Education & Training:

Immunization Update 2007 Broadcast:
Questions & Answers
Questions submitted during broadcast - August 9, 2007

Hepatitis A & B

1. When will a VIS statement be available for Twinrix?

   There is no plan to develop a VIS for Twinrix at this time. Vaccine recipients should be provided both the hepatitis A and hepatitis B VISs. http://www.cdc.gov/vaccines/pubs/vis/default.htm

2. When will ACIP develop guidelines on the accelerated dosing schedule of Twinrix? 

   We have no information on if or when ACIP will issue guidelines specific to Twinrix. Providers using the 4-dose alternative Twinrix schedule should follow guidelines in the product package insert. http://www.fda.gov/cber/label/hahbgsk032807LB.pdf

3. How quickly is a person protected from hepatitis A and B with accelerated dosing of Twinrix if they only receive two doses prior to travel?   

   It takes 2 to 4 weeks to mount an immune response.  We have no information regarding protection, other than what the manufacturer includes in their package insert. http://www.fda.gov/cber/label/hahbgsk032807LB.pdf

4. What if a patient doesn’t come back until day 80 when they should have received the third dose of Twinrix accelerated at day 21-30? 

   We have no data on how to manage a person who starts on the newly-approved 4-dose schedule and has a lapse in the schedule. But if exposure were still imminent it would seem reasonable to simply continue the series from where it was interrupted.  On the other hand, if the lapse occurs after the FIRST dose of the new schedule, and the second dose can be administered according to the STANDARD schedule, 1 to 2 months after the first dose, we suggest reverting to the standard schedule of either Twinrix or single-antigen vaccine.

5. Please review the recent information on the use of hepatitis A vaccine versus immunoglobulin related to prophylaxis during a mass hepatitis A exposure, e.g., related to a food handler exposure.

   This is unpublished data from the June, 2007 ACIP meeting.

   Persons who recently have been exposed to HAV and who previously have not received hepatitis A vaccine should be administered a single dose of vaccine or IG (0.02 mL/kg) as soon as possible. Information about the relative efficacy of vaccine compared with IG postexposure is limited, and no data are available on persons greater than 40 years of age or those with underlying medical conditions. Therefore, decisions to use vaccine or IG should take into account patient characteristics associated with more severe manifestations of hepatitis A, including older age and chronic liver disease. Additionally, the magnitude of the risk of HAV transmission from the exposure should be considered.

   1. For healthy persons 12 months through 40 years of age, hepatitis A vaccine at the age appropriate dose is preferred to IG because of vaccine’s advantages, including long term protection and ease of administration.

   2. For persons older than 40 years of age, IG is preferred because of the absence of information regarding vaccine performance and the more severe manifestations of hepatitis A in this age group. Vaccine can be used if IG cannot be obtained.

   3. IG should be used for children younger than 12 months of age, immunocompromised persons, persons who have been diagnosed with chronic liver disease, and persons for whom vaccine is contraindicated.

   Persons administered IG for whom hepatitis A vaccine is also recommended should receive the two products simultaneously. For persons who receive vaccine, the second dose should be administered 6 to 12 months later to complete the series. The efficacy of IG or vaccine when administered more than 2 weeks after exposure has not been established.

6. If a person starts with the 4-dose Twinrix schedule and then needs to switch to monovalent hepatitis B, which intervals should be used for subsequent doses?

   If the person is switched from Twinrix to monovalent hepatitis B vaccine, revert to the monovalent minimum intervals for all doses. If the person has already received two doses of Twinrix using the 4-dose schedule at an interval of 7 days apart, the second hepatitis B dose given as Twinrix will not count using the monovalent schedule. The same principle applies when switching to monovalent hepatitis A vaccine.

HPV

1. Is there a problem if a dose of HPV vaccine is not given within the recommended time frame? Does the series have to be started over?

   No, do not restart the series.  Just pick up where the patient left off and complete the series.  You must observe MINIMUM intervals (4 weeks between HPV1 & HPV2 and 12 weeks between HPV 2 & HPV3) but there are no MAXIMUM intervals between doses. The series must be completed by the woman’s 27th birthday.

2. Should females be screened for sexual activity or pap results before giving HPV vaccine?

   This is not a prerequisite for vaccination. A woman should continue routine pap test and screening following vaccination. These recommendations have not changed with availability of the HPV vaccine.

3. Is the history of an abnormal pap a contraindication to the HPV vaccine series?

   No. Even if a woman was subsequently found to be infected with an HPV strain that is in the vaccine, she could still receive protection from the other 3 strains in the vaccine.

4. What should we do if a woman receives two doses of HPV vaccine and then reports that she is pregnant?

   If a woman is found to be pregnant after initiating the vaccination series, the remainder of the 3-dose regimen should be delayed until after completion of the pregnancy. If a vaccine dose has been administered during pregnancy, no intervention is needed. A vaccine in pregnancy registry has been established; patients or healthcare providers should report any exposure to HPV vaccine during pregnancy (telephone: 800-986-8999).

5. Is it necessary for gay females to receive HPV vaccine?

   Eligibility for HPV vaccine is not determined by sexual preference. The vaccine is recommended for all females 11-12 years of age, and catch-up vaccination for all females 13-26 years of age as long as there are no contraindications (e.g., pregnancy).

   While most HPV transmission occurs with sexual intercourse, the virus can be transmitted through sexual activity that does not involve penetration and rarely can be transmitted through non-sexual routes, e.g. mother to newborn at time of birth.

6. If HPV vaccine is inadvertently administered by the subQ route instead of IM, should we repeat the dose?

   We have no specific published recommendation regarding subQ administration of HPV vaccine. At this time we do not recommend repeating a dose of HPV vaccine administered by the subcutaneous route.

7. What vaccines can be administered at the same time as HPV vaccine?

   HPV vaccine is an inactivated vaccine. Any live or inactivated vaccine can be administered at the same time, http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf (see Table 2 on page 6).

