Issue Number 49
January 22, 1999
CONTENTS OF THIS ISSUE
- Here's the just-published ACIP
recommendation that describes who to vaccinate against hepatitis B
- MMWR publishes announcement of FDA
approval of vaccine for Lyme disease
- MMWR publishes announcement of FDA
approval of change in pediatric formulation for Recombivax HB
- MMWR publishes article on influenza
activity in the United States
- MMWR publishes article on the final
stages of poliomyelitis eradication -- Western Pacific Region
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(1)
January 22, 1999
HERE'S THE JUST-PUBLISHED ACIP RECOMMENDATION THAT DESCRIBES WHO TO VACCINATE AGAINST
HEPATITIS B
The following article, "Update: Recommendations to Prevent Hepatitis B Virus
Transmission United States," was published as a "Notice to Readers" in the
January 22, 1999, issue of the MMWR.
[IAC EXPRESS EDITORS' NOTE: This is an excellent one-page official document that
describes who needs to be vaccinated against hepatitis B!]
Included in this article is a description of the expanded recommendation to vaccinate all
children 0-18 years of age against hepatitis B virus infection. The expanded
recommendation encourages vaccination of previously unvaccinated children and adolescents
0-18 years of age whenever they are seen for routine medical visits. Also identified in
the article are adults who are in defined risk groups for hepatitis B virus infection and
need to receive hepatitis B vaccine.
The complete article is reprinted below:
UPDATE: RECOMMENDATIONS TO PREVENT HEPATITIS B VIRUS TRANSMISSION -- UNITED STATES
In October 1997, the Advisory Committee on Immunization Practices
(ACIP) expanded its hepatitis B vaccination recommendations to include all unvaccinated
children aged 0-18 years and made hepatitis B vaccine available through the Vaccines for
Children program (VFC) for persons aged 0-18 years who are eligible for VFC. ACIP
priorities for hepatitis B vaccination of children remain unchanged and include all
infants; children in populations at high risk for hepatitis B virus (HBV) infection (e.g.,
Alaska Natives, Pacific Islanders, and children who reside in households of
first-generation immigrants from countries where HBV infection is moderately or highly
endemic); previously unvaccinated children aged 11-12 years; and older adolescents and
adults in defined risk groups.
In 1991, the ACIP recommended a comprehensive hepatitis B vaccination strategy to
eliminate HBV transmission in the United States (1). Critical elements of this strategy
include preventing perinatal HBV transmission by identifying and providing
immunoprophylaxis to infants of hepatitis B surface antigen-positive mothers and universal
hepatitis B vaccination of infants to interrupt transmission. In 1994, the ACIP expanded
the recommendations to include previously unvaccinated children aged 11-12 years (2). The
percentage of children aged 19-35 months who have received three doses of hepatitis B
vaccine has increased substantially from less than 10% in 1991 to 84% in 1997 (3). No
nationwide vaccine coverage data are available to assess vaccine coverage among children
aged 11-12 years; however, vaccine coverage in this group is expected to increase in
states that have implemented middle school entry requirements for hepatitis B vaccination
(4).
To increase access to hepatitis B vaccine, the new recommendations encourage vaccination
of previously unvaccinated children and adolescents aged 0-18 years whenever they
are seen for routine medical visits. This expansion of the recommended age group for
vaccination and for VFC eligibility simplifies previous recommendations and the
eligibility criteria for VFC vaccine. Providers should ensure that vaccination records of
children and adolescents presenting for vaccination are checked for receipt of previous
doses.
Universal vaccination of infants and children aged 11-12 years will result in a highly
immune population and is expected to eliminate HBV transmission in the United States.
However, high rates of HBV infection continue to occur among Alaska Native and Pacific
Islander children and among children residing in households of first-generation immigrants
from countries where HBV infection is endemic (5,6). As a result, targeted programs are
needed to achieve high vaccination coverage among these children. In addition, because
most HBV infections in the United States occur among adults, vaccinating infants and
adolescents aged 11-12 years alone will not substantially lower disease incidence for
several years. Most HBV infections in adults occur among persons who have defined risk
factors for HBV infection, including persons with multiple sex partners (more than one
partner during the preceding 6 months); men who have sex with men; and injecting-drug
users (7). The primary means to prevent these infections is to identify settings where
adolescents and adults with high-risk drug and sexual practices can be routinely accessed
and vaccinated (e.g., sexually transmitted disease
clinics, family-planning clinics, drug-treatment clinics, community-based human
immunodeficiency virus prevention sites, and correctional facilities).
