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Issue 1355: March 15, 2018
Ask the Experts: CDC Experts Answer Your Questions
As a thank-you to our loyal IAC Express readers, we will periodically publish extra editions such as this one, with new "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).
Polio Vaccine
Meningococcal B Vaccines
Administering Vaccines
Polio Vaccine
Q: What is the routine schedule for giving IPV (IPOL, Sanofi Pasteur) to children?
A: In the U.S., all infants and children should receive 4 doses of IPV at ages 2, 4, 6–18 months, and 4–6 years. The first dose may be given as early as 6 weeks of age. The final dose should be administered at 4 years of age or older, regardless of the number of previous doses, and should be given 6 months or more after the previous dose. A fourth dose in the routine IPV series is not necessary if the third dose was given at 4 years of age or older and 6 months or more after the previous dose.
Infants and children traveling to areas where there has been wild or vaccine-derived poliovirus circulation in the last 12 months should be vaccinated according to the routine schedule (see wwwnc.cdc.gov/travel/news-announcements/polio-guidance-new-requirements for details). If the routine series cannot be administered within the recommended intervals before protection is needed, an accelerated schedule can be used: 1) the first dose should be given to infants 6 weeks of age and older, 2) the second and third doses should be administered at 4 weeks or more after the previous doses, and 3) the minimum interval between the third and fourth doses is 6 months. If the age-appropriate series is not completed before departure, the remaining IPV doses to complete a full series should be administered when feasible, at the intervals recommended for the accelerated schedule. If doses are needed while residing in the affected country, the polio vaccine that is available (IPV or oral polio vaccine) may be administered.
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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 April 1 through April 30, 2016, it can be counted as valid only if the record indicates it was trivalent (tOPV). If the dose was administered on or after May 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. IPV schedule. See www.cdc.gov/mmwr/volumes/66/wr/pdfs/mm6601a6.pdf for more information on this issue.
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Q: If an immigrant infant has a record of 1 or 2 doses of OPV in their country of origin, how many more doses of IPV should be given?
A: 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). See the previous question for details on assessment of OPV doses by the date of administration.
If both tOPV and IPV were or will be administered as part of a series, the total number of doses needed to complete the series is the same as that recommended for the U.S. IPV schedule. If the child is younger than 4 years of age a total of 4 doses of polio vaccine are recommended. If the child is currently 4 years of age or older, a total of 3 doses completes the series. A minimum interval of 4 weeks should separate doses in the series, with the final dose administered on or after the fourth birthday and at least 6 months after the previous dose. If only tOPV was administered, and all doses were given before 4 years of age, 1 dose of IPV should be given at 4 years of age or older, at least 6 months after the last tOPV dose.
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Q: Should adults get vaccinated against polio?
A: Routine polio vaccination of U.S. residents 18 years of age and older—including those working in healthcare or in healthcare-related training—is not recommended. Polio vaccination is recommended for all travelers to countries with wild poliovirus (WPV) or vaccine-derived poliovirus (VDPV) circulation. Countries are considered to have WPV or VDPV circulation if they have evidence during the previous 12 months of ongoing endemic circulation (WPV only), a polio outbreak, or environmental evidence (through sewage sampling) of WPV or VDPV circulation. For additional information on countries with WPV or VDPV circulation and vaccine recommendations, consult the travel notices on the CDC Travelers’ Health website (www.cdc.gov/travel) or the weekly update of reported WPV and VDPV cases at the Global Polio Eradication Initiative website (www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx).
Adults who are traveling to areas where WPV or VDPV is actively circulating and who are unvaccinated, incompletely vaccinated, or whose vaccination status is unknown should receive a series of 3 doses: 2 doses of IPV administered at an interval of 4–8 weeks; a third dose should be administered 6–12 months after the second. If 3 doses of IPV cannot be administered within the recommended intervals before protection is needed, the following alternatives are recommended:
- If more than 8 weeks is available before protection is needed, 3 doses of IPV should be administered at least 4 weeks apart.
- If less than 8 weeks but more than 4 weeks is available before protection is needed, 2 doses of IPV should be administered at least 4 weeks apart.
- If less than 4 weeks is available before protection is needed, a single dose of IPV is recommended.
If less than 3 doses are administered, the remaining IPV doses to complete a 3-dose series should be administered when feasible, at the intervals recommended above, if the person remains at increased risk for poliovirus exposure.
If an adult at risk previously received only one or two documented doses of polio vaccine (either OPV or IPV), he or she should receive the remaining dose(s) of IPV, regardless of the interval since the last dose. It is not necessary to restart the vaccination series.
Adults who have completed a routine series of polio vaccine are considered to have lifelong immunity to poliomyelitis, but data on duration of immunity are lacking. As a precaution, adults 18 years of age or older who are traveling to areas where WPV or VDPV is actively circulating and who have received a routine series with either IPV or OPV in childhood should receive another dose of IPV before departure. For adults, available data do not indicate the need for more than a single lifetime booster dose with IPV.
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Meningococcal B Vaccines
Q: Which patients should receive a 2-dose schedule of Trumenba (MenB, Pfizer)?
A: Healthy adolescents who are not at increased risk for meningococcal disease should receive 2 doses of Trumenba administered at 0 and 6 months. If the second dose is given at an interval of less than 6 months, a third dose should be given at least 4 months after the 2nd dose.
