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Issue 1378: August 3, 2018
Ask the Experts: CDC Experts Answer Your Questions
As a thank-you to our loyal IAC Express readers, we periodically publish extra editions such as this one, with new and updated "Ask the Experts" Q&As answered by CDC experts.
IAC extends thanks to our experts: Andrew T. Kroger, MD, MPH; Candice L. Robinson, MD, MPH; Raymond A. Strikas, MD, MPH, FACP, FIDSA; and JoEllen Wolicki, BSN, RN, all from the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC).
Hepatitis B Vaccines
Hepatitis A Vaccines
DTaP/Td/Tdap Vaccines
Polio Vaccines
Rotavirus Vaccines
Meningococcal ACWY Vaccines
Zoster Vaccines
Administering Vaccines
Documenting Vaccines
Billing and Reimbursement
Hepatitis B Vaccines
Q: A physician ordered a 40-mcg dose of hepatitis B vaccine for a hemodialysis patient. The clinic does not stock the Recombivax HB 40-mcg dose dialysis formulation (Merck) and would like to give 2 doses of Engerix-B 20-mcg dose (GSK) for each dose in the series. Is this acceptable?
A: Yes. If given on the same day as separate injections in separate sites, two injections of Engerix-B 20 mcg can be counted as the equivalent of one Recombivax HB 40-mcg dose. According to the package insert, Engerix-B is licensed for use in this manner (vaccine package inserts for all vaccines are available at www.immunize.org/fda). Note that an all-Engerix-B or mixed-brand dialysis schedule is a 4-dose series (doses at 0, 1, 2, and 6 months). Vaccination using only Recombivax HB dialysis formulation is a 3-dose schedule (doses at 0, 1, and 6 months).
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Hepatitis A Vaccines
Q: How does immune globulin (IG) work?
A: IG provides protection against HAV infection through passive transfer of antibody. Depending on the IG dosage, protection lasts from 1 to 2 months. When administered for pre-exposure prophylaxis, a dose of 0.1 mL/kg will provide protection for up to 1 month and a dose of 0.2 mL/kg will provide protection for up to 2 months. A dose of 0.2 mL/kg can be repeated every 2 months. For post-exposure prophylaxis, the recommended dosage is 0.1 mL/kg. There is no maximum dosage of IG for hepatitis A prophylaxis.
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DTaP/Td/Tdap Vaccines
Q: If a teen or adult patient never received Tdap but received a dose of Td vaccine 2 years ago, should I wait 8 more years before administering a dose of Tdap to the patient?
A: No. ACIP recommends that people age 11 years and older who have not yet received Tdap receive a single dose of Tdap now. ACIP specifies no waiting interval between administering Td and Tdap.
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Polio Vaccines
Q: We frequently see children (mostly from certain foreign countries) who have received 6 or more doses of polio vaccine, all administered before 4 years of age. How do we handle this when assessing the child’s immunization history?
A: It is common practice in many developing countries to administer oral polio vaccine to children during both routine visits and periodic vaccination campaigns, so a child’s record may indicate more than 4 doses. Depending on the timing, some of these doses may not be valid according to the U.S. immunization schedule. Polio vaccine given outside the United States is valid if written documentation indicates that all doses were given after 6 weeks of age and the vaccine received was IPV or trivalent OPV (tOPV).
If the history is of a complete series of IPV, at least one dose should be administered on or after 4 years of age and at least 6 months after the previous dose. If a complete series cannot be identified that meets these criteria, then the child should receive as many doses of IPV as needed to complete the U.S. recommended schedule.
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Q: How do I determine if doses of polio vaccine administered outside the United States were trivalent OPV?
A: Use the date of administration to make a presumptive determination of what type of OPV was received. Only trivalent doses count as valid for the U.S. polio vaccination schedule.
Trivalent OPV was used throughout the world prior to April 2016. In April 2016, all countries using OPV switched to bivalent OPV (bOPV). In addition, some countries also use monovalent OPV (mOPV) during special vaccination campaigns. Doses recorded as bOPV or mOPV, or doses given during a vaccination campaign (which may be included on the record), do not count as valid doses for the U.S. polio vaccination schedule.
If the record indicates OPV, and the dose was given prior to April 1, 2016, it can be counted as a valid tOPV dose. If the dose was administered on or after April 1, 2016, it should not be counted as a valid dose for the U.S. polio vaccination schedule because it was bivalent or monovalent vaccine rather than trivalent.
