The State Of Pediatric Immunizations Today
Polio Vaccine Form Continues To be Debated
By Sally Peters
Since the 1960s, the routine childhood immunization schedule has remained fairly constant. The biggest changes have occurred during the past few years, with the addition of an inactive form of the polio vaccine and the introduction of the varicella vaccine (Varivax).
Now, in light of a recent study that suggests the new polio vaccine is not cost-effective, the immunization schedule may undergo more changes as bureaucrats attempt to put a multimillion dollar price tag on the immunization market. Further, parents and consumer groups based in Washington, D.C., are charging that the recommendations of the American Academy of Pediatrics (AAP) are unsafe.
The Polio Vaccine
Traditionally, the polio vaccine has been administered as an oral solution at ages 2 months, 4 months, 6 months to 18 months, and again at school entry (4 to 6 years). In June 1996, the Advisory Committee on Immunization Practices (ACIP), a committee providing national guidelines for immunization policy, endorsed a change of the schedule from four doses of oral polio vaccine (OPV) to two doses of inactivated polio vaccine followed by two doses of OPV, with alternative regimens of four doses of inactivated polio vaccine (IPV) or four doses of OPV. The Centers for Disease Control and Prevention (CDC) endorsed this method.
According to the AAP's February 1997 immunization schedule, each of the following schedules is acceptable: sequential: IPV at 2 and 4 months, OPV at 12 to 18 months, and 4 to 6 years; IPV only: IPV at 2, 4, 12 to 18 months, and 4 to 6 years; OPV only: OPV at 2, 4, 6 to 18 months, and 4 to 6 years.
But immunization practices haven't changed, and some clinicians speculate they never will. S. Michael Marcy, MD, who practices at Kaiser Permanente Health Care Program in Panorama City, Calif., offers several explanations for this phenomenon.
The first is cost. IPV simply costs more and "it's an extra injection," Dr. Marcy says.
Child advocates have voiced concern that compliance for other vaccines will diminish if the extra shot of IPV is administered. Also, health advocates for disadvantaged children have said that poor children will suffer because their parents may not be able to afford the injection and may refuse extra shots, Marcy says.
The second factor is time. Many health care providers don't have time to explain to parents the difference between IPV and oral polio vaccine and the benefits of the IPV injection, Dr. Marcy says. The time factor may also deter providers from suggesting the IPV to parents.
Finally, specific recommendations for usage of inactivated vaccine have not been developed and many clinicians want to stick with oral polio vacccine, Dr. Marcy notes.
Other reasons drive the reliance on OPV as well. Some health maintenance organizations (HMOs) might endorse and reimburse for OPV because it is less expensive, Dr. Marcy suggests.
In addition, he predicts that polio will probably be wiped out in 5 to 8 years, making the vaccine virtually unnecessary. Health care providers may opt to use the less expensive OPV until the disease is exterminated.
This same phenomenon occurred with the smallpox scourge, Dr. Marcy points out.
The Study and Cost Comparisons
A study by M.A. Miller et al. (Cost-effectiveness of incorporating inactivated poliovirus vaccine into the routine childhood immunization schedule. JAMA. 1996;276:967-971) concluded that the introduction of IPV to reduce vaccine-associated paralytic poliomyelitis (VAPP) would not be "cost-beneficial."
The inactivated polio vaccine is being manufactured by Connaught Laboratories Inc., under the brand name IPOL. Connaught Labs has been making the drug for several years, initially for immunocompromised children. The company recently obtained FDA clearance to expand IPOL's distribution to healthy children, a spokesperson says.
Taking into account costs like the price of vaccines and the current compensation awards paid for VAPP cases, Miller et al found that changing to an IPV-only schedule would cost $28.1 million, and that changing to a sequential schedule would cost $14.7 million. The IPV cost per case of VAPP prevented was estimated at $3 million and $3.1 million, respectively. (The CDC reports that as of February 1996, IPV was sold in the private sector for $15.24 per dose, and OPV was sold for $10.46 per dose.)
"The analysis provides a range of costs that policy makers need to consider if they wish to prevent VAPP," Miller et al concluded. "Although these costs are higher than those of other public health prevention programs, they may be justified because VAPP continues to occur as a result of government-mandated vaccination policies in the absence of known wild poliovirus transmission in the United States."
