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Issue 1350: February 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; Donna L. Weaver, RN, MN; and JoEllen Wolicki, BSN, RN, all from the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC).
Influenza Vaccines
Mumps Vaccine
Varicella Vaccine
Hepatitis B Vaccines
Zoster Vaccines
Influenza Vaccines
Q: Please provide details about the use of FluLaval and Fluarix influenza vaccines in children younger than 3 years.
A: On November 18, 2016, the Food and Drug Administration (FDA) approved an extension of the age range of FluLaval Quadrivalent (GSK) inactivated influenza vaccine (IIV) to include children 6 through 35 months of age. FluLaval was previously approved for people 3 years of age and older. The approval of the extended age range for FluLaval was based on a study showing an equivalent ("non-inferior") response compared to children who received the Fluzone (Sanofi Pasteur) pediatric dosage. The vaccine will be supplied in manufacturer-filled syringes and multi-dose vials. The dosage approved for children 6 through 35 months of age is 0.5 mL—the same dosage as for people 3 years of age and older.
On January 11, 2018, the FDA approved an extension of the age range of Fluarix Quadrivalent IIV (GSK) to include children 6 through 35 months of age. Fluarix was previously approved for people 3 years of age and older. The approval of the extended age range for Fluarix was based on a study that demonstrated protection from influenza virus infection and reduced influenza-associated complications compared to a non-influenza vaccine. The vaccine will be supplied in manufacturer-filled syringes. The dosage approved for children 6 through 35 months of age is 0.5 mL—the same dosage as for people 3 years of age and older.
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Q: Which influenza vaccines can we give to children?
A: Among the injectable inactivated influenza vaccines, only Fluzone, FluLaval, and Fluarix are approved by FDA for use in children age 6 through 35 months. There are several inactivated influenza vaccines that can be given to children age 3 years or older.
The nasal spray live attenuated influenza vaccine (LAIV, FluMist, AstraZeneca) is approved for healthy children age 2 years and older. However, both the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics recommend that LAIV not be used during the 2017–2018 influenza season. Information about all influenza vaccines available in the U.S. is available in IAC's handout titled "Influenza Vaccine Products for the 2017–2018 Influenza Season" at www.immunize.org/catg.d/p4072.pdf.
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Q: Can a child 6 through 35 months of age who needs 2 doses of influenza vaccine this season receive a combination of Fluzone, FluLaval, or Fluarix vaccine?
A: Yes. Fluzone (0.25 mL dose), FluLaval (0.5 mL dose) and Fluarix (0.5 mL dose) are approved by the FDA for use in children 6 through 35 months of age.
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Q: Can a child 36 months through 8 years of age who needs 2 doses of influenza vaccine this season receive a combination of Fluzone, FluLaval, or Fluarix vaccine?
A: Yes. Fluzone (0.5 mL dose), FluLaval (0.5 mL dose), and Fluarix (0.5 mL dose) are approved by the FDA for use in children age 3 years and older.
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Mumps Vaccine
Q: During a mumps outbreak should we offer a third dose of MMR (MMR II, Merck) to persons who have two prior documented doses of MMR?
A: In recent years, mumps outbreaks have occurred primarily in populations in institutional settings with close contact (such as college dormitories) or in close-knit communities. The current routine recommendation for 2 doses of MMR vaccine appears to be sufficient for mumps control in the general population, but insufficient for preventing mumps outbreaks in prolonged, close-contact settings, even where coverage with 2 doses of MMR vaccine is high.
In January 2018, ACIP published new guidance for MMR vaccination of persons at increased risk for acquiring mumps during an outbreak. People previously vaccinated with 2 doses of a mumps virus–containing vaccine who are identified by public health authorities as being part of a group or population at increased risk for acquiring mumps because of an outbreak should receive a third dose of a mumps virus–containing vaccine to improve protection against mumps disease and related complications. More information about this recommendation is available at www.cdc.gov/mmwr/volumes/67/wr/mm6701a7.htm.
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Varicella Vaccine
Q: A child received only one dose of varicella vaccine (Varivax, Merck) and subsequently tests positive for varicella IgG antibody. Does the child still need a second dose of varicella vaccine?
A: If a person tests positive for varicella antibody 28 days or more after vaccination, ACIP considers the person to be immune. CDC prefers that the child receive a second dose to assure long-term immunity, but doing so is not absolutely necessary. You can access the ACIP varicella vaccine recommendations, which include evidence of immunity (page 16) at www.cdc.gov/mmwr/pdf/rr/rr5604.pdf.
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Q: A child in our practice received her first dose of varicella vaccine when she was 12 months old and her second dose when she was 14 months old. The second dose was only 2 months after the first. Is the second dose valid or does it need to be repeated?
A: The recommended minimum interval between two doses of varicella vaccine for children 12 months through 12 years of age is 12 weeks. However, the second dose of varicella vaccine does not need to be repeated if it was separated from the first dose by at least 4 weeks. See www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/age-interval-table.pdf (footnote 23).
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Hepatitis B Vaccines
Q: Please provide information about the new hepatitis B vaccine Heplisav-B (Dynavax).
A: Heplisav-B was approved by FDA in November 2017 for people 18 years of age and older. It is given by the intramuscular route as a 2-dose series with doses separated by 1 month.
The vaccine is stored at refrigerator temperature between 2° and 8°C (between 36° and 46°F).
