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August 21, 2014—Updated Vaccine Information Statement (VIS) for influenza vaccines—for both Inactivated Influenza Vaccines (IIV), and Live Attenuated Influenza Vaccines (LAIV) were posted by the Centers for Disease Control and Prevention. These VISs reflect the latest recommendations, and new VIS format.
These VIS are attached for your reference and can be found online at: www.cdc.gov/vaccines/hcp/vis/vis-statements/flu.html and www.cdc.gov/vaccines/hcp/vis/vis-statements/flulive.html.
Translations of most VISs are available in a variety of languages. Foreign language translations of VISs (www.immunize.org/vis/?f=9) are coordinated by the Immunization Action Coalition (IAC), through a cooperative agreement with the Centers for Disease Control and Prevention.
The Florida SHOTS system will print the current VIS for participants, so this transition should be seamless. We encourage ALL providers to regularly check the VIS being distributed by their staff. Check for the current versions at: www.cdc.gov/vaccines/hcp/vis/current-vis.html.
Please distribute this important information to colleagues, members, coalitions, and partners who provide or have an interest in immunizations. Please place this information prominently on your website.
August 18, 2014—On August 15, 2014 the Centers for Disease Control and Prevention published Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP)—United States, 2014–2015 Influenza Season Morbidity and Mortality Weekly Report (MMWR) August 15, 2014 / 63(32); 691–697. To read the entire document visit: www.cdc.gov/mmwr/preview/mmwrhtml/mm6332a3.htm?s_cid=mm6332a3_e.
Routine annual influenza vaccination is recommended for all persons aged ≥6 months.
For the 2014–2015 influenza season:
Vaccine virus strains included in the 2014–2015 U.S. Trivalent influenza vaccines will contain hemagglutinin (HA) derived from an A/California/7/2009 (H1N1)-like virus, an A/Texas/50/2012 (H3N2)-like virus, and a B/Massachusetts/2/2012-like (Yamagata lineage) virus. Quadrivalent influenza vaccines will contain these antigens, and also a B/Brisbane/60/2008-like (Victoria lineage) virus.
When immediately available, LAIV should be used for healthy children aged 2 through 8 years who have no contraindications or precautions (Category A). If LAIV is not immediately available, IIV should be used. Vaccination should not be delayed to procure LAIV.
LAIV should not be used in the following populations:
Influenza Vaccination of Persons with a History of Egg Allergy
Persons with a history of egg allergy who have experienced only hives after exposure to egg should receive influenza vaccine. IIV or trivalent recombinant influenza vaccine (RIV3) should be used. RIV3 may be used for persons aged 18 through 49 years who have no other contraindications. However, IIV (egg- or cell-culture based) may also be used.
Other influenza vaccine recommendations pertaining to persons with egg allergies are listed in the publication.
The Immunization Section supports the ACIP recommendations that health care workers and those who have contact with vulnerable persons be vaccinated, not only to protect themselves, but also for those to whom they serve and care. Anyone who wants protection from influenza should be vaccinated, and health care providers should recommend vaccination at every opportunity to all eligible persons. Health care providers should offer influenza vaccine as soon as it becomes available and should continue to offer it throughout the influenza season (i.e., as long as influenza viruses are circulating in the community).
The CDC and the Immunization Section have developed influenza educational materials found online at www.cdc.gov/flu/ and www.floridahealth.gov/programs-and-services/prevention/flu-prevention/index.html.
August 14, 2014—The Immunization Section would like to remind our immunization providers of the process for reporting adverse events following administration of any vaccines. The Vaccine Adverse Event Report System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States.
Health care providers should report any adverse event that occurs after the administration of a vaccine licensed in the United States. You may report adverse events even if you are unsure whether a vaccine caused them.
The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report:
Anyone can file a VAERS report, including health care providers, manufacturers, and vaccine recipients. VAERS reports may be submitted by mail, fax or online.
The VAERS Web submission site is located at vaers.hhs.gov/esub/step1. Please review the online help for data entry before entering reports using the online system. Prior to submitting the report electronically to VAERS, please print an additional copy of the report and fax it to the VAERS coordinator in the Immunization Section at 850-922-4195, following the current security and confidentiality protocols. County health departments should refer to DOHP 350-5-14 available on the department's intranet.
August 7, 2014—The Immunization Section is pleased to announce the Vaccine Education Center at the Children’s Hospital of Philadelphia is hosting a “Current Issues in Vaccines” webinar covering information from the Advisory Committee on Immunization Practices (ACIP) June meeting. The webinar is scheduled for September 10, 2014 at Noon (EST).
Topics of discussion include:
Dr. Paul Offit, MD will present the webinar. Dr. Offit is the Director of the Vaccine Education Center for the Division of Infectious Diseases at the Children’s Hospital of Philadelphia. He is also a Professor of Pediatrics and Maurice Hilleman Professor of Vaccinology at the University of Pennsylvania School of Medicine.
Each “Current Issues in Vaccines” webinar presents topics being addressed by the ACIP, covered by the media or asked by parents. Each presentation will be 40 to 45 minutes, followed by 15 to 20 minutes of audience questions.
The “Current Issues in Vaccines” webinars are co-sponsored by the Pennsylvania Chapter, American Academy of Pediatrics, and are supported by the Thomas F. McNair Scott Endowed Research and Lectureship Fund.
There will be CEU offered and this presentation will be archived for review at: http://www.chop.edu/professionals/vaccine-healthcare-providers/vaccine-webinar-series/vaccine-webinar-series.html?utm_source=newsletter&utm_medium=email&utm_term=vec+announcements&utm_content=sept+webinar&utm_campaign=vecupdatesjuly2014
Note: The Immunization Section makes every attempt to provide training on a variety of subjects/issues, without endorsement, for those interested in immunizations.