For persons at increased risk for meningococcal disease (those with functional or anatomic asplenia or persistent complement component deficiency, including people taking eculizumab (Soliris), and microbiologists who work with meningococcus bacteria in a laboratory) and for use during serogroup B outbreaks, 3 doses of Trumenba should be administered at 0, 1–2, and 6 months.
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Q: A microbiologist in our facility received 2 doses of Trumenba 6 months apart. Does he need to receive a third dose?
A: No. The 3-dose series (at 0, 1–2 and 6 months) is intended to rapidly induce immunity to serogroup B meningococcal bacteria. If a microbiologist or other person at increased risk has received 2 doses of Trumenba separated by 6 months, their vaccine series can be considered to be complete.
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Administering Vaccines
Q: Some manufacturers’ package inserts state that a vaccine should be used immediately after reconstitution. In the context of reconstitution and administration of vaccines, how does CDC define “immediately”?
A: There are various requirements for the use of vaccines after reconstitution. Some manufacturers’ package inserts require that the vaccine be used or discarded in varying time frames ranging from 24 hours after reconstitution to immediately after reconstitution. While the specific time frames are simple to interpret, there can be some confusion as to what the requirement of “immediately” actually means.
CDC considers “immediately” to be the reasonable time it takes to prepare and transport the vaccine to the patient to be administered. This would include any limited documentation that may be related to this process. It is up to the judgment of a provider to determine if a vaccine has not been used in the appropriate time. Some manufacturers have indicated to providers that “immediately” can be up to 30 minutes. The definition of “immediately” varies from manufacturer to manufacturer. Some do not have the data to put forth a general time frame as to what “immediately” means. CDC recommends that the provider contact the manufacturer any time (s)he has any question about whether or not the vaccine has been used in the appropriate time frame.
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Q: We have a nurse in one of our clinics who gave separate doses of hepatitis A and hepatitis B vaccine in the gluteus. Are the doses of each antigen considered invalid? If so, can they be repeated at any time or do I need to count the spacing between doses from the date when the invalid dose was administered?
A: Although the gluteus muscle is not a recommended site for vaccination, in general, a dose given there can be considered valid. The exceptions to this general rule are hepatitis B and rabies vaccines, so the hepatitis B vaccine should not be counted in this situation. The hepatitis B vaccine can be repeated immediately. See the Advisory Committee on Immunization Practice’s (ACIP) General Best Practices Guidelines for Immunization, available at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/administration.html.
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Q: Is it okay to draw up vaccines at the beginning of the shift? If it isn't, how much in advance can this be done?
A: ACIP discourages the practice of prefilling vaccine into syringes, primarily because of the increased possibility of administration and dosing errors. An exception may be considered when only a single type of vaccine is to be administered during a clinic (for example, influenza). Another reason to discourage the practice in general is that some vaccines have a very limited shelf life after reconstitution. If the reconstituted vaccine is not used within the designated time period, it must be discarded. A chart of the time allowed between reconstitution and use, "Vaccines with Diluents: How to Use Them," is available at www.immunize.org/catg.d/p3040.pdf. For more information on prefilling syringes, please read www.immunize.org/technically-speaking/20110901.asp.
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Q: If you place a needle on a manufacturer-filled syringe and then don't administer the vaccine, how long can you store the syringe with the needle attached?
A: In general, a vaccine should not be prepared until the provider is ready to administer it to a patient. This is because once the syringe cap is removed or a needle is attached, the sterile seal is broken. However, if a sterile seal has been broken, staff should be sure to maintain the syringe at the appropriate temperature and either use it or discard it at the end of the clinic day. This issue is addressed in the CDC Storage and Handling Toolkit, available at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, page 38.
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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, and live zoster vaccines. No other diluent can be used for these vaccines, and these diluents must not be used to reconstitute any other lyophilized vaccine.
If the wrong diluent is used, the vaccination should always be repeated. If an inactivated vaccine is reconstituted with the wrong diluent and is administered, the dose is invalid and should be repeated as soon as possible. If a live vaccine is reconstituted with the wrong diluent and is administered, the dose is invalid. If the dose can't be repeated on the same clinic day, it needs to be repeated no earlier than four weeks after the invalid dose. This spacing is due to the effects of generating a partial immune response that could suppress the live replication of subsequent doses, even of the same live vaccine.
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Q: What should we do if a dose of expired vaccine is given to a patient?
A: The dose should be repeated. If the expired dose is a live virus vaccine, you should wait at least 4 weeks after the previous (expired) dose was given before repeating it. If the expired dose is not a live vaccine, the dose should be repeated as soon as possible. If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, mumps, rubella, varicella, and hepatitis A).
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Q: Does live oral cholera vaccine (Vaxchora, PaxVax) need to be administered at an interval from other live oral or injectable vaccines?
A: In general, no. According to ACIP's General Best Practice Guidelines for Immunization, concerns about spacing between doses of live vaccines not given at the same visit applies only to live injectable or intranasal vaccines. So live oral cholera vaccine may be administered simultaneously or at any interval before or after administration of most other vaccines. One exception is Ty21a oral typhoid vaccine (Vivotif, Berna) and oral cholera vaccine. Oral cholera vaccine should be administered before Ty21a vaccine, and 8 hours should separate the cholera vaccine and the first dose of Ty21a.
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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.
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