Persons younger than 18 years of age with doses of OPV that do not count towards the U.S. vaccination requirements should receive IPV to complete the schedule according to the U.S. polio immunization schedule. See www.cdc.gov/mmwr/volumes/66/wr/pdfs/mm6601a6.pdf for more information on this issue.
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Rotavirus Vaccines
Q: Which infants should not receive rotavirus vaccine?
A: Do not give rotavirus vaccine to an infant who has a history of a severe allergic reaction (for example, anaphylaxis) after a previous dose of rotavirus vaccine or to a vaccine component. The oral applicator for Rotarix (GSK) contains latex rubber so infants with a severe (anaphylactic) allergy to latex should not be given Rotarix; the RotaTeq (Merck) dosing tube is latex-free. Rotavirus vaccine is contraindicated in infants with the rare disorder severe combined immunodeficiency (SCID) and in infants with a history of intussusception.
Practitioners should consider the potential risks and benefits of administering rotavirus vaccine to infants with known or suspected altered immunocompetence, including those whose mothers received immunosuppressive biologics (such as infliximab) during pregnancy. Consultation with an immunologist or infectious diseases specialist is advised.
Children and adults who are immunocompromised because of congenital immunodeficiency, hematopoietic transplantation, or solid organ transplantation sometimes experience severe or prolonged rotavirus gastroenteritis. However, few safety or efficacy data are available for the administration of rotavirus vaccine to infants who are immunocompromised or potentially immunocompromised, including 1) infants with primary and acquired immunodeficiency, cellular immunodeficiency, and hypogammaglobulinemia and dysgammaglobulinemia; 2) infants with blood dyscrasias, leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic system; 3) infants on immunosuppressive therapy (including high-dose systemic corticosteroids); and 4) infants who are HIV-exposed or infected.
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Q: A woman in our practice received infliximab (Remicade, Janssen Pharmaceuticals) for treatment of Crohn's disease while she was pregnant. Should we modify her infant's rotavirus vaccination schedule because of this treatment?
A: Infliximab is an IgG monoclonal antibody that neutralizes the biological activity of tumor necrosis factor-alpha. Like other IgG antibodies, infliximab crosses the placenta. Infliximab has been detected in the blood of infants up to 6 months following birth. Consequently, these infants may be at increased risk of serious infection.
Neither ACIP nor CDC provides specific guidance on this issue because there are no data on safety or efficacy in children exposed to potentially immunosuppressive biologics during pregnancy. As noted above, practitioners should consider the potential risks and benefits of administering rotavirus vaccine to infants with known or suspected altered immunocompetence. Consultation with an immunologist or infectious diseases specialist is advised.
The manufacturer recommends that live vaccines (rotavirus and BCG) be deferred for at least six months after birth for infants whose mothers received infliximab during pregnancy. Hence, if a practitioner follows the manufacturer’s recommendation, the child would not be eligible to receive rotavirus vaccine because, according to ACIP guidelines, the rotavirus vaccine series should not to be started after age 15 weeks 0 days.
Inactivated vaccines should be given on schedule.
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Meningococcal ACWY Vaccines
Q: What is the schedule for MenACWY vaccine?
A: All adolescents should receive a dose of MenACWY at 11 or 12 years of age. A second (booster) dose is recommended at 16 years of age. Adolescents who receive their first dose at age 13 through 15 years should receive a booster dose at age 16 years. The minimum interval between MenACWY doses is 8 weeks. Adolescents who receive a first dose after their 16th birthday do not need a booster dose unless they become at increased risk for meningococcal disease. Colleges may not consider a second dose given even a few days before age 16 years as valid, so keep that in mind when scheduling patients.
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Q: If someone received MPSV4 or MenACWY vaccine at age 10 years and a dose of MenACWY before the 16th birthday, will they still need a booster dose at age 16?
A: Yes, they should receive a booster dose. A booster dose of MenACWY is recommended at age 16 years even if 2 (or more) doses of meningococcal ACWY vaccine were received before age 16 years. People age 19 through 21 years who are entering college or are first-year students living in a residence hall, and who have not received a dose of MenACWY on or after age 16 years, should also be vaccinated.
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Zoster Vaccines
Q: Should a person who received 2 doses of varicella vaccine be vaccinated with zoster vaccine when they turn 50?
A: In its 2018 zoster vaccine recommendations, the Advisory Committee on Immunization Practices states that recombinant zoster vaccine (RZV; Shingrix, GlaxoSmithKline) may be used in adults age 50 years or older irrespective of prior receipt of varicella vaccine or live zoster vaccine (ZVL; Zostavax, Merck).
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Q: What is the minimum interval between doses of RZV (Shingrix)?
