The American College of Obstetricians and Gynecologists WOMEN’S HEALTH CARE PHYSICIANS 409 12th Street SW, Washington, DC 20024-2188 Mailing Address: PO Box 96920, Washington, DC 20090-6920

Influenza Immunization During Pregnancy

The American College of Obstetricians and Gynecologists WOMEN’S HEALTH CARE PHYSICIANS

The American College of Obstetricians and Gynecologists WOMEN’S HEALTH CARE PHYSICIANS Vice President, Practice Activites Gerald F. Joseph Jr, MD, FACOG Telephone: 202-863-2577 Fax: 202-863-4909 Email: [email protected]

August 2012

Dear Colleague: The American College of Obstetricians and Gynecologists (the College) recommends that every pregnant and nonpregnant woman receive an inactivated influenza vaccine. The most effective way to increase influenza immunization rates among pregnant women is for the physician to directly recommend the flu shot to patients. The second most effective way is to implement standing orders within your practice, ensuring that every pregnant patient is offered an inactivated influenza vaccine. If your patient does not accept your recommendation initially, continue to offer her the flu shot on subsequent office visits. Live, attenuated influenza vaccine is contraindicated for pregnant women. However, inadvertent vaccination of a pregnant woman with the live, attenuated influenza vaccine has not been shown to be harmful and, thus, is not an indication for pregnancy termination. This purple folder includes materials to help you and your staff communicate with pregnant women about the importance of receiving a flu shot. The College’s Committee Opinion Number 468, Influenza Vaccination During Pregnancy, stresses influenza immunization for all pregnant women. The physician script encourages you to directly offer your pregnant patients a flu shot. The back of the physician script contains influenza coding information. If your patient has questions about receiving the flu shot, please give her a sheet from the pregnancy and flu shot tear pad. If your patient has questions about vaccine safety, please give her a sheet from the vaccine safety tear pad. In addition, federal law requires that each patient receive a vaccine information statement (VIS) before receiving a vaccine. To find VIS in more than 35 languages, please visit www.immunize.org/vis/. If you are interested in implementing standing orders into your practice, view sample standing orders at www.immunize.org/standing-orders/. Set an example for your patients by getting yourself and all of your office staff vaccinated. Educate your practice team about the importance of flu vaccination during pregnancy. For up-to-date informationon influenza, please encourage your staff and patients to visit the College’s immunization web page, Immunization for Women, www.immunizationforwomen.org. We hope the enclosed materials are helpful to you, your practice team, and your patients. If you have additional questions, please email us at [email protected] or call 202-863-2453. If you would like additional materials, please visit us at sales.acog.org. Sincerely,

Gerald F. Joseph Jr, MD, FACOG Vice President, Practice Activities

409 12th Street SW, Washington, DC 20024-2188 Mailing Address: PO Box 96920, Washington, DC 20090-6920 Telephone: 202-638-5577 www.acog.org

The American College of Obstetricians and Gynecologists Women’s Health Care Physicians

COMMITTEE OPINION Number 468 • October 2010

(Replaces No. 305, November 2004)

Committee on Obstetric Practice This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Influenza Vaccination During Pregnancy Abstract: Preventing influenza during pregnancy is an essential element of prenatal care, and the most effective strategy for preventing influenza is annual immunization. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practice recommends influenza vaccination for all women who will be pregnant through the influenza season (October through May in the United States). The American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice supports this recommendation. No study to date has shown an adverse consequence of inactivated influenza vaccine in pregnant women or their offspring. Vaccination early in the season and regardless of gestational age is optimal, but unvaccinated pregnant women should be immunized at any time during influenza season as long as the vaccine supply lasts.

