Vaccines: Answers

Contents

Learning Objectives:

  1. Identify useful resources for identifying which vaccinations are due
  2. Identify useful resources for questions and concerns about vaccination
  3. Understand the absolute and relative contraindications to immunization
  4. Understand common vaccine reactions and the VAERS (Vaccine Adverse Event Reporting System)

Primary References:

  1. Recommended Immunization Schedule for Persons Aged 0–6 Years- 2008; http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2008/08_0-6yrs_schedule_pr.pdf
  2. Catch-up Immunization Schedule for Persons Aged 4 Months–18 Years; 2008 http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2008/08_catch-up_schedule_pr.pdf
  3. GPGP specific immunization schedule (attached)
  4. Responding to 7 common parental concerns about vaccines & vaccine safety. AAP. Available at:  http://www.cispimmunize.org/pro/pdf/7ParentalConcerns2.pdf
  5. Strategies for pediatricians: addressing concerns of vaccine-hesitant parents. Available at: http://www.cispimmunize.org/pro/pdf/Vaccine-HesitantParent_Final.pdf
  6. AAP. Refusal to Vaccinate Form. Available at: http://www.cispimmunize.org/pro/pdf/RefusaltoVaccinate_revised%204-11-06.pdf
  7. Vaccine safety and contraindications. In Pickering LK, ed. Red Book: 2006 Report on the Committee on Infectious Diseases. 27th edition. Elk Grove Village, IL: American Academy of Pediatrics, 2006: 39-41. http://aapredbook.aappublications.org/cgi/content/full/2006/1/1.5.18
  8. VAERS Reportable Event Table. Available at http://vaers.hhs.gov/pdf/ReportableEventsTable.pdf

 

CASE:

You are in continuity clinic in December and you notice you have a family of three coming in.  The oldest child, Julia, who is 11 years old and her brother Juan, who is 4 years old, were previous patients of another resident but they have been in the DR for the last two years; they now have a 4 month old sister, Daniela.

1. What resources can you use to decide which vaccines are due today?  What about which ones they have?  If they are not up to date, what resources can use to decide what they need to catch-up?

To decide what vaccinations are due, you can look at the GPGP chart of what vaccines are due at what age. This is based on the put out by the Advisory Committee on Immunization Practices: Recommended Immunization Schedule for Persons Aged 0–6 Years- 2008.  For which ones they have it is best to look at parent held vaccination record and EzVAC.  In this case, also make sure to ask for any records of vaccines given in the Dominican Republic.   The Advisory Committee on Immunization Practices also puts out a table for catch up vaccinations.

2. If they are all up to date for previous vaccines, which vaccines are they due for?

Daniela is 4 months old, she is due for DTaP (diphtheria/tetanus/pertussis), IPV (polio), Hep B (hepatitis B), Hib (haemophilus influenza B), and Prevnar (pneumococcal). She cannot get the rotavirus vaccine unless she got the first dose when she was less than 12 weeks old. Of note, one cannot receive the last dose unless the child is less than 32 weeks old.  She should also get a PPD since she spent an extended time in the DR.

Juan is 4 years old.  He is due for MMR (measles, mumps, rubella), varicella, DTaP (diphtheria/tetanus/pertussis), IPV (polio), Hepatitis A and influenza. All children 6 months to 18 years old should get an influenza vaccine. If he has never had the vaccine before or if it is the second year he is getting the vaccine but only got one dose in the previous year, he needs a second dose in 4 weeks after the first.  This is true for any child less than 9 years old.  He can get either the inactivated shot or the live attenuated nasal spray.  He also needs a hepatitis A vaccination, with a second dose in 6 months.  He should also get a PPD since he spent an extended time in the DR.

Julia is 11 years old.  She is due for Tdap (tetanus, diphtheria and pertussis); this is mandatory in NYC for children entering 6th grade who have not had a tetanus containing vaccine in the last two years.  She should also get Menactra (meningococcal) and HPV (human papilloma virus) which are recommended but not required.  It would also be important to check that she is not due for second varicella vaccine, since many children her age will not have had the recommended two doses. She also should get the influenza vaccine.  Finally, she should get a PPD since she spent an extended time in the DR.