8. If a woman begins the HPV series at 18 years of age through the Vaccines for Children (VFC) Program and will turn 19 before completing the series, should the series be accelerated?

   The routine schedule for HPV vaccine is to administer HPV2 two months after HPV1 and HPV3 four months after HPV2, completing the series in a 6 month period. It is acceptable to accelerate the schedule using the minimum intervals when necessary. The minimum intervals between HPV1 and HPV2 and between HPV2 and HPV3 are 4 and 12 weeks, respectively, allowing the series to be completed in 4 months. If the series cannot be completed within this 4 month accelerated schedule, ACIP does recommend completion of the series for a 19-year-old even though another payment source than VFC may be necessary.

9. If a woman starts the series at 26 years of age and will turn 27 before completing the series, should the series be accelerated, or can the vaccine be given off-label after the 27th birthday?
   
   The series may be accelerated to be completed within 4 months (see question 8). In any case, the series should be completed, using either recommended or minimum intervals, even if this means that the series is completed after a woman turns 27.

Influenza

1. How many doses of influenza vaccine should a 6-month-old child receive?

   This will be the child’s first year of influenza vaccination. The child should receive two 0.25 mL doses of TIV separated by 4 weeks.

2. Is it safe to give LAIV to a child with a cardiac history of a bicuspid aortic valve receiving antibiotics prophylactically prior to dental procedures?

   LAIV contains attenuated viruses, not bacteria; so it is not affected by antibiotics. As long as the child is healthy and has no chronic illnesses and is at least 5 years of age, LAIV can be administered, http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf(page 29).

3. If a child younger than 9 years of age received a single dose of influenza vaccine in one flu season but no vaccine in any subsequent year, should that child receive 1 or 2 doses of vaccine this influenza season?  Does the number of intervening years make any difference?

   A child younger than 9 years of age who received only one dose of influenza vaccine in their first year of influenza vaccination, will need two doses the next year that they receive influenza vaccine, even if there is a gap of years in which the child receives no influenza vaccine – as long as they are still younger than 9 years of age. Example #1: Child younger than 9 years receives one dose of influenza vaccine in year-1, no vaccine in year-2 or year-3. The child returns in year-4 for influenza vaccine and is still younger than 9 years of age. The child needs 2 doses of influenza vaccine because this is the second influenza vaccination year. Example #2: Child younger than 9 years receives one dose of influenza vaccine in year-1, and only one dose of vaccine in year-2. The child returns in year-3 for influenza vaccine and is still younger than 9 years of age. The child needs 1 dose of influenza vaccine because this is the third influenza vaccination year.

4. For children needing two doses of influenza vaccine, can one dose be TIV and the second dose LAIV?

   Yes. There are no published recommendations on this, but we recommend that If TIV is administered first, wait 4 weeks to administer LAIV. If LAIV is given first, wait 6 weeks to administer the TIV dose. Just remember that the child must be healthy and at least 5 years of age to receive LAIV.

5. Is it safe for a breastfeeding mother to receive TIV or LAIV? Is one vaccine preferred over the other?

   A woman who is breastfeeding can receive TIV. She can also receive LAIV as long as she is younger than 50 years of age, healthy and not pregnant. ACIP has not stated a preference for one vaccine over the other, http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf (see page 32) and http://www.cdc.gov/mmwr/PDF/rr/rr5606.pdf (see page 26).

6. When using preservative-free influenza vaccine, is it wise to give 2 of the 0.25mL doses to older children if their parents request a preservative-free influenza vaccine? Our practice usually orders the preservative-containing mulitdose vials for older children.

   This would be a better option than the child not receiving influenza vaccine at all. Do not, however, combine two prefilled syringes into another syringe. You should administer two separate injections at separate sites. We would encourage you to try to educate the parent about thimerosal and the minute amount in influenza vaccine. If you anticipate requests for thimerosal-free vaccine for persons older than 35 months you should consider stocking some 0.5 mL (adult) doses of Fluzone in single dose vials or syringes.

7. When should we start administering influenza vaccine for the 2007-2008 season?

   In general, providers should begin offering vaccination soon after vaccine becomes available – by October, if possible.
   
   Children aged 6 months–8 years who have not been vaccinated previously or who were vaccinated for the first time during the previous season and received only 1 dose should receive 2 doses of vaccine.  These children should receive their first dose as soon after vaccine becomes available as is feasible, so both doses can be administered before the onset of influenza activity.
   
   Persons and institutions planning substantial organized vaccination campaigns (e.g., health departments, occupational health clinics, and community vaccinators) should consider scheduling these events after at least mid-October because the availability of vaccine in any location cannot be ensured consistently in early fall. Scheduling campaigns after mid-October will minimize the need for cancellations because vaccine is unavailable.
   
   These vaccination clinics should be scheduled through December, and later if feasible, with attention to settings that serve children aged 6–59 months, pregnant women, other persons younger than 50 years at increased risk for influenza-related complications, persons aged 50 years of age and older, HCP, and household contacts of children 59 months of age and younger or other persons at high risk. Planners are encouraged to develop the capacity and flexibility to schedule at least one vaccination clinic in December.
   
   When the vaccine is substantially delayed or disease activity has not subsided, agencies should consider offering vaccination clinics into January and beyond as long as vaccine supplies are available. Campaigns using LAIV also may extend into January and beyond.

8. The current LAIV VIS indicates an interval of 6-10 weeks between doses, but the manufacturer has said 4 weeks. Which is correct?

   Both the manufacturer and ACIP recommend at least 6 weeks between two doses of LAIV for children 5 through 8 years of age being vaccinated for the first time .

9. I had a pregnant client who was concerned after reading material that the amount of thimerosol in the flu vaccine delivers a much greater amount to the fetus than to the client receiving the vaccine. Should we recommend that a pregnant client only receive thimerosal-free vaccine?