Influenza vaccination is an essential element of prenatal care because pregnant women are at an increased risk of serious illness due to influenza. Most reports of excess seasonal influenza-related morbidity have focused on excess hospital admissions for respiratory illness during influenza season. For example, a retrospective cohort study in Nova Scotia compared hospitalizations and respiratory illness among pregnant women during influenza season with hospital admissions during influenza season for the same women in the year before their pregnancies. Women were more likely to have increased medical visits or increased lengths of stay if hospitalized for respiratory illnesses during pregnancy than when not pregnant, especially during the third trimester; the association between pregnancy status and hospital admission was particularly striking for women with comorbidities (1). In addition to the risks from seasonal influenza, pregnant women experienced excess mortality during the influenza pandemics of 1918–1919, 1957–1958, and most recently, the 2009 pandemic (2–10). The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that all women who will be pregnant during influenza season (October through May in the United States) receive inactivated influenza vaccine at any point in gestation; live attenuated influenza vaccine is contraindicated for pregnant women (11). No study to date has shown an adverse consequence of inactivated influenza vaccine in pregnant women or their offspring (12). The

vaccine is made the same way each year, with the only difference being the use of a new strain of influenza based on predictions of prevalent strains in the community. There have been no reports of any adverse outcomes in pregnant women or their infants. Thimerosal, a mercurycontaining preservative used in multidose vials, has not been shown to cause any adverse effects except for occasional local skin reactions. There is no scientific evidence that thimerosal-containing vaccines cause adverse effects in children born to women who received vaccines with thimerosal. Hence, ACIP does not indicate a preference for thimerosal-containing or thimerosal-free vaccines for any group, including pregnant women (11). In addition to the benefits of immunization for pregnant women, a prospective, controlled, blinded randomized trial demonstrated fewer cases of laboratory-confirmed influenza among infants whose mothers had been immunized compared with women in the control group, as well as fewer cases of respiratory illness with fever. Maternal immunity is the only effective strategy in newborns because the vaccine is not approved for use in infants younger than 6 months (13). The American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice supports ACIP’s recommendation that all women who are pregnant during influenza season receive inactivated influenza vaccine. Despite the safety of the vaccine, many obstetrician–gynecologists have not participated in influenza vaccination programs. Survey data suggest vaccination

rates in pregnancy for seasonal influenza in recent years of 15–25% (11) and for 2009, an H1N1 vaccination rate of 38% (14). However, small numbers of pregnant women were surveyed, and confidence intervals around the estimates are wide. Provider education with simple chart prompts has been shown to increase the frequency of discussion between physicians and pregnant women regarding influenza and vaccination (15). This is particularly important because it has been shown that lack of knowledge about the benefits of the vaccine is a barrier to vaccine acceptance (16, 17). Pregnant women represent a vulnerable population with regard to influenza, and influenza vaccination is an integral element of prenatal care. It is imperative that health care providers, health care organizations, and public health officials continue efforts to improve the rate of influenza vaccination among pregnant women.

References 1. Dodds L, McNeil SA, Fell DB, Allen VM, Coombs A, Scott J, et al. Impact of influenza exposure on rates of hospital admissions and physician visits because of respiratory illness among pregnant women. CMAJ 2007;176:463–8. 2. Harris JW. Influenza occurring in pregnant women: a statistical study of thirteen hundred and fifty cases. J Am Med Assoc 1919;72:978–80. 3. Freeman DW, Barno A. Deaths from Asian influenza associated with pregnancy. Am J Obstet Gynecol 1959;78:1172–5. 4. Greenberg M, Jacobziner H, Pakter J, Weisl BA. Maternal mortality in the epidemic of Asian influenza, New York City, 1957. Am J Obstet Gynecol 1958;76:897–902. 5. Jamieson DJ, Honein MA, Rasmussen SA, Williams JL, Swerdlow DL, Biggerstaff MS, et al. H1N1 2009 influenza virus infection during pregnancy in the USA. Novel Influenza A (H1N1) Pregnancy Working Group. Lancet 2009;374:451–8. 6. Louie JK, Acosta M, Jamieson DJ, Honein MA. Severe 2009 H1N1 influenza in pregnant and postpartum women in California. California Pandemic (H1N1) Working Group. New Engl J Med 2010;362:27–35. 7. Saleeby E, Chapman J, Morse J, Bryant A. H1N1 influenza in pregnancy: cause for concern. Obstet Gynecol 2009; 114:885–91. 8. Greer LG, Abbassi-Ghanavati M, Sheffield JS, Casey BM. Diagnostic dilemmas in a pregnant woman with influenza A (H1N1) infection. Obstet Gynecol 2010;115:409–12. 9. Brown CM. Severe influenza A virus (H1N1) infection in pregnancy. Obstet Gynecol 2010;115:412–4. 10. Siston AM, Rasmussen SA, Honein MA, Fry AM, Seib K, Callaghan WM, et al. Pandemic 2009 influenza A (H1N1) virus illness among pregnant women in the United States.