August 6, 2014—The Immunization Section is pleased to announce a webcast presented by Sanofi Pasteur Inc., and facilitated by PRI Healthcare Solutions, “Vaccine Confidence” The Key to Communication With Parents of Pediatric Patients. Joseph Domachowske, MD, will moderate the educational webcast on the concept of vaccine confidence and the pivotal role health care professionals can play in ensuring children are fully immunized in a timely manner.
The program will highlight strategies for overcoming vaccine hesitancy and building vaccine confidence among parents of pediatric patients. Considering the recent outbreaks of vaccine-preventable diseases such as pertussis and measles, and the impact of non-medical exemptions on immunization coverage rates, confident approaches to communication about vaccines are needed more than ever.
The program will be available once a week for a 2-week period: August 7, 2014 at noon and August 12, 2014 at 3:00 p.m. (EDT)
To register logon to: vaccineconfidence2014.prihcs.com/access.html
For additional details about this program, as well as information on how to participate, please refer to the attachment.
No CEUs or CMEs are available for this program.
Note: The Immunization Section makes every attempt to provide training on a variety of subjects/issues, without endorsement, for those interested in immunizations.
August 5, 2014—The Immunization Section is pleased to announce a MedImmune, National Flu Immunization Webinar ”Benefits and Safety of 4-Strain Live, Attenuated Influenza Vaccine.” Presentation schedules and presenters are listed below.
August 13, 2014: Dr. Henry Wojtczak, Pediatric Pulmonology, Department of Pediatrics, Naval Medical Center will present the webinar at noon (EST), August 13, 2014. The courses will be one hour with a question and answer session to follow. RSVP required by August 7, 2014.
August 20, 2014: Dr. William Michael Brown Pediatrics, Bayfront Health, St. Petersburg will present the webinar at 3 p.m. (EST), August 20,2014. The courses will be one hour with a question and answer session to follow. RSVP required by August 14, 2014.
To register online please visit: medimmuneprograms.webex.com/mw0401l/mywebex/default.do?siteurl=medimmuneprograms.
If you have any questions or want to know if the webinar is being archived please contact: MedImmuneSpeakers@Insyght.com
No CEUs are available for this program.
Note: The Immunization Section makes every attempt to provide training on a variety of subjects/issues, without endorsement, for those interested in immunizations.
July 31, 2014—We are pleased to share the following vaccine information with our immunization partners. The Centers for Disease Control and Prevention (CDC) has provided updated interim recommendations for the use of pneumococcal and influenza vaccines among unaccompanied children transitioning through the large processing centers and the Department of Defense (DoD) facilities receiving these children.
Thousands of children from Central America are currently sheltered and cared for at U.S. government facilities. From July 10, 2014 through July 24, 2014, seven cases of severe pneumococcal pneumonia have been identified among unaccompanied children. There is also an increased risk of influenza among these children. H1N1 and influenza B have been detected in several children.
To address the outbreaks of pneumococcal pneumonia and the increased risk of influenza transmission, interim recommendations are outlined below:
July 31, 2014—The Immunization Section is taking this opportunity to update our immunization partners regarding Vaccine Information Statements (VISs).
A Vaccine Information Statement (VIS) is a one-page (two-sided) information sheet, produced by CDC. VISs inform vaccine recipients—or their parents or legal representatives—about the benefits and risks of a vaccine.
Federal law requires that VISs be handed out whenever (before each dose) certain vaccinations are given. It is a requirement of the National Childhood Vaccine Injury Act (NCVIA) of 1986. VISs are worded so they may be used by adults as well as children. An exception is the DTaP VIS, since DTaP is not licensed for adults. There are separate VISs for adult Td and Tdap vaccines. Apart from legal requirements, it is good practice to give the appropriate VIS every time any vaccine is administered, to anyone of any age.
The NCVIA requires providers to supplement the VISs with "visual presentations" or oral "explanations" as needed. If patients are unable to read the VISs, it is up to the provider to ensure that they have that information. VISs can be read to these patients, or videotapes can be used as supplements. At least one CD-ROM is being produced on which users can hear the VISs read. The VISs available on CDC's website are compatible with screen reader devices.
A VIS with a date several years old is not necessarily out of date. VISs are not updated annually or on any other routine schedule. An updated VIS with a new date is posted when there is a change in recommendations. Providers can check weekly for VIS updates at www.immunize.org/new/vis.asp or www.cdc.gov/vaccines/hcp/vis/what-is-new.html. VIS is NOT an informed consent form. People sometimes use the term “informed consent” loosely when referring to VISs. But even when vaccine information materials had tear-off sheets for parents to sign, they were not technically informed consent forms. The signature was simply to confirm that the "Duty to Warn" clause in the vaccine contract was being fulfilled.
There is no Federal or state requirements for informed consent for administration of vaccines. VISs are written to fulfill the information requirements of the NCVIA. But, because they cover both benefits and risks associated with vaccinations, they provide enough information that anyone reading them should be adequately informed. This consent is generally considered included in the "Consent to treat" which patients grant to providers early on. Vaccine would be covered under the general "consent to treat", just as any other treatment or medication. Section 743.0645, Florida Statutes defines who can consent to ordinary medical care and treatment, which includes immunization for a minor. Visit archive.flsenate.gov/Statutes/Index.cfm?App_mode=Display_Index&Title_Request=XLIII#TitleXLIII.
This is a listing of VISs and the dates they were issued. Vaccines covered by the NCVIA are in bold.
The Multi-Vaccine Information Statement is being temporarily removed from circulation while being updated. In the meantime please use the individual VISs when vaccinating children with DTaP, Hib, Hepatitis B, PCV13, Polio and Rotavirus vaccines. An updated edition is expected by mid-2014.