3. Their mother has been hearing some things about vaccine safety.  She wants to know if there is mercury in the vaccine and whether the vaccines can cause autism. She also heard that the vaccine for diarrhea was taken off the market, so she wants to know if this vaccine different.  While she is at it she wants to know about the safety of the meningococcal vaccine.   Finally, she also is afraid that the influenza vaccination will give her kids the “flu”.  How do you address these issues with her? 

Some parents worried about link between thimerosal and health issue especially autism.  Thimerosal is a preservative that contains a form of mercury, used particularly in multi-dose vials to prevent contamination from bacteria and fungi.  In 1999, AAP recommended that thimerosal be taken out of vaccines as a precaution and by the end of 2001, all routine pediatric vaccines contained no thimerosal or only trace amounts (some influenza and Td vaccines).  As of July 1, 2008, New York State Public Health Law prohibits the administration of vaccines containing more than trace amounts of thimerosal to children < 3 years old and women who know they are pregnant (0do NOT need to test for pregnancy).  Even so, there is NO convincing evidence of harm caused by the small amounts of thimerosal in vaccines, except for minor effects like swelling and redness at the injection site due to sensitivity to thimerosal.

Autism is common, affecting an estimated 1 in 500 children. Because MMR vaccine is given at age 12-15 months and the first signs of autism often appear at 15-18 months of age, parents get concerned about a possible link between the vaccine and the development of autism.   Multiple studies and panels of independent scientists have found NO association between the MMR vaccine and autism.  Although the cause of autism is unknown, genetics is though to play a role since there is a 3-8% risk of recurrence in families with one affected child.  Scientists are looking in siblings for early signs of autism to show once again that not vaccine related.

Every year in the US 1400-2800 people get meningococcal disease; ten to 14% of people with meningococcal disease die, and 11-19% of survivors have permanent disabilities (such as mental retardation, hearing loss, and loss of limbs).  It can have an abrupt onset with a rapid course of disease.  A quadrivalent conjugate vaccine to protect against invasive meningococcal disease is recommended for children 11-12 and teens entering high school, as well as college freshmen living in dormitories.  The CDC and FDA, in partnership with state health departments, are investigating cases of Guillain-Barré syndrome (GBS) among adolescents who recently received Menactra.  GBS is a serious neurologic disorder involving inflammatory demyelination of peripheral nerves. It can occur spontaneously or after certain events such as infections.  Patients develop subacute onset of progressive, symmetrical weakness in the legs and arms, with loss of reflexes +/- sensory abnormalities, involvement of cranial nerves, and paralysis of respiratory muscles also can occur.   A small proportion of patients die, and 20% of hospitalized patients can have prolonged disability.  The precise rate of GBS in adolescents is unknown, but the background annual incidence of 1 to 2 cases per 100,000 persons per year is similar to the rate of GBS among Menactra recipients.  However, the timing of the onset of neurological symptoms (within 1.5 to 5 weeks of vaccination) is of concern.  Although the CDC is unable to determine if Menactra increases the risk of GBS in people who receive the vaccine at this time, ongoing known risk for serious meningococcal disease exists. Therefore, CDC recommends continuation of current vaccination strategies.  CDC recommends that adolescents and their caregivers be informed of this ongoing investigation as part of the consent process for vaccination with MCV4 using the vaccine information sheet for Meningococcal vaccine available at each clinical site. Persons with a history of GBS, who are not in a high-risk group for invasive meningococcal disease, should not receive MCV4.

A previous vaccine against rotavirus, Rotashield, was taken off the market in 1999 because of an increased risk of intussusception, a serious and potentially life-threatening condition that occurs when one portion of the intestine telescopes into a nearby portion, causing the intestinal obstruction.  A large study of the current vaccine, RotaTeq, including over 70,000 children, was designed specifically to assess a risk of intussusception found that there was no association found between the vaccine and an increased risk of intussusception. While there have been post-marketing reports of intussusception following administration of RotaTeq, the number does not exceed the number expected based on background rates of 18-43 per 100,000 per year for an unvaccinated population of children ages 6 to 35 weeks old.