   There is not a reason to do this. All of the inactivated influenza vaccines (TIV) can be given during pregnancy.

10. Is the physician required to inform parents that the multi-dose vial of influenza vaccine contains thimerosal?

    The federal requirement is to provide the Vaccine Information Statement with each dose of vaccine provided. Providers should consult their agency and state immunization program regarding informed consent requirements. If a parent or patient requests information about specific contents of a vaccine, or if you want to check the composition of a vaccine for a substance to which the patient has a severe allergy, that information is available from several resources including: product package insert; CDC at http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf; and FDA at http://www.fda.gov/cber/vaccine/thimerosal.htm#t1.

11. I am an employee health nurse at a hospital and offer LAIV to employees.  Many employees older than 50 years of age would like to receive LAIV. Is there any chance it will be approved for this age group at any time? 

    We have no indication that LAIV will be FDA approved for persons 50 years of age and older.  These persons should definitely receive TIV unless there is a medical contraindication. If you would like to keep track of vaccine applications that are before FDA for approval, please visit the following website, http://aapredbook.aappublications.org/news/vaccstatus.shtml.

12. If a client is on prophylactic antiviral therapy should influenza vaccine be given in the absence of influenza symptoms?

    Yes, the vaccine will provide season-long protection from influenza infection even after the post-exposure short term risk is over. Antiviral medication will have no effect on inactivated influenza vaccine (TIV). However, live-attenuated influenza vaccine (LAIV) should not be administered until 48 hours after cessation of therapy using antiviral influenza drugs. If feasible, antiviral medication should not be administered for 2 weeks after LAIV administration.

13. Does LAIV impact a PPD the way MMR does?

    The effect of LAIV on a PPD is unknown. However, it is prudent to follow the same guidelines for LAIV as for MMR regarding PPD. If LAIV and PPD cannot be administered on the same day, administer the PPD and defer the dose of LAIV until after the PPD is read. If LAIV is administered first, wait 4 weeks before administering PPD to avoid the risk of a false negative response to the PPD.

14. Will a person who receives influenza vaccine in the U.S. during influenza season and then travels to the Southern Hemisphere during their influenza season be protected?

    A dose of influenza vaccine might provide some protection to a person during travel to the Southern Hemisphere. The amount of protection would depend on the similarity of circulating viruses to those in the vaccine, and how well the person responded to the vaccine. If the person is at increased risk for complications of influenza (65 years or older, underlying medical or risk factors) it would be prudent to receive influenza vaccine upon arrival in the southern hemisphere if the person will be staying for 2 weeks or longer. Southern hemisphere influenza vaccines are not generally available in northern hemisphere countries.

15. Can a person who receives LAIV visit someone in a hospital who is not severely immunosuppressed if the hospital has other patients who are severely immunosuppressed.

    There is no reason to limit visitation to a hospitalized person who is not severely immunosuppressed. The vaccinated person should not visit someone who is severely immunosuppressed for at least 7 days after receiving LAIV. A severely immunosuppressed person is someone who has had their immune system ablated (e.g. bone marrow transplant) and is in protective (reverse) isolation.

16. For a person who receives LAIV and also needs another live vaccine, what is the recommended interval between LAIV and the other live vaccine?

    LAIV can be administered on the same day as other live vaccines. To minimize the potential risk for interference, injectable or nasally administered live vaccines not administered on the same day should be administered at least 4 weeks apart, http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf (page 6).

17. When vaccinating premature infants against influenza, do we vaccinate according to chronological age or do we adjust the age?

    Premature infants should receive influenza vaccine according to chronological age. For more detail on vaccinating premature infants please refer to the ACIP General Recommendations on Immunization, http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf (page 32).

Measles, Mumps, Rubella & Varicella

1. Did I understand that MMR is to be stored in the freezer or was it just MMRV?

   MMRV must be stored in the freezer at 5°F or less at all times.  MMR may be frozen or it may be stored in the refrigerator at 35°-46°F.

2. A local school nurse has a co-worker/teacher who does not want her 7-year-old to get the varicella vaccine because she has been told by her child's doctor that the vaccine contains fetal/embryonic components. Is there any truth to this?

   The virus in varicella-containing vaccines is grown, in part, in fetal tissue obtained in the 1960s from a legally aborted fetus. This tissue is removed during the manufacturing process.

3. Should a child who has had a case of chickenpox prior to the first birthday get the first dose of varicella vaccine at 1 year of age?

   If the child had confirmed varicella disease or if there is laboratory evidence of prior disease, it is not necessary to vaccinate regardless of age at infection.  If there is any doubt that the illness was actually varicella, the child should be vaccinated.

4. Our hospital routinely does lab testing to verify immunity to rubella, rubeola, mumps and varicella.   If our healthcare workers are not immune we immunize.   However, if you are saying that lab tests are not always accurate (potential for false negatives), then what do you recommend for employees who test negative?

   If they have other evidence of immunity, then we recommend you accept that evidence, http://www.cdc.gov/mmwr/PDF/rr/rr4618.pdff (Table 2); http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5522a4.htm?s_cid=mm5522a4_e  (updated evidence of immunity to mumps); http://www.cdc.gov/mmwr/pdf/rr/rr5604.pdf (updated evidence of immunity to varicella).  If not, vaccinate.

5. We are no longer able to purchase MMRV. Do you have any other suggestions, or will another company be manufacturing this vaccine in the future?

   The only company that manufactures and distributes MMRV is Merck. Please review the following information regarding the supply of varicella-containing vaccines, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5618a6.htm?s_cid=mm5618a6_e. This website will be updated as new information becomes available.