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Pandemic H1N1 Influenza in Pregnancy Working Group. JAMA 2010;303:1517–25. 11. Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. Centers for Disease Control and Prevention [published erratum appears in MMWR Morb Mortal Wkly Rep 2009;58:896–7]. MMWR Recomm Rep 2009;58(RR-8):1–52. 12. Tamma PD, Ault KA, del Rio C, Steinhoff MC, Halsey NA, Omar SB. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol 2009;201:547–52. 13. Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E, et al. Effectiveness of maternal influenza immunization in mothers and infants [published erratum appears in N Engl J Med 2009;360:648]. N Engl J Med 2008;359:1555–64. 14. Interim results: influenza A (H1N1) 2009 monovalent vaccination coverage––United States, October-December 2009. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep 2010;59:44–8. 15. Wallis DH, Chin JL, Sur DK, Lee MY. Increasing rates of influenza vaccination during pregnancy: a multisite interventional study. J Am Board Fam Med 2006;19:345–9. 16. Beigi RH, Switzer GE, Meyn LA. Acceptance of a pandemic avian influenza vaccine in pregnancy. J Reprod Med 2009;54:341–6. 17. Yudin MH, Salaripour M, Sgro MD. Pregnant women’s knowledge of influenza and the use and safety of the influenza vaccine during pregnancy. J Obstet Gynaecol Can 2009;31:120–5.

Resources

Centers for Disease Control and Prevention www.cdc.gov/flu www.cdc.gov/flr/professional/index.htm FLU.GOV www.flu.gov Copyright October 2010 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400. ISSN 1074-861X Influenza vaccination during pregnancy. Committee Opinion No. 468. American College of Obstetricians and Gynecologists. Obstet Gynecol 2010;116:1006–7.

Committee Opinion No. 468

The American College of Obstetricians and Gynecologists WOMEN’S HEALTH CARE PHYSICIANS

Physician Script on Influenza Immunization During Pregnancy All women should receive the influenza vaccine; this is particularly important during pregnancy and the postpartum period. The influenza vaccination is an essential element of prenatal care because pregnant women are at an increased risk of serious illness and mortality due to influenza. In addition, maternal vaccination is the most effective strategy to protect newborns because the vaccine is not approved for use in infants younger than 6 months. • Only the inactivated influenza vaccine is recommended during pregnancy. Live, attenuated influenza vaccine, which is given as a nasal spray, is contraindicated for pregnant women. • Inadvertent administration of the live, attenuated influenza vaccine during pregnancy has not been shown to be harmful. The live, attenuated influenza vaccine is safe to administer postpartum and to family members. • It is safe for pregnant women to receive a vaccine with thimerosal. Thimerosal, a mercury-containing preservative used in multidose vials, has not been shown to cause any adverse effects except for occasional local skin reactions. • There is no scientific evidence that thimerosal-containing vaccines cause adverse effects in children born to women who received vaccines with thimerosal. • Some women may still be concerned; preservative free single-dose influenza vaccines are available from certain manufacturers. • It is required by law for you to give your patients a Vaccine Information Statement upon receiving an immunization. Vaccine Information Statement forms can be found in multiple languages at www. immunize.org/vis/. • Multiple studies show that the most effective way to increase your patient’s vaccination acceptance rate is for you to directly recommend and provide the vaccine. Talk to your patients about the flu shot today. Here is a script for your consideration: “I strongly recommend you get the flu shot today. I offer the influenza vaccine to all of my pregnant patients and to women who are considering becoming pregnant. The vaccine is safe and effective for pregnant women. The risks of getting sick with the flu are far greater for a pregnant woman and her baby than the possibility of having a complication from the vaccine. The flu shot will protect you as well as your baby in the first 6 months of life from getting the flu. Your family members who have contact with your newborn also should be vaccinated.”