Some parents think influenza is a relatively mild disease and worried about thimerosal and also that can cause the flu.  Parents should know that influenza can be a serious disease and an annual flu vaccine is the best way to protect oneself and their family. Annual shots are necessary because flu viruses change from year to year. The viruses in the flu shot are killed (inactivated), so one cannot get the flu from a flu shot.  Some minor side effects can occur, such as soreness, redness or swelling at injection site, low grade fever and/or aches.  If they do occur, they usually begin soon after the shot and usually last 1 to 2 days. Rarely, people can have serious side effect, such as severe allergic reaction.  The viruses in the nasal-spray vaccine are weakened and do not cause severe symptoms often associated with influenza illness.  Side effects in children can include runny nose, wheezing, headache, vomiting, muscle aches and fever. In clinical studies, transmission of vaccine viruses to close contacts has occurred only rarely.

There are some overall strategies for addressing parent’s concerns. Many vaccine-hesitant parents believe they can control their child’s susceptibility to disease, have doubts about the reliability of vaccine information, prefer errors of omission over errors of commission (negative outcomes due to inaction [not vaccinating] versus negative outcomes due to action [vaccinating]), or rely on herd immunity to protect their child. If you have a hesitant parent ask them what their concerns are, acknowledge them in a no confrontational manner and then clarify and reaffirm parents’ correct beliefs about immunization and modify misconceptions.  It is important to use clear language to discuss the benefits of vaccines, and the possibility of adverse events and provide them with Vaccine Information Statements and other educational resources as well as discuss state laws for school entry and the rationale for them.  Finally, stress the number of lives saved by immunization, as a positive approach, rather than focusing on the number of deaths from not immunizing.  If, after these discussions, the parent refuses, the pediatrician should document the discussion and have the parent sign a waiver affirming his/her decision not to vaccinate (i.e., AAP Refusal to Vaccinate Form). If you are no longer comfortable having them in your practice, the AAP manual, “Medical Liability for Pediatricians”, Chapter 3, offers resources for risk communication and termination of the physician-patient relationship. (both are listed as resources)

4. Their mother agrees to give the vaccines but first wants to make sure if it is ok to give the children the vaccines today.  Daniela had a febrile seizure two weeks after her last set of shots, Juan has an egg allergy and Julia has a runny nose with a temperature to 100.3.  Also, their grandmother who lives with them is undergoing chemotherapy and their uncle who also lives with then has endstage HIV.

