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Immunization Action Coalition
Ask the Experts
As appeared in the August 2010 issue of Needle Tips
Click here for PDF version
Vaccine questions
Q:

When a vaccine vial is new and the cap has just been removed, is the rubber stopper sterile, or should it be cleansed with alcohol before inserting the needle?

A:  

The rubber stopper is not sterile. When you remove the protective cap from a vaccine or diluent vial, you should always clean the stopper with an alcohol wipe. This practice is covered in CDC's online vaccine storage and handling toolkit. To access the kit, go to www2a.cdc.gov/vaccines/ed/shtoolkit.

 
Q:

We're glad that CDC has made a universal influenza vaccination recommendation to vaccinate everyone 6 months and older. Would you tell us how this came about?

A:  

Prior to the 2010–11 vaccination season, only children ages 6 months through 18 years and adults age 50 years and older were universally recommended for vaccination; recommendations for adults ages 19 through 49 years were targeted to people with specific risk factors, although other adults could be vaccinated if they wanted protection. Collectively, these targeted risk groups made up 85% of the U.S. population. During the 2009 H1N1 outbreak, additional risk groups were identified, such as obese individuals. The new universal vaccination recommendation simplifies previous recommendations, making it easier for healthcare providers to determine whom to vaccinate. The new recommendation also makes it easier for patients to remember to get vaccinated every year.

 
Q:

Will there be enough influenza vaccine to reach all people ages 6 months and older who want to be protected?

A:  

Supplies will be ample and there will likely be enough vaccine available to protect any person seeking vaccination. Vaccine manufacturers have projected supplies at around 165 million doses for the 2010–11 vaccination season. This is a significant increase in the number of doses of seasonal vaccine compared with any previous year. It should be noted that in the past, vaccine has consistently been left over at the end of each influenza season.

 
Q:

Can we give 2010–11 influenza vaccine to patients who report they were recently vaccinated with 2009 H1N1 vaccine?

A:  

Yes, but you will have to observe a minimum interval of 4 weeks between the time the patient received 2009 H1N1 and the time you administer 2010–11 vaccine, regardless if the 2009 H1N1 dose was injectable or nasal-spray vaccine.

 
Q:

Which of our pediatric patients will need 2 doses of influenza vaccine for the 2010–11 vaccination season?

A:  

Whether you give injectable vaccine or nasal-spray vaccine or one of each, give 2 doses separated by at least 4 weeks to all children ages 6 months through 8 years who (1) are receiving influenza vaccine for the first time; (2) received their first dose of seasonal vaccine during the 2009–10 season but failed to get their second dose; or (3) failed to get at least 1 dose of 2009 H1N1 vaccine, regardless of their previous influenza vaccination history. If there is uncertainty about the previous season's vaccination history, give 2 doses this season to any child age 6 months through 8 years. CDC has developed a flow chart to aid in making the decision based on the child's previous vaccination history (see www.cdc.gov/vaccines/ed/imzupdate/downloads/doses-algorithm.pdf). The chart at the bottom of this page provides a different format of the information in the flow chart.

 
Q:

What is the appropriate month to begin vaccinating patients against influenza?

A:  

You can begin offering vaccine as soon as it becomes available, which is usually mid-to-late summer.

 
Q:

We have heard that ACIP advises waiting until October before vaccinating residents of long-term care facilities because of concern that vaccinating them before October will cause antibodies to wane, which could result in insufficient protection when the disease hits the community later in the influenza season. Is this correct?

A:  

ACIP no longer advises this. It made this recommendation in the past, but removed it from the influenza recommendations in 2007 because of lack of evidence. Therefore, you should begin vaccinating everyone, including residents of long-term care facilities as soon as vaccine becomes available. A literature review of 14 studies that examined this issue is available at www.immunize.org/journalarticles/skowronski_21508.pdf.

 
Q:

Please review which healthcare workers (HCWs) can be given the intranasal live attenuated influenza vaccine (LAIV) and which cannot.

A:  

LAIV can be administered to all HCWs for whom it is indicated based on age and health history—except to those who care for severely immunocompromised patients in a protective environment (typically defined as a specialized patient-care area with a positive airflow relative to the corridor, high-efficiency particulate air filtration, and frequent air changes). Despite the clarity of this strong recommendation, we have heard that some healthcare facilities erroneously take extreme measures to protect ALL patients from exposure to someone recently vaccinated with LAIV. Some even restrict visitors from seeing hospitalized patients, allowing only people vaccinated with injectable trivalent inactivated influenza vaccine (TIV) to visit. CDC addressed this issue in the recommendations for use of the 2010–11 influenza vaccine as follows: "Concerns about the theoretic risk posed by transmission of live attenuated vaccine viruses contained in LAIV to patients should not be used to justify preferential use of TIV in healthcare settings other than inpatient units that house severely immunocompromised patients requiring protective environments. Some healthcare facilities might choose to not restrict use of LAIV in close contacts of severely immunocompromised persons, based on the lack of evidence for transmission in healthcare settings since [LAIV's] licensure in 2004." To read more on this topic, see pages 35–37 of "Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices [ACIP], 2010" MMWR 2010; 59(No. RR-8):35–37 at www.cdc.gov/mmwr/PDF/rr/rr5908.pdf.

