -$150M
FY2025 $2.0B $1.1B -$900M -$1.05B
FY2026 $2.0B $1.1B -$900M -$1.95B
FY2027 $2.0B $1.1B -$900M -$2.85B
FY2028 $2.0B $0B -$2.0B -$4.85B

As we’ve shared in previous updates, the PPHF accounts for 53% of Centers for Disease Control and Prevention’s (CDC’s) Immunization Program budget. Any cut could mean serious reductions in our country’s and states’ abilities to:

  • Support the science that informs our national immunization policy.
  • Provide a safety net to uninsured, low-income adults by enabling vaccine purchases;
  • Monitor the safety of vaccines.
  • Educate healthcare providers.
  • Perform community outreach.
  • Conduct surveillance, laboratory testing and epidemiology in response to disease outbreaks.

With the U.S. continuously facing costly outbreaks of vaccine-preventable diseases such as influenza, measles and pertussis (also known as whooping cough), now is not the time to weaken the backbone of our nation’s public health infrastructure.

We are watching these budget developments closely.

While it’s somewhat reassuring that Congress is replacing the money they cut from the PPHF to reauthorize the Children’s Health Insurance Program (CHIP) in this CR, no cut is acceptable. On the positive side, this delay in finalizing the budget does give us time to shore up support among Congressional Members for the critical services funded by the PPHF.

We will continue to send you updates on immunization funding and will be sure to let you know if we need to begin reaching out to our Members of Congress.

Thank you as always for your support of immunizations!



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Every Child By Two/Vaccinate Your Family has prepared our second annual State of the ImmUnion report to examine how strong our defenses truly are against vaccine-preventable diseases and what we can do as public health advocates and legislators to make our country stronger and more resilient in the face of emerging health threats.

We hope this report will offer you insights into areas of improvement to strengthen our protection against dangerous, and potentially deadly, vaccine-preventable diseases.

Impact of Latest Congressional Actions on Immunization Programs

December 12, 2017 Leave a comment
By Erica DeWald, Director of Advocacy, Every Child By Two/Vaccinate Your Family

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As we near the end of 2017, we want to extend a big thanks to each of you! Without your support for immunizations, our voice would not be heard in Washington. Only through regular outreach to our lawmakers have we been able to demonstrate the impact federal policies would have on vaccination rates and thus our country’s health.

Unfortunately, our work for the year isn’t over yet. We are still closely monitoring the appropriations process as well as the reauthorization of the Children’s Health Program (CHIP), which provides health coverage for 8.9 million children who are uninsured.

Congress has twice extended the deadline for an FY18 spending bill. The next Continuing Resolution (CR) expires December 22. A new proposal from House Appropriations Chairman Frelinghuysen would extend funding for all non-defense spending through January 19 and reauthorize the CHIP funding for five-years. Unfortunately, the proposal also includes $6.35 billion in cuts to the Prevention and Public Health Fund (PPHF). As a reminder, PPHF accounts for 53% of the Immunization Program’s funding.

The Immunization Program’s non-PPHF funding also remains in jeopardy. The Senate has proposed level funding from FY17 for the Centers for Disease Control and Prevention’s Immunization Program (which received a 4 million dollar cut last year), while the House has proposed a 50 million dollar cut. That large of a cut would devastate immunization infrastructure. 

Both CHIP and the Immunization Program enjoy bipartisan support but Congress has had difficulty understanding how their funding choices affect our nation’s health. If fewer children are able to access health care through CHIP – either because Congress is delaying reauthorization or because they have instituted new demands that states match funds – then less children will end up receiving life-saving vaccines. Second, if Congress uses Prevention & Public Health Fund (PPHF) dollars to help pay for CHIP as proposed in the House bill, they are in fact cutting essential funds from the very public health clinics and immunization programs that accept CHIP and provide care to children.

Please consider calling your Representative and Senators to urge them to support ALL public health funding. Ask them to reauthorize CHIP without using the PPHF as a budgetary offset. You can find contact information for your legislators at whoismyrepresentative.com.

Every Child By Two/Vaccinate Your Family will continue to watch these legislative issues and do our best to keep you informed.   

Thank you again for your interest and support!

Educating Legislators About Preventative Health and Vaccination

October 30, 2017 Leave a comment

Every Child By Two will be making a special presentation on Capitol Hill on Tuesday, October 31st, alongside experts from the American Public Health Association, the American Diabetes Association and the National Council on Aging.

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The panel, which will be moderated by the National Coalition on Health Care, will discuss the vital role of Health and Human Services initiatives to drive down health costs and improve health outcomes at each stage of life.

Every Child By Two’s Executive Director, Amy Pisani, will explain the ability of vaccines to save both lives and money – and the impact federal funding cuts will have on our efforts to combat vaccine-preventable diseases in the U.S.

Please contact your legislators and suggest they attend this special presentation on Prevention Across the Lifespan.  

It will be held at the U.S. Capitol Visitor Center from 10-11:30 am on October 31st in room SVC-203.  If you are unable to attend, we encourage you to watch Every Child By Two’s portion of the presentation via Facebook Live on the Vaccinate Your Family Facebook page.

You may also want to review and share our 2017 State of the ImmUnion report with your legislators.

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This report examines what we can do, as public health advocates and legislators, to make our ImmUnion stronger and more resilient in the face of emerging health threats. The report highlights the successes of vaccines, the economic and societal savings incurred from vaccines, challenges facing the public health system and key areas of focus to achieve optimal protection against vaccine-preventable diseases.  There are even resources within the report that help individuals learn more about the vaccination rates in their state and what can be done to ensure the health of families throughout the nation.  To access the report, click here.

Help Stop Devastating Cuts to Immunization Infrastructure

July 20, 2017 18 comments

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The House is moving forward on budget proposals for Fiscal Year 2018 (FY18) and has suggested a $50 million cut to immunization funding to the Centers for Disease Control and Prevention (CDC).

This could mean serious reductions in our country’s and states’ abilities to:

  • Support the science that informs our national immunization policy;
  • Provide a safety net to uninsured, low-income adults by enabling vaccine purchases;
  • Monitor the safety of vaccines;
  • Educate healthcare providers;
  • Perform community outreach; and
  • Conduct surveillance, laboratory testing and epidemiology in response to disease outbreaks.
With the U.S. currently facing costly outbreaks of vaccine-preventable diseases such as measles and pertussis (also known as whooping cough), now is not the time to weaken the backbone of our nation’s public health infrastructure.
We are not asking for a funding increase, we are simply asking that Congress not reduce current levels of immunization funding.
States have already had to make tough decisions because of a $4 million cut in funds in the 2017 budget.

Please call your Representative today and tell him or her:

“Please reject the proposed $50 million cut to the CDC Immunization Program and maintain level funding for FY18. A funding reduction would have serious consequences for communities across the country at a time when outbreaks of vaccine-preventable diseases such as measles are on the rise.”

SOTI-Report_Cover.pngYou can also reference Every Child By Two’s State of the ImmUnion report to examine how strong our defenses truly are against vaccine-preventable diseases and what we can do, as public health advocates and legislators, to make our ImmUnion stronger and more resilient in the face of emerging health threats. You may even want to share this report with your Representative since it highlights the successes of vaccines, the economic and societal savings incurred from vaccines, challenges facing the public health system and key areas that we need to focus on to achieve optimal protection against vaccine-preventable diseases.

Please use Who Is My Representative? to quickly find your Member of Congress in the House.

Thank you for your continued support of immunizations and their critical role in protecting our health!

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…