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Ask the Experts

General Vaccine Questions

Vaccine recommendations Back to top
Where can I find information about vaccine shortages and delays?
Visit CDC's website at www.cdc.gov/vaccines/vac-gen/shortages/default.htm.
Where can I find the most current vaccine recommendations?
Vaccine recommendations in the U.S. are issued primarily by two national bodies—the U.S. Public Health Service's Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) Committee on Infectious Diseases. To access the most current ACIP recommendations, go to www.cdc.gov/vaccines/pubs/acip-list.htm for statements in alphabetical order or www.immunize.org/acip for statements in chronological order. For the AAP policy statements on immunizations, go to www.immunize.org/aap.
How do I obtain copies of the newest U.S. recommended immunization schedules for children and for adults?
You can download electronic versions of the schedules from CDC's website at www.cdc.gov/vaccines/recs/schedules/default.htm. IAC has also created laminated versions of the child and adolescent schedule, as well as the adult schedule, which make an excellent resource for placement in each exam room. Each is based on the official schedules adopted by ACIP, AAP, AAFP, ACOG, and ACP. You can find them by going to www.immunize.org/shop.
Why do ACIP recommendations not always agree with package inserts?
There is usually very close agreement between vaccine package inserts and ACIP statements. The Food and Drug Administration (FDA) must approve the package insert, and requires documentation for all claims and recommendations made in the insert. Occasionally, ACIP may use different data to formulate its recommendations, or try to add flexibility to its recommendations, which results in wording different than on the package insert. ACIP sometimes makes recommendations based on expert opinion and public health considerations. Published recommendations of national advisory groups (such as ACIP or AAP's Committee on Infectious Diseases) should be considered equally as authoritative as those on the package insert.
What vaccinations are recommended for new immigrants to the United States?
In 1996 Congress amended the Immigration and Nationality Act and added vaccination requirements for any person who is applying for permanent resident status in the United States. Children and adults must have evidence of having received (or at least having started the series of) the same vaccines recommended for an American citizen of the same age, if the disease being prevented is communicable in a school setting. Children must be vaccinated according to the current U.S. childhood schedule. Adults 18 years of age and older must have evidence of vaccination for tetanus and diphtheria. People born after 1956 must have evidence of immunity (vaccination or serology) for measles, mumps, and rubella. All people 12 months of age and older must have evidence of varicella immunity (vaccination or history of chickenpox). Children adopted from outside the U.S. and political refugees are recommended to receive age-appropriate vaccination, with catch-up vaccination as appropriate, per the guidance in ACIP's "General Recommendations on Immunization" (see www.cdc.gov/vaccines/pubs/acip-list.htm). People entering the U.S. as visitors are not required to provide proof of vaccination regardless of the length of stay.
Scheduling vaccinations Back to top
Why are vaccines generally not given to infants under 6 weeks of age in the U.S.?
Mainly because little safety or efficacy data exist on doses given before 6 weeks of age, and the vaccines aren't licensed for this use. The data that exist suggest that the response to doses given before 6 weeks is poor; the response to hepatitis B vaccine is the exception.
What resources does IAC have to help parents and child caretakers evaluate the immunization needs of children and adolescents?
There are several very easy to read pieces that can be downloaded from the IAC website. This includes "Vaccinations for Infants and Children, Age 0—10 Years", "When do children and teens need vaccinations?", "Vaccinations for Preteens and Teens, Age 11—19 Years".
What resources are available to help adult patients evaluate their individual immunization needs?
There are several screening questionnaires that IAC has developed for patient use. These include an adult assessment piece "Do I need any vaccinations today?", "Vaccinations for Adults with HIV", "Vaccinations for Adults with Hepatitis C Infection", "Should You Be Vaccinated Against Hepatitis B? A screening questionnaire for adults", and "Should You Be Vaccinated for Hepatitis A? A screening questionnaire for adults".
In addition to these printed pieces, there are several interactive tools on CDC's website. For children, go to http://www2a.cdc.gov/nip/kidstuff/newscheduler_le and for adults, go to www2.cdc.gov/nip/adultImmSched.
When a 3-month-old infant presents having had no prior immunizations, would you start the accelerated schedule?
The accelerated schedule should be used when the child is more than a month behind schedule, until you get them caught up. You can give the child the first set of recommended vaccines at age 3 months and then bring him back at age 4 months and give the second set of vaccinations. At this point the child will be caught up and can return to the usual schedule. As long as you observe the minimum intervals between doses and minimum ages for specific vaccines, this is fine to do. Once you have them back on schedule, stick with the recommended ages and intervals on the recommended childhood schedule. It is also important to educate the parents and talk to them about the importance of bringing the child in on time.
How can we quickly determine how to "catch up" children who have fallen behind on their shots?
As a general rule, infants or children who are more than 1 month or 1 dose behind schedule should be on an accelerated schedule, which means the intervals between doses should be reduced to the minimum allowable. Catch-up schedules for children ages 4 months through 18 years are included with each year's recommended immunization schedule that is issued by ACIP, AAP, and American Academy of Family Physicians (AAFP). To obtain a copy, go to http://www.cdc.gov/vaccines/schedules/child-schedule.htm#hcp.
How many vaccines can be given during an office visit?
No upper limit exists for the number of vaccines that can be administered during one visit. ACIP and AAP consistently recommend that all needed vaccines be administered during an office visit.
The number of injections recommended to be given at a single office visit is increasing, and we are running out of injection sites. Should we defer certain vaccines?
We strongly recommend that you do not defer any recommended vaccines. This would be a missed opportunity. No upper limit has been established regarding the number of vaccines that can be administered in one visit. ACIP and AAP consistently recommend administering all vaccines indicated for the patient's age. When giving several injections at a single visit, separate two IM vaccines by at least 1 inch in the body of the muscle to reduce the likelihood of local reactions overlapping. Here are some helpful site maps for different ages so you can record where shots were given:
What is the maximum number of IM or SC doses of vaccines that a child can receive at a single visit? Is it okay for a child to receive 3 live vaccines at one visit (e.g., MMR, VAR, and LAIV)?
All vaccines can be administered at the same visit. There is no limit to the number of IM or SC injections that can be given at a single visit. So, an age-appropriate child can get MMR, VAR, and LAIV vaccines during a single visit. If live parenteral (injected) vaccines (MMR, VAR, MMRV, zoster, and/or yellow fever) and LAIV are not administered during the same visit, they should be separated by 4 weeks or more. For details, consult CDC's "General Recommendations on Immunization" at www.cdc.gov/vaccines/pubs/ACIP-list.htm.
We have some adults who are in need of multiple vaccines (e.g., influenza, pneumococcal, and a tetanus-containing vaccine). When only 2 vaccines are needed, we inject 1 in each arm, but when 3 or more are recommended, we're not sure whether we should give all of them or defer 1 or more until a later date.
ACIP recommends giving all indicated vaccines simultaneously (i.e., at the same visit, NOT in the same syringe). Giving vaccines together produces seroconversion rates and occurrences of adverse reactions similar to those observed when the vaccines are administered separately. Simultaneous administration also eliminates the possibility that the patient will not return in a timely manner for the deferred vaccine.
When giving two IM injections in the same limb, the vaccines should be separated by 1 inch or more if possible in the muscle so that any local reactions are unlikely to overlap.
If all needed vaccines aren't administered during the same visit, does one need to wait a certain period of time before administering the other needed vaccines?
All inactivated vaccines can be given on the same day, or on any day before or after giving other inactivated or live vaccines. However, if two live vaccines are not given on the same day, they need to be spaced at least 4 weeks apart.
What is meant by "minimum intervals" between vaccine doses?
Vaccination schedules are generally determined by clinical trials, usually prior to licensure of the vaccine. The spacing of doses in the clinical trial usually becomes the recommended schedule. A "minimum interval" is shorter than the recommended interval, and is the shortest time between two doses of a vaccine series in which an adequate response to the second dose can be expected. The concern is that a dose given too soon after the previous dose may reduce the response. The minimum spacing between doses is generally included in the ACIP recommendation for that vaccine which can be found at www.cdc.gov/vaccines/pubs/ACIP-list.htm. In addition, an extensive listing of recommended and minimum intervals and ages for vaccination can be found at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/age-interval-table.pdf.
If two live virus vaccines are inadvertently given less than 4 weeks apart, what should be done?