Heplisav-B was approved based on clinical trials that compared seroprotection rates (SPR, defined as anti-HBs of 10 mIU or higher) following 2 doses of Heplisav-B to rates following 3 doses of Engerix-B (HepB, GlaxoSmithKline). Among persons age 18 through 70 years, SPRs were 90%–95% following 2 doses of Heplisav-B and 65%–81% following 3 doses of Engerix-B. Local reactions were most commonly reported (injection site pain, redness, and swelling) and were similar in frequency to those following Engerix-B.
As of this writing, ACIP has not yet published recommendations on the use of Heplisav-B.
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Q: I heard there is a new hepatitis B ACIP statement. What’s new in the updated document?
A: A new hepatitis B ACIP statement was published in January 2018. It is available at www.cdc.gov/mmwr/volumes/67/rr/rr6701a1.htm.
New or updated recommendations include the following:
- All pregnant women who test positive for hepatitis B surface antigen (HBsAg) should be tested for hepatitis B virus deoxyribonucleic acid (HBV DNA). Antiviral therapy should be considered when maternal HBV DNA is 200,000 mIU/mL or higher to reduce the risk of hepatitis B virus transmission at birth.
- Removal of permissive language for delaying the birth dose until after hospital discharge.
- Universal hepatitis B vaccination within 24 hours of birth for medically stable infants weighing 2,000 grams or more. The previous recommendation was for vaccination before hospital discharge.
- Postvaccination serologic testing for infants whose mother’s HBsAg status remains unknown indefinitely (for example, when a parent or person with lawful custody surrenders an infant shortly after birth).
- Single-dose revaccination for infants born to HBsAg-positive women not responding to the initial vaccine series with repeat serologic testing for antibody to hepatitis B surface antigen (anti-HBs) 1–2 months later. The previous recommendation was to complete a second 3-dose series for infants who do not respond to the first series.
- Expansion of routine vaccination to include adults with chronic liver disease (including, but not limited to, those with hepatitis C virus [HCV] infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase [ALT] or aspartate aminotransferase [AST] level greater than twice the upper limit of normal).
The 2018 statement incorporates guidance for vaccination and testing of people at occupational risk for hepatitis B virus exposure (such as healthcare providers), including persons vaccinated as infants or adolescents who now test negative for anti-HBs. This guidance was previously published in 2013.
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Zoster Vaccines
Q: Please tell us about the new zoster vaccine Shingrix (recombinant zoster vaccine–RZV, GlaxoSmithKline).
A: RZV was approved by FDA in October 2017 for people 50 years of age and older. It is given by the intramuscular route as a 2-dose series with doses separated by 2 to 6 months. It is provided as a lyophilized powder that is reconstituted with a liquid that contains the adjuvant. Both the vaccine and adjuvant solution are stored at refrigerator temperature between 2° and 8°C (between 36° and 46°F).
RZV is a recombinant subunit vaccine that does not contain live varicella zoster virus. RZV was approved based on clinical trials that compared the occurrence of shingles and post-herpetic neuralgia (PHN) among RZV recipients compared those who received a placebo. The efficacy of RZV was 97% among participants 50 years of age and older, and 89% among participants age 80 years and older. RZV reduced the occurrence of PHN by 89% compared to those who received a placebo. Local reactions (injection site pain, redness, and swelling) were most commonly reported and were much more common among RZV recipients than among placebo recipients. More than 70% of RZV recipients reported injection site pain; 4%–10% (depending on age group) reported that pain interfered with their daily activities.
ACIP recommends that people 50 years of age and older receive 2 doses of RZV 2 months apart regardless of a history of shingles or prior receipt of live zoster vaccine (ZVL, Zostavax, Merck). RZV should be administered at least 2 months after receipt of ZVL. For people 60 years of age and older either RZV or ZVL may be administered but RZV is preferred. Revised ACIP recommendations for use of zoster vaccine were published in January 2018 and are available at www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm6703a5-H.pdf.
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Q: How should RZV vaccine be stored?
A: Both lyophilized RZV and the adjuvant solution must be stored at refrigerator temperature between 2° and 8°C (between 36° and 46°F). Protect the vials from light. Do not freeze. Vaccine or adjuvant solution that has been exposed to freezing temperature must be discarded.
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Q: Why are zoster (Zostavax, Merck; Shingrix, GlaxoSmithKline) and pneumococcal polysaccharide (PPSV23; Pneumovax, Merck) vaccines not covered by the National Vaccine Injury Compensation Program?
A: The National Vaccine Injury Compensation Program includes payment only for injuries determined to have occurred following vaccination with a vaccine routinely recommended for children in the United States. The recipient can be of any age, but the vaccine must be routinely recommended for children and teens through age 18 years. Zoster and PPSV23 vaccines are not routinely recommended for children. Zoster is only licensed and recommended for adults. More information about the program and the covered vaccines is at www.hrsa.gov/vaccine-compensation/covered-vaccines/index.html.
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How to submit a question to Ask the Experts
IAC works with CDC to compile new Ask the Experts Q&As for our publications based on commonly asked questions. We also consider the need to provide information about new vaccines and recommendations. Most of the questions are thus a composite of several inquiries.
You can email your question about vaccines or immunization to IAC at admin@immunize.org.
As we receive hundreds of emails each month, we cannot promise that we will print your specific question in our Ask the Experts feature. However, you will get an answer.
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