PNEUMOCOCCAL VACCINE FOR INFANTS AND TODDLERS

FDA today approved the first vaccine to prevent invasive pneumococcal diseases in infants and toddlers -- diseases which can cause brain damage and, in rare cases, death. The vaccine prevents invasive diseases caused by the organism Streptococcus pneumonia (also known as Pneumococcus) including bacteria (an infection of the bloodstream) and meningitis, an infection of the lining of the brain or spinal cord.

The vaccine -- Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197Protein)-- will be marketed as Prevnar by a unit of Wyeth-Ayerst Laboratories, a Division of American Home Products Corporation in Philadelphia, Pennsylvania.

Infants can receive the vaccine as a series of four inoculations administered at 2,4,6, and 12-15 months of age. For children who cannot receive the vaccine starting at age two months, it is recommended that parents see their health care provider for alternative schedules.

Prevnar is the first multivalent conjugate pneumococcal vaccine for children under the age of two. It targets the most common seven strains of pneumococcus that account for approximately 80 percent of invasive disease in infants. It is manufactured by attaching the polysaccharides (purified surface components of the different strains) to a genetically modified nontoxic form of the diphtheria toxin protein called CRM197.

"This new vaccine is great news for parents and their children because now, for the first time, we have a highly effective way to prevent a major cause of meningitis and serious blood infections in the most susceptible children -- those under two years of age." said Dr. Jane Henney, Commissioner of Food and Drugs. "When we prevent these infections, we are also preventing brain damage and mortality from pneumococcal diseases."

It is estimated that each year in the U.S. there are about 16,000 cases of pneumococcal bacteremia and 1400 cases of pneumococcal meningitis among children under age five. Children under the age of two are at highest risk for infection. In up to half the cases of meningitis, brain damage and hearing loss occurs and about 10 percent die.

Clinical trials included a large multicenter safety and efficacy study conducted at Northern California Kaiser Permanente in Oakland, Calif. The controlled, double- blind trial enrolled approximately 38,000 children, about half of whom received Prevnar. The vaccine was given at 2,4, 6 and 12-15 months of age along with routinely recommended vaccines. In this trial, the vaccine was 100 percent effective in preventing invasive pneumococcal disease caused by the seven strains of pneumococcus in the vaccine. The vaccine was approximately 90 percent effective in preventing invasive disease for illnesses caused by all pneumococcal subtypes.

This vaccine is not indicated for use in adults or as a substitute for other approved pneumococcal polysaccharide vaccines approved for high risk children over the age of two.

Side-effects in the trials were generally mild and included local injection site reactions, irritability, drowsiness and decreased appetite. Approximately 21 percent of the children had fevers over 100.3 compared to about 14 percent in the control group not receiving Prevnar.

The vaccine's effectiveness in preventing ear infections, another infection caused by pneumococcus, has not been evaluated by FDA.

Meningitis is usually caused by a viral or bacterial infection. There are different types of bacterial meningitis. Before the approval of the first Haemophilus influenza type b (HIB) conjugate vaccine in 1990 for infants, Hib was the leading cause of bacterial meningitis, but today Streptococcus pneumonia is one of the leading causes of bacterial meningitis.

This is not a vaccine against ear infections as many think.  It does decrease ear infections somewhat but it is for preventing meningitis, bacteremia (blood infection --- it killed Jim Hensen of the Muppets) and decrease pneumonia and ear infections caused by this germ.

Dose for ages:
0-6m -------- 3 doses and a booster at 15 months
6-12m ------  2 doses and a booster at 15 months
12-24m ----- 2 doses
2-4y -------- 1 dose only is susceptible to infections.
>4y --------- not given usually

Some insurance companies are paying for it and some are not yet.  We will give it as soon as we can.

Here is the AAP handout for this vaccine:

Pneumococcal Infection and Vaccine

Pneumococcus is a type of bacteria that can attack different parts of the body and cause many serious infections including
• Meningitis (brain)
• Bacteremia (blood stream)
• Pneumonia (lungs)
• Sinusitis (sinus membranes)
• Otitis media (ears)

These infections can be dangerous to very young children, the elderly, and people with certain high-risk health conditions.

Pneumococcal infection
What is pneumococcal infection?

Pneumococcal bacteria live naturally in humans in the back of the nose. Many people carry the bacteria and never Set sick. In fact, being a carrier helps boost one's natural immunity to the disease. Others are not immune and can get very sick from the infections caused by the bacteria.