Whether these recent findings will have any effect on the administration of the polio vaccine remains to be seen. In the meantime, both the CDC and AAP continue their stand on diligent vaccination.
Nancy B. Quigley, CPNP, of St. Louis, says practitioners in the large physician-NP practice where she works have not started giving the inactivated polio vaccine. But members of the practice do provide IPV under certain circumstances, she notes. Quigley says if the AAP required the polio vaccine to be given under the new administration, she didn't think the cost of the vaccine would keep practitioners from administering it.
In November, the AAP issued a statement to pediatricians offering updated recommendations on the use of polio vaccines. The Academy's new recommendations now offer health care providers three options for immunizing their patients against poliomyelitis. According to the statement, the AAP now recommends that health providers choose IPV, OPV or a schedule utilizing both vaccines sequentially for the complete 4-dose polio regimen. The sequential IPV/OPV schedule calls for infants to receive IPV for the first two doses followed by the oral polio vaccine for the last two doses.
In response to the recommendations by the AAP, a coalition of parents, consumer advocates and patient groups calling themselves Informed Parents Against VAPP (IPAV) sprung up in Washington, D.C. Use of the oral vaccine is responsible for the small number of cases of VAPP that occur in the United States each year, and the group recommends that health care providers embrace the "stronger" recommendations of the CDC rather than those of the AAP.
"Informed parental choice is an important first step, but frankly, we're worried that in a busy pediatrician's office, a parent stands little chance of being fully educated about the risks of the oral vaccine," says John Salamone, a parent whose child contracted polio from the oral vaccine and who is spearheading IPAV. Salamone says the group has written to the AAP Board of Directors to ask for a meeting.
Other groups that have signed on the the IPAV agenda include the National Consumers' League and the National Immune Deficiency Foundation (IDF).
Vaccines should be given as part of comprehensive child care, and the polio vaccine is only one on a schedule that providers should know inside and out. (See chart accompanying this article.) Aside from the dosage form change for the polio vaccine, the varicella vaccine (Varivax) is the latest addition to the immunization table. The AAP recommends administration of Varivax any time after 12 months of age. Unvaccinated children who lack a reliable history of chickenpox should be vaccinated between the ages of 11 and 12.
A new policy from the AAP offers health care providers updated recommendations about the use of pertussis vaccine. The action is in response to the recent FDA approval of new recommendations for the acellular pertussis vaccine. The acellular pertussis vaccine is combined with diphtheria and tetanus (DTaP) and is preferred because it has been associated with fewer vaccine reactions, the AAP says.
According to the AAP, as of Dec. 5, 1996, one acellular pertussis vaccine (Tripedia) combined with diphtheria and tetanus toxoids (DTaP) was approved by the FDA for use in infants. DTaP is preferred for use at all ages, but whole-cell pertussis vaccines (DTP) are acceptable alternatives. FDA approval of additional DTaP products for use in American infants is anticipated before the AAP publishes its next schedule in February 1998.
A new combination of DTaP with a conjugate Haemophilus influenzae type b (Hib) vaccine (Tripedia-ActHIB) has been approved only for administration as the fourth dose in the DTaP/DTP series for children 15 months of age and older. As of Nov. 15, 1996, this combination was not approved for use in the primary series in infants.
A new combination product (Comvax) of hepatitis B and Hib vaccines has been approved for immunization at 2, 4 and 12 to 15 months of age.
This and other Hib-containing vaccines should not be administered to infants younger than 6 weeks. The Hib component administered at an early age is not adequately immunogenic and could have an adverse effect on the immune response to doses of Hib vaccines administered at older ages, according to the February 1997 recommendations from the AAP.
The AAP has long recommended that all infants should be immunized routinely with five doses of pertussis vaccine. The primary series of three doses is given at 2, 4 and 6 months of age, supplemented by two additional doses at 12 to 18 months and 4 to 6 years of age. Until now, only the whole cell version of the pertussis vaccine (DTwP) was approved for use in the primary series. However, either DTwP or DTaP could be used for the fourth and fifth doses. In August, the FDA approved a DTaP vaccine for use in the first four doses of the series. However, there is currently insufficient data to evaluate the effectiveness of DTaP vaccine for the fifth dose in children who have received the acellular version for the first four doses.