 
Q:

Which influenza vaccine products can we use in children and which in adults?

A:  

Many influenza vaccine products are available for vaccinating children during the 2010–11 influenza vaccination season: Afluria (CSL Laboratories, distributed by Merck); Fluarix (GlaxoSmithKline [GSK]); FluMist (MedImmune); Fluvirin (Novartis); and Fluzone (sanofi pasteur). You can use any of these vaccines in adults, as well as FluLaval (ID Biomedical Corp, distributed by GSK), Agriflu (Novartis), and Fluzone High-Dose (sanofi pasteur). On page 7 of this issue of Needle Tips you'll find a chart that lists all the available influenza vaccines for the 2010–11 vaccination season and simple instructions for administering them. You can also access the chart at www.immunize.org/catg.d/p4072.pdf.

 
Q:
We've heard that ACIP has limited the use of one of the influenza vaccine products for children. Is that true?
A:  

Yes. You are referring to Afluria, which is manufactured in Australia by CSL Laboratories for the U.S. market. CSL's 2010 Southern Hemisphere influenza vaccine (Fluvax and Fluvax Junior) has been associated with increased post-marketing reports of fever and febrile seizures in children predominantly younger than age 5 years as compared with previous years. For this reason, on August 5, ACIP recommended that Afluria, 0.5 mL, licensed for use in people age 36 months and older, not be used in children younger than age 9 years. ACIP further recommended that Afluria could be administered to children ages 5 through 8 years who are at high risk for influenza complications if there is no other age-appropriate trivalent inactivated influenza vaccine (TIV; injectable) available, after risks and benefits of using this vaccine in this age group have been discussed with the parent or guardian. The vaccine should not be given to children younger than age 5 years. For detailed information, go to www.cdc.gov/mmwr/pdf/wk/mm5931.pdf, and see pages 989–92.

 
Q:
We have pre-ordered Afluria but now need to find other vaccine for pediatric patients ages 6 months through 8 years. What should we do?
A:  

Several other products licensed for use in children are displayed on the chart on page 7 of this issue. If you don't have a regular supplier for influenza vaccine, you may want to check a listing of influenza vaccine distributors that have vaccine in stock or on order by going to www.preventinfluenza.org/ivats/ivats_10_11.pdf. The National Influenza Vaccine Summit maintains this list and updates it periodically; check back weekly if you don't find a vaccine on the list that you can use.

 
Q:
Is it okay to draw up vaccine into syringes at the beginning of the day? If it isn't, how much in advance can this be done?
A:  

CDC discourages the practice of prefilling vaccine into syringes for several reasons, including

the increased possibility of administration and dosing errors,
the increased risk of inappropriate storage,
the probability of bacterial contamination since the syringe will not contain a bacteriostatic agent, and
the probability of reducing the vaccine's potency over time because of its interaction with the plastic syringe components.
Prefilling vaccine into syringes also violates basic medication administration guidelines, which state that an individual should administer only those medications he or she has prepared and drawn up.
Although pre-drawing vaccine is discouraged, a limited amount of vaccine may be pre-drawn in a mass-immunization clinic setting under the following conditions:
only a single type of vaccine (e.g., influenza) is administered at the mass-immunization clinic setting,
vaccine is not drawn up in advance of its arrival at the mass-vaccination clinic site,
these pre-drawn syringes are stored at temperatures appropriate for the vaccine they hold,
no more than 1 vial or 10 doses (whichever is greater) is drawn into syringes, and
clinic staff monitor patient flow carefully and avoid drawing up unnecessary doses or delaying administration of pre-drawn doses.
At the end of the clinic day, any remaining vaccine in syringes prefilled by staff should be discarded.
 
Q:
Later on in influenza season, if a patient isn't sure if they received a dose of influenza vaccine and there is no way to check, should we assume they didn't receive it and give them a dose?
A:  

Yes.