6. Why doesn't the ACIP recommend MMRV at twelve to fifteen months with the second dose 3 months later?

                   

   The recommendation at 4-6 years for the 2nd dose of MMR and varicella vaccines (or MMRV) is consistent with current ACIP school entry recommendations. This is as much a programmatic issue as anything.  It is a good time to capture kids before school entry to make sure they are current on all recommended immunizations when exposure risks are very likely to increase. Some providers recommend a routine pediatric visit at 15 months of age. If patients received the first dose of MMRV at 12 months of age, the minimum acceptable interval to the second dose of MMRV is 3 months (12 weeks).

7. Why is MMRV not recommended for persons 13 years of age and older?

   Persons 13 years of age and older were not included in the manufacturer’s clinical trials for this vaccine. Without that data, FDA could not approve use of this vaccine for persons 13 years of age and older.

8. Could you elaborate on making a retrospective diagnosis of varicella disease as acceptable evidence of immunity.

   This is discussed in the ACIP varicella recommendations, http://www.cdc.gov/mmwr/pdf/rr/rr5604.pdf (page 16).

   “Historically, self-reporting of varicella disease by adults or by parents for their children has been considered valid evidence of immunity. The predictive value of a self-reported positive disease history was extremely high in adults in the prevaccine era although data on positive predictive value are lacking in parental reports regarding their children. As disease incidence decreases and the proportion of vaccinated persons with varicella having mild cases increases, varicella will be less readily recognized clinically. A recent study demonstrated that only 75% of unvaccinated children aged 12 months–4 years who reported a positive history of varicella were in fact immune (confirmed by serological testing), compared with 89% of children aged 5–9 years and 10–14 years. To limit the number of false-positive reports and ensure immunity, ACIP recommends that evidence of immunity should be either a diagnosis of varicella by a healthcare provider or a health-care provider verification of a history of disease rather than parental or self-reporting.

   "Verification of history or diagnosis of typical disease can be provided by any healthcare provider (e.g., school or occupational clinic nurse, nurse practitioner, physician assistant, or physician). For persons reporting a history of, or reporting with, atypical or mild cases, assessment by a physician or their designee is recommended, and one of the following should be sought: 1) an epidemiologic link to a typical varicella case to a laboratory-confirmed case or 2) evidence of laboratory confirmation, if it was performed at the time of acute disease. When such documentation is lacking, persons should not be considered as having a valid history of disease because other diseases might mimic mild atypical varicella."

9. I would like to clarify a point from the "Varicella Vaccine Recommendations" slide from the 2007 Immunization Update broadcast, because I think this is going to come up time and again with parents trying to avoid the second dose of varicella vaccine. The third bulleted point states that "2 doses are recommended for all persons older than 4 to 6 years who do not have evidence of varicella immunity." The third bulleted point states that a "Second dose [is] recommended for persons of ANY age who have only received one dose." W ould the phrase "who do not have evidence of varicella immunity" follow this bullet point as well?

   If a person meets any of the definitions of immunity in the new ACIP varicella recommendations, then a 2nd dose is not indicated.  If a person has had breakthrough disease, and the provider is sure it was varicella, then the 2nd dose is not indicated.  However, when in doubt vaccinate, because a dose of vaccine will not harm a person who is already immune.

10. Concerning the new recommendation for a second dose of varicella vaccine, do you recommend that children who received one dose at preschool age ten years ago should get a second dose now?

    Yes. The current recommendation is for two doses regardless of age, for anyone school age and older without evidence of immunity. For everyone whose varicella immunity is based on vaccination, two doses of varicella vaccine are required.

11. A healthcare worker reports having had chickenpox as a child.  The titer results are “equivocal”.  Does this person need 2 doses of varicella vaccine or will one booster dose be acceptable?

    Unless the person meets one of the criteria accepted as evidence of varicella immunity, then two doses of vaccine should be administered, http://www.cdc.gov/mmwr/pdf/rr/rr5604.pdf  (page 16). An equivocal lab result is not acceptable evidence of varicella immunity.

12. If a woman receives only one dose of varicella vaccine before becoming pregnant, should she be screened for varicella during pregnancy?

    No. Just administer a second dose of varicella vaccine in the postpartum period.

13. If a person has received one dose of varicella vaccine and then later develops confirmed breakthrough disease, does the person need a second dose of varicella vaccine?

    No. If you are sure that what the person experienced was varicella disease, then a second dose is not necessary. However, if there is any doubt, vaccinate. It is not harmful to vaccinate a person who is already immune.

14. If a child has a history of shingles before one year of age, should s/he still receive two doses of varicella vaccine at the appropriate ages?

    Varicella vaccine is not necessary if you are certain the child had shingles. However, if there is any doubt, vaccinate. It is not harmful to vaccinate a person who is already immune.

15. Should healthcare personnel avoid immunocompromised patients after receiving varicella vaccine?

    This is not necessary unless the person who was vaccinated develops a rash.

16. What are the varicella immunization recommendations for person born outside the U.S. before 1980?

    If they do not meet one of the other evidences of varicella immunity, then they should receive two doses of varicella vaccine at the age-appropriate intervals. Evidence of varicella immunity is defined in the ACIP varicella recommendations, http://www.cdc.gov/mmwr/pdf/rr/rr5604.pdf (page 16).

17. We are having trouble getting varicella vaccine. What should we do regarding school entry requirements?

    Production of Varicella Zoster Virus (VZV) bulk has been temporarily suspended due to low yields. VZV bulk is used to manufacture varicella vaccine, MMRV vaccine, and zoster vaccine. Stocks of MMRV have been depleted as of June 15, 2007. Current projections are for adequate supply to fully implement the recommended immunization schedule for varicella vaccine for all age groups and for the recommended use of zoster vaccine. Updates will be provided when available at http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm. You should consult your state immunization program. A short-term deferral would seem reasonable if vaccine is not available to meet school entry requirements, but maintaining a deferral list with a recall system in place for these students as soon as vaccine is available will be necessary.