If two live virus vaccines are administered less than 4 weeks apart and not on the same day, the vaccine given second should be considered invalid and repeated. The repeat dose should be administered at least 4 weeks after the invalid dose. Alternatively, one can perform serologic testing to check for immunity, but this option may be more costly.
We gave a dose of vaccine too soon after the previous dose. When can we give another (valid) dose?
ACIP allows a grace period of 4 days (i.e., vaccine doses administered up to 4 days before the recommended minimum interval or age can be counted as valid). However, if a dose was administered 5 or more days earlier than the recommended minimum interval between doses, it is not valid and must be repeated. The repeat dose should be spaced after the invalid dose by the recommended minimum interval.
If the first dose in a series is given >5 days before the recommended minimum age, the dose should be repeated on or after the date when the child reaches at least the minimum age. If the vaccine is a live vaccine, ensuring that a minimum interval of 28 days has elapsed from the invalid dose is recommended. Avoid such errors by knowing the minimum intervals and ages for routinely given vaccines. You can look up such information www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/age-interval-table.pdf.
What should we do if we give a dose of vaccine at less than the minimum interval since the previous dose?
If vaccines are given too close together, it can result in a less than optimal immune response. However, in most instances, a difference of a few days is unlikely to have a negative effect on immune response. With the exception of rabies vaccine, CDC recommends that vaccine doses given 4 or fewer days before the minimum interval be counted as valid, unless local or state requirements specify otherwise. If the dose needs to be repeated, the repeat dose should be spaced after the invalid dose by the recommended minimum interval. You can look up minimum intervals here: www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/age-interval-table.pdf
We sometimes have differences of opinion among our staff in determining the minimum interval or age for administering vaccines. Recommendations are sometimes written in months, weeks, or days. Can you help clarify?
This is a common source of frustration. Customarily, if the dosing interval is 4 months or more, it is common to use calendar months (e.g., 6 months from October 1 is April 1). If the interval is less than 4 months, it is common to convert months into days or weeks (e.g., 1 month = 4 weeks = 28 days).
What is the 4-day "grace period" for vaccine administration and when can I use it?
Since 2002, in an effort to increase the flexibility of the complicated childhood and adult immunization schedules, ACIP recommends that vaccine doses administered up to 4 days before the minimum interval or age can be counted as valid. ACIP believes that administering a dose a few days earlier than the minimum interval or age is unlikely to have a significant negative effect on the immune response to that dose.
The 4-day "grace period" should not be used when scheduling future vaccination visits, and should not be applied to the 28-day interval between live parenteral vaccines not administered at the same visit. It should be used primarily when reviewing vaccination records (for example, when evaluating a vaccination record prior to entry to daycare or school).
Use of the grace period may create a conflict with state daycare or school entry vaccination requirements. In particular, many states require MMR be given on or after the first birthday. ACIP recommends that providers comply with state and local immunization requirements when scheduling and administering vaccines.
A 3-year-old who was otherwise on schedule received some of her 15-month vaccinations (MMR, DTaP, IPV) twice due to a change in health plans. Can these doses be counted toward kindergarten vaccinations?
Whether these doses count as part of the child's series depends on the intervals between these doses and the ones that preceded them. If the second MMR was separated from the previous one by at least 4 weeks, it can be counted as the second MMR. No additional doses are indicated. (Exception: the 4th dose of IPV is recommended after the 4th birthday. In this case, the child would need a fifth dose of IPV on or after her fourth birthday.) The fifth dose of DTaP should not be given earlier than age 4 years. Assuming this dose of DTaP was the fifth the child received, it was given much too early and should not be counted. The DTaP should be repeated on or after the child's fourth birthday.
Is it necessary to start a vaccine series over if a patient doesn't come back for a dose at the recommended time, even if there's been a year or more delay?
For routinely administered vaccines, there is no vaccine series that needs to be restarted because of an interval that is longer than recommended. In certain circumstances, oral typhoid vaccine (which is sometimes given for international travel) needs to be restarted if the vaccine series isn't completed within the recommended time frame.
If I give a pneumococcal polysaccharide vaccine to my patient now, how long must I wait before giving the influenza or Td vaccine?
Influenza vaccine and Td (or Tdap) may be given at the same time or at any time before or after a dose of pneumococcal polysaccharide vaccine.
Precautions and contraindications Back to top
Do we have to check vital signs before giving vaccines?
No. ACIP does not recommend routinely checking a patient's temperature or other vital signs before vaccination. Requiring these extra steps can be a barrier to immunization.
Is it necessary to routinely obtain a pregnancy test before administering any vaccines to young women?
No. Pregnancy tests are not routinely recommended. However, females of childbearing age should be asked about the possibility of their being pregnant prior to being given any vaccine for which pregnancy is a contraindication or precaution. The patient's answer should be documented in the medical record. If the patient is uncertain if she is pregnant, a test should be performed before administering live virus vaccines (e.g., measles-mumps-rubella [MMR], varicella [VAR], LAIV [live attenuated influenza vaccine, i.e., FluMist]).
Should I vaccinate a child who has recently been exposed to an infectious disease? What about a child who is convalescing from illness?
Neither of these situations is a contraindication or precaution to vaccination.
For which vaccines is an egg allergy a contraindication?
1) Yellow fever is contraindicated for people who have a history of a severe (anaphylactic) allergy to eggs.
2) People who have experienced a serious systemic or anaphylactic reaction (e.g., hives, swelling of the lips or tongue, acute respiratory distress, or collapse) after eating eggs should consult a specialist for appropriate evaluation to help determine if influenza vaccine should be administered.
People who have documented immunoglobulin E (IgE)-mediated hypersensitivity to eggs, including those who have had occupational asthma or other allergic responses to egg protein, might also be at increased risk for allergic reactions to influenza vaccine. Protocols have been published for safely administering influenza vaccine to people with egg allergies.
Some people who report allergy to egg might not be egg allergic. If a person can eat lightly cooked eggs (e.g., scrambled eggs), they are unlikely to have an egg allergy. However, people who can tolerate egg in baked products (e.g., cake) might still have an egg allergy. If the person develops hives only after ingesting eggs, CDC recommends (1) they receive TIV (not LAIV), (2) the vaccine be administered by a healthcare provider familiar with the potential manifestations of egg allergy, and (3) the vaccine recipient be observed for at least 30 minutes after receipt of the vaccine for signs of a reaction.
For more details about giving influenza vaccine to people with a history of egg allergy, see Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP)—United States, 2012–13. You may find the IAC handout "Influenza Vaccination of People with a History of Egg Allergy" helpful.
NOTE: A new influenza vaccine [Flucelvax; Novartis] was licensed in November 2012. It is produced using cultured animal cells, instead of fertilized chicken eggs, and is approved to prevent seasonal influenza in people age 18 years and older. Novartis plans to begin distribution of this product in the 2013–14 influenza season.
Isn't egg allergy a contraindication for MMR?
Allergy to eggs is no longer considered a contraindication for giving MMR vaccine. Though measles and mumps vaccines are grown in chick embryo tissue culture, several studies have documented the safety of these vaccines in children with severe egg allergy. In 1994, ACIP's General Recommendations for Immunization listed egg allergy as a contraindication for administering MMR. That was changed, however, and by 1998 when ACIP's most recent recommendations for MMR were published, egg allergy was no longer listed as a contraindication. That remains true today: Neither AAP's Committee on Infectious Diseases ("Red Book Committee") nor ACIP consider egg allergy a contraindication to MMR vaccine.
What should we ask a patient when screening to determine a gelatin allergy?
Begin by asking a general question about whether the person has an allergy to any food, medication, or vaccine. If they report an allergy to gelatin or foods that contain gelatin, you could follow up by asking if they can eat Jell-O™ and gelatin-type products. Gelatin allergies are extremely rare. Only severe, life-threatening (anaphylactic) allergy is a contraindication to vaccination.
What is a latex allergy and why should we be concerned?
Latex is a product of the rubber tree – Hevea basiliensis. It is processed and used in various products (e.g., medical gloves), including some that come in contact with vaccines. Latex may be present in syringe plungers, vial stoppers, or in the tip caps on prefilled syringes. Some people develop sensitivities to latex, particularly if they have had significant cumulative latex exposure, such as from repeated surgeries early in life or employment in the healthcare industry. The most common type of latex sensitivity is contact-type allergy; however, on rare occasions, severe (anaphylactic) allergy occurs. People with a history of anaphylactic reactions to latex should generally not be given vaccines that have been in contact with natural rubber, either in the vial or in the syringe. People with latex allergies that are not anaphylactic in nature may be vaccinated as usual.