Pneumococcal infections occur most often during the winter months. They spread from person to person the same way a cold or the flu spreads - by droplets passed through the air from coughing or sneezing, and through direct contact such as touching unwashed hands or kissing. The disease may spread quickly, especially in places where there are a lot of children, like child care centers and preschools.

Very young children do not have fully developed immune systems. This makes them more at risk from bacteria] infections like pneumococcus. In addition, pneumococcal infections can be life threatening for people with certain health problems such as
• HIV infection or other immune system disorders
• Sickle-cell disease
• White cell cancers like leukemia or lymphoma
• Chronic lung, heart, or kidney disease
• A removed spleen or one that doesn't work properly
• Bone marrow or organ transplants

Common pneumococcal infections and their symptoms
Bacteremia and meningitis
Pneumococcal bacteremia and pneumococcal meningitis occur when pneumococcal bacteria get into the bloodstream and/or the central nervous system. Bacteremia is the presence of bacteria in the blood. Meningitis is an infection of the thin lining and blood vessels that cover the brain and spinal cord. Symptoms of meningitis include High fever Stiff neck
• Headache
• Vomiting
• Extreme tiredness and/or irritability
• Loss of appetite

Pneumonia
Pneumococcal pneumonia is a chest infection in which the lungs become filled with fluid. Symptoms of pneumonia include
• Cough that may bring up thick yellow-green or bloody mucus
• High fever
• Shortness of breath or chest pain
• Extreme tiredness
• Hard and rapid breathing

Sinusitis
Sinusitis occurs when the membranes lining the airfilled pockets in the bone of the face (sinuses) swell. The sinus cavities may fill with fluid. Symptoms of sinusitis include
• Pressure behind the eyes
• Pain in the face
• Trouble breathing through the nose
• Postnasal drip or prolonged runny nose
• Fever
• Toothache

Otitis media
Otitis media is an infection of the middle ear. Young children commonly develop middle ear infections when they have colds, the flu, or other viral respiratory infections. Symptoms of an ear infection include
• Ear pain (very young children may pull at their ears because of the pain)
• Fever
• Restlessness or irritability
• Crying
• Runny nose

Diagnosis and treatment of pneumococcal infections
Your pediatrician will be able to tell if your child has a pneumococcal infection by your child's symptoms, a physical examination, and looking at your child's medical history. X-rays, blood tests, and sometimes a spinal tap also may be done to confirm pneumococcal infection in your child.

Prompt treatment with antibiotics is usually effective. In addition, your child may need bed rest and a lot of fluids. In some cases, your child may need to be hospitalized.

Unfortunately, some strains of the pneumococcal bacteria are developing resistance to the antibiotics usually used to kill them. This means that other antibiotics must be used. Your pediatrician will let you know which antibiotic is best for your child.

Prevention of pneumococcal infections

•Teach your children to wash their hands regularly with soap and water. This helps prevent the spread of infection.
•Avoid dust, tobacco smoke, and other substances that may interfere with breathing and make children more likely to set sick.

Pneumococcal vaccine

A vaccine now offers infants and young children protection against pneumococcal infections. It is most effective against the major pneumococcal diseases - bacteremia, meningitis, and pneumonia. The vaccine is minimally effective in preventing otitis media and sinusitis. Pneumococcal vaccine is safe and can be given as a separate injection at the same time as other immunizations.

Who should receive the vaccine?

The American Academy of Pediatrics recommends that all children younger than 2 years of age receive the Heptavalent Pneumococcal Conjugate Vaccine (PCV7 or Prevnar). A series of doses may be given at 2, 4, 6, and 12 to 15 months of age. A "catch-up" immunization schedule is available for children who get a late start.

Some children between the ages of 2 and 5 years who have certain health problems also need pneumococcal vaccine because they are at higher risk of getting serious infections. Two types of vaccines may be given to children in that group. Your pediatrician can explain which vaccine is best for your child.

Pneumococcal vaccines may be given to some children 5 years of age and older, although the risk associated with pneumococcal infections is much lower in older children.

Are there side effects to pneumococcal vaccines?

Most children have no side effects with pneumococcal vaccines. Those side effects that do occur are mild and temporary. The possible side effects include

• Soreness, swelling, and redness where the shot was given
• A mild-to-moderate fever
• Fussiness

These symptoms may begin within 24 hours after the shot and usually go away within 48 to 72 hours.