References
1. CDC. Hepatitis B virus: a comprehensive strategy for eliminating transmission through
universal childhood vaccination: recommendations of the Immunization Practices Advisory
Committee (ACIP). MMWR 1991;40(no. RR-13):1-20.
2. CDC. Update: recommendations to prevent hepatitis B virus transmission United States.
MMWR 1995;44:574-5.
3. CDC. National, state, and urban area vaccination coverage levels among children aged
19-35 months -- United States, 1997. MMWR 1998;47:547-54.
4. CDC. Effectiveness of a seventh grade school entry vaccination requirement -- statewide
and Orange County, Florida, 1997-1998. MMWR 1998;47:711-5.
5. Hurie MB, Mast EE, Davis JP. Horizontal transmission of hepatitis B virus infection to
United States-born children among refugees. Pediatrics 1992;89:269-73.
6. Mahoney FJ, Lawrence M, Scott K, Le Q, Farley T. Continuing risk for hepatitis B virus
transmission among children born in the United States to southeast Asian children in
Louisiana. Pediatrics 1995;95:1113-6.
7. CDC. Hepatitis surveillance report no. 56. Atlanta, Georgia: US Department of Health
and Human Services, Public Health Service, CDC, 1995.
To access the complete article in text format, click here:
http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00056293.htm
TO GET A FREE ELECTRONIC SUBSCRIPTION TO THE MMWR (delivered weekly), go to the MMWR
website and sign up. When you sign up, you will also receive all new ACIP statements which
are published as MMWR's "Recommendations and Reports." To get to the MMWR
website, click here: http://www.cdc.gov/epo/mmwr/mmwr.html
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(2)
January 22, 1999
MMWR PUBLISHES ANNOUNCEMENT OF FDA APPROVAL OF VACCINE FOR LYME DISEASE
An article entitled "Availability of Lyme Disease Vaccine" was published as a
"Notice to Readers" in the January 22, 1999, issue of the MMWR. The entire
article (with the exception of Figure 1, which is a map that shows the 1997 reported cases
of Lyme disease in the United States) is reprinted below:
AVAILABILITY OF LYME DISEASE VACCINE
On December 21, 1998, the Food and Drug Administration (FDA) licensed LYMErix (TM)
(SmithKline Beecham Biologicals, Reixensart, Belgium),* a new vaccine against Lyme disease
(LD). This report summarizes information about this vaccine and provides epidemiologic
information about LD relevant to vaccine use.
Each dose of LYMErix (TM) contains 30 ug of lipidated recombinant outer surface protein A
(OspA) of Borrelia burgdorferi sensu stricto, the causative agent of LD in North America,
adsorbed onto aluminum adjuvant (1). It is indicated for use in persons aged 15-70 years
(1). Three doses of the vaccine are administered by intramuscular injection. The initial
dose is followed by a second dose 1 month later and a third dose 12 months after the
first. Vaccine administration should be timed so the second dose and the third dose are
given several weeks before the beginning of the B. burgdorferi transmission season (1),
which usually begins in April. In a randomized, double-blind, multicenter trial involving
10,936 participants living in areas of the northeastern and upper north central United
States where LD is endemic, the vaccine efficacy in preventing LD was 50% (95% confidence
interval {CI}=14%-71%) after the first two doses and 78% (95% CI=59%-88%) after three
doses (1). Efficacy against asymptomatic seroconversion was 83% (95% CI=25%-96%) after two
doses and 100% (95% CI=30%-100%) after three doses (1). The duration of immunity following
the three-dose vaccination series is unknown, and the need for booster doses has not been
determined.
Local reactions at the site of injection were reported by significantly more vaccine
recipients than placebo recipients (1). Unsolicited reports of myalgia,
influenza-like illness, fever, and chills within 30 days after a dose were significantly
more common among vaccine recipients than placebo recipients, but none of these were
reported by greater than 5% of either group (1). Reports of arthritis were not
significantly different between vaccine and placebo recipients, but vaccine recipients
reported significantly more transient arthralgia and myalgia following each dose of
vaccine (1).