There are few contraindications and precautions. Common conditions or circumstances that are not contraindications include
  • Mild acute illness with low-grade fever; mild diarrheal illness in an otherwise well child
  • The convalescent phase of illness.
  • Currently receiving antimicrobial therapy.
  • Reaction to a previous vaccine dose that involved only soreness, redness, or swelling in the immediate vicinity of the immunization site or temperature of less than 105°F
  • Preterm birth—the appropriate age for initiating most immunizations in the preterm infant usually is the recommended chronologic age; vaccine doses should not be reduced for preterm infants
    • Exception is preterm infants with birth weight  less than 2,000 grams do not seroconvert well with a birth dose of Hep B but by one month will respond to all vaccines as well as a term infant
  • Pregnancy in a household contact is not a contraindication to administration of any routinely recommended live-virus vaccine to a child or other nonpregnant household contact as recommended.
  • Immunosuppression of a household contact is not a contraindication to administration of any routinely recommended live-virus vaccines, except inactivated influenza vaccines, when available, are preferred to live-attenuated influenza vaccine.
  • Recent exposure to an infectious disease.
  • Breastfeeding— rubella has been isolated from human milk but no evidence indicates that human milk from women immunized against rubella is harmful to infants. The small pox vaccine should not be given to  breastfeeding mothers
  • History of nonspecific allergies or relatives with allergies.
  • History of allergies to penicillin or any other antimicrobial agent, except anaphylactic reactions to neomycin or streptomycin —these reactions occur rarely, if ever
  • Allergies to duck meat or duck feathers—no vaccine available in the US is produced in substrates containing duck antigens.
  • Family history of seizures in a person considered for pertussis or measles immunization
  • Family history of sudden infant death syndrome in children considered for DTaP immunization.
  • Family history of an adverse event after immunization
  • Multiple vaccines
  • Malnutrition
Contraindications:
  • Severe allergic reaction to vaccine components or following prior dose.  Most common cause of anaphylactic reaction is from vaccines made in embryonic chicken eggs like influenza and yellow fever.  MMR is ok since grown in chick fibroblasts not eggs.  History of anaphylactic reaction to neomycin, neomycin-containing vaccines should not be used. No currently recommended vaccine contains penicillin or its derivatives
  • Moderate or severe febrile (or non-febrile) illness at the time of scheduled immunizations.  Children should be asked to return as soon as the acute phase of the illness resolves so that immunization can be completed the child, because evolving signs and symptoms associated with the illness may be difficult to distinguish from a vaccine adverse event especially DTaP, (although the newer versions have much lower rates vaccines of adverse events)
  • Pregnancy: no live vaccines; in general can give inactivated but not HPV
  • Encephalopathy not due to other cause within 7 days of pertussis vaccine
  • Immunocompromised children. Special consideration needs to be given to immunocompromised children, including children with congenital immunodeficiencies, human immunodeficiency virus (HIV) infection, or malignant neoplasm or who are recipients of immunosuppressive therapy.  Of note, steroid use can cause immunosuppression if 20mg or more per day of prednisone or 2mg/kg or more per day prednisone for 14 days or longer
Notes:
  • MMR vaccine will decrease the reactivity to a tuberculin skin test so either needs to be done on the same day or allow 4 weeks to pass before doing the PPD
  • If MMR and varicella are not administered on the same day, they should be separated by an interval of at least 28 days.
  • Antivirals may affect response to vaccine replication with influenza and varicella

5.  Their mother calls you the next day.  Daniela has a swollen thigh, Juan has a temperature to 102 and Julia had an anaphylaxis episode.  Which of these, if any, need to be reported and to whom? 

Local reactions, including pain, swelling, and redness at site of injection, are common with inactivated vaccines.  They are usually mild and self limited.  Sterile abscesses can also occur at the site of injection of certain inactivated vaccines, either from an inflammatory response to the vaccine or its adjuvant or by inadvertent subcutaneous inoculation of a vaccine intended for intramuscular use.   People with high serum concentrations of tetanus IgG antibody, usually as the result of frequent booster immunizations, may have an increased incidence and severity of adverse reactions to subsequent vaccine administration.  These Arthus-like reactions present as extensive painful swelling, often from shoulder to elbow. Some systemic reactions might also occur such as fever, malaise, headache, or nonspecific symptoms.  Although allergic reactions due to vaccine or vaccine components are rare, one can reduce the risk by screening. Rarely, serious adverse effects of immunization occur, resulting in permanent sequelae or life-threatening illness.

Unexpected events after administration of any vaccine, particularly those that are clinically significant, should be described in the patient’s medical record, and a VAERS (Vaccine Adverse Event Reporting System) report should be made. There is no time limit for reporting an adverse event, but a possible reaction should be reported when the reaction is recognized and is mandated by the National Childhood Vaccine Injury Act of 1986.  Vaccine failures (disease in an immunized person who received 1 dose or more of vaccine) and vaccine administration errors also may be reported.  Forms can be obtained from the VAERS at 1-800-822-7967 and can be mailed or faxed. Reports also can be obtained and submitted electronically through a secure Web site (http://vaers.hhs.gov). Submission of a report does not necessarily indicate that the vaccine caused the adverse event. All patient-identifying information is kept confidential.