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| Ask the Experts: Immunize.org Answers Questions About Vaccine Recommendations, Administering, and Documenting Vaccinations
As an additional service to IZ Express readers, we periodically publish special editions such as this one, providing you with Ask the Experts questions and answers from Immunize.org experts. This issue does not focus on a particular vaccine. Instead, it includes 4 general Q&As about vaccine recommendations, 6 Q&As about administering vaccinations, and 2 Q&As about documenting vaccinations. You can find all of these questions and answers, plus more than 1,300 others about vaccines and vaccine administration, on our "Ask the Experts" main page at www.immunize.org/ask-experts. Immunize.org’s team of experts includes Kelly L. Moore, MD, MPH (team lead); Carolyn B. Bridges, MD, FACP; Iyabode Beysolow, MD, MPH; and Jane R. Zucker, MD, MSc. Vaccine Recommendations
Administering Vaccinations
Documenting Vaccination
Editorial Information Vaccine Recommendations
A: There is usually very close agreement between vaccine package inserts and ACIP statements. The Food and Drug Administration (FDA) must approve the package insert and requires documentation for all data and recommendations made in the insert. Occasionally, ACIP may use different data to formulate its recommendations, or try to add flexibility to its recommendations, which results in wording different than that in the package insert. ACIP sometimes makes recommendations based on expert opinion and public health considerations. Published recommendations of ACIP should be considered equally as authoritative as those on the package insert. Back to top
Q: Where can I get the most up-to-date information on vaccination recommendations for people who travel outside the United States? A: You can get this information from CDC’s Travel Health website at wwwnc.cdc.gov/travel. CDC also publishes Health Information for International Travel (a.k.a. the “Yellow Book”) as a reference for those who advise international travelers of health risks. The “Yellow Book” is written primarily for healthcare providers, although others might find it useful. The contents of the book are available on the CDC Travel Health website. The book can also be ordered in print form. The book can also be ordered in print form. See the “Yellow Book” at www.cdc.gov/yellow-book/index.html. A: Infants who will travel outside the United States should be up to date for all routinely recommended vaccines. One dose of MMR is recommended for infants age 6 through 11 months before international travel. This dose does not count toward the two doses needed to complete the childhood schedule. Infants 6 through 11 months of age traveling to an area at risk for hepatitis A exposure also should receive a dose of hepatitis A vaccine. This dose does not count toward the two doses needed to complete the childhood schedule. Infants younger than age 12 months traveling to a hepatitis A endemic area are not recommended to receive immune globulin for prevention of hepatitis A because immune globulin could interfere with the response to MMR. Varicella vaccine is not recommended before age 12 months, even for travelers. For other vaccine recommendations for travelers, consult the CDC travel website at wwwnc.cdc.gov/travel. Back to top
Q: Is there a strict limit to the volume of vaccine and/or monoclonal antibody that can be administered in a single limb (deltoid or thigh) at one immunization visit? A: This question has arisen more frequently since the introduction of the RSV preventive antibody, nirsevimab (Beyfortus, Sanofi), which has an injection volume of 1 mL for infants younger than 8 months who weigh 5 kg or more at the time of immunization. High-risk children entering their second RSV season require a Beyfortus dose volume of 2 mL. Beyfortus is often administered at a routine visit when other infant immunizations are due. There is no specific guidance to not exceed 1 mL in one muscle. In fact, there is no clear standard of practice and reference texts vary in guidance. Facilities or health systems may have medication policies/procedures that outline guidance for their staff. Professional judgement is needed when administering intramuscular medications or immunizations to people, including children, because muscle size varies from person to person. Back to top
Administering Vaccinations
Q: The needle came loose while I was injecting a dose of vaccine, and approximately half the dose was lost. Should we revaccinate the patient? If so, when?