A: The recommended interval between RZV doses is 2 to 6 months. The minimum interval between doses of RZV is 4 weeks. If the second dose is given less than 4 weeks after the first dose, the second dose should be repeated at least 8 weeks after the invalid dose.
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Q: What is the minimum age for administering RZV?
A: The recommended and minimum age for RZV is 50 years. However, if a dose is inadvertently administered to an adult 18 through 49 years of age CDC does not recommend repeating the dose. The second RZV dose should not be administered until the 50th birthday. This guidance does not appear in the most recent zoster ACIP statement but is in the General Best Practice Guidelines (Table 3-1 in the Timing and Spacing of Immunobiologics section at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html) and is based on guidance from CDC’s zoster subject matter experts.
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Q: I have ZVL in my freezer but I do not have recombinant zoster vaccine. The manufacturer told us to anticipate ordering limits and intermittent shipping delays for RZV during 2018 so I don’t know when I will get RZV doses. In this situation, what is the appropriate approach to patients who come to my practice for shingles vaccine?
A: ACIP has stated a preference for RZV for people age 50 years and older. However, ACIP also states that ZVL may be used at the clinician's discretion for people age 60 years and older. So, if a person age 60 years and older wants zoster vaccine and RZV is not available, then use of ZVL is appropriate. ZVL provides the best protection in the first year after vaccination. ACIP recommends that people who receive ZVL should be revaccinated with a 2-dose series of RZV. The minimum interval between ZVL and RZV is 8 weeks.
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Q: How should zoster vaccine be stored?
A: RZV (Shingrix)
Both lyophilized RZV and the adjuvant solution diluent must be stored at refrigerator temperature, between 2° and 8°C (between 36° and 46°F). Protect the vials from light. Do not freeze. Vaccine or adjuvant solution that has been frozen must be discarded. If vaccine that was frozen was administered, the dose does not count and should be repeated. The repeat dose should be administered 4 weeks after the frozen dose.
After reconstitution, administer RZV immediately or store refrigerated between 2° and 8°C (between 36° and 46°F) and use within 6 hours. Discard reconstituted vaccine if not used within 6 hours.
ZVL (Zostavax)
All vaccines that contain live varicella virus, including ZVL, must be stored frozen at a temperature of between -50°C and -15°C (between -58°F and +5°F) until they are reconstituted. Although the manufacturer states that any freezer that has a separate sealed freezer door and reliably maintains a temperature between -50°C and -15°C is acceptable for storage of varicella-containing vaccines, CDC recommends the use of a separate stand-alone freezer to store frozen vaccines. A storage unit that is frost-free or has an automatic defrost cycle is preferred. The diluent should be stored separately at room temperature or in the refrigerator.
ZVL should be reconstituted immediately upon removal from the freezer. Administer zoster vaccine immediately after reconstitution to minimize loss of potency. Discard reconstituted vaccine if not used within 30 minutes. Do not freeze reconstituted vaccine.
If necessary, ZVL may be stored at refrigerator temperature between 2°C and 8°C (between 36°F and 46°F) for up to 72 continuous hours prior to reconstitution. ZVL stored between 2°C and 8°C that is not used within 72 hours of removal from a freezer should be discarded.
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Administering Vaccines
Q: Are vaccine diluents interchangeable?
A: Diluents are not interchangeable, except for the sterile water used in Merck’s measles-mumps-rubella (MMR), measles-mumps-rubella-varicella (MMRV), varicella (VAR), and live zoster (ZVL) vaccines.
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Q: One of our staff gave a dose of pediatric hepatitis A vaccine to an adult patient by mistake. How do we remedy this error?
A: In general, if the error is discovered on the same clinic day, you can administer the other "half" of the dose on that same day. If the error is discovered later, the dose should not be counted, and then the person should be recalled to the office and given a full age-appropriate repeat dose.
There are, however, two exceptions to the general rule: (1) If a patient sneezes after receiving nasal-spray live attenuated influenza vaccine, count the dose as valid. (2) If an infant regurgitates, spits, or vomits during or after receiving oral rotavirus vaccine, count the dose as valid.
If you give more than an age-appropriate dose, count the dose as valid and notify the patient/parent about the error. Using larger than recommended dosages can be hazardous because of excessive local or systemic concentrations of antigens or other vaccine constituents. Avoid such errors by checking the vaccine vial label 3 times.
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Documenting Vaccines
Q: Where can I find a list of vaccines currently licensed for use in the U.S.?
A: CDC maintains a list of vaccine names at www.cdc.gov/vaccines/vpd/vaccines-list.html.