What precautions should we take for patients that have a latex allergy?
Although rare, people having had a severe, anaphylactic reaction to latex should generally not be given vaccines that have been in contact with natural rubber, unless the benefit of vaccination outweighs the risk of a potential allergic reaction. People with latex allergies that are not anaphylactic may be vaccinated as usual; this would include a contact-type allergy, such as what occurs with prolonged contact with latex-containing gloves.
Do any or all stoppers still contain latex?
Not all stoppers in vaccine vials contain latex. Manufacturers are beginning to switch to synthetic rubber-like materials that do not contain rubber latex or dry natural rubber. The best approach is to check the package insert, which will indicate if the packaging contains latex. Also, remember that prefilled syringes could contain natural rubber in the plunger, in the needle cover, or in the tip cap. This information is also supplied in the package insert.
Which vaccines are supplied in vials or syringes containing latex?
You can find information on latex in vaccine packaging in Appendix B of CDC's Epidemiology and Prevention of Vaccine-Preventable Diseases (the "Pink Book") at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/latex-table.pdf.
If we have a patient who has a severe latex allergy, why shouldn't we just remove the stopper from the vial before withdrawing the vaccine in order to prevent a latex reaction?
We do not recommend removing the stopper from a vaccine vial before administering a vaccine to a person who has a severe life-threatening allergy to latex. The vaccine has already been exposed to the rubber stopper in the vial, which might be just enough of an exposure to cause a reaction. These people should not be given the vaccine.
What are the special recommendations for administering intramuscular injections in people with clotting disorders?
This issue is discussed in ACIP's "General Recommendations on Immunization" www.immunize.org/askexperts/experts_inf.asp#contraindications (pages 29-30). Intramuscular (IM) injections should be scheduled shortly after antihemophilia therapy or prior to a dose of anticoagulant. For both IM and subcutaneous (SC) injections, a fine needle (23 gauge or smaller) should be used and firm pressure applied to the site, without rubbing, for at least 2 minutes. Providers should not administer a vaccine by a route that is not approved by the FDA for that particular vaccine (e.g., administration of IM vaccines by the SC route).
Which vaccines can be given to breastfeeding women?
All vaccines except smallpox can be given to breastfeeding women. Breastfeeding is a precaution for yellow fever vaccine. Women who are breastfeeding should be advised to postpone travel to yellow fever endemic or epidemic regions; however, if travel cannot be postponed, the woman should receive yellow fever vaccine.
What percentage of vaccine recipients will experience an anaphylactic reaction?
It is estimated that for every million doses administered, about one (~0.0001%) will result in an anaphylactic reaction following vaccination. With proper screening, most providers who administer thousands of vaccines in their lifetimes will never see an anaphylactic reaction.
Administering vaccines Back to top
Where can I obtain standing orders for vaccination?
The Immunization Action Coalition (IAC) has developed suggested standing orders for all vaccines commonly given to children and adults. They are based on CDC's Advisory Committee on Immunization Practices (ACIP) recommendations and are reviewed for technical accuracy by CDC staff. You can find the standing orders and protocols for medical management of vaccine reactions at www.immunize.org/standing-orders.
Is it necessary to wear gloves when we administer vaccinations?
No. Occupational Safety and Health Administration (OSHA) regulations do not require the wearing of gloves when administering vaccinations, unless the person administering the vaccine is likely to come into contact with potentially infectious body fluids or has an open lesion on their hand. If a healthcare worker chooses to wear gloves, he or she must change them between each patient encounter.
On October 17, 2009, The Lancet published a study that found that infants who received 3 doses of acetaminophen following immunization had reduced immune responses to certain vaccines. Based on these findings, should we stop recommending acetaminophen for fever or discomfort after infant immunizations?
Evidence from this study discourages the prophylactic use of paracetamol (acetaminophen) prior to or immediately following vaccination. Acetaminophen can be used to treat pain or fever if it should occur following vaccination. ACIP's 2011 General Recommendations on Immunization state: "Evidence does not support use of antipyretics before or at the time of vaccination; however, they can be used for the treatment of fever and local discomfort that might occur following vaccination. Studies of children with previous febrile seizures have not demonstrated antipyretics to be effective in the prevention of febrile seizures." For more information on this issue, see www.cdc.gov/mmwr/pdf/rr/rr6002.pdf (page 16).
What guidance is there for preventing patients from fainting after vaccination?
All providers who administer vaccinations should be aware of the potential for syncope (fainting) after vaccination and take appropriate measures to prevent it. Thus, clinicians should (1) make sure that people who are being vaccinated are always seated; (2) be aware of symptoms that precede fainting (weakness, dizziness, pallor, etc.); and (3) take appropriate measures to prevent injuries if such symptoms occur. [Note: IAC has two pertinent educational pieces for healthcare professionals: "Medical Management of Vaccine Reactions in Children and Teens" and "Medical Management of Vaccine Reactions in Adult Patients"].
Since 2005, VAERS has received an increasing number of reports of syncope, coinciding with the licensure of three vaccines for adolescents – HPV, meningococcal conjugate, and Tdap. Fainting among girls and young women ages 11-18 accounted for most of the increase. Serious injuries have occurred, including one fatality from intracranial hemorrhage caused by head trauma. The May 2, 2008, MMWR included a summary of findings on the increase in fainting after vaccination (see www.cdc.gov/mmwr/preview/mmwrhtml/mm5717a2.htm). In people for whom vaccination time and fainting time were reported, it was discovered that 80% occurred within 15 minutes of receiving the vaccine. Vaccine providers should strongly consider observing vaccinated people for 15 minutes after vaccination in accordance with ACIP General Recommendations (see www.cdc.gov/vaccines/pubs/acip-list.htm). This is particularly important when vaccinating adolescents and young adults.
CDC has posted frequently asked questions on this topic at http://www.cdc.gov/vaccinesafety/Concerns/syncope_faqs.html.
Are vaccine diluents interchangeable?
As a general rule vaccine diluents are not interchangeable. One exception is that the diluent for MMR can be used to reconstitute varicella vaccine, and vice versa. The diluent for both vaccines is sterile water for injection, and is produced by the same company. No other diluent can be used for MMR and varicella vaccines, and these diluents must not be used to reconstitute any other lyophilized vaccine.
If the wrong diluent is used, the vaccination will always need to be repeated. If an inactivated vaccine is reconstituted with the wrong diluent and is administered, the dose is invalid and should be repeated ASAP. If a live vaccine is reconstituted with the wrong diluent and is administered, the dose is invalid and if it can't be repeated on the same clinic day, it needs to be repeated no earlier than four weeks after the invalid dose. This spacing is due to the effects of generating a partial immune response that could suppress the live replication of subsequent doses, even of the same live vaccine.
I know that it is advisable to clean the vaccine vial stopper with an alcohol wipe after removing the protective cap from a vaccine or diluent vial. Do you have to wait for the alcohol to dry before you insert the needle in to the stopper?
The stopper of a single-dose vial is often assumed to be sterile. However, not all vaccine manufacturers guarantee the tops of unused vials are sterile, and the manner in which the cover over the stopper is removed can potentially contaminate the stopper. Therefore, using friction and a sterile alcohol pad to swab the stopper may help to assure aseptic technique in preparing the single-dose vial prior to inserting a sterile syringe. Alcohol evaporates quickly and will dry while the needle is being prepared for insertion into the vial.
In cleaning the vaccine vial stopper, is it okay to use a non-sterile cotton ball or do we need to use a pre-packaged sterile alcohol prep pad?
Using a pre-packaged sterile alcohol prep pad is recommended to maintain aseptic technique. Not only are cotton balls not sterile, but neither is a bottle of sterile alcohol, once it's opened.
Is it recommended to change needles after a vaccine dose has been drawn into a syringe?
No. Also, it is unnecessary to change the needle if it has passed through two stoppers, which is done when a lyophilized vaccine is reconstituted. Changing needles is a waste of resources and increases the risk of needle stick injury.
When patients need multiple vaccines (e.g., influenza and pneumococcal), can we just combine them in the same syringe?
Absolutely not. No vaccines should ever be mixed in the same syringe unless the combination has been specifically approved by the FDA. At present, only the combined DTaP and Hib vaccine (TriHIBit by sanofi) has been approved for mixing in the same syringe and only for the fourth dose.