Providers (both public and private) have certain responsibilities with respect to these information statements. Today, there are more ways to obtain VISs electronically than there have been in the past, and providers have found innovative ways to comply with the VIS law while conserving paper—all of which have led to confusion about exactly what a provider's responsibilities are regarding use of VISs. Detailed recommendations for using vaccines are available from the manufacturers' package inserts, Advisory Committee on Immunization Practices (ACIP) statements on specific vaccines, and the American Academy of Pediatrics Red Book. ACIP statements for all recommended childhood vaccines can be viewed, downloaded, and printed from this web site: www.cdc.gov/vaccines/hcp/acip-recs/index.html.
Consult the Vaccine Adverse Event Reporting System (VAERS) site for guidance on how to obtain and complete a VAERS form at: vaers.hhs.gov/index or call 1-800-822-7967.
Within the context of the NCVIA mandate, and given the variety of ways a VIS can now be offered, note the following instructions:
Providers May Also
Providers Should Not
VIS is available from:
July 28, 2014—The Immunization Section is pleased to announce a Virtual Immunization Communication (VIC) Network webinar, “Are You Ready for Flu?” The webinar is scheduled for August 13, 2014 at 2 p.m. (EDT). The presentation will include the Centers for Disease Control and Prevention’s (CDC) recommendations and communication plans for the 2014–2015 influenza season.
"Are You Ready for Flu?" webinar will provide an overview of the 2014–2015 influenza season and information about this year’s flu vaccine communication campaign plan for the general public along with new materials that will assist with reaching Hispanic, African American and American Indian/Alaska Native populations.
To register logon to: nphic-cic.webex.com/mw0401l/mywebex/default.do?siteurl=nphic-cic.
The VIC Network is a nationwide “virtual immunization community” of health educators, public health communicators and others who promote immunizations to exchange and share resources and materials and the best practices. This presentation will be archived (http://www.vicnetwork.org/) for review at a later date. No CEUs are available for this program.
July 28, 2014—We are pleased to share the following MMWR publication with our immunization partners. In the July 25, 2014/63(29); 625-33 issue, the Centers for Disease Control and Prevention published the National, Regional, State and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–7 Years – United States, 2013. You can read the article in its entirety at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6329a4.htm.
The latest vaccination coverage estimates for adolescents show only small increase for HPV vaccine. CDC officials announced that the number of girls and boys aged 13–17 years receiving human papillomavirus (HPV) vaccine remains unacceptably low. NIS-Teen summary is available at: www.cdc.gov/vaccines/who/teens/vaccination-coverage.html.
Teen vaccine related information has been attachment for your convenience:
July 18, 2014—We are pleased to share the following vaccine report with our immunization partners. The Centers for Disease Control and prevention (CDC) features articles on vaccinations in the Morbidity and Mortality Weekly Report (MMWR) Volume 63(24); 527–530. This report is available at: www.cdc.gov/mmwr/preview/mmwrhtml/mm6324a2.htm on June 20, 2014.
The Advisory Committee on Immunization Practices (ACIP) at the October 2013 meeting recommended use of a third meningococcal conjugate vaccine, MenACWY-CRM (Menveo, Novartis), as an additional option for vaccinating infants aged 2 through 23 months at increased risk for meningococcal disease.
MenACWY-CRM is the first quadrivalent meningococcal conjugate vaccine licensed for use in children aged 2 through 8 months. MenACWY-D (Menactra, Sanofi Pasteur) is recommended for use in children aged 9 through 23 months who are at increased risk for meningococcal disease, and Hib-MenCY-TT (MenHibrix, GlaxoSmithKline) is recommended for use in children aged 6 weeks through 18 months at increased risk.
Infants at increased risk for meningococcal disease are:
Routine vaccination against meningococcal disease is not recommended for children aged 2 months through 10 years.
July 11, 2014—The Centers for Disease Control and Prevention (CDC), the leader in the fight of infectious diseases, deems August National Immunization Awareness Month (NIAM). This event highlights the necessity of immunizations to combat vaccine-preventable diseases and improving coverage levels for people of all ages.
Activities to raise awareness about immunization will focus on encouraging people to protect their health by being immunized. Different age groups have different immunization needs. This includes: pregnant women, babies, children, teens, young adults and adults. Although the needs vary the outcome is the same, to protect each individual from vaccine-preventable diseases.
In August look for National Immunization Awareness Month activities hosted in your community.
June 25, 2014—The Immunization Section would like to remind all immunization partners of the childcare facilities and school immunization requirements for the 2014–2015 school year. Documentation for required immunizations is mandatory for all students entering, attending, or transferring into a Florida school in grades pre-Kindergarten through 12 as detailed in the Immunization Guidelines for Florida Schools, Childcare Facilities, and Family Daycare Homes, effective March 2013 and incorporated by reference in Rule 64D-3.046, Florida Administrative Code. The Guidelines, located at the Immunization Section website at: www.immunizeflorida.org/schoolguide.pdf, provide technical assistance to health care providers, schools, childcare facility operators, family daycare home operators, school health personnel, and county health department personnel, and are updated when there are changes to immunization recommendations impacting childcare and/or school requirements. There have been no changes to childcare requirements.
There is no time like the present to update children’s immunizations and provide them with the required documentation for school. Many health care providers and families have already begun the process to get ready for the new school year. Immunizations should be updated at each encounter, including annual physicals, interim check-ups or sport physicals.
Reminders and updates to school requirements for the 2014–2015 school year include:
Grades K through 12:
The flyer link below, containing the phase-in schedule, may assist providers in determining the phase-in grade schedule for Tdap and varicella vaccine requirements.