RESOURCES American College of Obstetricians and Gynecologists. Immunization for women: seasonal influenza (flu) for ob-gyns. Available at: http://www.immunizationforwomen.org/immunization_facts/seasonal_ influenza. Retrieved November 9, 2011. Centers for Disease Control and Prevention. Seasonal influenza: pregnant women and influenza (flu). Available at: http://www.cdc.gov/flu/protect/vaccine/pregnant.htm. Retrieved November 9, 2011. Department of Health and Human Services. What pregnant women should know about flu. Available at: http://www.flu.gov/individualfamily/parents/pregnant/index.html. Retrieved November 9, 2011.

The American College of Obstetricians and Gynecologists WOMEN’S HEALTH CARE PHYSICIANS

Coding Information on Influenza Immunization for Pregnant Patients CPT Codes for Vaccine Administration Code Method

Route of Administration

Type of Service

Reporting Rules

90471 Injection Percutaneous, Primary Report only one primary vaccine intradermal, administration per encounter. subcutaneous, or intramuscular +90472 Injection Percutaneous, Additional Report for secondary or intradermal, subsequent vaccine afministraton. subcutaneous, or Report only with code 90471. intramuscular 90460 Any route Percutaneous, Primary Report only one primary vaccine intradermal, administration per day. subcutaneous, Report for administration of or intramuscular first vaccine if more than one was provided. Physician also provides counseling. Patient is 18 years of age or younger. 90461 Any route Percutaneous, Additional Report for secondary or intradermal, subsequent vaccine subcutaneous, administration. or intramuscular . Physician also provides counseling. Patient is 18 years of age or younger.

Influenza Vaccines Administered to Adolescents and Adults Vaccine

Code for Vaccine Product

CPT Administration Code

Influenza virus, split, preservative free, patients 3 years of age and older, intramuscular Influenza virus, split, patients 3 years of age and older, intramuscular

90656

90471–90472

90658

90471–90472

For more information, please visit the Coding section on the Immunization for Women web page, http://www.immunizationforwomen.org/practice_management/coding. Copyright 2012 by the American College of Obstetricians and Gynecologists, 409 12th Street SW, PO Box 96920, Washington, DC 20090-6920

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The American College of Obstetricians and Gynecologists WOMEN’S HEALTH CARE PHYSICIANS

Flu Shot for Pregnant Patients: Frequently Asked Questions I am pregnant. Is it recommended to receive the inactivated influenza vaccine (flu shot)? Yes. Flu shots are an effective and safe way to protect you and your baby from serious illness and complications of the flu. The flu shot given during pregnancy helps protect infants younger than 6 months who are too young to be vaccinated and have no other way of receiving influenza antibodies. The flu shot has been given to millions of pregnant women over many years, and flu shots have been shown to be safe for pregnant women and their babies.

During which trimester is it safe to have a flu shot? The flu shot is recommended for pregnant women and can be given at any time during pregnancy. Pregnant women are advised to get vaccinated as soon as possible and to speak to their health care providers about being immunized.

Which flu vaccine should pregnant women receive? Pregnant women should receive the flu shot, which is given with a needle, usually in the arm. The Advisory Committee on Immunization Practices and the American College of Obstetricians and Gynecologists (the College) recommend that pregnant women should receive this vaccine.

Will the flu shot give me the flu? No, you cannot get the flu from receiving the flu vaccine.

Is there a flu vaccine that pregnant women should not receive? Yes. Pregnant women should not receive the nasal spray vaccine, which is made with the live flu virus. The nasal spray vaccine is safe for women after they have given birth, even if they are breastfeeding, and for family members.

Are preservatives in influenza vaccines safe for my baby? Yes. The type of preservative (eg, thimerosal) used in trace amounts in some vaccines has not been shown to be harmful to a pregnant woman or her baby. Some women may be concerned about exposure to preservatives during pregnancy. Single-dose influenza vaccines that contain a mercury-free preservative are available through some manufactures. The Centers for Disease Control and Prevention and the College recommend that pregnant women may receive the inactivated influenza vaccine with or without thimerosal. (see reverse)

What else can I do to protect my baby against the flu? Getting your flu shot is the most important step in protecting yourself and your baby against the flu. In addition, breastfeeding your baby and making sure other family members and caregivers receive the flu vaccine will further protect your baby.