Talk to your pediatrician to see if your child should be vaccinated for pneumococcal infection and about the possible reactions to these immunizations.

The information contained in this publication should not be used as a substitute for the medical care and advice of your pediatrician. There may be variations in treatment that your pediatrician may recommend based on individual facts and circumstances.

'Me American Academy of Pediatrics is an organization of 55,000 primary care pediatricians, pediatric medical subspecialists, and pediatric surgical specialists dedicated to the health, safety, and well-being of infants, children, adolescents, and young adults.

Now available from the American Academy of Pediatrics ... Guide to Your Child's Symptoms. More than 100 common symptoms are listed alphabetically and designed to enable a parent to quickly identify a symptom, learn its possible cause, and determine how best to proceed. To order this 266-page deluxe hardcover edition, send a check or money order for $19,95, plus $5.50 shipping and handling, to: AAP Publications - Symptoms, PO Box 747, Elk Grove Village, IL 60009-0747. Or visit the AAP Web site at http://www.aap.org to order online.

Other parenting guides from the Academy include Caring for Your Baby and Young Child. Birth to Age 5, Caring for Your School-age Child. Ages 5 to 12, and Caring for Your Adolescent, Ages 12 to 21. These books (except Caring for Your Adolescent) are available in softcover each for only $15.95, plus $5.50 shipping and handling, and all three books are available in hardcover each for $19.95, plus $5.50 shipping and handling.

American Academy of Pediatrics
Division of Publications
PO Box 747
Elk Grove Village, IL 60009-0747
Web site - http://wwwaap.org
Copyright
All rights reserved.
HE0302

VACCINE BULLETIN 138 SEPT 2000
Copyright NCM Publishers, Inc

The pneumococcus is the most common cause of invasive pneumococcal disease (IPD) and acute otitis media in children. Although a 23-valent pneumococcal vaccine composed of purified capsular polysaccharide antigens of 23 pneumococcal serotypes (23PS) has long been available, like other polysaccharide antigens, many of the pneumococcal serotypes in the vaccine have limited immunogenicity in children younger than 2 to 3 years of age. With the recent licensure of a heptavalent pneumococcal conjugate vaccine (Prevnar"', PCV7), which contains serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F conjugated to CRM,197, a mutant diphtheria toxin, an important new tool is available to prevent serious pneumococcal infections in children.

The American Academy of Pediatrics (AAP) recently issued recommendations for the prevention of pneumococcal infections, including the use of pneumococcal conjugate vaccine, pneumococcal polysaccharide vaccine, and antibiotic prophylaxis (Pediatrics. 2000;106:367-376). These guidelines should be useful as physicians incorporate pneumococcal conjugate vaccine into the routine childhood immunization schedule.

According to Larry K. Pickering, MD, special consultant to the director, National Immunization Program, Centers for Disease Control and Prevention, in Atlanta, Georgia, the guidelines for use of pneumococcal conjugate vaccine from the Advisory Committee on Immunization Practices will be available in late summer or early fall and will be very similar to those issued by the AAP and the American Academy of Family Physicians.

"The pneumococcal conjugate vaccine is an important vaccine, said Jon Abramson, MD, chairperson of the AAP's Committee on Infectious Diseases and Weston M. Kelsey Professor and Chair, Department of Pediatrics, Wake Forest University School of Medicine, in Winston Salem, North Carolina. "Since Haemophilus influenzae type b conjugate vaccine has proven so effective in preventing invasive disease in children caused by that organism, the pneumococcal conjugate vaccine is the next vaccine to deal with the causes of important systemic bacterial infections in children," Dr Abramson told VACCINE BULLETIN.

At its June 2000 meeting, the ACIP added the pneumococcal conjugate vaccine to the Vaccines for Children program. According to Dr Abramson, reimbursement issues related to the pneumococcal conjugate vaccine are of concern and must be determined state by state. "Even the universal purchase states differ with respect to vaccine reimbursement," he added. The AAP is trying to deal with reimbursement issues to smooth the process by which a new vaccine is rolled out once a recommendation is made.

Who should receive the pneumococcal conjugate vaccine? According to the AAP, administration of PCV7 is of the highest priority for infants and toddlers 23 months of age and younger and for children at high risk for pneumococcal disease because of underlying illnesses. Currently, data are insufficient to support a recommendation for universal immunization of any children older than 24 months of age, other than those who are at high risk, according to the AAP.