A: When injectable vaccine volume is lost (patient moves, syringe leaks), it may be difficult to judge how much vaccine the patient actually received. Use your discretion to determine whether an adequate dose was given. In general, you should treat this as a nonstandard injectable dose and should not count it. If it was an inactivated vaccine, you should re-immunize the person as soon as possible. In the case of Shingrix (RZV; GSK), if the person is still in the office the dose can be repeated immediately; however, if the repeat Shingrix dose cannot be given on the same day, then CDC recommends that it should be given 4 weeks after the invalid dose. 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 cannot be corrected on the same day, the dose should not be counted, and then the person should be recalled to the office and given a full age-appropriate repeat dose. A: Pneumococcal polysaccharide vaccine (PPSV23, Pneumovax, Merck) is not licensed or assumed to be effective in children younger than 24 months of age. PPSV23 given at this age should not be counted as part of the pneumococcal vaccination series. Pneumococcal conjugate vaccine should be administered as soon as the error is discovered. Any time the wrong vaccine is given, the parent/patient should be notified. Q: A 60-year-old patient was inadvertently given varicella vaccine instead of recombinant zoster vaccine, Shingrix. Should the patient still be given Shingrix? If so, how long an interval should occur between the 2 doses?
A: CDC recommends that if a provider mistakenly administers varicella vaccine to a person for whom recombinant zoster vaccine (RZV, Shingrix, GSK) is indicated, no specific safety concerns exist, but the dose should not be considered valid. You should administer a dose of Shingrix to the patient during that same visit (same day). If the error is not detected and corrected on the same day, Shingrix should be administered at least 8 weeks after receipt of the varicella vaccine. However, if Shingrix is inadvertently administered less than 8 weeks after the varicella vaccine, CDC experts state that the Shingrix dose does not need to be repeated if given at least 4 weeks (28 days) after the varicella vaccine. A second dose of Shingrix should be given 2–6 months after the first dose of Shingrix to complete the series. Q: Several doses (antigen and diluent) of RZV (Shingrix) were mistakenly stored in our office freezer. One of these doses was administered to a patient. Is this dose valid and if not, when can it be repeated?
A: Any RZV, either antigen or diluent, that is exposed to freezing temperature should not be used. If a dose exposed to freezing temperature is given to a patient the dose should be considered invalid and should be repeated 4 weeks after the invalid dose. Back to top
Q: Why are some vaccinations given subcutaneously (subcut) while others must be given intramuscularly (IM)?
A: In general, vaccines containing adjuvants (a component that enhances the antigenic response) are administered IM to avoid the risk of irritation, swelling, skin discoloration, inflammation, or granuloma formation if injected into subcutaneous tissue. This includes most of the inactivated vaccines, with a few exceptions (such as inactivated polio vaccine and pneumococcal polysaccharide vaccine, which may be given either subcut or IM). Vaccine efficacy may also be reduced if not given by the recommended route. Back to top
Q: If a patient or parent refuses recommended vaccinations, is it necessary for them to sign a refusal form, or is the provider’s documentation sufficient? A: There is no federal law requiring a refusal form. Several major medical organizations, including the American Academy of Pediatrics, have stated that healthcare providers may decide it is in their best interest to formally document a parent’s refusal to accept vaccination for their (minor) child. To read a discussion on this topic and to access a prototype refusal form, see “Record of Vaccine Declination” that can be accessed at www.immunize.org/catg.d/p4059.pdf. Documenting Vaccination
A: If a patient clicks a link or scans a QR code to access an electronic copy of the VIS before vaccination, that complies with federal law to provide the VIS. Immunize.org provides clinical resources displaying QR codes linking to VISs that may be printed out and used in clinics on its “VIS-related resources” page: www.immunize.org/clinical/topic/vis. Back to top
A: Yes. The National Childhood Vaccine Injury Act requires that a VIS be given to people of any age before they receive a dose of any vaccine included in the Act. Tetanus and diphtheria toxoids (and pertussis vaccine) are included in the Act. If the patient is unaccompanied and unable to clearly read and understand the information in the VIS (e.g., the patient is unconscious), this should be noted in the patient’s chart. Suggest a question for "Ask the Experts"
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