I am breastfeeding my baby. Is it safe to get vaccinated? Yes. Influenza vaccines can be given to breastfeeding mothers if they were not immunized when they were pregnant. Breastfeeding women can receive either the flu shot or the nasal spray. Breastfeeding mothers pass antibodies through breast milk, which may also reduce the infant’s chances of getting sick with the flu.  

RESOURCES American College of Obstetricians and Gynecologists. Immunization for women: seasonal influenza (flu) for ob-gyns. Available at: http://www.immunizationforwomen.org/immunization_ facts/seasonal_influenza. Retrieved November 9, 2011. Centers for Disease Control and Prevention. Seasonal influenza: pregnant women and influenza (flu). Available at: http://www.cdc.gov/flu/protect/vaccine/pregnant.htm. Retrieved November 9, 2011. Department of Health and Human Services. What pregnant women should know about flu. Available at: http://www.flu.gov/individualfamily/parents/pregnant/index.html. Retrieved November 9, 2011.

 

Copyright 2012 by the American College of Obstetricians and Gynecologists, 409 12th Street SW, PO Box 96920, Washington, DC 20090-6920

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The American College of Obstetricians and Gynecologists WOMEN’S HEALTH CARE PHYSICIANS

Frequently Asked Questions for Patients Concerning Vaccine Safety How does getting vaccinated during pregnancy protect my unborn baby? Newborns cannot receive many vaccines until 2–6 months of age. Some of the protection from the vaccines that you get is transferred to your baby during pregnancy. This helps protect your baby from illness during the first months of life.

How do I know what vaccines I need? Discuss the vaccines that you have had with your health care provider. Your health care provider will recommend the vaccines you need based on your medical history and lifestyle. If you do not receive recommended vaccines during pregnancy, you should get them immediately after your baby is born.

Are vaccines safe for me? Are vaccines safe for my baby? Vaccination is one of the most important things that you can do for yourself and your baby. Vaccines help protect you and your baby from diseases that you both are at risk of and can make you both seriously ill. Vaccination is safe for you and your baby. For example, flu vaccines have been given safely to millions of pregnant women for more than 50 years.

I have heard that some vaccines contain mercury. Is getting these vaccines during pregnancy safe for my baby? Thimerosal, a type of mercury, has not been shown to be harmful to pregnant women or unborn babies, and it does not cause autism. The benefits of preventing life-threatening illnesses in a mother and child far outweigh any potential risks of the vaccine.

Where can I find more information about vaccines for me and my family? To find accurate, trusted information, visit www.immunizationforwomen.org, www.cdc.gov, and www.flu.gov.

(see reverse)

RESOURCES The American College of Obstetricians and Gynecologists Immunization for Women www.immunizationforwomen.org American Medical Association www.ama-assn.org Society for Maternal–Fetal Medicine www.smfm.org

Copyright 2012 by the American College of Obstetricians and Gynecologists, 409 12th Street SW, PO Box 96920, Washington, DC 20090-6920

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Immunization for Women Web Site The American College of Obstetricians and Gynecologists’ immunization web page, Immunization for Women, is an excellent resource for health care providers and patients to find up-to-date information about immunizations and vaccine-preventable diseases. On the web page you can find information on the following:

F Updated immunization recommendations for adult and adolescent females F Specific information for pregnant and breastfeeding women F Details on proper immunization coding and reimbursement F Information on how to set up and expand an office-based immunization program

www.immunizationforwomen.org

VACCINE INFORMATION STATEMENT

Influenza Vaccine Inactivated What You Need to Know 1

Why get vaccinated?

Influenza (“flu”) is a contagious disease. It is caused by the influenza virus, which can be spread by coughing, sneezing, or nasal secretions. Anyone can get influenza, but rates of infection are highest among children. For most people, symptoms last only a few days. They include: • fever/chills • sore throat • muscle aches • fatigue • cough • headache • runny or stuffy nose Other illnesses can have the same symptoms and are often mistaken for influenza. Young children, people 65 and older, pregnant women, and people with certain health conditions – such as heart, lung or kidney disease, or a weakened immune system – can get much sicker. Flu can cause high fever and pneumonia, and make existing medical conditions worse. It can cause diarrhea and seizures in children. Each year thousands of people die from influenza and even more require hospitalization. By getting flu vaccine you can protect yourself from influenza and may also avoid spreading influenza to others.