Infants immunized with the newly approved series of four DTaP vaccines will most likely be able to receive it for the fifth dose. The FDA is now collecting safety and efficacy data and it is anticipated that they will approve the fifth dose by the time today's infants reach 4 to 6 years of age.
According to the statement from the AAP, health care providers have more pertussis immunization options than ever. Choices now include DTaP, DTwP and a combination of the DTwP-Hib vaccines. In addition, the AAP supports the recent FDA approval of the combined acellular vaccine with a Hib vaccine (DTaP-Hib) as a single injection for the fourth dose in children who are at least 15 months of age.
FDA approval confirms it is possible to make improved pertussis vaccines that are highly effective and that cause fewer minor adverse effects, such as fever and local reaction. The AAP welcomes data that improves immunization technology and the ability to protect children against the disease and is aware that additional acellular pertussis vaccines are likely to be licensed for use in the primary series in the near future.
The vaccine for measles, mumps and rubella should be administered at 12 to 15 months, with the second immunization at 4 to 6 years.
NPs should also consider flu immunizations for children with chronic illness or other flu-related risks. The Food and Drug Administration Vaccines and Related Biological Products Advisory Committee has recommended that the 1996-97 trivalent influenza vaccine contain A/Texas/36/91-like (H1N1), A/Wuhan/359/95-like (H3N2), and B/Beijing/184/93-like hemagglutinin antigens.
Hib disease is especially important for children younger than 5 years who are at risk for developing meningitis, one of the most severe manifestations of the disease. (It should be given at 2, 4 and 6 months, with the fourth dose at 12 to 18 months.) The hepatitis B vaccination is important for all infants to help prevent liver disease as adults.
Regardless of the work of policy-making bodies like the CDC and AAP, 25% of America's children are under-immunized. This leaves individual practitioners to shoulder the responsibility of making sure these kids get their shots. Many practitioners rely on the AAP's 1994 Red Book: Report of the Committee on Infectious Diseases, which places equal emphasis on education and vaccine administration for guidance. (A new edition of the Red Book will be published this May.)
Terry Yamauchi, MD, professor and vice chairman of the Department of Pediatrics at The University of Arkansas for Medical Sciences in Little Rock, says vaccination education should start with the parents as soon as a child is born. "Vaccines contribute to a total picture of health," he says.
To help parents keep up-to-date on their child's vaccinations, Dr. Yamauchi gives immunization cards to parents to remind them when immunizations are due. Other practitioners have similar ways to help parents remember. Many use well visits as an opportunity to ask parents about their children's immunizations and to schedule them.
Quigley says she gives handouts outlining the vaccination schedule to parents of newborns. She then makes sure to remind parents about upcoming immunizations at each well visit. Through this method, NPs identify children who would otherwise fall through the cracks. "Our immunization rate is quite good," she says of her practice.
Education is only one part of NPs' responsibilities for immunization, however. They must also make sure vaccines are readily available--and that their practice arrangement and office hours are conducive to getting children in on time. Practitioners in urban areas should have office hours every day for at least 8 hours, experts recommend. In rural clinics, which may be open less frequently, practitioners should consider having hours during off times, like lunch hours or weekends, the Red Book suggests.
Minimal acceptable screening procedures for contraindications include asking parents questions about their child's health history and history of adverse events and determining whether any current conditions would contraindicate vaccination, according to the Red Book.
While health care providers should be aware of contraindications to vaccinations, some of them misunderstand or misinterpret the contraindications, delaying the immunization process, says Dr. Marcy. True contraindications and precautions, according to the AAP, include anaphylactic reaction to a vaccine or to a vaccine constituent and moderate or severe illness with or without a fever.
The Red Book also identifies symptoms that are not true contraindications to vaccination, including mild to moderate local reaction, mild acute illness with a low-grade fever, current antimicrobial therapy, convalescent phase of illness, prematurity, recent exposure to an infectious disease and history of penicillin or other nonspecific allergies (or allergy in the child's relatives). Dr. Marcy points out that even a fever of 104.5° with a prior DTP immunization is not a contraindication to a subsequent DTP shot.
Dr. Yamauchi notes that illnesses themselves are not true contraindications, though early symptoms may be a prodrome of something else. Regardless, he says, risks of the diseases are usually greater than the complications of vaccination.
The Red Book committee notes that in some cases, contraindications listed on manufacturers' package inserts may differ from those universally accepted. When in doubt, health care providers should consult information published by the ACIP, the AAP, the American Academy of Family Physicians (AAFP) and manufacturers' inserts.
