Ask the Experts
General Vaccine Questions
Vaccine recommendations
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. 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 persons 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). Persons entering the U.S. as visitors are not required to provide proof of vaccination regardless of the length of stay.
Scheduling vaccinations
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 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.

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 "Immunizations for Babies" found at www.immunize.org/catg.d/p4010.pdf, "When do children and teens need vaccinations?" found at www.immunize.org/catg.d/p4050.pdf, and "Are you 11-19 years old? Then you need to be vaccinated against these serious diseases." found at www.immunize.org/catg.d/p4020.pdf

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?" (www.immunize.org/catg.d/p4036.pdf), "If You Have HIV Infection, Which Vaccinations Do You Need?" (www.immunize.org/catg.d/p4041.pdf), "If You Have Hepatitis C, Which Vaccinations Do You Need?" (www.immunize.org/catg.d/p4042.pdf), "Should You Be Vaccinated Against Hepatitis B? A screening questionnaire for adults" (www.immunize.org/catg.d/2191hepb.pdf), and "Should You Be Vaccinated for Hepatitis A? A screening questionnaire for adults" (www.immunize.org/catg.d/2190hepa.pdf).
In addition to these printed pieces, there are several interactive tools on CDC's website. For children, go to 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 www.cdc.gov/nip/recs/child-schedule.htm#catchup
Can combination vaccines be used with children who have fallen behind with their vaccinations?
Combination vaccines can be used for children who are on an accelerated schedule. In this case, the minimum intervals between doses would be the greatest interval between any of the individual antigens. For example, the minimum interval between Hib dose #2 and Hib dose #3 is 4 weeks and the minimum interval between HepB dose #2 and HepB dose #3 is 8 weeks. When the two antigens are combined, as in Comvax, the minimum interval between Comvax dose #2 and Comvax dose #3 would be 8 weeks, which is the greatest of the minimum intervals of the two vaccines if given separately. Likewise, the minimum age for the 3rd dose of Comvax is the oldest minimum age of the two antigens (i.e., age 24 weeks).
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.
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 statement for that vaccine. In addition, an extensive listing of recommended and minimum intervals
and ages for vaccination can be found in Table 1 of the ACIP's "General Recommendations on Immunization" (see www.cdc.gov/vaccines/pubs/ACIP-list.htm).
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 doses of MMR and IPV were separated from the previous ones by at least 4 weeks, they can be counted as the second MMR and fourth IPV. No additional doses are indicated. (Exception: some states require a dose of polio vaccine on or after the fourth birthday for school entry. 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.
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. There are no minimum interval requirements between the doses of any inactivated vaccines.
Precautions and contraindications
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?
Some vaccine vial stoppers are made with natural rubber, which may contain latex as well as other impurities from the original latex material. Latex and other impurities may therefore be present in very small quantities in the vaccine, or on the needle as it passes through the stopper. Persons 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. Persons 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?
The most common type of latex sensitivity is contact-type allergy, such as with persons who have prolonged contact with latex-containing gloves. Some syringes plungers and vial stoppers are made with natural rubber, which may contain latex as well as other impurities from the original latex material. Latex and other impurities may therefore be present in very small quantities in the vaccine, or on the needle as it passes through the
stopper. Although rare, persons 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. Persons with latex allergies that are not anaphylactic may be vaccinated as usual.
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 or in the needle cover. This information is also supplied in the package insert.
If we have a patient who has 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 persons 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 the ACIP "General Recommendations on Immunization" (www.cdc.gov/vaccines/pubs/acip-list.htm). Intramuscular (IM) injections should be scheduled shortly after antihemophilia therapy or just 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).
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
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/standingorders
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.
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.
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 needlestick 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. In particular, varicella, zoster, and meningococcal polysaccharide vaccines must all be administered within 30 minutes of reconstitution, and MMR must be administered within 8 hours.
When you inject a vaccine, why is it not necessary to aspirate?