Rotavirus

1. We have an infant who received rotavirus dose 1 at 10 weeks of age. The child now presents at 6 months of age. We want to give rotavirus dose 2 now and rotavirus dose 3 four weeks later before the child is too old to receive the vaccine. But is it too late since more than 10 weeks have elapsed since the first dose? The package insert says the interval between doses should be 4-10 weeks.

   Several providers have been confused by this language in the package insert. As long as the doses are separated from each other by at least 4 weeks, you are not violating the minimum intervals. ACIP has not defined maximum intervals for doses of rotavirus vaccine.

2. What is the difference between Rotashield and RotaTeq vaccines?

   Rotashield was the first rotavirus vaccine licensed in the U.S. in 1998.

   This vaccine contained a rhesus monkey parent strain with genes that expressed an antigen for the predominant serotypes of human rotavirus. Rotashield protected against 3 strains of rotavirus. This vaccine was withdrawn from the U.S. market within one year of its introduction because of its association with intussusception.

   RotaTeq is the second rotavirus vaccine manufactured by a different pharmaceutical company and licensed in the U.S. in 2006. This rotavirus vaccine contains 5 strains of live rotavirus developed from human and bovine rotavirus strains.

3. Are there studies documenting the difference in rates of rotavirus in infants exclusively breastfed vs. those who are not?

   There is evidence that breastfeeding reduces the incidence of symptomatic rotavirus infection ( J Hosp Infect. 2002 Jan;50(1):13-7). There is also evidence that breastfeeding reduces the risk of hospitalization due to rotavirus gastroenteritis among children younger than 6 months of age ( Pediatr Infect Dis J. 2006 Dec;25(12):1123-31).

4. What are recommendations for cleaning up rotavirus vaccine that is regurgitated by an infant or spilled by the provider?  Does the dose need to be repeated?

   There are no specific recommendations for cleanup.  It would seem reasonable to treat any cloth/tissue used for cleanup as medical waste and dispose of it in a biohazard container.  ACIP does have recommendations regarding completion of the vaccine series.  The dose should NOT be repeated.  You should document what happened and that the dose was administered. Then at the appropriate interval, complete the series with remaining dose(s), http://www.cdc.gov/mmwr/PDF/rr/rr5512.pdf (page 9).

5. Are there any recommendations for administering rotavirus vaccine to children who are NPO with G-tubes, J-tubes, etc?

   Neither ACIP or AAP address this. We can't think of a reason why the vaccine could not be administered via a gastric tube. You should follow the routine procedure for administering any medication via a tube and receive approval from the infant’s primary healthcare provider or gastroenterologist (if applicable).

6. Would you please clarify the definition of the maximum ages for doses of rotavirus vaccine?

   A child is 12 weeks old until his or her 13th week birthday. A child is 32 weeks old until the 33rd week birthday.

7. Our experience has been that most, if not all, of the babies to whom we've given this vaccine spit most, if not all, of this liquid vaccine out.  We know not to give them more but how can we be sure that what little they might have ingested will be enough?

   The only thing we can offer you is to try to follow general guidelines for oral administration.  First of all, give this vaccine first while the baby is still happy before you administer injections or perform other procedures.  You should also make every effort to administer the liquid down one side toward the back of the child's mouth, but don't go so far back that you would gag the child.

   You may find the following resource helpful: https://www.merckvaccines.com/rotateqProductPage_frmst.html. Click on “Dosage and Administration” and scroll down for an educational video on administration.

8. If a child received the 1st dose of rotavirus vaccine at 2 months of age and reports to clinic at 31 weeks of age, should the child be given a 2nd and last dose at that time? How much immunity does this provide the child compared with only receiving only one dose?

   We do not know how much immunity is conferred with a partial series of one or two doses. However we recommend you give as much of the 3-dose series as you can before the child is 33 weeks of age. It seems reasonable to think that one or two doses would be better than none.

9. Can the 4-day grace period be applied to the minimum interval of 4 weeks between rotavirus doses?

   Yes, it can be used if absolutely necessary. The 4-day grace period can be applied to any interval between doses of the same vaccine that are indicated in Table 1 (Minimum Ages and Minimum Intervals) in the ACIP General Recommendations on Immunization, http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf (page 3).

10. How many infants in the control group of the rotavirus clinical trials developed a rotavirus infection, regardless of whether they had intussusception or not?

    Information regarding the incidence of rotavirus disease in the placebo group is described in detail in the ACIP rotavirus recommendations, http://www.cdc.gov/mmwr/PDF/rr/rr5512.pdf (page 5-6).

Tdap

1. After an adult has either been infected with or exposed to pertussis, is vaccination with Adacel recommended, and if so when?

   Yes. Adults who have a history of pertussis disease generally should receive Tdap according to the routine recommendation. This practice is recommended because the duration of protection induced by pertussis is unknown (waning might begin as early as 7 years after infection) and because diagnosis of pertussis can be difficult to confirm, particularly with tests other than culture for B. pertussis. Administering pertussis vaccine to persons with a history of pertussis presents no theoretical risk. http://www.cdc.gov/mmwr/PDF/rr/rr5517.pdf(pages 24-25).

2. We have heard multiple discussions regarding a child who received a dose of Td due to an injury but still needs a Tdap booster for entry into middle school. We’ve heard its ok to administer the Tdap 2 years after the Td and then other literature states 5 years. Would you please clarify this for us?

   This situation is discussed in the adolescent Tdap ACIP recommendations, http://www.cdc.gov/mmwr/PDF/rr/rr5503.pdf (page 22).