The 2014–2015 school flyer link is also below for your reference and is available at the Immunization Section website at:
As a reminder, to complete the Florida Certification of Immunization (Form DH 680) meeting all kindergarten requirements, you select Part A: Complete with either Code 1 (K through 12) or Code 8 (7th Grade requirement). A number of health care providers have provided kindergarten students who meet all kindergarten requirements with Part B: Temporary Medical Exemptions (TMEs) extending until the student is due to enter 7th grade.
A TME should be completed only if a child is not fully immunized for their current school grade, based on the proper spacing of vaccines. The expiration date should coincide with the date that the child is due to receive his/her next immunization, plus 15 days, based on the catch-up schedule. For example: a kindergarten student receives a dose of varicella vaccine the day prior to entering school and is required to receive a second dose of varicella vaccine as required for school attendance. A TME is issued for the child to return in a minimum of three months, to receive the second dose of varicella vaccine.
The improper issuance of TMEs has a negative effect on the overall compliance rates when assessing each county’s coverage for school immunizations.
Form DH 681, Religious Exemption from Immunization, should only be accessed by county health departments through the immunization registry, the Florida State Health Online Tracking System (SHOTS). Please contact the Florida SHOTS staff at 1-877-888-SHOT (7468) if you have questions regarding the electronic Form DH 681.
June 19, 2014—The Immunization Section is pleased to share the following information from Sanofi Pasteur regarding their change of cap color for the Pentacel® vaccines. The half-moon colored cap is being replaced with a solid blue colored cap. There is no change to the product itself or to the NDC, so nothing will need to be changed when ordering Pentacel®
This change is effective with all new Pentacel® vaccines. Providers may still receive the previous half-moon colored caps as the solid blue colored caps are being phased into the market. This means that providers may have both the new packaging and the old in their storage units during this brief transition time.
June 17, 2014—We are pleased to share this influenza vaccine composition information with our immunization partners.
FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on February 28, 2014, to select the influenza viruses for the composition of the influenza vaccine for the 2014–2015 U.S. influenza season. During the meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2013–2014 vaccines, and the availability of candidate strains and reagents. Their recommendations were published in the Morbidity and Mortality Weekly Report (MMWR) as Influenza Activity—United States, 2013–2014 Season and Composition of the 2014–2015 Influenza Vaccine June 6, 2014 / 63(22);483–490 available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6322a2.htm?s_cid=mm6322a2_w.
This report summarizes influenza activity in the United States during the 2013–2014 influenza season (September 29, 2013–May 17, 2014) as of June 6, 2014, and includes recommendations for the components of the 2014–2015 Northern Hemisphere influenza vaccine.
This influenza season was the first since the 2009 pH1N1 pandemic in which pH1N1 viruses predominated and was characterized overall by lower levels of outpatient illness and mortality than influenza A (H3N2)–predominant seasons, but higher rates of hospitalization among adults aged 50–64 years compared with recent years.
During the 2013–2014 influenza season in the United States, influenza activity increased through November and December before peaking in late December. Influenza A (H1N1)pdm09 (pH1N1) viruses predominated overall, but influenza B viruses and, to a lesser extent, influenza A (H3N2) viruses also were reported in the United States.
The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2014–2015 influenza season contain the following:
The committee also recommended that quadrivalent influenza vaccines contain the above three strains and the following additional B strain:
An annual influenza vaccination is recommended for all persons aged ≥6 months. Immunization providers should consult Food and Drug Administration-approved prescribing information for 2014–2015 influenza vaccines and the 2014–2015 Advisory Committee on Immunization Practices influenza recommendation statement for the most current information concerning indications, contraindications, and precautions.
June 3, 2014—We are pleased to share the report “Measles—United States, January 1–May 23, 2014.” Measles is a highly contagious, acute viral illness that can lead to serious complications and death. The disease was declared eliminated in the United States in 2000. In 2014, 288 cases have been reported to the CDC. The patients range from 2-weeks-old to 65-years-old. No deaths have been reported. The report is published in the Morbidity and Mortality Weekly Report, volume 63 (Early Release); 1–4, written by Paul A. Gastañaduy, MD, Susan B. Redd, Amy Parker Fiebelkorn, MSN, et al.
The report focuses on measles outbreaks in relation to age, location and importations. The majority of the cases are associated with importations from at least 18 countries. Most of the cases reported have been in persons who were unvaccinated. Health care providers are urged to remind persons who plan to travel internationally to get vaccinated.
To read the report in its entirety visit: www.cdc.gov/mmwr/preview/mmwrhtml/mm63e0529a1.htm?s_cid=mm63e0529a1_e.
May 20, 2014—The Immunization Section is pleased to announce a “Current Issues in Immunization” NetConference on “Why Measles Matters.” The presentation is scheduled for May 22, 2014 at 3 p.m. (EDT). The Centers for Disease Control and Prevention’s (CDC) Gregory S. Wallace, MD, MS, MPH, will discuss this highly contagious disease as well as the importance of ongoing immunization efforts.
To register logon to: www2.cdc.gov/vaccines/ed/ciinc/.
Measles is an acute viral illness that can lead to severe complications and death. Measles was declared eliminated from the United States (the absence of continuous disease transmission for more than 12 months) in 2000. The United States highlights the importance of ensuring age-appropriate vaccination for international travelers and maintaining high vaccination coverage, as well as the need for heightened awareness among healthcare providers regarding the possibility of measles.
"Current Issues in Immunization" is a series of NetConferences which features live, one hour presentations that combine an online visual presentation with simultaneous audio via telephone conference call followed by a live question and answer session. Internet access and a separate phone line are needed to participate. On-demand replays and presentations are made available shortly after each event.