Is it okay to draw up vaccines at the beginning of the shift? If it isn't, how much in advance can this be done?
The ACIP discourages the practice of prefilling vaccine into syringes, primarily because of the increased possibility of administration and dosing errors. An exception may be considered when only a single type of vaccine is to be administered during a clinic (e.g., influenza). Another reason to discourage the practice in general is that some vaccines have a very limited shelf life after reconstitution. If the reconstituted vaccine is not used within the designated time period, it must be discarded. A chart of the time allowed between reconstitution and use, "Vaccines with Diluents: How to Use Them," is available at www.immunize.org/catg.d/p3040.pdf. For more information on prefilling syringes, please read www.immunize.org/technically-speaking/20110901.asp.
If you place a needle on a pre-filled syringe and then don't administer the vaccine, how long can you store the pre-filled syringe with the needle attached?
In general, a vaccine should not be prepared until the provider is ready to administer it to a patient. This is because once the syringe cap is removed or a needle is attached, the sterile seal is broken. However, if a sterile seal has been broken, staff should be sure to maintain the syringe at the appropriate temperature and either use it or discard it at the end of the clinic day. CDC's Pink Book has a new chapter about vaccine storage and handling at www.cdc.gov/vaccines/pubs/pinkbook/downloads/vac-storage.pdf.
Do you need to aspirate before giving a vaccination?
No. ACIP does not recommend aspiration when administering vaccines because no data exist to justify the need for this practice. There are data that show that aspiration is more painful for the vaccine recipient. IM injections are not given in areas where large vessels are present. Given the size of the needle and the angle at which you inject the vaccine, it is difficult to cannulate a vessel without rupturing it and even more difficult to actually deliver the vaccine intravenously. We are aware of no reports of a vaccine being administered intravenously and causing harm in the absence of aspiration.
While giving an injection, a nurse had blood return in the syringe upon aspirating. What should she have done with the vaccine?
Although aspiration is no longer recommended, if you do aspirate and get a flash of blood, then the procedure is to withdraw the needle and start over. The syringe, needle, and contaminated dose of vaccine should be discarded in a sharps container, and a new syringe and needle should be used to draw up and administer another dose of vaccine. This is a waste of expensive vaccine that could be avoided by simply not aspirating.
When reconstituting a vaccine with the manufacturer-supplied diluent, should the clinic nurse administer exactly 0.5 mL and then discard the rest?
No. The nurse should administer the entire volume supplied. The package inserts include this information.
If some portion of a vaccine (e.g., influenza) leaks out of the syringe while it is injected into a patient, does the dose need to be repeated and if so, when?
When this happens, it is difficult to judge how much vaccine the person received. This would be a nonstandard dose and should not be counted. You should go ahead and re-immunize the individual at that time.
A child wiggled when we were injecting a dose of vaccine, and approximately half the dose was lost. Should we revaccinate the child? If so, when?
When injectable vaccine volume is lost (patient moves, syringe leaks), it may be difficult to judge how much vaccine the patient actually received. In general, you should treat this as a nonstandard injectable dose and should not count it. If it was an inactivated vaccine, you should re-immunize the person as soon as possible. If it was a live vaccine, you can give another dose if you detect the error on the same clinic day; otherwise you should wait 28 days to give the next dose. However, if part of a dose of an oral vaccine (rotavirus) was spit out, count the dose and do not administer a second dose.
What should we do if a dose of expired vaccine is given to a patient?
The dose should be repeated. If the expired dose is a live virus vaccine, you should wait at least 4 weeks after the previous (expired) dose was given before repeating it. If the expired dose is not a live vaccine, the dose should be repeated as soon as possible. If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, rubella, hepatitis A, polio, diphtheria, and tetanus).
Why are some vaccinations given subcutaneously while others must be given intramuscularly?
In general, vaccines containing adjuvants (a component that enhances the antigenic response) are administered IM to avoid irritation, induration, skin discoloration, inflammation, and granuloma formation if injected into subcutaneous tissue. This includes most of the inactivated vaccines, with a few exceptions (e.g., IPV and pneumococcal vaccines may be given either SC or IM). Vaccine efficacy may also be reduced if not given by the recommended route.
What should we do if we give an injection by the wrong route (e.g., IM instead of SC)?
Vaccines should always be given by the route recommended by the manufacturer because data regarding safety and efficacy of alternate routes are limited. If this does inadvertently happen, ACIP recommends that vaccines given by the wrong route be counted as valid with three exceptions: hepatitis B or rabies vaccine given by any route other than IM and HPV given by SC rather than IM route should not be counted as valid and should be repeated. This and other information on vaccine administration is discussed in the ACIP "General Recommendations on Immunization".
One of our staff gave a dose of pediatric hepatitis A vaccine to an adult patient by mistake. How do we remedy this error?
In general, if you give less than a full age-appropriate dose of any vaccine, the dose is invalid. You should revaccinate the person with the appropriate dose as soon as feasible.
There are, however, two exceptions to the general rule: (1) If a patient sneezes after receiving nasal-spray live attenuated influenza vaccine, count the dose as valid. (2) If an infant regurgitates, spits, or vomits during or after receiving oral rotavirus vaccine, count the dose as valid.
If you give more than an age-appropriate dose, count the dose as valid and notify the patient/parent about the error. Using larger than recommended dosages can be hazardous because of excessive local or systemic concentrations of antigens or other vaccine constituents.
Avoid such errors by checking the vaccine vial label 3 TIMES!
Which vaccines may be given simultaneously?
All vaccines used for routine* vaccination in the United States may be given simultaneously (i.e., at the same visit, not in the same syringe). There is no evidence that simultaneous administration of vaccines either reduces vaccine effectiveness or increases the risk of adverse events. If you miss giving recommended vaccines at the same visit, any inactivated vaccine (e.g., DTaP, Tdap, HPV) can be administered any time before or after a different inactivated or live vaccine (e.g., MMR, VAR, LAIV). Any 2 live vaccines not given at the same time must be given at least 4 weeks apart.
*There are 3 NONROUTINE exceptions to the 'simultaneous' rule: a) If you need to give *both* PCV13 and PPSV23 to a high-risk patient, these 2 vaccines should not be given simultaneously. Give PCV13 first and then wait 8 weeks before giving PPSV23. If PPSV has already been given, wait 8 weeks (for a child) or 1 year (for an adult age 19+) before giving PCV13 to avoid interference between the 2 vaccines. b) When a child with anatomic or functional asplenia needs meningococcal vaccine, he should first be caught up with PCV13 before you vaccinate him with MCV4. If you are going to give him MCV4-D (Menactra; sanofi pasteur), you need to wait at least 4 weeks after he completes the PCV13 series before giving him the MCV4-D. There is no similar space consideration if MCV4-CRM (Menveo; Novartis) is used; it may be given simultaneously with PCV13 or at any interval since receipt of PCV13. c) Varicella and smallpox vaccines should not be given together, which is a situation that will almost never come up anyway.
What does "simultaneous administration of vaccines" mean? Does it mean the same day, hour, or what?
Simultaneous means the same day—the same clinic day. If someone receives a vaccine in the morning and then another that same afternoon, it would be considered simultaneous administration.
One of our nurses accidentally gave Zostavax IM instead of SC. What do we need to do?
You can count the dose as valid. ACIP recommends that vaccines given by the wrong route be counted as valid with three exceptions: hepatitis B or rabies vaccine given by any route other than IM and HPV given by SC rather than IM route should not be counted as valid and should be repeated. Vaccines should always be given by the route recommended by the manufacturer, but errors do occur. Your practice should put procedures in place to ensure that you give vaccines by the recommended route.
What length of needle should be used to give infants IM injections? One of our clinical coordinators says a 1" needle and another says a 5/8" needle.
ACIP recommends that a 5/8" needle may be used to administer IM injections in a newborn or premature infant only if the skin is stretched tight and the subcutaneous tissues are not bunched. For infants age 1 month or older, IM injections should be given in the anterolateral thigh with 1" needle. For a detailed discussion of needle length and injection sites, refer to the ACIP's "General Recommendations on Immunization."
If I have to give more than 1 injection in a muscle, are certain vaccines best given together?