   "Adolescents aged 11–18 years who received Td, but not Tdap, are encouraged to receive a single dose of Tdap to provide protection against pertussis if they have completed the recommended childhood DTP/DTaP vaccination series. An interval of at least 5 years between Td and Tdap is encouraged to reduce the risk for local and systemic reactions after Tdap vaccination. However, an interval less than 5 years between Td and Tdap can be used. The benefit of using Tdap at a shorter interval to protect against pertussis generally outweighs the risk for local and systemic reactions after vaccination in settings with increased risk for pertussis or its complications. . . "

   ACIP has not defined an absolute minimum interval between Td and Tdap. If the adolescent has close contact with an infant younger than 12 months of age or there is a pertussis outbreak, then Tdap can be administered regardless of the interval since the last Td, because the risk of pertussis infection/transmission is greater than the risk of a sore arm. This is a decision that must be made by the clinician on a case-by-case basis.

3. Sometimes we see swelling at the site of injection when giving Td. Will giving Tdap before a five year interval increase the incidence of swelling?

   It is possible when tetanus- and diphtheria-containing vaccines are given close together for the person to experience an increased local reaction (redness, tenderness, and swelling) at the site of injection. However, it is a risk benefit situation. If there is a risk of pertussis infection or transmission, then it would seem that the benefit of vaccination against pertussis would outweigh the potential for a sore arm.

4. If a child received DT instead of DTaP, should the child receive Td or Tdap?

   It depends on why the child did not receive DTaP. Not all of the contraindications and precautions for DTaP are the same for Tdap. Please review the ACIP's recommendations for this situation, http://www.cdc.gov/mmwr/PDF/rr/rr5503.pdf (pages 23-24).

5. If a pregnant woman must get a dose of Td during pregnancy, how soon can she get her postpartum dose of Tdap?

   The mother is taking home an infant who is susceptible to pertussis, so she should receive Tdap during the postpartum period, e.g., before discharge.  There is no minimum interval between Td and Tdap.

6. If a 10-year-old presents with an injury and tetanus prophylaxis is indicated can Adacel be given?

   Tdap can be used in place of Td if wound prophylaxis is indicated for a 10-year-old. However, Adacel is not FDA approved for use until 11 years of age. For a 10-year-old, you should use Boostrix.

7. Three siblings were brought to the clinic. One of them, a 7 year 1 month old girl, was given DTaP instead of Td. What counseling would you advise for this child and mother?

   Pediatric DTaP is not indicated for persons aged 7 Years of age or older; the increased diphtheria toxoid content is associated with higher rates of adverse reactions in older persons. Guidance on the best approach to vaccination following inadvertent administration of pediatric DTaP is based primarily on expert opinion. The family should be informed, and a VAERS report should be filed regardless of whether or not an adverse reaction occured. This dose can be counted as the adolescent Tdap dose, or the child can later receive an adolescent booster dose of Tdap, http://www.cdc.gov/mmwr/PDF/rr/rr5503.pdf (see page 27, section 3-J).

   Every effort should be taken to prevent medication errors in the future. You may want to consider posting this flyer in your clinic, http://www.dhs.ca.gov/ps/dcdc/izgroup/pdf/IMM-508.pdf.

8. What if a person never received the DTaP series as a child, but as an adult has received Td every 10 years – is this person protected against tetanus?

   The adult Td series consists of three doses with minimum intervals of 0, 1, and 6 months.  If this patient has had 3 doses with at least these intervals, their primary series is complete and they are considered protected as long as a booster is given every 10 years (5 years if wound prophylaxis is needed). If the person is younger than 65 years of age, the next booster should be Tdap instead of Td.

9. Can a booster dose of Tdap be given to persons 65 years of age and older?

   No brand of Tdap is approved for persons 65 years of age or older. ACIP does not recommend off-label use of Tdap for this age group. However, a clinician may choose to administer Tdap to a person 65 years of age or older if they agree that the benefit of Tdap outweighs the risk of a local adverse event.

10. Tdap is approved through 64 yrs of age. Should the recommendation of a booster every 10 yrs be recommended for persons older than 64 yrs?

    All persons, including persons 65 years of age and older, should receive a Td booster every 10 years throughout life. For adults younger than 65, their next routine Td booster should be replaced with a dose of Tdap dose unless they have already received a Tdap dose.

11. Can a pregnant woman receive a primary series of Td, and use Tdap?

    If a pregnant woman has no evidence of tetanus immunity, she can receive two doses of Td 4 weeks apart. In this situation, unless there is an imminent risk of pertussis, ACIP recommends administering the Tdap dose during the postpartum period with a minimum interval of 6 calendar months between the second Td and the Tdap dose. Administering one dose of Tdap as part of the 3-dose primary series is an off-label ACIP recommendation.

12. If a woman is trying to get pregnant, should the recommended dose of Tdap be administered or should it be delayed until the postpartum period?

    We recommend that you administer the Tdap dose before pregnancy.

13. What are the recommendations for vaccinating breastfeeding women with Tdap?

    Tdap may be administered to a woman who is breastfeeding. For further information on vaccination of breastfeeding/lactating women, please review the information at, http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf (page 32).

Zoster

1. If a person with shingles comes in contact with a person who is susceptible to varicella, what is the risk to the susceptible person of developing varicella, and what is the transmission route?  

   A person with shingles can can transmit varicella virus to someone who is susceptible to varicella.  The varicella zoster virus is transmitted by direct contact with the rash. The person exposed would develop chickenpox, not shingles. The virus is not spread through sneezing, coughing or casual contact. A person with shingles can spread the disease when the rash is in the blister-phase. Once the rash has developed crusts, the person is no longer contagious. A person is not infectious before blisters appear or with post-herpetic neuralgia (pain after the rash is gone).

2. A 60-year-old man has no history of chickenpox, but he was born in the U.S. before 1980. This makes him eligible for zoster vaccine according to the ACIP guidelines. If he receives zoster vaccine and truly had no prior exposure to varicella, would his immune system develop protection from both varicella and shingles?

   There are no data regarding the administration of zoster vaccine to a person who has not had chickenpox. However, it is reasonable to assume that zoster vaccine administered to a susceptible person would produce immunity to varicella the same as single antigen varicella vaccine would.