ACIP does not recommend aspiration when administering vaccines because no data exist to justify the need for this practice. 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.
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 two exceptions: hepatitis B or rabies vaccine given by any route other than IM 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" (www.cdc.gov/vaccines/pubs/acip-list.htm).
Which vaccines may be given simultaneously?
All vaccines used for routine vaccination in the United States may be given simultaneously. There is no evidence that simultaneous administration of vaccines either reduces vaccine effectiveness or increases the risk of adverse events.
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 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" (www.cdc.gov/vaccines/pubs/acip-list.htm).
When giving two IM injections in the same limb, what is the minimum spacing between the two injection sites?
The vaccines should be separated by at least one inch in the body of the muscle so that any local reactions are unlikely to overlap.
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.
Does ACIP recommend that providers observe patients for a period of time after a vaccination?
The ACIP recommends that providers strongly consider observing patients for 15 minutes after vaccination, if possible, due to the slight risk of syncope, particularly when vaccinating adolescents and young adults. This issue is discussed in the ACIP's "General Recommendations on Immunization" (www.cdc.gov/vaccines/pubs/acip-list.htm).
Regarding persons with health conditions
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.
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 who have not previously been vaccinated with Tdap need 1 dose to protect their newborn; (2) women who did not receive influenza vaccination during pregnancy need to be vaccinated if it is still influenza vaccination season (through April); (3) women who tested susceptible to rubella on prenatal testing need MMR vaccine if they don't have a documented dose 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.
 
Do persons 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 persons 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 (HSCT)?
Antibody titers to vaccine-preventable diseases decline during the 1–4 years after HSCT, if the recipient is not revaccinated. HSCT recipients are at increased risk for certain vaccine-preventable diseases, including those caused by encapsulated bacteria. In short, all HSCT recipients should begin revaccination with inactivated vaccines 12 months after HSCT, except inactivated influenza vaccine which should begin at least 6 months following the transplant and annually thereafter. PPV should be administered at 12 and 24 months after HSCT, and 2 doses of PCV (with 8 weeks between doses) can be considered, especially for children younger than age 60 months. A 3-dose series of Hib vaccine should also be given at 12, 14, and 24 months following
transplantation for persons of any age. Immunocompetent persons 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" (www.cdc.gov/vaccines/pubs/acip-list.htm).
Should vaccines be withheld for patients on steroids?
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.
With what frequency should splenectomized patients receive Hib, pneumococcal, and meningococcal vaccines?
Persons with anatomic or functional asplenia (including sickle cell disease) are at increased risk of infection with encapsulated bacteria, especially with S. pneumoniae (pneumococcus), N. meningitidis (meningococcus), and Hib. If unvaccinated, these persons should receive age-appropriate Hib, pneumococcal, and meningococcal vaccines. Although Hib vaccine is not routinely recommended for persons 5 years of age and older, studies suggest good immunogenicity in patients who have sickle cell disease or have had splenectomies. Therefore, healthcare providers may choose to administer Hib vaccine to older children and adults with chronic conditions associated with an increased risk for Hib disease.
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, and varicella).
Can persons with minor illnesses be vaccinated?
Yes. Persons with minor acute illness (e.g., diarrhea or mild upper-respiratory tract infections with or without fever) should be vaccinated. Healthcare providers should use all opportunities to provide vaccinations, including acute care visits. If the illness is moderate or severe, vaccination should proceed as soon as the acute illness has improved.
Documentation issues
We frequently see new patients who have no immunization records. This is a particular concern with new immigrants. Should we be concerned about "over immunization"?
As a general rule, ACIP recommends that persons who do not have valid documentation of other vaccinations be revaccinated. Excessive doses of tetanus toxoid (e.g., DTP, DTaP, DT, Tdap, or Td) can increase the risk of a local adverse reaction. Serologic testing for immunity is an alternative to vaccination for certain antigens (e.g., measles, rubella, hepatitis A, and tetanus). This issue is discussed at length in the ACIP's "General Recommendations on Immunization" (www.cdc.gov/vaccines/pubs/acip-list.htm).