Since DTaP and pneumococcal conjugate are the vaccines most likely to cause a local reaction, it's practical to give DTaP and PCV in separate limbs (if possible), so there is no confusion about which vaccine caused the reaction.
When we have to give multiple injections, can we give two in the same limb?
If a patient requires more than one vaccine, ACIP and AAP consistently recommend administering all needed vaccines during a single office visit (unless there are contraindications or precautions). If you have the option of giving the vaccines in different anatomic sites, do so. If you need to give multiple injections in the same limb, separate two intramuscular injections by 1 inch or more in the body of the muscle, if possible, to reduce the likelihood of local reactions overlapping. Likewise, separate two subcutaneous injections by 1 inch or more in the fatty tissue.
Is it safe to give a vaccine directly into an area where there is a tattoo?
Both IM and SC vaccines may be given through a tattoo.
We run a student health center and are wondering what the position is on discarding empty vaccine vials. Do they need to go in a sharps container after they are drawn up or can they go in the trash?
Empty or expired vaccine vials are considered medical waste and should be disposed of according to state regulations.
Regarding persons with health conditions Back to top
Which vaccines are contraindicated if a child is breast-feeding?
Breast-feeding is not a contraindication to the administration of any routinely recommended vaccine, either to the mother or to the child.
Which vaccines are contraindicated if a child's mother or other household member is pregnant?
Having a pregnant woman in a household, including the child's mother, is not a contraindication to administration of any routinely recommended vaccine.
Is it acceptable practice to administer MMR, Tdap, and influenza vaccines to a postpartum mom at the same time as administering RhoGam?
Yes. Receipt of RhoGam is not a reason to delay vaccination. See page 9 of CDC's General Recommendations on Immunization at www.cdc.gov/mmwr/pdf/rr/rr6002.pdf.
For how long should a woman of child-bearing age avoid pregnancy after receiving a live attenuated vaccine?
Due to theoretical risks to the developing fetus, ACIP recommends that women avoid pregnancy for four weeks after receiving a live attenuated vaccine (e.g., MMR, varicella, LAIV). This interval may be shorter than that recommended by the manufacturer.
Is there a risk for a pregnant staff person administering live-virus vaccines?
A pregnant woman may administer any vaccine except smallpox vaccine.
Which vaccines are recommended to be given postpartum to mothers of newborns before hospital discharge?
The following vaccines are recommended for new mothers before they leave the hospital: (1) women without documentation of previous Tdap vaccination need a dose to protect themselves and their newborn; (2) women who did not receive influenza vaccination during pregnancy need to be vaccinated if it is still influenza vaccination season (October through March); (3) women who tested susceptible to rubella on prenatal testing need MMR vaccine even if they have 1 or 2 documented doses of MMR in their medical record; (4) women who are not immune to chickenpox need 2 doses of varicella vaccine, dose #1 before hospital discharge and dose #2 given 4–8 weeks after dose #1.
Is there any reason to delay or adjust the immunization schedule for children with Down syndrome?
No. Children with Down syndrome should receive all indicated vaccines on the recommended schedule. These children are often at greater risk for complications from vaccine-preventable diseases than are children without Down syndrome.
Do people who received chemotherapy need their vaccines repeated?
Vaccines received before starting chemotherapy do not need to be repeated after chemotherapy is completed. Chemotherapy does not negate vaccine-induced immunity. However, revaccination is recommended for people who are recipients of a hematopoietic stem cell transplant (HSCT), such as a bone marrow transplant, because immunity present before the transplant is lost and may not be replaced by donor cells.
Which vaccinations should be given to a patient who is a recipient of hematopoietic stem cell transplantation (HCT)?
Antibody titers to vaccine-preventable diseases decline during the 1-4 years after HCT, if the recipient is not revaccinated. HCT recipients are at increased risk for certain vaccine-preventable diseases, including those caused by encapsulated bacteria. In short, all HCT recipients should begin revaccination with inactivated vaccines 6 months after HCT Three doses of PCV13 should be given 6 months following transplant followed by a dose of PPSV23. A 3-dose series of Hib vaccine should also be given beginning at 6 months following transplant. A one month interval between these doses is reasonable. Immunocompetent people should receive MMR 24 months after transplant. For a complete discussion of the indications and schedule of vaccination, refer to the ACIP's "General Recommendations on Immunization," pages 22-23.
Should vaccines be withheld for patients on steroids?
Steroid treatment, and possible immunosuppression, is only a concern with live vaccines. Steroid therapies that are short term (less than 2 weeks); alternate-day; physiologic replacement; topical (skin or eyes); aerosol; or given by intra-articular, bursal, or tendon injection are not considered contraindications to the use of live virus vaccines. The immunosuppressive effects of corticosteroid treatment vary, but many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg per day of prednisone for 2 or more weeks as sufficiently immunosuppressive to raise concern about the safety of vaccination with live virus vaccines (e.g., MMR, varicella, LAIV, yellow fever). Providers should wait at least 1 month after discontinuation of therapy or reduction of dose before administering a live virus vaccine to patients who have received high systemically absorbed doses of corticosteroids for 2 weeks or more. Inactivated vaccines and toxoids can be administered to all immunocompromised patients in usual doses and schedules, although the response to these vaccines may be suboptimal.
What vaccines are indicated for someone who has had a splenectomy, and is there concern that they may have a less than optimum response to vaccines?
Regarding which vaccines are indicated: People who do not have a functioning spleen or who have had a splenectomy do not handle encapsulated bacteria well and, therefore, are at increased risk for infection with encapsulated bacteria, especially Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type b. They should be vaccinated with age-appropriate pneumococcal vaccines (PCV13 and PPSV23), meningococcal, and possibly Hib vaccines.
Regarding immune response to vaccines: Immunosuppression is not an issue unless the patient has other health issues or treatments that are suppressing the immune system. Their response to vaccination should not be affected by the lack of a functioning spleen.
In addition to receiving their routine vaccinations, children and adults without a functioning spleen who are age 2 years and older should receive 1 dose of pneumococcal polysaccharide vaccine (PPSV23) and for adults, 1 dose of pneumococcal conjugate vaccine (PCV13), and 1 dose of quadrivalent meningococcal conjugate vaccine (MCV4). However, if the person is age 56 years or older, give meningococcal polysaccharide vaccine (MPSV4). If the person is a child age 2 through 4 years who has recently been vaccinated with pneumococcal conjugate vaccine (PCV13), wait at least 8 weeks following PCV13 before giving PPSV23. Although Haemophilus influenzae type b (Hib) vaccine generally is not recommended for people age 5 years and older, studies suggest good immunogenicity in patients who have had a splenectomy. Giving 1 pediatric dose of Hib vaccine to these patients who have not previously received Hib vaccine is not contraindicated. Ideally, PPSV23, meningococcal, and Hib vaccines should be administered at least 2 weeks before a scheduled splenectomy, if possible. If vaccines are not administered before surgery, they should be administered as soon as the person's condition stabilizes post-operatively.
Should you administer vaccine to a child who is taking antibiotics?
Treatment with antibiotics is not a valid reason to defer vaccination. If the child or adult is otherwise well, or has only a minor illness, vaccines should be administered. But if the person has a moderate or severe acute illness (regardless of antibiotic use) one should defer vaccination until the person's condition has improved.
What vaccines can a patient with severe combined immunodeficiency disease (SCID) receive?
Patients with SCID may be given inactivated vaccines (e.g., DTaP, Hib, hepatitis B, IPV, injectable influenza, and, if indicated, pneumococcal and hepatitis A). They should not be given live virus vaccines (e.g., intranasal influenza, MMR, oral polio, rotavirus, and varicella).
We frequently see patients who are febrile or have an acute illness and are due for vaccinations. We're never quite sure if we should withhold the vaccines or not. What do you advise?
A "moderate or severe acute illness" is a precaution for administering any vaccine. A mild acute illness (e.g., diarrhea or mild upper-respiratory tract infection) with or without fever is not. The concern in vaccinating someone with moderate or severe illness is that a fever following the vaccine could complicate management of the concurrent illness (that is, it could be difficult to determine if the fever was from the vaccine or due to the concurrent illness). In deciding whether to vaccinate a patient with moderate or severe illness, the clinician needs to determine if forgoing vaccination will increase the patient's risk to vaccine-preventable diseases, as is the case if the patient is unlikely to return for vaccination or to seek vaccination elsewhere.
Documentation issues Back to top
Where can I find a list of vaccines currently licensed for use in the U.S.?