3. In the situation above, would it be more prudent to give two doses of varicella vaccine instead of zoster vaccine?

   ACIP recommends that you accept birth before 1980 in the U.S. as evidence of immunity (except for healthcare personnel, immunocompromised persons, and pregnant women) and administer zoster vaccine. 

4. In the situation above, if two doses of varicella vaccine were administered, would the person need to receive zoster vaccine in the future? If so, what would the interval be?   

   If a person’s varicella immunity is based on vaccination, zoster vaccine is not indicated.

5. When reconstituted, the volume of zoster vaccine is 0.65 mL. Should 0.65 mL or 0.5 mL be administered? Since the same diluent is used for MMR, varicella vaccine, and MMRV vaccine, do we administer 0.65 mL or 0.5 mL for each of these vaccines?

   Follow reconstitution and dose amounts indicated in the product package insert. The prescribed dose for zoster vaccine is 0.65 mL; for MMR, varicella vaccine, and MMRV vaccine the dose is 0.5 mL. These documents are included with each product shipment.

6. An eighty-year-old woman came to our clinic for zoster vaccine.  During discussion, we discovered she had been exposed to shingles by her daughter-in-law but had no recollection of ever having chickenpox herself.  After much debate among the clinic nurses and finally a telephone call to the client’s physician, we decided to vaccinate her with varicella vaccine rather than zoster vaccine. Was this correct, or should we have assumed her to be immune to chickenpox and given her zoster vaccine? 

   ACIP recommends that clinicians accept birth in the U.S. before 1980 as evidence of varicella immunity for everyone except immunocompromised persons, healthcare personnel, and pregnant women.

7. In the situation above, do we complete the varicella vaccine series with the second dose or administer a dose of zoster vaccine? If we give a second dose of varicella vaccine, when can this person receive zoster vaccine?

   The person should be assumed to have had chickenpox because of her age. The dose of single antigen varicella vaccine will not reduce the person’s risk for zoster. Zoster vaccine should be administered at the next visit rather than a second dose of single antigen varicella vaccine.

8. Is there an upper age limit for receipt of the zoster vaccine?  Local providers are reluctant to give zoster vaccine to persons 80+ years of age.  What educational resource would you suggest using to encourage use of zoster vaccine with older adults?  

   There is no upper age limit for zoster vaccine.  The incidence of herpes zoster increases with age.  It is known that about 50% of persons living until age 85 years will develop zoster.  When the ACIP recommendations are published, there will most likely be more information about the risks and incidence of zoster.

9. A patient at my pharmacy was diagnosed with shingles five months ago, and had a very severe case, including Ramsay Hunt Syndrome, http://www.nlm.nih.gov/medlineplus/ency/article/001647.htm.  She still has some symptoms, such as dizziness.  Her physician would like her to receive the zoster vaccine from our pharmacy, and the patient would also like to receive the vaccine to prevent recurrence.  Our question is, how long after having shingles should you wait to vaccinate the patient, and can we vaccinate this patient now, even though she still has some symptoms?

   Any vaccine should be delayed during a moderate to severe illness until symptoms abate. In the absence of acute illness, there is no minimum waiting period between a case of shingles and administration of zoster vaccine.

10. If a person older than 60 years has had zoster with herpetic neuralgia ophthalmic complications, when can they receive the zoster vaccine? They are no longer acutely ill with it but have long-term complications.

    Once acute illness has abated, the vaccine can be administered. There is no evidence that the vaccine will have any therapeutic effect for a person with postherpetic neuralgia.

11. People are picking up zoster vaccine at a local pharmacy and transporting it to the physician’s office to be given.  Should this vaccine be given?  

    Zoster vaccine must be stored at freezer temperature at all times. If the vaccine has been out of the freezer for more than 30 minutes it should not be used.

12. Were the zoster vaccine studies done on nursing home patients? What do you think about zoster vaccine to nursing home patients? Should healthcare personnel in nursing homes be tested to see if they had chickenpox before taking care of someone who has received zoster vaccine?

    Zoster vaccine can be administered to anyone 60 years and older without a contraindication to vaccination regardless of where they reside. All healthcare personnel should ensure that they are immune to varicella regardless of the setting in which they work and regardless of whether patients receive zoster vaccine.

13. A 55-year-old patient who had a mild case of chickenpox as a child had a bad case of shingles 3 years ago. She has requested zoster vaccine and we would like to give it to her. What do you advise?

    FDA has not approved zoster vaccine for anyone younger than 60 years of age and ACIP has not made an off-label recommendation for this situation.

14. Do zoster and varicella vaccines offer crossover protection against herpes simplex?

    No. Zoster and varicella vaccines offer protection only against varicella zoster virus.

15. Would a dose of zoster vaccine provide healthcare personnel 60 years of age or older valid evidence of varicella immunity?

    Being 60 years of age or older (birth in the U.S. before 1980) is not acceptable evidence of varicella immunity for healthcare personnel. If a healthcare person does not meet one of the other criteria for varicella immunity, two doses of varicella vaccine separated by 4 weeks should be administered, http://www.cdc.gov/mmwr/pdf/rr/rr5604.pdf (page 16). A dose of zoster vaccine can be counted as one of the two doses.

16. If zoster vaccine is not indicated for persons whose varicella immunity is based vaccination, will these recommendations change with time as all these vaccinated persons age and approach 60?

    We cannot project what revisions might be made regarding the use of zoster vaccine in the future.

17. Do patients who received the varicella vaccine have the same risk of developing zoster as someone who had chickenpox?

    The risk of zoster following vaccination appears to be lower than the risk of zoster following infection with wild-type varicella virus. The majority of reported zoster cases following varicella vaccination have been mild and have not been associated with complications like postherpetic neuralgia.

Vaccine Information Statements

1. Do Vaccine Information Statements (VISs) exist for immune globulin products?

   No. VISs exist only for vaccines.