Children 23 Months of Age and Younger

The PCV7 vaccine is recommended for routine administration to all children 23 months and younger, at 2,4,6, and 12 to 15 months of age (Table 1). Each 0.5-mL dose of the vaccine should be administered intramuscularly. The initial 2month dose should be given no earlier than 6 weeks of age; very-low-birth-weight infants (<1500 g) should be immunized at the time they attain a chronological age of 6 to 8 weeks, regardless of their calculated gestational age.

All children 23 months of age and younger who have not received doses of PCV7 prior to 6 months of age should be given catch-up doses according to the schedules given in Table 1:

- Children 7 to 11 months of age who have not previously received vaccine should receive two doses at least 6 to 8 weeks apart, followed by a third dose at 12 to 15 months of age or at least 6 to 8 weeks after the second dose.

- Children 12 to 23 months of age who have not been immunized previously should receive two doses at least 6 to 8 weeks apart.

According to the AAP, infants should receive the PCV7 immunization series in conjunction with other required childhood vaccines at the time of the first regularly scheduled well-child visit after at least 6 weeks of age. For children 23 months of age or younger who begin a catch-up immunization series at 7 months of age or older, the PCV7 immunization series should start at the time of their next clinic visit, including those visits that are not related to well-child care unless contraindicated.

Children 24 to 59 Months of Age at High Risk for I PD

The AAP recommends PCV7 vaccine for all children 24 to 59 months old who are at high risk for IPD, i.e., rates of infection of at least 150 / 100,000 (Table 2). Among the conditions that render a child at high risk for IPD are sickle-cell disease, other types of functional or anatomic asplenia, HIV infection, and primary immune deficiency. Children who are receiving immunosuppressive drugs also are in the high risk category for IPD.

Recommended schedules of pneumococcal immunization for high-risk children who are 24 to 59 months of age and who may or may not have received prior doses of 23PS or PCV7 vaccine are given in Table 3. These schedules advocate the use of both 23PS and PCV7 vaccines in older children.

The AAP policy statement points out that few data exist regarding the safety and immunogenicity of combined regimens of PCV7 and 23PS vaccines, and no data are available that address the efficacy of such regimens for the prevention of pneumococcal disease. But immunogenicity data suggest that PCV7 induces a primary immune response that will provide immune memory for the boosting of antibody to some serotypes contained in 23PS vaccine. Because 23PS vaccine provides a potential expansion of serotype coverage, it is recommended for use in high risk children. However, because of concern that repeated doses of 23PS vaccine may result in an increased incidence of local reactions, recommendations for the number of doses and dose intervals for pneumococcal vaccines (Table 3) should be carefully followed.

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TABLE 1. RECOMMENDED SCHEDULE OF DOSES FOR PCV7, INCLUDING PRIMARY SERIES AND CATCH-UP IMMUNIZATIONS, IN PREVIOUSLY UNVACCINATED CHILDREN*

Age at First Dose (months) Primary Series                         Booster Doses'

2-6                                             3 doses, 6-8 weeks apart                 1 dose at 12 -15 months of age

7-11                                             2 doses, 6-8 weeks apart                 1 dose at 12-15 months of age

12-23                                     2 doses, 6-8 weeks apart

>24                                             1 dose

*Recommendations for high-risk groups are given in Table 3.
Booster doses to be given at least 6 to 8 weeks after the final dose of the primary series.

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TABLE 2. CHILDREN AT HIGH RISK OF IPD

High Risk (IPD attack rate >150 cases/100,000/y)
1. Sickle-cell disease, congenital or acquired asplenia, or splenic dysfunction
2. Infection with HIV

Presumed High Risk (I PD attack rate not calculated)
1. Congenital immune deficiency: some B- (humoral) or T-lymphocyte deficiencies, complement deficiencies (particularly C1, C2, C3, and C4 deficiencies), or phagocytic disorders (excluding chronic granulomatous disease.
2. Chronic cardiac disease (particularly cyanotic congenital heart disease and cardiac failure)
3. Chronic pulmonary disease (including asthma treated with high-dose oral corticosteroid therapy)
4. Cerebrospinal fluid leaks
5. Chronic renal insufficiency, including nephrotic syndrome
6. Diseases associated with immunosuppressive therapy or radiation therapy (including malignant neoplasms, leukemias, lymphomas, and Hodgkin's disease) and solid organ transplantation*
7. Diabetes mellitus

Moderate Risk (I PD attack rate >20 cases/1 00,000/y)
1. All children 24-35 months of age
2. Children 36-59 months of age attending out-of-home care
3. Children 36-59 months of age who are of Native American (American Indian and Alaska Native) or African-American descent

*Guidelines for the use of pneumococcal vaccines for children who have received bone marrow transplants are currently undergoing revision.