Providers should also not hesitate to administer simultaneously all vaccine doses for which a child is eligible at each visit. The Red Book notes that simultaneous administration of vaccines is considered safe and effective. The MMR vaccine should always be used in combined form when providing vaccinations, the manual states.
Correct documentation of required vaccinations is essential. Providers are required by federal statute to record which vaccine was given, when it was given, the manufacturer, the lot number, signature and title of the person who gave the vaccine, and the address where the vaccine was given. Practitioners should provide parents with a card detailing their child's immunizations. If parents fail to bring their card to an appointment, provide a new one containing previous shots and shots just administered.
Dr. Yamauchi says recording is computerized at his hospital-based practice, and most providers today probably rely on a computerized system. But some providers may still rely on manual record-keeping, and the Red Book provides suggestions for those who do.
Providers with manual systems should keep their files separate and easily retrievable, the Red Book recommends. They should sort preschool immunization files periodically, placing inactive records into a separate file.
Immunization records at Quigley's practice are not computerized, though records of billing are kept on a computer. These billing records help practitioners find out when a person's last shot was administered and what shot he or she is due for. Practitioners at her practice also record immunizations in the patient's record and on an ongoing roster of immunizations. It's a good idea to record immunizations in at least two places, Quigley says.
All providers should make vaccine education a priority and should be aware of the most current administration guidelines. The Red Book committee says training and education should consist of current guidelines established by the ACIP, AAP and AAFP, as well as other sources, like manufacturers' package inserts. *
* Review immunizations at every visit.
* Use a flow chart to record immunizations.
* Keep two records of each patient's immunizations, one in the chart and one else where in the office.
* Give parents an easy-to-read card that tells them when their child's next immuniza tion is.
* Send out reminder cards to parents who have missed an immunization for their child.
* Use automated dialing calls to remind forgetful parents.
* Make phone calls prior to scheduled visits.
* Make immunizations avail able in urgent care centers.
Nurse Education Program for Vaccination
To ensure that more babies are protected from the hepatitis B virus, SmithKline Beecham, the distributor of Engerix-B® (Hepatitis B Vaccine, Recombinant) announces the launch of a nurse education program underscoring the benefits of vaccination at birth.
The centerpiece of this new program is an easy-to-use information kit including a video, a question-and-answer booklet, a flipchart and a continuing education program for nurses and other healthcare personnel involved in the care of newborns.
Healthcare authorities recommend hepatitis B vaccination for all infants, preferably during the newborn period before discharge from the hospital. "Since this virus is a significant cause of liver disease, it's crucial that infants be protected," says Eileen Tyrala, M.D., director of neonatology at Temple University Hospital in Philadelphia, in the video that accompanies the kit. "And with safe vaccines available, it makes good common sense and good public health practice to begin the vaccination series in newborns before they're discharged from the hospital."
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention, the American Academy of Pediatrics (AAP) and the American College of Obstetrics and Gynecology (ACOG) recommend that infants born to mothers carrying the hepatitis B virus, or to mothers with unknown hepatitis B status, receive the vaccine within 12 hours of birth.
Since 38 states do not require pregnant women to be screened for hepatitis B, the health care provider may not be aware of the status of the mother. Further, there is a documented lack of communication between obstetricians and pediatricians with regard to mothers' hepatitis B serology results. "Failure to communicate hepatitis B serology results could have serious clinical implications for the newborn," concluded Philip Rosenthal, M.D., director of pediatric hepatology of the University of California-San Francisco, in his 1995 study of the topic.
The ACIP, the AAP and ACOG recommend universal infant vaccination, preferably before newborns are discharged from the hospital.
Engerix-B is the only hepatitis B vaccine that allows vaccination of all newborns, regardless of the mother's hepatitis B status, with a single dose (10mcg/0.5mL). (See recommendations for hepatitis B immunoglobulin use for infants born to HBsAg-positive mothers.)
Hepatitis B is one of the most common preventable infectious diseases in the United States and a major cause of infectious liver disease throughout the world. ACOG estimates that each year 1 in 500 to 1,000 pregnant women has hepatitis B when she gives birth. Approximately 200,000 new cases occur annually in the United States, and estimates on the number of carriers of the virus run as high as 1 million.