CDC maintains a sortable list of vaccine names at www.cdc.gov/vaccines/about/terms/USVaccines.html.
When we are giving multiple injections in a limb, what is the best way to accurately document the injection site? It is not unusual for us to give 4-6 injections to each infant/child that we see, and I want to ensure that we are doing this safely and documenting it adequately.
One way to handle this is to indicate if the vaccination was given either in the "upper" or "lower" portion of the injection area selected (e.g., DTaP: right thigh, upper; Hib: right thigh, lower; or PCV13: left thigh, upper; HepB: left thigh, lower). It is helpful if everyone in your office or clinic uses the same sites for each vaccine. Use of a standardized site map can facilitate this. Here are some helpful site maps for different ages so you can record where shots were given:
We frequently see patients who do not have records of past vaccination (e.g., new immigrants) or who insist they or their children are up to date. Should we go ahead and give vaccinations anyway or is there a concern for "over immunization?"
Vaccination providers frequently encounter people who do not have adequate documentation of vaccinations. Providers should only accept written, dated records as evidence of vaccination. With the exception of influenza vaccine and pneumococcal polysaccharide vaccine (PPSV), self-reported doses of vaccine without written documentation should not be accepted. An attempt to locate missing records should be made whenever possible-by contacting previous healthcare providers, reviewing state or local immunization information systems, and searching for a personally held record. However, if records cannot be located or will definitely not be available anywhere because of the patient's circumstances, children without adequate documentation should be considered susceptible and should be started on the age-appropriate vaccination schedule. Serologic testing for immunity is an alternative to vaccination for certain antigens (e.g., measles, rubella, hepatitis A, polio, diphtheria, and tetanus).
In general, although it is not ideal, receiving extra doses of vaccine poses no medical problem. Receiving excessive doses of tetanus toxoid (e.g., DTP, DTaP, DT, Tdap, or Td) can increase the risk of a local adverse reaction, however. For details, consult CDC's "General Recommendations on Immunization".
We sometimes encounter patients with foreign vaccination records. Sometimes we suspect the record isn't valid. What should we do?
If a provider suspects an invalid vaccination record in any person vaccinated outside the U.S., one of two approaches can be taken. Repeating the vaccinations is an acceptable option. Doing so is usually safe and avoids the need to obtain and interpret serologic tests. If avoiding unnecessary injections is desired, judicious use of serologic testing might be helpful in determining which immunizations are needed. This may be particularly helpful in determining tetanus and diphtheria antitoxin levels for children whose records indicate 3 or more doses of DTP or DTaP. This issue is discussed in the ACIP's "General Recommendations on Immunization".
Where can I find names of vaccines used outside the U.S.?
Appendix B of the CDC publication Epidemiology and Prevention of Vaccine-Preventable Diseases ("The Pink Book") contains a list of vaccines used outside the U.S. You'll find Appendix B at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/foreign-products-tables.pdf.
Since the Health Insurance Portability and Accountability Act (HIPAA) went into effect, we are unsure if we can share immunization information on our pediatric patients with staff in schools or daycare facilities.
Healthcare providers (or other covered entities) may share immunization information with schools or daycare facilities, without authorization, if permitted or required by state law. These state laws would not be preempted by the HIPAA Privacy Rule [45 CFR 160.203(c)].
If a patient or parent refuses recommended vaccinations, is it necessary for them to sign a refusal form, or is the provider's documentation sufficient?
There is no national law requiring such documentation. Several major medical organizations, including the American Academy of Pediatrics, have stated that healthcare providers may decide it is in their best interest to formally document a parent's refusal to accept vaccination for their (minor) child. To read a discussion on this topic and to access a prototype refusal form, see "Decision to not vaccinate my child" that can be accessed at www.immunize.org/catg.d/p4059.pdf.
Is a parent signature required for vaccination?
Federal law does not require parent signatures, but state or local requirements may apply. Providers should check with their state immunization program to determine whether additional requirements exist under state law. For information on state contacts, go to www.immunize.org/coordinators.
If my state has a registry, do I still need to give patients vaccine record cards?
Yes. Patient-held cards are an extremely important part of a person's medical history. The person may move to an area without a registry, and the personal record may be the only vaccination record available. In addition, even within a state, all healthcare providers may not participate in the registry, and the personal record card would be needed.
Vaccine safety issues Back to top
Some parents are requesting that we space out their infant's vaccinations because they are concerned that receiving multiple vaccinations at a single office visit might overwhelm the infant's immune system. What do you think about using alternative schedules?
Vaccine recommendations are determined after extensive studies in large clinical trials. They include studies on how vaccine recipients respond to multiple vaccines given simultaneously. The overall aim is to provide early protection for infants and children against vaccine-preventable diseases that could endanger their health and life. No scientific evidence exists to support that delaying vaccinations or separating them into individual antigens is beneficial for children. Rather, this practice prolongs susceptibility to disease, which could result in a greater likelihood of the child becoming sick with a serious or life-threatening disease. There could also be added expense (e.g., multiple office visits), additional time off from work for parents, and increased likelihood that the child will fail to get all necessary vaccinations.
Many of my patients are reading The Vaccine Book, in which the author, Dr. Robert W. Sears, cites studies that he interprets as showing that the amount of aluminum found in certain vaccines might be unsafe. He thinks it is better to separate aluminum-containing vaccines, rather than give them according to the recommended U.S. immunization schedule. I would love any information you have about this.
Paul Offit, MD, and Charlotte Moser, BS, of the Vaccine Education Center (VEC) at the Children's Hospital of Philadelphia, published an article, "The Problem with Dr. Bob's Alternative Vaccine Schedule," in the January 2009 issue of Pediatrics. It includes a section about aluminum. You can read it in its entirety at http://pediatrics.aappublications.org/cgi/content/full/123/1/e164.
Here are some additional sources of related information:
"Aluminum in Vaccines: What you should know" is available from VEC at www.chop.edu/export/download/pdfs/articles/vaccine-education-center/aluminum.pdf.
"Vaccine Ingredients: What you should know" is available from VEC at www.chop.edu/export/download/pdfs/articles/vaccine-education-center/vaccine-ingredients.pdf.
"Questions and Answers about Vaccine Ingredients" is available from the AAP at www.aap.org/immunization/families/faq/Vaccineingredients.pdf.
Does the thimerosal in some of the injectable influenza vaccines pose a risk?
Thimerosal, a very effective preservative, has been used to prevent bacterial contamination in vaccine vials for more than 50 years. It contains a type of mercury known as ethylmercury, which is different from the type of mercury found in fish and seafood (methylmercury). At very high levels, methylmercury can be toxic to people, especially to the neurological development of infants.
In recent years, several large scientific studies have determined that thimerosal in vaccines does not lead to neurologic problems, such as autism. Nonetheless, because we generally try to reduce people's exposure to mercury if at all possible, vaccine manufacturers have voluntarily changed their production methods to produce vaccines that are now free of thimerosal or have only trace amounts. They have done this because it is possible to do, not because there was any evidence that the thimerosal was harmful.
A patient has expressed concern that some vaccines have been produced in fetal tissue. How can I address this concern?
The production of a few vaccines, including those for varicella, rubella, and hepatitis A, involves growing the viruses in human cell culture. Two human cell lines provide the cell cultures needed for producing vaccines; these lines were developed from two legally aborted fetuses in the 1960s. These cell lines are maintained to have an indefinite life span. No fetal tissue has been added since the cell lines were originally created.
Some parents are concerned about this issue because of misinformation they have encountered on the Internet. Two such untrue statements are that ongoing abortions are needed to manufacture vaccines and vaccines are contaminated with fetal tissue. Parents can read the facts and several thought-provoking articles about this issue at www.immunize.org/concerns/religious.asp and then make an informed decision.
A Catholic bishop's statement that Catholic parents have no general obligation to refuse permission for these vaccines can be accessed at www.cdc.gov/vaccines/vac-gen/laws/rubella-cathnews.htm.
Where can I find more information to help address my patients' concerns about vaccine safety?
Where can I find more information to help address my patients' concerns about vaccine safety?
There are many excellent websites that have information about vaccine safety, including the American Academy of Pediatrics, the CDC, Every Child by Two,
Immunization Action Coalition, the National Network for Immunization Information, the Institute of Medicine, and the Vaccine Education Center, Children's
Hospital of Philadelphia.