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Inactivated influenza vaccine

There are two types of influenza vaccine: 1. Inactivated (killed) vaccine, the “flu shot,” is given by injection with a needle. 2. Live, attenuated (weakened) influenza vaccine is sprayed into the nostrils. This vaccine is described in a separate Vaccine Information Statement. A “high-dose” inactivated influenza vaccine is available for people 65 years of age and older. Ask your doctor for more information. Influenza viruses are always changing, so annual vaccination is recommended. Each year scientists try to match the viruses in the vaccine to those most likely to cause flu that year. Flu vaccine will not prevent disease from other viruses, including flu viruses not contained in the vaccine. It takes up to 2 weeks for protection to develop after the shot. Protection lasts about a year.

2012 - 2013 Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis. Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite http://www.immunize.org/vis

Some inactivated influenza vaccine contains a preservative called thimerosal. Thimerosal-free influenza vaccine is available. Ask your doctor for more information.

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Who should get inactivated influenza vaccine and when?

WHO All people 6 months of age and older should get flu vaccine. Vaccination is especially important for people at higher risk of severe influenza and their close contacts, including healthcare personnel and close contacts of children younger than 6 months. WHEN Get the vaccine as soon as it is available. This should provide protection if the flu season comes early. You can get the vaccine as long as illness is occurring in your community. Influenza can occur at any time, but most influenza occurs from October through May. In recent seasons, most infections have occurred in January and February. Getting vaccinated in December, or even later, will still be beneficial in most years. Adults and older children need one dose of influenza vaccine each year. But some children younger than 9 years of age need two doses to be protected. Ask your doctor. Influenza vaccine may be given at the same time as other vaccines, including pneumococcal vaccine.

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Some people should not get inactivated influenza vaccine or should wait.

• Tell your doctor if you have any severe (lifethreatening) allergies, including a severe allergy to eggs. A severe allergy to any vaccine component may be a reason not to get the vaccine. Allergic reactions to influenza vaccine are rare.

• Tell your doctor if you ever had a severe reaction after a dose of influenza vaccine. • Tell your doctor if you ever had Guillain-Barré Syndrome (a severe paralytic illness, also called GBS). Your doctor will help you decide whether the vaccine is recommended for you. • People who are moderately or severely ill should usually wait until they recover before getting flu vaccine. If you are ill, talk to your doctor about whether to reschedule the vaccination. People with a mild illness can usually get the vaccine.

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What are the risks from inactivated influenza vaccine?

A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. The risk of a vaccine causing serious harm, or death, is extremely small. Serious problems from inactivated influenza vaccine are very rare. The viruses in inactivated influenza vaccine have been killed, so you cannot get influenza from the vaccine. Mild problems: • soreness, redness, or swelling where the shot was given • hoarseness; sore, red or itchy eyes; cough • fever • aches • headache • itching • fatigue If these problems occur, they usually begin soon after the shot and last 1-2 days. Moderate problems: Young children who get inactivated flu vaccine and pneumococcal vaccine (PCV13) at the same time appear to be at increased risk for seizures caused by fever. Ask your doctor for more information. Tell your doctor if a child who is getting flu vaccine has ever had a seizure. Severe problems: • Life-threatening allergic reactions from vaccines are very rare. If they do occur, it is usually within a few minutes to a few hours after the shot. • In 1976, a type of inactivated influenza (swine flu) vaccine was associated with Guillain-Barré Syndrome (GBS). Since then, flu vaccines have not been clearly linked to GBS. However, if there is a risk of GBS from current flu vaccines, it would be no more than 1 or 2 cases per million people vaccinated. This is much lower than the risk of severe influenza, which can be prevented by vaccination. The safety of vaccines is always being monitored. For more information, visit: www.cdc.gov/vaccinesafety/Vaccine_Monitoring/Index.html and

www.cdc.gov/vaccinesafety/Activities/Activities_Index.html

One brand of inactivated flu vaccine, called Afluria, should not be given to children 8 years of age or younger, except in special circumstances. A related vaccine was associated with fevers and fever-related seizures in young children in Australia. Your doctor can give you more information.