May 19, 2014—The National Center for Immunization and Respiratory Diseases (NCIRD) at the Centers for Disease Control and Prevention is requesting all immunization programs share the following information with all health care providers and infection control specialists:
This year, the United States is having more reported cases of measles than usual. Many health care providers in the United States have never seen a patient with measles and may not recognize the signs and symptoms. Health care providers need to be more alert than ever to the possibility of measles.
Health care providers should consider measles in patients who:
Health care providers should also consider measles when evaluating patients for other febrile rash illnesses, including Dengue and Kawasaki’s Disease.
If you suspect measles, do the following immediately:
Additional guidance for health care providers can be found at: www.cdc.gov/measles/hcp/index.html. Also, see CDC’s measles surveillance guidance: www.cdc.gov/vaccines/pubs/surv-manual/chpt07-measles.html.
Section 381.0031(1,2), Florida Statutes provides that “Any practitioner, licensed in Florida to practice medicine, osteopathic medicine, chiropractic, naturopathy, or veterinary medicine, who diagnoses or suspects the existence of a disease of public health significance shall immediately report the fact to the Department of Health.” The FDOH county health departments serve as the Department's representative in this reporting requirement. For contact information for the local county health departments, please visit: www.floridahealth.gov/public-health-in-your-life/county-health-departments/CHDlisting.html.
We are pleased to share the following information with our immunization partners. The Advisory Committee on Immunization Practices (ACIP) reviews the recommended immunization schedules each year to ensure that the schedule reflects current recommendations for licensed vaccines. The Binational Immunization Schedule which includes the immunization schedule for Mexico can assist providers in interpreting immunization records for children entering the United States from Mexico. This information will assist providers in determining the completeness of these children’s immunization records.
To review the Binational immunization resource tool for children from birth through 18 years, visit: www.cdc.gov/vaccines/schedules/downloads/child/binational-schedule-pr.pdf
May 5, 2014—We are pleased to inform you that the Food and Drug Administration (FDA) has expanded the approved age indication of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) (Tdap) for active booster immunization for the prevention of tetanus, diphtheria, and pertussis as a single dose in persons 10 through 64 years of age. Attached is the customer letter from Sanofi-Pasteur for your reference.
With a rise in reported pertussis incidences, this approval also provides an additional opportunity to administer the vaccine to a younger age group to help prevent this highly contagious disease.
Adacel® vaccine was originally licensed by the FDA in June 2005 as the first booster to address pertussis protection for both adolescents and adults 11 through 64 years of age.
May 1, 2014—The Immunization Section is pleased to announce that David Berman, MD, has been selected as the 2014 CDC Childhood Immunization Champion for Florida. This award is sponsored by the Centers for Disease Control and Prevention (CDC), the National Center for Immunization and Respiratory Diseases (NCIRD), and the CDC Foundation. This award is given annually to recognize individuals who make a significant contribution toward improving public health through their work in childhood immunization.
Dr. Berman is a Pediatric Infectious Diseases Specialist at All Children’s Hospital in St. Petersburg, Florida. He has volunteered his time to work with the Florida Chapter of the American Academy of Pediatrics (AAP) to promote vaccine advocacy in the State of Florida. Working with other colleagues in Florida, the Florida Chapter of the AAP secured a vaccine hesitancy education grant to educate physicians the community about the safety and effectiveness of vaccines. Dr. Berman has also partnered locally with the Florida Department of Health in Pinellas County to use a portion of the grant to develop a community team called “PITCH” (The Pinellas Immunization Team for Community Health) to improve childhood immunization rates in Pinellas County children 0-2 years of age. Dr. Berman also reached out to the film producer of “Invisible Threat,” an immunization documentary produced by high school students from San Diego County, California while garnering endorsement of the film by All Children’s Hospital, Johns Hopkins Pediatrics and Epidemiology, the Florida Chapter of the AAP , and the Resident, Fellow and Medical Student Section of the AAP. Each of these groups endorsed the film. Dr. Berman along with his community colleagues are now using the film in an outreach project in Pinellas County to educate community members about immunizations with plans to promote the campaign throughout Florida.
Dr. Berman’s efforts to collaborate with community partners to ensure children are immunized and providers are educated on the importance of immunizing makes him Florida’s CDC Childhood Immunization Champion. Visit the CDC Childhood Immunization Champion website at www.cdc.gov/vaccines/events/niiw/champions/profiles-2014.html for additional information on Dr. Berman and other state champions.
Please join the Immunization Section in congratulating Dr. Berman.
April 4, 2014—The Immunization Section is pleased to share information regarding the 2014 National Adult and Influenza Immunization Summit Meeting. The 2014 face-to-face annual meeting of the National Adult and Influenza Immunization Summit will be held in Atlanta, Georgia, at the Hyatt Regency hotel on May 13–15, 2014.
The National Adult and Influenza Immunization Summit (NAIIS) was founded by the American Medical Association (AMA) and the Centers for Disease Control and Prevention (CDC). Currently the NAIIS is led by the Immunization Action Coalition (IAC), the CDC, and the National Vaccine Program Office (NVPO). The NAIIS is dedicated to addressing and resolving adult and influenza immunization issues.
The NAIIS now consists of over 400 partners, representing more than 100 public and private organizations. Summit participants include a wide range of professionals from the healthcare industry, public health and private medical sectors, vaccine manufacturers and distributors, consumers, and others interested in stopping the transmission of vaccine-preventable diseases.
The Immunization Section would like to make you aware of this important information from Sanofi Pasteur regarding their changing the packaging for ActHIB. The new packaging will establish new NDCs and lot numbers for the inner components of the vaccine packages, as well as modifying the carton to incorporate dividers between each of the vials and diluent to prevent movement within the box. Currently, the NDC is only on the outer carton, the new packaging will now have NDC numbers for the outer carton, vaccine vial, and diluent. It is important to note, that with any vaccine products with multiple NDCs for different pieces or components that the only NDC that can be used to order, to report inventory, or to submit vaccine returns is the one that is listed on the CDC contract, this is the number listed on the outer carton. Sanofi Pasteur will maintain the current NDC on the outer carton of the new packaging for ActHIB, so nothing will need to be changed when ordering ActHIB.
