American Academy of Family Physicians (AAFP) ROCKWELL, Pamela G., D.O.
Associate Professor, Department of Family Medicine, University of Michigan Medical School
Medical Director, Dominos Farms Family Medicine Ann Arbor, MI
American Academy of Pediatrics (AAP) BYINGTON, Carrie L., MD
Chair, AAP Committee on Infectious Diseases
The Jean and Thomas McMullin Professor and Dean of Medicine Senior Vice President Health Science Center
Vice Chancellor for Health Services Texas A&M University
Bryan, TX
American Academy of Pediatrics (AAP) Red Book Editor
KIMBERLIN, David, MD Professor of Pediatrics
Division of Pediatric Infectious Diseases
The University of Alabama at Birmingham School of Medicine Birmingham, AL American Academy of Physician Assistants (AAPA)
LÉGER, Marie-Michèle, MPH, PA-C Senior Director, Clinical and Health Affairs
American Academy of Physician Assistants Alexandria, VA American College Health Association (ACHA)
EVEN, Susan, MD Executive Director
Student Health Center University of Missouri
Columbia, MO
American College of Nurse Midwives (ACNM) HAYES, Carol E., CNM, MN, MPH
Lead Clinician
Clinical Quality Compliance and Management Planned Parenthood Southeast
Atlanta, GA
American College of Nurse Midwives (ACNM) (alternate) MEHARRY, Pamela M., PHD, CNM
Midwifery Educator, Human Resources for Health
In partnership with University of Rwanda and University of Illinois, Chicago
American College of Obstetricians and Gynecologists (ACOG) AULT, Kevin A., MD, FACOG
Professor and Division Director
Department of Obstetrics and Gynecology University of Kansas Medical Center Kansas City, KS
American College of Physicians (ACP) FRYHOFER, Sandra Adamson., MD, MACP Adjunct Associate Professor of Medicine Emory University School of Medicine Atlanta, GA
American College of Physicians (ACP) (alternate) POLAND, Gregory A., MD
Mary Lowell Professor of Medicine and Infectious Diseases Mayo Clinic
Rochester, MN
American Geriatrics Society (AGS) SCHMADER, Kenneth, MD
Professor of Medicine-Geriatrics Geriatrics Division Chief
Duke University and Durham VA Medical Centers Durham, NC America’s Health Insurance Plans (AHIP)
NETOSKIE, Mark J., MD, MBA Market Medical Executive, CIGNA Houston, TX
American Immunization Registry Association (AIRA) COYLE, Rebecca, MSEd
Executive Director, AIRA Washington, DC
American Medical Association (AMA) FRYHOFER, Sandra Adamson, MD Adjunct Associate Professor of Medicine Emory University School of Medicine Atlanta, GA
American Nurses Association (ANA) RITTLE, Charles (Chad), DNP, MPH, RN Assistant Professor, Nursing Faculty
Chatham University, School of Health Sciences Pittsburgh, PA
American Osteopathic Association (AOA) GROGG, Stanley E., DO
Associate Dean/Professor of Pediatrics
Oklahoma State University-Center for Health Sciences Tulsa, OK
American Pharmacists Association (APhA) FOSTER, Stephan L., PharmD CAPT
(Ret) U.S.P.H.S.
Professor, College of Pharmacy
University of Tennessee Health Sciences Center Memphis, TN
Association of Immunization Managers (AIM) FINLEY, Christine, RN, MPH
Immunization Program Manager Vermont Department of Health Burlington, VT
Association for Prevention Teaching and Research (APTR) McKINNEY, W. Paul, MD
Professor and Associate Dean
University of Louisville School of Public Health and Information Sciences Louisville, KY
Association of State and Territorial Health Officials (ASTHO) SMITH, Nathaniel, MD, MPH
Director and State Health Officer Arkansas Department of Health Little Rock, AR
Biotechnology Industry Organization (BIO) ARTHUR, Phyllis A., MBA
Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy Washington, DC
Council of State and Territorial Epidemiologists (CSTE) HAHN, Christine, MD State
Epidemiologist
Office of Epidemiology, Food Protection and Immunization Idaho Department of Health and Welfare
Boise, ID
Canadian National Advisory Committee on Immunization (NACI) QUACH, Caroline, MD, MSc
Pediatric Infectious Disease Specialist and Medical Microbiologist Medical Lead, Infection Prevention and Control Unit
Medical Co-director – Laboratory Medicine, Optilab Montreal-CHUM
Montreal, Québec, Canada
Infectious Diseases Society of America (IDSA) NEUZIL, Kathleen M., MD, MPH
Professor of Medicine
Director, Center for Vaccine Development University of Maryland School of Medicine Baltimore, MD
Infectious Diseases Society of America (IDSA) (alternate) BAKER, Carol J., MD
Professor of Pediatrics
Molecular Virology and Microbiology Baylor College of Medicine
Houston, TX
National Association of County and City Health Officials (NACCHO) ZAHN, Matthew, MD
Medical Director, Epidemiology
Orange County Health Care Agency Santa Ana, CA
National Association of County and City Health Officials (NACCHO) (alternate) DUCHIN, Jeffrey, MD
Health Officer and Chief, Communicable Disease Epidemiology and Immunization Section
Public Health - Seattle and King County Professor in Medicine
Division of Allergy and Infectious Diseases
University of Washington School of Medicine and School of Public Health Seattle, WA National Association of Pediatric Nurse Practitioners (NAPNAP)
STINCHFIELD, Patricia A., RN, MS, CPNP Director
Infectious Disease/Immunology/Infection Control Children's Hospitals and Clinics of Minnesota
St. Paul, MN
National Foundation for Infectious Diseases (NFID) SCHAFFNER, William, MD
Chairman, Department of Preventive Medicine
Vanderbilt University School of Medicine Nashville, TN