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Children 24 to 59 Months of Age at Moderate Risk for IPD

Data are inadequate to recommend routine universal administration of PCV7 or 23PS vaccine to children greater than 24 months of age who are at moderate risk for IPD (attack rates of at least 20/100,000 but less than those deemed high-risk). Children who are considered to be at moderate risk for IPD include

- All children 24 to 35 months of age

- Children 36 to 59 months of age who attend out-of-home care (>4 hours weekly in the company of at least two unrelated children)

- Children 36 to 59 months of age who are of Native American (American Indian and Alaska Native) or African American descent

Other factors that might be considered when establishing priorities for possible elective immunization of children 24 to 59 months of age with a pneumococcal vaccine include
- Social or economic disadvantage
- Residence in crowded or substandard housing/state of homelessness
- Chronic exposure to tobacco smoke
- History of severe or recurrent otitis media within the year prior to immunization or prior tympanostomy tube placement

According to the AAP, PCV7 vaccine administered electively for children 24 to 59 months of age should be given according to the schedule in Table 1. An alternative is administration of a single dose of the 23PS vaccine for all children 2 years of age or older. If PCV7 is used , a single dose of 23PS vaccine after administration of PCV7 should be considered, particularly in children of American Indian descent, to provide broadened pneumococcal serotype coverage. The dose of 23PS vaccine should be given no earlier than 6 to 8 weeks after the last dose of PCV7.

Healthy Children 5 Years of Age and Older

Health care professionals also may elect immunization with PCV7 or 23PS vaccine for certain children 60 months of age or older, although the risks for IPD are much lower in these older children, according to the AAP. Although data are limited, studies of small numbers of children with sickle-cell disease and HIV suggest that PCV7 is safe and immunogenic when administered to children up to 13 years of age. Therefore, administration of a single dose of PCV7 to children of any age, particularly children at high risk for IPD, is not contraindicated. However, 23PS also may be effective and immunogenic in older children at increased risk of invasive or severe respiratory tract infections caused by pneumococci. Therefore, immunization with a single dose of PCV7 or 23PS vaccine is acceptable. If both vaccines are used, they should be given 6 to 8 weeks apart.

Use of Pneumococcal Vaccine in Children With Severe or Recurrent Otitis Media

Pneumococcal polysaccharide vaccines have not been successful in reducing the incidence of acute otitis media (AOM) in children of any age. Therefore, 23PS vaccine is not recommended for the prevention of AOM. However, PCV7 vaccine has effected a modest reduction (<10 ) in the incidence of AOM in children with a history of recurrent AOM (defined as three or more episodes in 6 months or four or more episodes in the year before vaccine administration). And PCV7 may be beneficial for children 24 to 59 months of age who have not previously received pneumococcal vaccines and who have a history of recurrent AOM or who have AOM complicated by placement of tympanostomy tubes.

Control of Pneumococcal Disease Among Children Attending Out-of-Home Care

Studies have found that rates of IPD among children attending out-of-home care are 2- to 3-fold higher than those among other healthy children of the same age group who are not enrolled in out-of-home care (defined as at least 4 hours per week in out-of-home care shared with at least two unrelated children). Immunization with 23PS vaccine does not reduce nasopharyngeal carriage of pneumococci, and available data are insufficient to determine efficacy of PCV7 in preventing or interrupting nasopharyngeal carriage or transmission of pneumococcal infection in out-of home-care settings where one or more invasive pneumococcal infections have occurred. Until additional data become available, routine immunization with PCV7 or 23PS vaccine is not recommended for children in out-of-home care, although the elective use of either vaccine is not contraindicated.

Use of Pneumococcal Vaccines in Children With a History of Pneumococcal Disease

Children who have had IPD should receive all recommended doses of pneumococcal vaccines (PCV7 or 23PS) appropriate for their age and underlying condition. The full series of scheduled doses should be completed even if the series is interrupted by an episode of IPD.