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What if there is a severe reaction?

What should I look for? • Any unusual condition, such as a high fever or unusual behavior. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? • Call a doctor, or get the person to a doctor right away. • Tell your doctor what happened, the date and time it happened, and when the vaccination was given. • Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967. VAERS does not provide medical advice.

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The National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program (VICP) was created in 1986. People who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP website at www.hrsa.gov/vaccinecompensation.

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How can I learn more?

• Ask your doctor They can give you the vaccine package insert or suggest other sources of information. • Call your local or state health department. • Contact the Centers for Disease Control and Prevention (CDC): - Call 1-800-232-4636 (1-800-CDC-INFO) or - Visit CDC’s website at www.cdc.gov/flu

Vaccine Information Statement (Interim)

Influenza Vaccine (Inactivated) 7/2/2012 42 U.S.C. § 300aa-26

Office Use Only

It’s Federal Law! You must give your patients current Vaccine Information Statements (VISs)

As healthcare professionals understand, the risks of serious consequences following vaccination are many hundreds or thousands of times less likely than the risks associated with the diseases that the vaccines protect against. Most adverse reactions from vaccines are mild and self-limited. Serious complications are rare, but they can have a devastating effect on the recipient, family members, and the providers involved with the care of the patient. We must continue the efforts to make vaccines as safe as possible. Equally important is the need to furnish vaccine recipients (or the parents/legal representatives of minors) with objective information on vaccine safety and the diseases that the vaccines protect against, so that they are actively involved in making decisions affecting their health or the health of their children. When people are not informed about vaccine adverse events, even common, mild events, they can lose their trust in healthcare providers and vaccines. Vaccine Information Statements (VISs) provide a standardized way to present objective information about vaccine benefits and adverse events.

What are VISs? VISs are developed by the staff of the Centers for Disease Control and Prevention (CDC) and undergo intense scrutiny by panels of experts for accuracy. Each VIS provides information to properly inform the adult vaccine recipient or the minor child’s parent or legal representative about the risks and benefits of each vaccine. VISs are not meant to replace interactions with healthcare providers, who should answer

To obtain current VISs in more than 30 languages, visit the Immunization Action Coalition’s website at www.immunize.org/vis

questions and address concerns that the recipient or the parent/legal representative may have.

Use of the VIS is mandatory! Before a healthcare provider vaccinates a child or an adult with a dose of any vaccine containing diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) vaccine, the provider is required by the National Childhood Vaccine Injury Act (NCVIA) to provide a copy of the VIS to either the adult recipient or to the child’s parent/legal representative.

How to get VISs All available VISs can be downloaded from the website of the Immunization Action Coalition at www.immunize.org/vis or from CDC’s website at www.cdc.gov/vaccines/pubs/vis/default.htm. Ready-to-copy versions may also be available from your state or local health department. You can find VISs in more than 30 languages on the Immunization Action Coalition website at www.immunize.org/vis. To find VISs in alternative formats (e.g., audio, web-video), go to: www.immunize.org/vis/vis_sources.asp

Most current versions of VISs As of July 2, 2012, the most recent versions of the VISs are as follows:

According to CDC, every time one of these vaccines is given — regardless of what combination vaccine it is given in — regardless of whether it is given by a public health clinic or a private provider — regardless of how the vaccine was purchased — and regardless of the age of the recipient — the appropriate VIS must be given out prior to the vaccination. Source: www.cdc.gov/vaccines/pubs/vis/vis-facts.htm

MMR ............................4/20/12 DTaP/DT .......................5/17/07 MMRV..........................5/21/10 Hepatitis A .................10/25/11 PCV13 ..........................4/16/10 Hepatitis B .....................2/2/12 PPSV .............................10/6/09 Hib ............................12/16/98 Polio ............................11/8/11 HPV (H. papillomavirus) ............... Rabies .........................10/6/09 Cervarix ........................5/3/11 Rotavirus .....................12/6/10 Gardasil ......................2/22/12 Shingles .......................10/6/09 Influenza (inactive)..........7/2/12 Td/Tdap .......................1/24/12 Influenza (live) ................7/2/12 Typhoid.........................5/29/12 Japanese encephalitis. .12/7/11 Varicella (chickenpox) ...3/13/08 Meningococcal ........... 10/14/11 Yellow fever .................3/30/11 Multi-vaccine VIS .......................................................................... 9/18/08 (for 6 vaccines given to infants/children: DTaP, IPV, Hib, Hep B, PCV, RV)