National Immunization Council and Child Health Program, Mexico DURAN, Luis, MD
Director, Center for Children and Adolescent Health (CeNSIA) Ministry of Health / Secretaría de Salud
Mexico
National Medical Association (NMA) WHITLEY-WILLIAMS, Patricia, MD Professor and Chair
University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical School
New Brunswick, NJ
National Vaccine Advisory Committee (NVAC) THOMPSON, Kimberly, ScD
Chair, NVAC
Professor of Preventive Medicine and Global Health University of Central Florida, College of Medicine Orlando, FL
Pediatric Infectious Diseases Society (PIDS) O’LEARY, Sean, MD, MPH
Associate Professor of Pediatrics Pediatric Infectious Diseases General Academic Pediatrics Children’s Hospital Colorado
University of Colorado School of Medicine
Pediatric Infectious Diseases Society (PIDS) (alternate) SAWYER, Mark H, MD
Professor of Clinical Pediatrics
University of California, San Diego School of Medicine San Diego, CA
Pharmaceutical Research and Manufacturers of America (PhRMA) JOHNSON, David R, MD, MPH
Associate Vice President, Global Medical Affairs, Sanofi Pasteur Swiftwater, PA
Society for Adolescent Health and Medicine (SAHM) MIDDLEMAN, Amy B., MD, MSEd, MPH
Professor of Pediatrics
Chief, Section of Adolescent Medicine
University of Oklahoma Health Sciences Center Oklahoma City, OK
Society for Healthcare Epidemiology of America (SHEA) WEBER, David, MD, MPH
Professor of Medicine, Pediatrics, and Epidemiology
University of North Carolina Schools of Medicine and Public Health
Medical Director, Hospital Epidemiology and Occupational Health, UNC Health Care University of North Carolina
Chapel Hill, NC
To the Advisory Committee on Immunization Practices (ACIP),
This letter is in support of ACIP’s recommendation for the FDA-approved HEPLISAV-B Hepatitis B vaccine for adults 18 years and older.
Our federally qualified health center in New York City serves a largely Asian immigrant population at risk for hepatitis B virus (HBV). Over the years, we have screened more than 55,000 adult patients for hepatitis B, approximately 15% who are susceptible to HBV infection and whom we offer HBV vaccination with the currently available 3-shot vaccination
series. Approximately one-third of adults offered HBV immunization at our health center do not complete all 3 vaccines that must be given over a minimum of 6 months.
These are largely adults who are at increased risk for HBV infection due to their birth from a region with high to intermediate prevalence of HBV or household contact with someone with HBV. Ensuring completion of the hepatitis B vaccination series is of particular importance in our patient population to prevent further transmission of HBV.
As a community health center, we follow ACIP guidance for immunization and know that without an ACIP recommendation, HEPLISAV will not be distributed to our at-risk population.
Please recommend HEPLISAV-B as an available option for immunization of adults who need hepatitis B vaccination.
I have no conflicts of interest to declare.
Sincerely,
Amy Shen Tang, MD
Hepatitis B Program Director
Charles B. Wang Community Health Center 268 Canal St.
New York, NY 10013 Email: astang@cbwchc.org Phone: 212-379-6999
Appendix B: Public Comment Letters Submitted
Advisory Committee on Immunization Practices (ACIP) Secretariat 1600 Clifton Road, N.E., Mailstop A27 Atlanta, GA 30329
RE: Comments on the ACIP’s Review and Consideration of HEPLISAV-B (February 21, 2018 Meeting)
To the Members of the Advisory Committee on Immunization Practices:
Thank you for the opportunity to be here to add my voice along with those of scientists, health experts, and advocates in support of the new science-based, two-dose hepatitis B vaccine regimen, HEPLISAV-B.
I have been receiving treatment for hepatitis B close to 4 years now, but thinking back it amazes me how lightly I took this disease. Even after knowing I had Hepatitis B, several years passed before I received treatment.
As a member of the diverse Lesbian, Gay, Bisexual and Transgender community, I was there because I wanted to protect myself against HIV/AIDS. I am well aware of those risks. I was there to start on PrEP (pre-exposure prophylaxis) and it was there that I was told my viral load was in the hundreds of millions.
I share this anecdote to show how little I knew, and the public knows, about this disease. I am fortunate to stumble upon treatment, but many others may not be. The rate of hepatitis B infections in adults increased 20.7% in 2015 alone. At least 5,000 lives are unnecessarily lost each year from liver failure or liver cancer.
The availability of two-dose vaccines over 1 month instead of the 3 doses over 6 months is a critical tool to protect many more Americans. Considering the low percentage of those who currently complete all three doses, this is one less barrier for vulnerable and at-risk communities to receive the necessary protection.
There is no cure for hepatitis B. Disease prevention through more effective vaccines is critical to reducing the spread of the disease and to break the cycle of infection among families and partners. I count myself among the fortunate, but I also believe that in this resource rich country, the health of Americans should not be left to chance. Through evidence-based policies, I believe we can better protect all Americans.
Thank you again for this opportunity.
Binh T. Ly
223 N. George Mason Dr., Unit 3 Arlington, VA 22203
binhtly@vt.edu