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" (www.cdc.gov/vaccines/pubs/acip-list.htm).
What about new patients who have no immunization records. We would like to vaccinate but are concerned about "over immunization." What should we do?
As a general rule, ACIP recommends that persons who do not have valid documentation of vaccinations be revaccinated. The one exception to this rule is for excessive or too-frequent doses of tetanus toxoid (e.g., DTP, DTaP, DT, Tdap, or Td); doses given too frequently can increase the risk of a local adverse reaction. Serologic testing for immunity is an alternative to vaccination for certain antigens (e.g., measles, rubella, and tetanus). This issue is discussed at length in ACIP's "General Recommendations on Immunization" (www.cdc.gov/vaccines/pubs/acip-list.htm).
 
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)].
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 health care providers may not participate in the registry, and the personal record card would be needed.
Vaccine storage and handling
When is a "dormitory style" refrigerator not adequate for storing vaccines?
This type of unit is not acceptable for storing varicella, MMRV, LAIV, or zoster vaccines because the freezer compartment cannot maintain 5°F (-15°C) or colder consistently. A dormitory refrigerator may be used for storing small amounts of vaccines that require only refrigeration if the unit can maintain a consistent temperature of 35-46°F (2-8°C).
Can we store vaccine in the same unit where we store employees' lunches?
No, don't use the same unit. Frequent opening of the refrigerator's door to retrieve food items can adversely affect the internal temperature of the unit and potentially damage the vaccines.
There is a vent in our refrigerator that brings in cold air from the freezer. Vaccines stored near this vent are colder to the touch. Could this be a problem?
Yes. Vaccines that are stored in a household refrigerator with a separate freezer compartment should be moved away from the vent located in the refrigerator compartment as the cold air from the freezer can cause your vaccines to freeze. Inactivated vaccines must be kept at 35-46°F (2-8°C) and not frozen.
 
One morning, our refrigerator thermometer registered 32 degrees F. The vaccine didn't look frozen so we kept using it. Was this okay?
No. If you find that a vaccine has been exposed to an inappropriate temperature, determine the reason for the temperature alteration, mark the vaccine "Do Not Use," and contact the manufacturer or state/local health department to determine if the vaccine can be used.
We have a large quantity of vaccines, and space is always an issue. Since you cannot put vaccines in the vegetable bins, can we remove them and then put vaccines in that space?
Vaccines should not be stored in vegetable bins or the space occupied by vegetable bins because this area is commonly closer to the motor of the unit and temperatures may be less stable. We recommend that you remove the vegetable bins and put bottles of water in that space to help maintain a constant temperature in your refrigerator. Vaccines should be placed in the center of the refrigerator, away from the walls and floor of the unit in open containers so air can circulate around the vaccines. You also do not want the top shelf in the refrigerator too close to the vents that come from the freezer because this can expose your vaccines to freezing temperatures.
What type of thermometer is good for measuring temperatures in a vaccine storage unit?
ACIP recommends either a standard fluid-filled, minimum-maximum, or continuous chart recorder thermometer. In addition, the thermometer should have a certificate that indicates a second calibration. While all thermometers are calibrated during manufacturing, certified calibrated thermometers undergo a second individual calibration against a reference standard from an appropriate agency. They are then given a certificate indicating successful completion of this process. Be sure to look for a thermometer with a "traceable certificate," usually to a National Institute of Standards and Technology (NIST) or American Society for Testing and Materials (ASTM) standard. The certificate is provided with the instrument when purchased and is different from the manufacturer's warranty. These thermometers may cost a bit more than the average hardware store thermometer, but it is better to invest in a more reliable model than to risk damaging thousands of dollars worth of vaccine because of inaccurate readings. This topic is discussed in the ACIP's "General Recommendations on Immunization" (www.cdc.gov/vaccines/pubs/acip-list.htm) and on the CDC website at www2a.cdc.gov/vaccines/ed/shtoolkit/pages/storage_equipment.htm#Thermometers
How can I find an appropriate thermometer for monitoring my vaccines?