Currently, it is estimated that the new packaging will be distributed in the private sector in mid to late April, which will be before public supplies. This means there will be a brief period of time that providers may have both the new packaging and the old in their storage units.
Click the link below to view a copy of the letter that Sanofi Pasteur will be using to announce the ActHIB NDC, lot number and packaging change. If you have any question regarding the packaging change, please call the Sanofi Pasteur Support Services at 1-800-VACCINE (1-800-822-2463).
April 1, 2014—NIIW is an annual observance to highlight the importance of protecting infants from vaccine-preventable diseases and to celebrate the achievements of immunization programs in promoting healthy communities throughout the United States. This year, NIIW is scheduled to be held April 26–May 3, 2014.
During the last week in April and the first week of May, hundreds of communities across the United States will join those in countries around the world to celebrate the critical role vaccination plays in protecting our children, communities, and public health. NIIW will be celebrated this year simultaneously with World Immunization Week, an initiative of the World Health Organization.
Immunization is a shared responsibility. Families, healthcare professionals, and public health officials must work together to help protect the entire community.
Children rely on adults to keep them safe and healthy. Those adults may be parents/guardians who keep a record of their child’s vaccinations and ask at each doctor appointment whether their child is up-to-date on immunizations. The adults may also be doctors, nurses, physician assistants, and other healthcare professionals who share scientifically-accurate, up-to-date information about vaccines with parents.
It's easy to think of these as diseases of the past. But the truth is they still exist. Children in the United States can—and do—still get some of these diseases. One example of the seriousness of vaccine-preventable diseases is an increase in measles cases or outbreaks that were reported in 2013. Data from 2013 showed a higher than normal number of measles cases nationally and in individual states, including an outbreak of 58 cases in New York City that was the largest reported outbreak of measles in the U.S. since 1996.
Please, visit the CDC resource site for this observance, www.cdc.gov/vaccines/events/niiw/overview.html, for educational and promotional materials to encourage community participation and enthusiasm for your NIIW activities.
March 7, 2014—We are pleased to share this VIS update news with our immunization partners. The pediatric Multi-Vaccine VIS is being temporarily removed from service so it can be updated to reflect current ACIP recommendations. An updated edition should be available by mid-2014. Do Not Use 11/16/12 edition of the Multi-Vaccine VIS. Use the individual VISs when DTaP, Hib, Hepatitis B, Polio, PCV13 and/or Rotavirus vaccines are administered. By federal law, all vaccine providers must give patients, or their parents or legal representatives, the appropriate Vaccine Information Statement (VIS) whenever a vaccination is given.
Two-Dose Varicella Vaccination Coverage Among Children Aged 7 years–Six Sentinel Sites, United States, 2006–2012
February 28, 2014—We are pleased to share the following articles with our immunization partners. The Centers for Disease Control and Prevention (CDC) features articles on vaccinations in the Morbidity and Mortality Weekly Report (MMWR) Volume 63, No. RR-1 and No.8, February 28, 2014. This report is available at www.cdc.gov/mmwr/.
Haemophilus influenzae–This report compiles and summarizes all recommendations from CDC's ACIP regarding prevention and control of Haemophilus influenzae type b (Hib) disease in the United States.
This report does not contain any new recommendations; it is intended for use by clinicians, public health officials, vaccination providers, and immunization program personnel as a resource. ACIP recommends routine vaccination with a licensed conjugate Hib vaccine for infants aged 2 through 6 months (2 or 3 doses, depending on vaccine product) with a booster dose at age 12 through 15 months. ACIP also recommends vaccination for certain persons at increased risk for Hib disease (i.e., persons who have early component complement deficiencies, immunoglobulin deficiency, anatomic or functional asplenia, or HIV infection; recipients of hematopoietic stem cell transplant; and recipients of chemotherapy or radiation therapy for malignant neoplasms). This report summarizes current information on Hib epidemiology in the United States and describes Hib vaccines licensed for use in the United States. Guidelines for antimicrobial chemoprophylaxis of contacts of persons with Hib disease also are provided.
Two-Dose Varicella–In 2007, the ACIP recommended a routine second dose of varicella vaccine for children at age 4–6 years. Data on the number of states with 1-dose and 2-dose varicella vaccine elementary school entry requirements at the start of the school year were obtained from state immunization websites for 2007 and 2012. By 2012, thirty-six states require two doses of varicella vaccine for school entry.
February 28, 2014—We are pleased to share the Adult Immunization Standards of Practice published in the February 20th Public Health Reports with our immunization partners. The Standards lay out the roles and responsibilities of major stakeholders involved in vaccinating adults. The Association of Immunization Managers (AIM) supports the Adult Immunization Standards of Practice. Also, attached is the Morbidity and Mortality Weekly Report, volume 63, number 5, titled Noninfluenza Vaccination Coverage Among Adults—United States, 2012, documenting adult immunization coverage levels.
Research shows that adult patients are willing to get a vaccine when it is recommended by their provider. We encourage you to adopt the Adult Immunization Standards of Practice in your own practice to increase uptake of adult vaccines.
The Adult Immunization Standards of Practice guidance document describes the four steps that every provider should take to encourage their adult patients to get vaccinated:
February 25, 2014—We are pleased to share the following training event with our immunization partners. Please see the flyer below for event detail.