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It’s Federal Law . . . you must give your patients current VISs

Top 10 Facts about VISs Fact 1 It’s federal law! Federal law requires that VISs must be used for the following vaccines when vaccinating patients of ALL ages: t
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coccal (PCV), polio (IPV), or rotavirus (RV). The multi-vaccine VIS can also be used when giving combination vaccines (e.g., Pediarix, Pentacel, Comvax) or when giving two or more routine vaccines at other pediatric visits (e.g., 12–15 months, 4–6 years). However, when giving combination vaccines for which no VIS exist (e.g., Twinrix), give out all relevant single VISs. For example, before administering Twinrix give your patient the VISs for both hepatitis A and hepatitis B vaccines. Fact 6 VISs are available in other formats, including more than 30 languages You may use laminated copies of VISs for patients and parents to read and return before leaving the clinic, but you must also offer the patient (parent/legal representative) a printed copy of the VIS to take home.

According to CDC, every time one of these vaccines is given — regardless of what comBy using the VISs with your bination vaccine it is given in — regardless of If they prefer to download the VIS whether it is given by a public health clinic or a patients, you are helping to onto a mobile device, direct them to private provider — regardless of how the vacCDC’s VIS Mobile Downloads web page: develop a better educated cine was purchased — and regardless of the age www.cdc.gov/vaccines/Pubs/vis/vis-downloads.htm patient population and you of the recipient — the appropriate VIS must be To download VISs in other languages, visit given out prior to the vaccination. There are are doing the right thing. www.immunize.org/vis also VISs for vaccines not covered by NCVIA: anthrax, Japanese encephalitis, pneumococcal polysaccharide, rabies, shingles, smallpox, typhoid, and yellow feFact 7 Federal law does not require signed consent in order for a person to be vaccinated ver. CDC recommends the use of VISs whenever these vaccines are Signed consent is not required by federal law (although some states given. The VIS must always be used if vaccine was purchased under may require them). CDC contract. Fact 2 VISs are required for both public and private sectors Federal law requires use of VISs in both the public and private sector settings and regardless of the source of payment for the vaccine. Fact 3 VIS must be provided before vaccine is administered to the patient The VIS provides information about the disease and the vaccine and should be given to the patient before vaccine is administered. It is also acceptable to hand out the VIS well before administering vaccines (e.g., at a prenatal visit or at birth for vaccines an infant will receive during infancy), as long as you still provide the VIS right before administering vaccines. Fact 4 You must provide a current VIS for each dose of vaccine The most current VIS must be provided before each dose of vaccine is given, including vaccines given as a series of doses. If five doses of a single vaccine are required, the patient (parent/legal representative) must have the opportunity to read the information on the VIS before each dose is given. Fact 5 You must provide VISs for combination vaccines too There is a VIS available for MMRV (ProQuad). An alternative VIS — the multi-vaccine VIS — is an option to providing singlevaccine VISs when administering one or more of these routine birth-through-6-month vaccines: DTaP, hepatitis B, Hib, pneumo-

Fact 8 To verify that a VIS was given, providers must record in the patient’s chart (or permanent office log or file) the following information: t
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The vaccine manufacturer and lot number of each dose administered VISs should not be altered before giving them to patients Providers should not change a VIS or write their own VISs. It is permissible to add a practice’s name, address, or phone number to an existing VIS. Providers are encouraged to supplement the VIS with additional patient-education materials. Fact 9

Fact 10 Provide VISs to all patients For patients who don’t read or speak English, the law requires that providers ensure all patients (parent/legal representatives) receive a VIS, regardless of their ability to read English. If available, provide a translation of the VIS in the patient’s language. Translations of VISs in more than 30 languages are available from IAC. Go to www.immunize.org/vis for VISs in multiple languages as well as in other formats.

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