While not endorsing any particular product or vendor, CDC has compiled a partial list of appropriate thermometers at www.cdc.gov/nip/vfc/st_immz_proj/faqs_storage-h.htm#4. Some of the vendors listed may also offer products that are not certified; buyers should make inquiries about the specific models they wish to purchase. Be sure to look for a thermometer with a "traceable certificate," usually to a National Institute of Standards and Technology (NIST) or American Society for Testing and Materials (ASTM) standard. These thermometers may cost a bit more than the average hardware store thermometer, but it is better to invest in a more reliable model than to risk damaging thousands of dollars worth of vaccine because of inaccurate readings.
How often should temperatures be checked and recorded on our vaccine storage unit's log?
It is important that you check and record the temperatures of both the refrigerator and freezer units at the beginning and end of the day. You should also record the room temperature on your log.
We are carefully logging our vaccine storage unit's temperatures each day. Is there anything else that could go wrong?
Congratulations on all your hard work. You would be surprised at the number of people who, just like you, do a careful job of recording temperatures but then they fail to act on them when the temperatures go out of range. Always take immediate action when you notice an out-of-range temperature. You may need to move the vaccines temporarily to a more reliable storage unit and determine the source of the problem. It may be something quite fixable (e.g., excessive lint or dust on the coils) and you will be back in business after you determine that the temperature is back in range after a few hours. Above all, don't chart an out-of-range temperature and not act on it!
Why is it recommended that we keep temperature logs for 3 years or longer?
It is important that you keep your temperature logs for at least 3 years. As the refrigerator ages, you can track recurring problems. If temperatures have been documented out of range, you can determine how long this has been happening and take appropriate action. Some states and localities may require providers to keep these logs for a longer period and some may also require providers to submit completed vaccine storage logs in order to receive vaccine from their program.
I've heard there is a vaccine storage and handling toolkit available from CDC. How do I get it?
You can access the toolkit on CDC's website at www2a.cdc.gov/vaccines/ed/shtoolkit/default.htm or you can purchase single or multiple copies from IAC. The toolkit contains 2 videos on CD-ROM (How to Protect Your Vaccine Supply and Top 10 Storage and Handling Errors); an interactive game; and resources including forms, checklists, posters, and contact information. To order this toolkit, go to www.immunize.org/shop/toolkit_vaxstorage.asp
How long is a vaccine viable if it has been stored in the refrigerator in a syringe?
Disposable syringes are meant for administration of immunobiologics, not for storage. CDC recommends that vaccines that have been drawn into syringes be discarded at the end of the clinic day.
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 must wait at least 4 weeks after the previous (expired) dose was given before repeating it. If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, rubella, hepatitis A, and tetanus).
I've heard that multidose vaccine vials should be disposed of after being open for 30 days. Is this true?
No. Multidose vials of vaccine that do not require reconstitution may be used through the expiration date printed on the label or box as long as the vaccine is not visibly contaminated.
When the expiration date of a vaccine indicates a month and year, does the vaccine expire on the first or last day of the month?
Vaccine may be used through the last day of the month indicated on the expiration date.
Vaccine safety issues
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.vaccineinformation.org/concern.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?
There are many excellent websites that have information about vaccine safety, including the American Academy of Pediatrics (www.cispimmunize.org), the CDC (www.cdc.gov/vaccinesafety), Every Child by Two (www.ecbt.org), Immunization Action Coalition (www.immunize.org/safety), the National Network for Immunization Information (www.immunizationinfo.org/vaccine_safety_issues.cfm), the Institute of Medicine (www.iom.edu/?id=4705&redirect=0), and the Vaccine Education Center, Children's Hospital of Philadelphia (www.chop.edu/consumer/jsp/division/generic.jsp?id=75694).
Federal requirements regarding vaccines