LD is the most commonly reported vectorborne disease in the United States. Since the
implementation of a standardized surveillance case definition in 1991, greater than
90% of cases have been reported from the northeast and north central states (Figure 1)
(2). Persons of all ages are susceptible to infection, but the highest reported rates of
LD occur in children aged less than 15 years and adults aged 30-59 years. Transmission
peaks from April through July, when the nymphal stages of the tick vectors of LD, Ixodes
scapularis and I. pacificus, are actively seeking hosts. These ticks are found primarily
in leaf litter and low-lying vegetation in wooded, brushy, or overgrown grassy areas and
can transmit other diseases such as babesiosis and ehrlichiosis (3,4).
An estimated 85% of persons with symptomatic LD have the characteristic rash, erythema
migrans (5). Untreated infection can cause arthritis or neurologic symptoms, such as
radiculoneuropathy or encephalopathy. At any stage, the disease can usually be
successfully treated with standard antibiotic regimens.
Strategies to prevent LD include avoiding tick habitats, wearing protective clothing,
using repellents to avoid tick attachment, promptly removing attached ticks, and employing
community measures to reduce tick abundance (6). Because the vaccine is less than 100%
efficacious and does not provide protection against other tickborne illnesses, vaccination
should not be considered a substitute for other preventive measures.
LD vaccine should be targeted to persons at risk for exposure to infected vector ticks.
This risk can be assessed by considering the focal geography of LD and the extent to which
a person's activities place him or her in contact with ticks (2). Vaccination of persons
with frequent or prolonged exposure to ticks in areas endemic for LD is likely to be an
important preventive strategy (7). For persons with only brief or intermittent exposure to
tick habitat in areas where LD is endemic, the public health benefits of vaccination,
compared with early diagnosis and treatment of LD, are not clear (7). Recommendations for
use of LD vaccine are being developed by the Advisory Committee for Immunization
Practices.
Reported by: Div of Vector-Borne Infectious Diseases, National Center for Infectious
Diseases, CDC.
References
1. SmithKline Beecham Biologicals. LYMErix (TM) product label. Reixensart, Belgium:
SmithKline Beecham Biologicals, December
1998.
2. Dennis DT. Epidemiology, ecology, and prevention of Lyme disease. In: Rahn DW, Evans J,
eds. Lyme disease. Philadelphia: American College of Physicians, 1998;7-34.
3. Spielman A, Wilson ML, Levine JF, et al. Ecology of Ixodes dammini-borne human
babesiosis and Lyme disease. Annu Rev Entomol
1985;30:439-60.
4. Des Vignes F, Fish D. Transmission of the agent of human granulocytic ehrlichiosis by
host-seeking Ixodes scapularis (Acari:Ixodidae) in southern New York state. J Med Entomol
1997;34:379-82.
5. Nadelman RB, Wormser GP. Lyme borreliosis. Lancet 1998;352:557-65.
6. Piesman J, Gray JS. Lyme disease/Lyme borreliosis. In: Sonenshine DR, Mather TN, eds.
Ecological dynamics of tick-borne zoonoses. New York: Oxford University Press,
1994:327-50.
7. Hayes EB, Dennis DT. Immunization against Lyme disease {Letter}.
N Engl J Med 1998;339:1637.
*Use of trade names and commercial sources is for identification only and does not imply
endorsement by CDC or the U.S. Department of Health and Human Services.
To access the complete article in text format, click here:
http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00056299.htm
TO GET A FREE ELECTRONIC SUBSCRIPTION TO THE MMWR (delivered weekly), go to the MMWR
website and sign up. When you sign up, you will also receive all new ACIP statements which
are published as MMWR's "Recommendations and Reports." To get to the MMWR
website, click here: http://www.cdc.gov/epo/mmwr/mmwr.html
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(3)
January 22, 1999
MMWR PUBLISHES ANNOUNCEMENT OF FDA APPROVAL OF CHANGE IN PEDIATRIC FORMULATION FOR
RECOMBIVAX HB
A "Notice to Readers" on the discontinued distribution and production of Merck
Vaccine Division's 2.5-ug dose of Recombivax HB was published in the January 22, 1999,
issue of the MMWR. It is reprinted below in its entirety:
FDA APPROVAL OF CHANGE IN PEDIATRIC FORMULATION FOR RECOMBIVAX HB
Effective August 27, 1998, the Merck Vaccine Division (Merck & Co., Inc., West Point,
Pennsylvania) discontinued distribution and production of the 2.5-ug dose of Recombivax HB
{Registered}* pediatric hepatitis B vaccine, which was licensed by the Food and Drug
Administration for infants of hepatitis B surface antigen (HBsAg)-negative mothers and
children aged less than or equal to 10 years. The 2.5-ug dose was replaced with a 5.0-ug
dose previously used for vaccination of adolescents and infants of HBsAg-positive mothers.