Federal requirements regarding vaccines Back to top
Please explain the federal requirements imposed on all healthcare providers under the National Childhood Vaccine Injury Act that administer vaccines?
The National Childhood Vaccine Injury Act (NCVIA), enacted in 1986, set forth 3 basic requirements for all vaccination providers, which are:
Providers must give the patient (or parent/legal representative of a minor) a copy of the relevant federal "Vaccine Information Statement" (VIS) for the vaccine they are about to receive.
Providers must record certain information about the vaccine(s) administered in the patient's medical record or a permanent office log.
Providers must document any adverse event following the vaccination that the patient experiences and that becomes known to the provider, whether or not it is felt to be caused by the vaccine, and submit the report to the Vaccine Adverse Event Reporting System (VAERS).
Which vaccines are covered by NCVIA?
As of January 2013, NCVIA requirements apply to diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), varicella, influenza, pneumococcal conjugate, meningococcal, rotavirus, and human papillomavirus (HPV) vaccine.
Where can I get instructions on how, why, and when to use the federally-mandated VISs?
Instructions on the use of VISs and many additional items are available on the CDC website at www.cdc.gov/vaccines/pubs/vis/default.htm or from your state immunization program. You can also visit IAC's website at www.immunize.org/vis for links to many important documents about the use of VISs.
When are Vaccine Information Statements (VISs) released for new vaccines?
An interim Vaccine Information Statement (VIS) can sometimes be released soon after licensure of the vaccine or after the official vote by ACIP is taken. The interim VIS is not replaced with a final version until the ACIP recommendations have been published and the new VIS has been developed according to legally-mandated procedures.
Is it required to use a VIS in an emergency room when we give Td/Tdap to a patient?
Yes. The National Childhood Vaccine Injury Act requires that a VIS be given to people of any age before they receive a dose of any vaccine included in the Act. Tetanus and diphtheria toxoids (and pertussis vaccine) are included in the Act. If the patient is unaccompanied and unable to clearly read and understand the information in the VIS (e.g., unconscious), this should be noted in the patient's chart.
Does the federal law that requires providing patients with VISs apply when administering influenza vaccine to employees and volunteers in hospitals or other workplaces?
Yes. Employees and volunteers are considered patients, and you need to provide them with a VIS. If a vaccine is covered under the National Childhood Vaccine Injury Act—and almost all vaccines routinely administered to adults are (with the exception of PPSV and zoster)—it is mandatory under federal law to give the VIS for that vaccine to the vaccinee. Therefore, when you give influenza vaccine to employees and staff, you are required by law to provide them with a VIS.
You can find more details about the requirements for using VISs at www.cdc.gov/vaccines/pubs/vis/downloads/vis-Instructions.pdf. For VISs in multiple languages, go to www.immunize.org/vis.
Our large pediatric practice is struggling with the requirement to provide VISs to the parents of every child we vaccinate. We think we have a solution and would like your opinion of it. We would like to create a re-usable packet of laminated VIS sheets (fastened together on a ring). We plan to place a packet in each exam room for parents to read prior to vaccine administration. On the bottom of each sheet would be a statement, "If you would like a copy of this sheet to take home, please ask our staff." This will ensure that parents are given the VIS sheets to read prior to vaccine administration. It will also help save paper; our experience is that many parents throw out the VIS documents or leave them behind in the waiting room.
Many clinicians are looking for ways to reduce paper overload, so this is a common question. Your solution will meet the spirit of the federal law, as long as you make sure to encourage the patient (or parent) to take home a paper copy of the VIS and to refer to it if needed (e.g., if they need to know what to do if there is an adverse event or how to contact VAERS). Patients can also download VISs onto mobile devices. For more information about this technology, go to www.cdc.gov/vaccines/pubs/vis/vis-downloads.htm.
We operate an acute care hospital and commonly give vaccinations to our employees and patients. Are we required to use Vaccine Information Statements (VISs), or does that apply only to patients seen in outpatient settings?
VISs must be given to all people, including adults, before administering HPV, Td, Tdap, MMR, varicella, hepatitis A, hepatitis B, meningococcal, influenza, or polio vaccine. This includes Td, Tdap, MMR, varicella, hepatitis A, hepatitis B, influenza, and others. Current VISs are available from the CDC's website at www.cdc.gov/vaccines/pubs/vis and from the Immunization Action Coalition's (IAC) website at www.immunize.org/vis. You'll also find many VIS translations on IAC's website at www.immunize.org/vis.
When using VISs and providing vaccines, is a parent/guardian signature required?
No. There is no federal requirement for signed consent for any dose of vaccine. The federal requirement is to provide all adult patients or parents/legal representatives of minor children with the appropriate VIS for each dose of vaccine administered. Federal law also requires that you record the date you gave the VIS to the patient or minor child's parent/legal representative and the edition date of the VIS, among other items, in the patient's medical record. Some clinics, agencies, and/or state immunization programs may have requirements for signatures. Contact information for your state health department is available at www.immunize.org/coordinators.
I'm unclear about when to use the multi-vaccine VIS versus the individual VISs.
The multi-vaccine VIS is a 4-page alternative VIS that you can use in place of the individual VISs for any or all of the 6 vaccines routinely given to infants (i.e., DTaP, IPV, Hib, PCV, HepB, and rotavirus). It is not designed to be used with adolescents or adults (risk factors that apply only to older people are not included on this VIS). Use of this VIS saves paper and staff time. When giving the multi-vaccine VIS to a parent, check the boxes on the first page that correspond to the vaccines you plan to administer at the current visit. The multi-vaccine VIS, as well as all other VISs in English and more than 35 languages, are available on IAC's website at www.immunize.org/vis. English-language VISs are available on CDC's website at www.cdc.gov/vaccines/pubs/vis.
Where can I get VISs for some of the newer combination vaccines?
CDC currently has no plans to develop VISs for Pediarix, Comvax, Twinrix, TriHIBit, Kinrix, or Pentacel. When administering these combination vaccines, use the VISs for all component vaccines. For certain combination vaccines given to children, you can use the multi-vaccine VIS and check the appropriate box(es), just as you would if you were administering the individual vaccines. A VIS was developed for MMRV vaccine because of its unique adverse reaction profile.
It seems CDC is changing the format of VISs. Do we have to throw our old supply away and use the new ones?
Not necessarily. CDC is in the process of re-releasing all VISs in a slightly modified format. The modified VISs have a consistent look and use consistent language in the sections common to all VISs. Modified VISs will not necessarily be new, but may simply be redesigned versions of existing VISs and have the same edition dates as existing VISs. Providers do not need to discard their existing VIS stocks when nothing but the VIS format has been changed. CDC posts information on its website to alert healthcare providers when the older version of a VIS should not be used. This information is available on CDC's web section titled What's New with VISs, available at www.cdc.gov/vaccines/hcp/vis/what-is-new.html.
Why does CDC include 2D barcodes on VISs now?
As part of a modernization initiative, CDC began adding barcodes to VISs in April 2012. The addition of the barcode is intended primarily to help immunization providers save time by allowing them to scan certain required information about the VIS (for example, the name and edition date of the VIS) into an electronic medical record, immunization information system, or other electronic database. Scanning the barcode instead of manually recording the information is optional.
Using barcodes requires a 2D barcode scanner and software that is programmed to accept and process data contained in the VIS barcodes. Providers may continue to use any VISs they printed before CDC started adding barcodes as long as the VIS content is otherwise the same. See the next question for more information about discarding old VISs. For more information about barcodes and scanning, visit www.cdc.gov/vaccines/hcp/vis/barcodes.html.
By law, when vaccinating adults or children, when and to whom is it required to give Vaccine Information Statements (VISs)?
The National Childhood Vaccine Injury Act requires that a VIS must be given to parents, legal representatives, or adult patients before administering the vaccine. A VIS must be provided prior to each dose, not just the first. Providers should be sure they are using the most current version of each VIS. Current VISs and their dates are available from on the CDC's website at www.cdc.gov/vaccines/pubs/vis/default.htm#download and from IAC's website at www.immunize.org/vis.
Where can I get foreign language VISs?
CDC publishes VISs in English only; all translations have been developed by others. To access all currently available VISs in more than 35 languages and links to some alternative formats (audio/video), go to IAC's website at www.immunize.org/vis.
What is the Vaccine Adverse Event Reporting System (VAERS)?