On March 13th, the Palm Beach County Childhood and Adult Coalition will present "Vaccines: Protect, Promote, Prevent." The event will take place Thursday, March 13, 2013 at the Bethesda Memorial Hospital Conference Room, 2815 South Seacrest Boulevard, Boynton Beach, from 5:30–8:30 pm. CEUs and CMEs are offered for this event. RSVP by Thursday, March 6, 2014 by calling 561-840-4568.
February 11, 2014—We are pleased to share this VIS update news with our immunization partners.
An updated VIS for Hib (Haemophilus Influenzae type b) and Td (Tetanus, Diphtheria) were posted at www.cdc.gov/vaccines/hcp/vis/index.html on February 4, 2014. Because both VISs contain a change in the adverse events section, the new VIS should be used beginning immediately. An accompanying Provider Information Sheet will be posted soon. By federal law, all vaccine providers must give patients, or their parents or legal representatives, the appropriate Vaccine Information Statement (VIS) whenever a vaccination is given.
Users of the Florida SHOTS immunization registry will automatically access this updated VIS when they print VIS from within the system.
February 7, 2014—We are pleased to share the following article with our immunization partners. The Centers for Disease Control and Prevention (CDC) features an article on adult vaccinations in the Morbidity and Mortality Weekly Report (MMWR) Volume 63, No.5, February 7, 2014. This report is available at www.cdc.gov/mmwr/.
Vaccinations are recommended throughout life to prevent vaccine-preventable diseases and their sequelae. Adult vaccination coverage, however, remains low for most routinely recommended vaccines and well below Healthy People 2020 targets. To assess vaccination coverage among adults aged ≥19 years for selected vaccines, CDC analyzed data from the 2012 National Health Interview Survey (NHIS). This report summarizes the results of that analysis.
February 5, 2014—The deadline is fast approaching to recognize individuals for their outstanding work in improving immunization services for children. Please submit your nominees for the 2014 Childhood Immunization Champion Award to Laura Rutledge, RN by Friday, February 14, 2014.
The Centers for Disease Control and Prevention (CDC) is proud to present the Third Annual Childhood Immunization Champion Award Program. This annual award recognizes individuals who make a significant contribution toward improving public health in their communities through their work in childhood immunization. Let's take this opportunity to garner some accolades for the great immunization partners in our state. Each year, up to one CDC Immunization Champion from each of the 50 U.S. states, 8 U.S. Territories and Freely Associated States, and the District of Columbia will be honored during National Infant Immunization Week (NIIW), April 26–May 3, 2014.
The Champion Award is intended to recognize individuals who are working at the local level. It honors those who are doing an exemplary job or going above and beyond to promote or foster childhood immunizations in their communities. The nomination and selection of a local Champion should be based on meeting one or more of the following criteria:
Champions can include coalition members, parents, health care professionals (e.g., physicians, nurses, physicians’ assistants, nurse practitioners, medical assistants, etc.), and other immunization leaders who meet the award criteria. Immunization program managers, state and federal government employees of health agencies, individuals who have been affiliated with and/or employed by pharmaceutical companies and those who have already received the award are not eligible to apply.
February 4, 2014—We are pleased to share the following MMWR publication with our immunization partners. In the February 3, 2014/63 (Early Release), the Centers for Disease Control and Prevention published the Advisory Committee on Immunization Practices Recommended Immunization Schedules for Persons Aged 0 Through 18 Years — United States, 2014 and Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2014.
Each year, recommendations for routine use of vaccines in children, adolescents, and adults in the United States are developed by the Advisory Committee on Immunization Practices (ACIP). We recommend that all healthcare providers visit http://www.cdc.gov/mmwr/ to read the article for important details and changes to last year's schedules.
Changes to the Immunization Schedules for Persons Aged 0 Through 18 Years:
Changes to the Immunization Schedules for Adults aged 19 Years or Older:
January 30, 2014—The Immunization Section is pleased to share the following training opportunities from GlaxoSmithKline (GSK) and Merck Medical Forums.
Please see GSK attachment for registration requirements, speakers and times. Programs are available on the following dates:
Please see Merck attachment for registration requirements and speaker information. The program is scheduled for: February 6, 2014, 1 PM Central/2 PM Eastern.
No CMEs or CEUs are available for these programs.
January 22, 2014—The Immunization Section is pleased to share the National Center for Immunization and Respiratory Diseases (NCIRD) at the Centers for Disease Control and Prevention webinar in preparation for National Infant Immunization Week (NIIW) 2014. NIIW is set for April 26–May 3, 2014. This year’s theme is Harnessing National Infant Immunization Week (NIIW) 2014 to Increase the Reach and Impact of Your Program Long-Term.
This webinar is scheduled for Tuesday, February 11 at 1 PM EST, the webinar will cover:
This free webinar requires pre-registration. To register, go to 2014 NIIW Webinar Registration and (Depending upon your computer, you may have to depress the CTRL key while clicking the link).
Once you are registered, you will receive a confirmation email with instructions for joining the session.
January 23, 2014—The Florida Immunization Section is pleased to share new training courses from the Centers for Disease Control and Prevention’s (CDC) You Call the Shots. You Call the Shots is an interactive, web-based immunization training course. It consists of a series of modules that discuss vaccine-preventable diseases and explains the latest recommendations for vaccine use. Each module provides learning opportunities, self-test practice questions, reference and resource materials and an extensive glossary. Modules ten and sixteen are updated and information is available below.
These free courses are available on the CDC’s Vaccine and Immunizations website at: www.cdc.gov/vaccines/ed/youcalltheshots.htm.
These courses are intended for nurses, nursing students, medical assistants, pharmacists and other health professionals who provide immunizations. Continuing education credit is available for the individual modules to physicians, nurses, health educators, and pharmacists.