Pneumococcal Vaccines: General Recommendations

Either PCV7 or 23PS may be given concomitantly with other vaccines. A separate syringe should be used for the injection of either type of pneumococcal vaccine, which should be administered at a different site than other vaccines given during the same visit. The concurrent administration of pneumococcal vaccine with diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, H influenzae type b conjugate vaccines, hepatitis B vaccine, inactivated poliovirus vaccine, measles-mumps-rubella vaccine, and varicella vaccine has not been shown to meaningfully impair the immune response to other vaccines.

Rates of local reactions after administration of PCV7 are similar to those seen with H influenzae type b conjugate vaccines, although fever and local reactions occur more often with PCV7. The PCV7 vaccine does not contain thimerosal.

In patients in whom elective splenectomy is performed for any reason, immunization with PCV7 or 23PS should be performed at least 2 weeks before splenectomy. Immunization should precede the initiation of immune-compromising therapy by at least 2 weeks, the AAP indicated. In general, pneumococcal vaccines should not be administered during pregnancy, because the effects on the developing fetus are unknown.

Questions for the future

According to Jerome 0. Klein, MD, professor of pediatrics, Boston University School of Medicine, in Boston, Massachusetts, questions that remain to be answered after recommendations for use of pneumococcal conjugate vaccine are implemented include
- What pattern of pneumococcal disease will be seen in the first few years following widespread use of the vaccine in infants and children?
- Will the incidence of pneumococcal bacteremia, meningitis, and pneumonia decline?
- Will carriage of pneumococcal vaccine types be reduced, and will carriage of nonvaccine types increase?
- Will the use of antibiotics for respiratory infections and suspected invasive disease decline?
- Will the incidence of multidrug-resistant pneumococci decline? -

FREQUENTLY ASKED QUESTIONS ABOUT PNEUMOCCCAL CONJUGATE VACCINE

The following Q&As were adapted from the "Doctors Frequently Asked Questions" section of the Web site www.pneumo.com, which is provided as an educational service of Wyeth Lederle Vaccines.

Q: In addition to the fact that the pneumococcal conjugate vaccine can be given to children younger than 2 years, what are its benefits, compared with the currently licensed polysaccharide pneumococcal vaccine?

Kathryn Edwards, MD, Vanderbilt University, Nashville, Tennessee: The pneumococcal conjugate vaccine includes seven most common serotypes in children, whereas the vaccine contains the 23 most common serotypes in adults and children. The conjugate vaccine generates memory to the seven serotypes included in the vaccine, while the 23-valent does not generate memory to the 23 serotypes in the vaccine. The conjugate vaccine generates an immune response in children as young as 2 months of age, while the 23-valent vaccine does not generate antibody until a child is 2 years of age. The conjugate vaccine has been shown to prevent invasive pneumococcal disease in infants, whereas the 23-valent vaccine has not.

Q: If a patient received the 23-valent pneumococcal vaccine at 2 years of age, would he still need to receive the 7-valent pneumococcal conjugate vaccine between the ages of 3 and 5 years?

Dr. Edwards: The use of pneumococcal conjugate vaccine booster doses in children who have been immunized with the 23-valent vaccine at the age of 2 years has been evaluated in a small number of studies to date. However, according to the available studies, it appears that the conjugate vaccine will result in a better antibody response than the 23-valent vaccine. The conjugate vaccine also primes for a memory response, so that subsequent boosters with the 23 valent vaccine would likely be very immunogenic. It has also been shown that children first receiving the 23-valent vaccine followed by the conjugate vaccine do not appear to have more frequent or severe local reactions.

Q: What about infants beginning the pneumococcal conjugate vaccine series at the 6-month well-child visit? Do they need the full four doses, or can an adequate response be achieved with doses at the 6-, 9-, and I 2-month visits?

George H. McCracken, Jr, MD, University of Texas South western Medical School, Dallas: Three doses of pneumococcal conjugate vaccine after 6 months will produce protective antibody titers, but the infant could be unprotected at 2 to 6 months, especially if the mother did not have adequate antibody titers to all seven serotypes at the time of birth. The 2-, 4-, and 6-month regimen was studied because it was the time of other childhood immunizations and also was the time H influenzae type b vaccine was given with such excellent results.

Q: What are the recommendations for use of the pneumococcal conjugate vaccine in premature infants?

Dr. McCracken: For most premature infants, routine immunizations are given when they reach 2 months of age, unless they remain hospitalized for medical problems. I am sure there are few data on the immunogenicity of the pneumococcal conjugate vaccine for most premature, low birth-weight babies, but studies will be done in the near future. I would administer pneumococcal conjugate vaccine to most premature infants when they have reached 2 months of age.