 
Q:
I understand that a prior history of Guillain-Barré syndrome (GBS) is no longer a precaution for giving meningococcal conjugate vaccine (MCV4). Please tell me more about this.
A:  

A history of GBS had previously been a precaution for Menactra MCV4 vaccine (sanofi pasteur). Findings from two studies that examined more than 2 million doses of Menactra given since 2005 showed no evidence of an increased risk of GBS. Consequently, ACIP voted in June 2010 to remove the precaution for use of Menactra in people with a history of GBS. This precaution did not apply to Menveo (Novartis) or Menomune (sanofi pasteur) vaccines.

 
Q:
If a healthcare worker (HCW) receives tetanus-diphtheria-acellular pertussis (Tdap) vaccine and is then exposed to someone with pertussis, do you treat the vaccinated HCW with prophylactic antibiotics or consider them immune to pertussis?
A:  

You should follow the post-exposure prophylaxis protocol for pertussis exposure recommended by CDC (www.cdc.gov/vaccines/pubs/pertussis-guide/guide.htm). Research is needed to evaluate the effectiveness of Tdap to prevent pertussis in healthcare settings. Until studies define the optimal management of exposed vaccinated healthcare personnel, or experts arrive at consensus, healthcare facilities should continue post-exposure prophylaxis protocol for vaccinated HCWs who are exposed to pertussis.

 
Q:
As a pediatrician, I am concerned about protecting my newborn patients from pertussis, especially given the recent outbreak in California where 7 infants have died. How many doses of pediatric diphtheria-tetanus-acellular pertussis (DTaP) vaccine does an infant need before she or he is protected from pertussis?
A:  

Vaccine efficacy is 80%–85% following 3 doses of DTaP vaccine. Efficacy data following just 1 or 2 doses are lacking but are likely lower. Therefore, it is especially important that you advise parents of infants that all people who live with the infant or who provide care to him or her be protected against pertussis. Recommend that all the infant's family members and visitors ages 10 through 64 years receive a one-time dose of adolescent/adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine if they have not already done so.

 
Q:

Tdap vaccine is licensed for use only in people ages 10–64 years. Are there exceptions for healthcare professionals or grandparents older than age 64 who are in contact with infants?

A:  

ACIP has not recommended off-label use of Tdap for adults age 65 years and older. However, there is no reason to believe that Tdap is any less safe for people age 65 years and older than it is for younger adults. Clinicians are always free to use their clinical judgment; they may decide that in this situation the benefit of administering Tdap off-label exceeds any hypothetical risk of giving the vaccine.

 
Q:
We have a 16-year-old patient who received tetanus-diphtheria (Td) vaccine in the emergency room after a nail puncture a year ago. Can we give him Tdap vaccine now?
A:  

No minimum interval is required between giving doses of Td and Tdap to an adolescent who is or might be in contact with an infant. This includes adolescents who are older siblings of infants, babysitters, hospital employees or volunteers, etc. In circumstances like this, give Tdap without delay. For adolescents who will not be in contact with infants, CDC/ACIP recommends a routine wait of 5 years between Td and Tdap administration unless a school vaccination mandate requires giving Tdap.

 
Q:
How would I follow up with a new healthcare worker (HCW) who has 2 documented doses of measles-mumps-rubella (MMR) vaccine but whose serologic testing doesn't show immunity to one of these diseases?
A:  

Two documented doses of MMR vaccine is considered proof of immunity according to ACIP. However, what ACIP recommends is not always what schools and institutions accept. Here are some basics about MMR vaccination and healthcare personnel.

1.
ACIP considers receipt of 2 documented doses of MMR vaccine, given on or after the first birthday and separated by at least 28 days, to be proof of immunity to measles, mumps, and rubella. No serologic testing is required or recommended to confirm immunity in this instance.
2.
If a HCW does not have any documented doses of MMR, he or she can (1) be tested for immunity or (2) just be given 2 doses of MMR at least 4 weeks apart. If the testing option is used, and the test indicates that the HCW is not immune to one or more of the vaccine components, the HCW should receive 2 doses of MMR at least 4 weeks apart. Note that a test finding of an "indeterminate" or "equivocal" level of immunity indicates that a HCW who lacks 2 documented doses of MMR vaccine be considered nonimmune. Also note, that ACIP does not recommend serologic testing after vaccination.
3.
ACIP does not routinely recommend more than 2 doses of MMR vaccine. A negative serology after 2 documented doses probably represents a false negative (i.e., antibody titer is too low to detect with commercial tests). If a healthcare setting relies on post-vaccination testing to determine immunity, a negative serology can erroneously indicate that a HCW needs additional doses. Remember, ACIP does not recommend routine serologic testing after MMR vaccination. For more information, see ACIP's recommendations on the use of MMR at www.cdc.gov/mmwr/PDF/rr/rr4708.pdf.
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