As the name implies, VAERS is a nationwide system for monitoring adverse events following vaccination. VAERS is operated jointly by the FDA and the CDC, and became fully operational in November 1990.
How do I report an adverse event to VAERS?
A standardized form is used to report to VAERS. The report forms and instructions, or a copy of the Vaccine Injury Table, may be obtained directly from VAERS by calling (800) 822-7967. The forms may also be obtained from your state immunization program, the FDA Drug Bulletin, the AAP's Red Book, and the Physician's Desk Reference.
If a patient faints following vaccination, should we submit a report to the federal Vaccine Adverse Event Reporting System (VAERS)?
Yes. Any occurrence of medical significance warrants a VAERS report. VAERS looks for trends, so such information is helpful. You can obtain more information about VAERS at http://vaers.hhs.gov or by calling (800) 822-7967.
How do I decide whether to report an adverse event to the Vaccine Adverse Events Reporting System (VAERS)?
All significant health events that may have been related to a dose of vaccine, particularly those that lead to hospitalization, disability, or death, should be reported to VAERS. The healthcare provider doesn't need to be certain the event was vaccine related in order to report it. It is not necessary to report minor adverse reactions, such as local reactions or low-grade fever.
Vaccine and vaccination resources Back to top
How can we quickly locate the most important recent publications (e.g., FDA licensures) and announcements about immunization issues?
Visit www.immunize.org/newreleases for IAC's chronological list of these events. Also, be sure to sign up for IAC Express to receive weekly email updates and links to newly released publications by going to www.immunize.org/subscribe.
We want to make sure that all our staff who administer vaccines are well trained. Is there a good tool we can use as a refresher?
One of the best resources available today is the DVD "Immunization Techniques: Best Practices with Infants, Children, and Adults." You can order this from IAC. Other good materials in print are available from IAC, including "How to Administer IM and SC Injections" which can be found at www.immunize.org/handouts.
What are the best places to get answers to my questions about immunization?
There are many excellent sources of information available for health professionals as well as the public. You can get a personal response to your questions regarding vaccines and practice issues by contacting immunization staff at your local or state health department.
You'll find answers to almost all questions about vaccines and the diseases they prevent by reading the appropriate ACIP statement. Although these may appear to be overwhelming documents, they are all organized in much the same manner and are easy to navigate and understand. Every office or clinic providing vaccinations should have a copy of all relevant ACIP statements for easy reference. IAC maintains an online library of ACIP statements at www.immunize.org/acip. You can also download them from CDC's website at www.cdc.gov/vaccines/pubs/acip-list.htm.
What are some of the most commonly used references for information about immunization for healthcare professionals who want to get answers on their own?
The following are some basic resources for anyone providing immunization services.
ACIP's "General Recommendations on Immunization" To obtain a ready-to-print (PDF) version, go to www.cdc.gov/mmwr/PDF/rr/rr6002.pdf.
All ACIP recommendations can be accessed on CDC's website at www.cdc.gov/vaccines/pubs/ACIP-list.htm or from IAC's website at www.immunize.org/acip.
The American Academy of Pediatrics' vaccine policy statements can be found on IAC's website at www.immunize.org/aap.
CDC's "Pink Book" To read or download this book as a whole or by chapter, go to. www.cdc.gov/vaccines/pubs/pinkbook/index.html
CDC's immunization schedules for infants, children, adolescents, and adults To access the schedule(s) of your choice, including catch-up schedules that contain minimum intervals, go to www.cdc.gov/vaccines/index.htm.
"Ask the Experts" To read IAC's collection of challenging questions answered by CDC experts, go to www.immunize.org/askexperts.
"Immunization Techniques: Best Practices for Infants, Teens, and Adults" This DVD was developed by the California Department of Health Services and is available for sale on IAC's website at www.immunize.org/shop.
Where can I get immunization education materials to hand out to my patients?
Many excellent websites offer easy-to-access, patient-friendly materials on vaccines and vaccine-preventable diseases. Here are just a few: the Centers for Disease Control and Prevention; American Academy of Pediatrics; Immunization Action Coalition; National Network for Immunization Information; and Vaccine Education Center at Children's Hospital of Philadelphia.
Where can I find the most up-to-date information about vaccine shortages?
The vaccine shortage/supply situation changes frequently. The most current information can be found at www.cdc.gov/vaccines/vac-gen/shortages/default.htm.
Miscellaneous Back to top
Can vaccinations be given without a physician's order?
Vaccines must always be dispensed with a prescription or order from a physician or other healthcare provider authorized by the state to prescribe medications. However, there are situations where vaccines can be administered under a standing order or vaccine protocol that is not patient-specific. In these situations, a physician or other healthcare provider does not need to be physically present for the vaccine to be administered. Several studies have shown that the use of standing orders can improve vaccination rates, and ACIP recommends the use of standing orders programs in both outpatient and inpatient settings. A comprehensive set of standing orders for most all vaccines given to children and adults can be found at www.immunize.org/standingorders
How can I find out if our state or locality has an automated immunization information system (IIS) in which I might participate?
Many states have made significant progress in the development of automated immunization information systems (IISs). Much of this information is available from the American Immunization Registry Association (AIRA) at www.immregistries.org AIRA provides a forum through which IIS programs, as well as interested organizations, individuals, and communities combine efforts and share knowledge that promotes IIS activities as a resource for both IISs and immunization programs. To view the current status of IIS development in your state, simply go to AIRA's Registry Profiles and click on a state on the map to bring up a list of IISs in that state. Clicking on an IIS will display all sorts of information about that IIS, including programmatic and technical contact information. If you would like to participate, contact your state health department immunization program. Phone numbers are available at www.immunize.org/coordinators.
Where can I get the most up-to-date information on vaccination recommendations for people who travel outside the U.S.?
You can get this information from CDC's Travel Health website at wwwn.cdc.gov/travel/default.aspx CDC also publishes Health Information for International Travel (a.k.a. "Yellow Book") every two years as a reference for those who advise international travelers of health risks. The Yellow Book is written primarily for healthcare providers, although others might find it useful. To order a copy of the Yellow Book from Elsevier Publishing, visit their website at www.elsevierhealth.com or call (800) 545-2522 and ask for ISBN# 978-0-7020-3481-7.
Who is responsible for reporting cases of vaccine-preventable diseases to the state? Which cases are reportable?
Reporting requirements vary from state to state but, in general, the responsibility for submitting a disease report is with the provider who diagnoses the disease. Most states prefer to receive reports of suspected as well as confirmed diseases, particularly for diseases in which prompt containment activities are needed to prevent further spread of the disease (e.g., measles, pertussis). While some diseases (e.g., measles, pertussis) are reportable in all states, some diseases are not. Your state health department can supply a list of reportable diseases and specific reporting procedures.
Why aren't people in the United States vaccinated with BCG?
BCG vaccine is used in countries of high endemicity to help prevent tuberculosis disease. A more effective strategy for the prevention of tuberculosis in countries where the endemicity is low is to identify infected people through tuberculin skin test screening, and eliminate the infection with anti-tuberculous drugs. This is the strategy used in the United States.
What is the Vaccines for Children (VFC) program?
VFC is a program designed to reduce or eliminate vaccine cost as a barrier to childhood vaccination. The program purchases vaccines from manufacturers at federal contract prices and provides them at no cost to participating public and private healthcare providers for use in children through age 18 years who are eligible for Medicaid, are uninsured, or are American Indian or Native American. Children whose health insurance benefit plan does not cover a particular VFC vaccine are also able to receive VFC vaccine at a Federally Qualified Health Center (FQHC) or Rural Health Clinic (RHC). If you are interested in becoming a VFC provider, you should contact your state immunization program. For more information on the VFC program in general, go to the CDC's website at www.cdc.gov/vaccines/programs/vfc/index.html.
If a child isn't covered by health insurance but the parent plans to get insurance, is the child eligible for VFC vaccine?
If the child has no health insurance on the day he or she presents at a medical practice or health department for immunization, the child is VFC eligible because he or she is uninsured. A child must be screened for VFC eligibility at each visit, even though the eligibility form needs to be updated only when the child's eligibility status changes.
Do I need to verify my patient's residency status before using VFC vaccine?
No. The CDC states that the only criteria are age (age 18 years or younger) and the four eligibility criteria listed previously. No other factors (for example, residency status) can be considered when screening for eligibility requirements for the VFC program.
Reviewed and revised January 2013
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This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.