Adverse reactions to the hepatitis B vaccine are generally mild and transient. Most commonly seen adverse reactions in neonates include fever, soreness, erythema and swelling at the injection site. As with any biological product, adverse reactions may occur.
Prescribing information for Engerix-B is available upon request.
For more information on immunization prac-
* The Immunization Hotline at The Centers for
Disease Control and Prevention,
* The American Academy of Pediatrics,
P.O. Box 927, Elk Grove Village, Ill.,
60009-0927, Attn: Vida Urban-Schwartz.
* The American Academy of Family Physicians,
8880 Ward Parkway, Kansas City, MO,
64114-2797. 1-816-333-9700. email: firstname.lastname@example.org.
1This schedule indicates the recommended age for routine administration of currently licensed childhood vaccines. Some combination vaccines are available and may be used whenever administration of all components of the vaccine is indicated. Providers should consult manufacturer package inserts for detailed recommendations.
2Infants born to HBsAg-negative mothers should receive 2.5 µg of Merck vaccine (Recombivax HB) or 10 µg of SmithKline Beecham (SB) vaccine (Engerix-B). The second dose should be administered >=1 month after the first dose.
Infants born to HBsAg-positive mothers should receive 0.5 mL hepatitis B immune globulin (HBIG) within 12 hours of birth, and either 5 µg of Merck vaccine or 10 µg of SB vaccine at a separate site. The second dose is recommended at 1-2 mos of age and the third dose at 6 mos of age.
Infants born to mothers whose HBsAg status is unknown should receive either 5 µg of Merck vaccine or 10 µg of SB vaccine within 12 hours of birth. The second dose of vaccine is recommended at 1 mo of age and the third dose at 6 mos of age. Blood should be drawn at the time of delivery to determine the mother's HBsAg status; if it is positive, the infant should receive HBIG as soon as possible (no later than 1 wk of age). The dosage and timing of subsequent vaccine doses should not be based upon the mother's HBsAg status.
3Children and adolescents who have not been vaccinated against hepatitis B in infancy may begin the series during any childhood visit. Those who have not previously received 3 doses of hepatitis B vaccine should initiate or complete the series during the 11-12 year-old visit. The second dose should be administered at least 1 mo after the first dose, and the third dose should be administered at least 4 mos after the first dose and at least 2 mos after the second dose.
4DTaP (diphtheria and tetanus toxoids and acellular pertussis vaccine) is the preferred vaccine for all doses in the vaccination series, including completion of the series in children who have received >=1 dose of whole-cell DTP vaccine. Whole-cell DTP is an acceptable alternative to DTaP. The fourth dose of DTaP may be administered as early as 12 months of age, provided 6 months have elapsed since the third dose, and if the child is considered unlikely to return at 15-18 months of age. Td (tetanus and diphtheria toxoids, absorbed, for adult use) is recommended at 11-12 years of age if at least 5 years have elapsed since the last dose of DTP, DTaP, or DT. Subsequent routine Td boosters are recommended every 10 years.
5Three H. influenzae type b (Hib) conjugate vaccines are licensed for infant use. If PRP-OMP (PedvaxHIB) is administered at 2 and 4 mos of age, a dose at 6 mos is not required. After completing the primary series, any Hib conjugate vaccine may be used as a booster.
6Two poliovirus vaccines are currently licensed in the US: inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV). The following schedules are all acceptable by the ACIP, the AAP and the AAFP, and parents and providers may choose among them:
1. IPV at 2 and 4 mos; OPV at 12-18 mos and 4-6 yrs;
2. IPV at 2, 4 , 12-18 mos and 4-6 yrs
3. OPV at 2, 4, 6-18 mos and 4-6 yrs.
The ACIP routinely recommends schedule 1. IPV is the only poliovirus vaccine recommended for immunocompromised persons and their household contacts.
7The second dose of MMR is routinely recommended at 4-6 yrs of age or at 11-12 yrs of age, but may be administered during any visit, provided at least 1 month has elapsed since receipt of the first dose and that both doses are administered at or after 12 months of age.
8Susceptible children may receive Varicella vaccine (Var) at any visit after the first birthday, and those who lack a reliable history of chickenpox should be immunized during the 11-12 year-old visit. Children >=13 years of age should receive 2 doses, at least 1 mo apart.