Issue Number
139
February 19,
2000
CONTENTS OF THIS ISSUE
- FDA approves first pneumococcal vaccine for infants
and toddlers
- National Vaccine Program Office sponsors workshop on
aluminum in vaccines in May
- CDC publishes article on importation of wild poliovirus
into Qinghai Province, China
- Updated fact sheet on hepatitis B and adoption is now
available from the Immunization Action Coalition
- Illinois Immunization and Communicable Disease
conference set for June
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February 17, 2000
FDA APPROVES FIRST PNEUMOCOCCAL VACCINE FOR INFANTS AND TODDLERS
The United States Food and Drug Administration (FDA) approved the first vaccine to prevent invasive
pneumococcal diseases in infants and toddlers on February 17, 2000. The full text of the press release
from the United States Department of Health and Human Services reads as follows:
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FIRST PNEUMOCOCCAL VACCINE APPROVED 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 pneumoniae (also known as pneumococcus) including bacteremia (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 1,400
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, California. 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
pneumoniae is one of the leading causes of bacterial meningitis.
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To obtain a copy of this FDA press release online, go to: http://www.fda.gov/bbs/topics/NEWS/NEW00716.html
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February 19, 2000
NATIONAL VACCINE PROGRAM OFFICE WILL SPONSOR WORKSHOP ON ALUMINUM IN VACCINES IN MAY
The National Vaccine Program Office (NVPO) will sponsor a workshop titled "Aluminum in Vaccines" on May 11-12, 2000.
The workshop will be held at the Caribe Hotel in San Juan, Puerto Rico, immediately following the Metal Ions in Biology & Medicine Conference. Issues covered in the workshop will include
vaccine adjuvants, aluminum salts in vaccines, the pharmacology and toxicology of aluminum,
and macrophagic myofasciitis.
For additional information, visit NVPO's website at: http://www.cdc.gov/od/nvpo/calendar.htm
or contact Sandra Browning or Lena Kombo at (404) 687-6672.
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February 18, 2000
CDC PUBLISHES ARTICLE ON IMPORTATION OF WILD POLIOVIRUS INTO QINGHAI PROVINCE, CHINA
The Centers for Disease Control and Prevention (CDC) published an article titled "Importation of Wild
Poliovirus into Qinghai Province -- China, 1999" in the February 18, 2000, issue of the MMWR.
To read this MMWR article in HTML format, go to: http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4906a1.htm
HOW TO OBTAIN A FREE ELECTRONIC SUBSCRIPTION TO THE MMWR
To obtain a free electronic subscription to the "Morbidity and Mortality Weekly
Report" (MMWR), visit CDC's MMWR website listed below. Select "Free MMWR Subscription" from
the menu at the left of the screen. Once you have submitted the required information, weekly issues of the MMWR and all
new ACIP statements (published as MMWR's "Recommendations and Reports") will automatically arrive in your e-mail box.
To go to the MMWR website, visit: http://www2.cdc.gov/mmwr
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February 19, 2000
UPDATED FACT SHEET ON HEPATITIS B AND ADOPTION IS NOW AVAILABLE FROM THE IMMUNIZATION ACTION COALITION
In January 2000, the Immunization Action Coalition (IAC) updated its fact sheet titled "A Brief Introduction to
Hepatitis B for Parents of Adopted Children" to include lamivudine as a treatment option for children suffering
from liver disease. Written by Sarah Jane Schwarzenberg, MD, pediatric gastroenterologist at the University of
Minnesota Hospitals and Clinics, this fact sheet is helpful for parents who are seeking information about hepatitis B
and what to do if their child is infected.
To obtain a camera-ready copy (PDF format) of this item,
go to: http://www.immunize.org/catg.d/p4150.pdf
To obtain the text version (HTML format) of this item, go to: http://www.immunize.org/catg.d/p4150.htm
PACKET OF HEPATITIS B AND ADOPTION INFORMATION
The fact sheet described above is also available as part of a combined information packet titled "Hepatitis B and
Adoption Information." Some additional items included in this adoption packet are "Hepatitis B vaccine
imperative for families adopting from abroad" by Dr. Jane Ellen Aronson, "A packet of hepatitis B and adoption materials" by Jerri
Ann Jenista, MD, editor, Adoption Medical News, and "Confused about the hepatitis B panel? You're
not alone," a reprint of a letter to IAC written by an adoptive parent.
To download items in this packet that are available online (in HTML format), go
to: http://www.immunize.org/catg.d/p4152.htm
If you would like to receive a complete camera-ready copy of the packet by mail, send a fax request to IAC at
(651) 647-9131.
OTHER MATERIALS FOR YOUNG PEOPLE INFECTED WITH HEPATITIS B
The Coalition publishes additional education materials that provide information
about living with chronic hepatitis B infection. Some of our most popular pieces for parents and
adolescents include:
- "Questions Frequently Asked About Hepatitis B"
PDF format:
http://www.immunize.org/catg.d/p4090.pdf
HTML format: http://www.immunize.org/catg.d/p4090.htm
- "You are not alone! Information for young adults who are
chronically infected with hepatitis B virus"
PDF format: http://www.immunize.org/catg.d/4118.pdf
HTML format: http://www.immunize.org/catg.d/4118.htm
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February 19, 2000
ILLINOIS IMMUNIZATION AND COMMUNICABLE DISEASE CONFERENCE SET FOR JUNE
The annual Illinois Immunization and Communicable Disease Conference is set for June 6-7, 2000, and will be held at
the Crowne Plaza Hotel in Springfield, Illinois. "Meeting the Challenge Together" is the theme of this
year's conference.
Confirmed workshop topics include sessions on vaccine safety, the newly-licensed pediatric pneumococcal conjugate vaccine, and prevention
and control of meningococcal disease. CEU and CME credits will be offered.
For more information, please contact the Illinois Public Health Association
(IPHA) at (217) 522-5687 or by e-mail at ipha@ipha.com
or visit IPHA's website at: http://www.ipha.com
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