Module Ten: Immunization: You Call the Shots–Storage and Handling—2014
Module Sixteen: Immunization: You Call the Shots–Vaccines for Children (VFC) Program—2014
December 20, 2013—The Immunization Section would like to share this important information with colleagues regarding reports of severe influenza illness in pregnant women.
In recent weeks, the Florida Department of Health has received reports of severe influenza illness, including hospitalizations requiring ICU care, among pregnant women. None of these pregnant women experiencing severe complications had received the 2013–2014 influenza vaccine. Via review of emergency department chief complaint data in ESSENCE-FL, the Bureau of Epidemiology has also seen an increase in recent weeks of the number of pregnant women presenting for care to emergency departments for influenza chief complaints.
Please see letter below signed by Anna Likos, MD, MPH, Director and State Epidemiologist, Division of Disease Control and Health Protection, for providers encouraging them to vaccinate pregnant women for influenza. County health department epidemiology programs have assisted in distributing this information in their communities with a special focus on the obstetrics community as well as pharmacies and other locations that administer vaccine to pregnant women.
December 20, 2013—The Immunization Section would like to make you aware of a voluntary recall of Gardasil Vaccine being communicated on December 20, 2013 by Merck to their customers via the attached letter, which provides instructions about the recall. Gardasil vaccine was distributed in both the public and private sectors.
This recall affects one lot of Gardasil vaccine (NDC 00006-4045-41; Lot # J007354). Merck is communicating with customers who received this lot number on Friday, December 20, 2013 via the attached documents, which provide instructions on the recall. If you do not receive communication from Merck, your vaccine is not involved in the recall. This voluntary recall is being conducted due to the potential for a limited number of vials in this lot to contain glass particles. Information about the details of the recall is included in the attached documents. Patients who received this lot number do not need to be revaccinated.
Distribution of this lot by CDC’s centralized distributor (McKesson Distribution Center) for the Vaccines for Children (VFC) Program occurred during the first two weeks of October 2013. VFC Program providers may review the “Transaction History” in the Florida State Health Online Tracking System (SHOTS) to determine if your office received this lot number.
Merck will be providing credit/replacement differently depending on whether the vaccine was privately purchased versus distributed through the VFC Program ordering and distribution mechanism:
Since providers will not be receiving replacement doses directly from Merck, VFC Program providers should order VFC Program vaccines their normal process to make up for any doses lost due to the recall.
Questions about this recall should be directed to Merck National Service Center: 1-800-672-6372, Select Prompt #2, then Prompt #3 (Monday to Friday 8:00 AM to 7:00 PM EST).
December 12, 2013—The Immunization Section would like to make you aware of a Meningococcal vaccine voluntary recall being communicated on December 2, 2013 by Novartis Vaccines to their customers via the attached letter, which provides instructions about the recall.
This precautionary and voluntary action is being taken following observation of higher-than-specified levels of residual moisture within the lyophilized Men A component vial of Menveo (NDC #46028-0208-01 , lot # M12115). Fortunately, this recall does not present any safety concerns or a need to revaccinate and there are no associated supply issues.
The vaccine in the recalled lot was distributed only in the private sector, and Novartis is working directly with the customers who purchased the vaccine regarding the recall.
Questions about this recall should be directed to Novartis Vaccines Customer Service at 1-877-683-4732 (select option #3).
November 21, 2013—The Immunization Section is pleased to provide an immunization update on meningococcal vaccine recommendations. This information was originally published in the Morbidity and Mortality Weekly Report (MMWR). Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP) (62(RR02);1–22) which was published on March 21, 2013 and is available online at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6202a1.htm?s_cid=rr6202a1_w. The Vaccines for Children (VFC) resolution is available at http://www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/02-13-2-hib.pdf.
ACIP recommends meningococcal vaccination for the following groups:
Two quadrivalent meningococcal polysaccharide-protein conjugate vaccines that provide protection against meningococcal serogroups A, C, W, and Y are licensed in the United States for use among persons as noted:
Quadrivalent meningococcal polysaccharide vaccine is the only vaccine licensed for use among persons aged ≥56 years.
A bivalent meningococcal polysaccharide protein conjugate vaccine that provides protection against meningococcal serogroups C and Y along with Haemophilus influenzae type b (Hib) is licensed for use in children aged 6 weeks through 18 months.
Both quadrivalent meningococcal conjugate vaccines and the bivalent meningococcal conjugate vaccine are available through the VFC Program.
There is limited supply of Hib-MenCY-TT (Menhibrix) as this vaccine should only be used for high-risk children. Refer to Table 7 in the above mentioned MMWR publication.
October 25, 2013—The Centers for Disease Control and Prevention published Surveillance of Influenza Vaccination Coverage—United States, 2007–08 Through 2011–12 Influenza Seasons—Surveillance Studies in the Morbidity and Mortality Weekly Report (MMWR) October 25, 2013 / 62(ss04):1–29. Visit http://www.cdc.gov/mmwr/ to read the entire document.
Seasonal influenza is associated with substantial morbidity and mortality in the United States. Rates for serious illness and death are higher among adults aged ≥65 years, children aged <2 years, pregnant women, and persons of any age who have medical conditions that place them at increased risk for influenza complications. The economic impact of influenza illness is substantial. Substantial improvement in annual influenza vaccination of recommended groups is needed to reduce the health effects of influenza and reach Healthy People 2020 targets.
The Immunization Section supports the Advisory Committee on Immunization Practices (ACIP) recommendation of routine annual influenza vaccination of all persons aged 6 months and older. Health care providers should recommend vaccination at every opportunity to all eligible persons. Health care providers should offer influenza vaccine as soon as it becomes available and should continue to offered it throughout the influenza season (i.e., as long as influenza viruses are circulating in the community).