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Q: We frequently see patients, such as immigrants, who do not have records of past vaccination or who insist they or their children are up to date. Should we accept their undocumented vaccination history?
A: Vaccination providers frequently encounter people who do not have adequate documentation of vaccinations. Providers should only accept written, dated records as evidence of vaccination. With the exception of influenza and pneumococcal polysaccharide vaccines, self-reported doses of vaccine without written documentation should not be accepted. An attempt to locate missing records should be made whenever possible by contacting previous healthcare providers, reviewing state or local immunization information systems, and searching for a personally held record. However, if records cannot be located or will definitely not be available anywhere because of the patient's circumstances, people without adequate documentation should be considered susceptible and should be started on the age-appropriate vaccination schedule. Serologic testing for immunity is an alternative to vaccination for certain antigens (e.g., measles, rubella, or hepatitis A).
In general, although it is not ideal, receiving extra doses of vaccine poses no medical problem. Receiving excessive doses of tetanus toxoid (DTaP, DT, Tdap, or Td) can increase the risk of a local adverse reaction, however. For details, consult the ACIP’s Best Practice Guidelines for Immunization chapter titled Timing and Spacing of Immunobiologics, available at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html.
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Q: We sometimes encounter patients with foreign vaccination records. We suspect that some of these records are not valid. What should we do?
A: If a provider suspects an invalid vaccination, including those from persons vaccinated outside the U.S., one of two approaches can be taken. Repeating the vaccinations is an acceptable option. Doing so is generally safe and avoids the need to obtain and interpret serologic tests. If avoiding unnecessary injections is desired, judicious use of serologic testing might be helpful in determining which immunizations are needed. This may be particularly helpful in determining tetanus and diphtheria antitoxin levels for children whose records indicate 3 or more doses of DTP or DTaP. This issue is discussed in detail in the ACIP’s General Best Practice Guidelines for Immunization chapter titled Special Situations, available at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/special-situations.html.
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Q: How can I find out if our state or locality has an Immunization Information System (IIS), or registry, in which I might participate?
A: To find out the status of the IIS in your state, you should contact your state IIS manager. CDC maintains a listing of contact information for all state IIS managers at www.cdc.gov/vaccines/programs/iis/contacts-registry-staff.html.
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Billing and Reimbursement
Q: What vaccines are covered by Medicare?
A: Medicare Part B (medical insurance) statutorily covers four recommended vaccines for Medicare beneficiaries: influenza, pneumococcal polysaccharide (Pneumovax 23, Merck), pneumococcal conjugate (Prevnar 13, Pfizer), and hepatitis B (for patients at high or intermediate risk). Medicare Part B does not cover other vaccinations (e.g., Tdap and zoster) unless they are directly related to the treatment of an injury or direct exposure to a disease, such as anti-rabies treatment or tetanus prevention due to an injury. In the absence of injury or direct exposure, preventive immunization against diseases such as tetanus, pertussis, or diphtheria is not covered by Part B.
Medicare Part D plans (outpatient prescription drug insurance) generally cover vaccines that Part B does not cover (for example Tdap and zoster), as long as the vaccine is recommended by the Advisory Committee on Immunization Practices. Payment for Part D-covered vaccines and their administration is determined solely by the patient’s prescription drug plan.
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Q: I want to begin providing vaccines for my adult patients but reimbursement for these vaccines is confusing. Can you provide guidance?
A: In 2017, the Immunization Action Coalition revised its comprehensive142-page guide titled Vaccinating Adults: A Step-by-Step Guide. The guide was written to assist medical practices to improve their adult vaccination services. Two of the chapters (7A and 7B) address financial considerations and provide guidance on how to obtain reimbursement for adult vaccines. The guide is available free of charge on the IAC website at www.immunize.org/guide. In addition, the National Adult and Influenza Immunization Summit has created a web section on this topic at www.izsummitpartners.org/naiis-workgroups/access-provider-workgroup/coding-and-billing.
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How to submit a question to Ask the Experts
IAC works with CDC to compile new Ask the Experts Q&As for our publications based on commonly asked questions. We also consider the need to provide information about new vaccines and recommendations. Most of the questions are thus a composite of several inquiries.
You can email your question about vaccines or immunization to IAC at admin@immunize.org.
As we receive hundreds of emails each month, we cannot promise that we will print your specific question in our Ask the Experts feature. However, you will get an answer.
You can also email CDC's immunization experts directly at nipinfo@cdc.gov. There is no charge for this service.
If you have a question about IAC materials or services, email admininfo@immunize.org.
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