2. When using VISs, is a parent/guardian signature required for all doses?

   No. There is no federal requirement for signed consent for any dose of vaccine. The federal requirement is to provide the patient or parent/legal representative with the appropriate VIS for each dose of vaccine administered and to document the date the VIS is provided and the edition date of the VIS in the patient’s medical record. Some agencies and/or state immunization programs do have signed consent requirements.

Miscellaneous

1. How can I get a copy of the General Recommendations on Immunization 2006 for our practice?

   You can download a copy at http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdfor order a copy at https://www2a.cdc.gov/nchstp_od/PIWeb/niporderform.asp (item #00-6430).

2. Would you please provide a list of vaccines that contain preservatives, e.g. thimerosal? This question comes up very frequently.

   Please refer to the following resources

   http://www.fda.gov/cber/vaccine/thimerosal.htm,

   http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-1.pdf , and

   http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf.

3. What should the interval be between the following adolescent vaccines if they are not all administered on the same day; Tdap, MCV4, HPV, Hep A, Var?

   There is no recommended interval between inactivated vaccines or inactivated and live vaccines (only two or more live vaccines).  The vaccines you list may be given at any time in relation to each other.  Please refer to the ACIP General Recommendations on Immunization, http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf  (see Table 2, page 6).

4. Many adolescents immigrating to the United States come to our clinic for vaccines.  Some of these adolescents did not bring vaccine records with them so we need to revaccinatee them.  We do not want to have missed opportunities, but they may need nine vaccines, including six intramuscular injections (Td, Hep A, Hep B, MCV4, HPV, and influenza).  In prior broadcasts you have stated that two 2 IM injections can be administered per site and they should be at least one inch apart.  Do you have any recommendations on how to get these six IM vaccines administered in one visit?  If two of the vaccines need to be deferred, which two would you recommend?

   We agree that 9 injections are a lot for one visit, and we would not recommend administering more than two IM injections in each deltoid.  You do have the option of administering additional IM injections in the anterolateral thigh, but there are better options:
   • New recommendations call for all immigrants to be tested for hepatitis B.  We think you should also test for hepatitis A.  So both these vaccines can be deferred.
   • Influenza vaccine could also wait if necessary.
   • Tdap, MCV, and HPV are the priority and can be given at the same time as subQ injections (IPV, MMR, and varicella).
   It is also a good idea to have these patients sit during administration and wait about 15-20 minutes in the clinic after vaccination because of the risk of syncope, http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf  (page 19).

5. During a recent program on vaccines and how expensive they are, several experts stated that underinsured children do not qualify for VFC. Please explain.

   Children 18 years of age and younger who meet at least one of the following criteria are eligible for VFC vaccine:

   • Medicaid eligible - a child who is eligible for the Medicaid program (in some states, children younger than 1 year of age are automatically entitled to Medicaid benefits, if their mother is enrolled).

   • Uninsured - a child who has no health insurance coverage.

   • American Indian or Alaska Native - as defined by the Indian Health Services Act.

   • Underinsured - a child whose health insurance benefit plan does not include vaccinations. Underinsured children are eligible to receive VFC vaccine only if they are served by a Federally Qualified Health Center (FQHC) or Rural Health Clinic (RHC).

   Underinsured children are defined as those children who have health insurance but coverage does not include vaccines. Children whose health insurance cover only select vaccines or caps the vaccine cost at a certain limit are also categorized as underinsured; thus only eligible for VFC program benefits at an FQHC or RHC.

   Some states provide supplemental funds to include underinsured children in their program. For more information on the Vaccines for Children Program (VFC), please visit the following website, http://www.cdc.gov/vaccines/programs/vfc/default.htm.

6. What is the recommendation for use of combination vaccines? Some parents have concerns about their safety.

   To minimize the number of injections children receive, combination vaccines should be used, if licensed and indicated for the patient’s age.

7. What is the difference between recommended and required vaccines?

   Recommendations: CDC’s Advisory Committee on Immunization Practices (ACIP) makes recommendations for the use of vaccines in the U.S. These recommendations are published annually on the childhood/adolescent and adult immunization schedules and in CDC’s Morbidity and Mortality Weekly Report (MMWR).
   Requirements: Each state mandates which vaccines are required for day care and school entry. Many colleges/universities and healthcare institutions also have immunization requirements. Finally, the federal government does have immunization requirements for immigrants and refugees entering the U.S.

8. What are the guidelines for revaccination with meningococcal conjugate vaccine (MCV) if a child has previously received meningococcal polysaccharide vaccine (MPSV)?

   ACIP addressed this situation in their 2005 meningococcal recommendations, http://www.cdc.gov/mmwr/PDF/rr/rr5407.pdf (page 15). Children should receive the recommended dose of MCV between the ages of 11-18 years once 5 years have elapsed since the MPSV dose. If a high-risk situation exists, the child can receive the MCV dose sooner as long as at least 2-3 years have elapsed since the MPSV dose. There are no recommendations for revaccination following a dose of MCV.

9. For minors without obtainable immunization records, what do you recommend for catch-up vaccination?

   We would recommend that you review guidelines in the ACIP General Recommendations on Immunization for persons vaccinated outside the U.S., http://www.cdc.gov/mmwr/PDF/rr/rr5515.pdf (pages 33-35) and then use the age-appropriate catch-up schedule, http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2007/child-schedule-color-print.pdf (page 3), to assist in scheduling the necessary immunizations.

10. Please specify the ages Pediarix can be used?

    As long as Pediarix is being used for any of the first 3 doses of hepatitis B, IPV, and DTaP, it can be used for children 6 weeks through 6 years of age. Pediarix should NOT be used for the following: 1) hepatitis B birth dose; 2) IPV dose #4; 3) DTaP doses #4 & #5; or 4) any child 7 years of age or older.

 

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