To simplify the vaccination schedule for infants and children, the Advisory Committee on
Immunization Practices recommends use of the 5.0-ug dose for all children and adolescents
aged 0-19 years. Either the 2.5-ug dose or the 5.0-ug dose may be used to complete any
vaccine series already started
for children aged less than or equal to 10 years, regardless of the initiating dose of
vaccine. Children who have completed the hepatitis B vaccination series with the 2.5-ug
dose do not need to be revaccinated.
*Use of trade names and commercial sources is for identification only and does not imply
endorsement by CDC or the U.S. Department of Health and Human Services.
To access the complete article in text format, click here:
http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00056298.htm
TO GET A FREE ELECTRONIC SUBSCRIPTION TO THE MMWR (delivered weekly), go to the MMWR
website and sign up. When you sign up, you will also receive all new ACIP statements which
are published as MMWR's "Recommendations and Reports." To get to the MMWR
website, click here: http://www.cdc.gov/epo/mmwr/mmwr.html
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(4)
January 22, 1999
MMWR PUBLISHES ARTICLE ON INFLUENZA ACTIVITY IN THE UNITED STATES
An article entitled "Update: Influenza Activity United States, 1998-99 Season"
was published in the MMWR on January 22, 1999.
The article summarizes influenza surveillance in the United States from October 4, 1998,
to January 9, 1999. Data in the report indicates that overall influenza activity for the
United States during this period was low.
The "Editorial Note" carries an important message about the need to continue
vaccination:
"The findings in this report indicate that, despite institutional outbreaks in
several states, this influenza season has been relatively mild. However, influenza
activity has increased since mid-December and may increase during subsequent weeks.
Although the optimal time for influenza vaccination is October through mid-November,
influenza vaccine should still be offered to unvaccinated high-risk persons, health-care
providers, caregivers, and household contacts of high-risk persons even after influenza
activity has been detected in the community."
To access the complete article in text format, click here:
http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00056270.htm
TO GET A FREE ELECTRONIC SUBSCRIPTION TO THE MMWR (delivered weekly), go to the MMWR
website and sign up. When you sign up, you will also receive all new ACIP statements which
are published as MMWR's "Recommendations and Reports." To get to the MMWR
website, click here: http://www.cdc.gov/epo/mmwr/mmwr.html
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(5)
January 22, 1999
MMWR PUBLISHES ARTICLE ON THE FINAL STAGES OF POLIOMYELITIS ERADICATION -- WESTERN PACIFIC
REGION, 1997-1998
An article entitled "Final Stages of Poliomyelitis Eradication -- Western Pacific
Region, 1997-1998" was published in the MMWR on January 22, 1999.
The article describes the extensive efforts that were undertaken to eliminate the last
chains of poliovirus transmission in the Mekong River area. Included in the data reported
in the article are these encouraging numbers: "From 1992 to 1997, the number of
confirmed polio cases decreased from 557 to one in Vietnam; from 146 to eight in Cambodia;
and from seven to zero in Laos."
The "Editorial Note" describes the intense efforts that were undertaken in the
final stages of poliomyelitis eradication:
"The efforts needed to interrupt the final chains of poliovirus transmission in the
last few remaining areas were far more intense than in the early stages when polio was
widely endemic. Critical conditions for the success of the mopping-up were 1) availability
of high-quality AFP and virological surveillance to identify high-risk areas; 2) timely
analysis of surveillance data to identify areas not reached by previous supplementary
vaccination rounds; 3) timely availability of laboratory results to identify areas where
wild poliovirus was circulating; 4) detailed local planning including the use of maps at
the sub-district level; and 5) use of new vaccination approaches, including mobile teams
to reach all target children."
To access the complete article in text format, click here:
http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00056285.htm
TO GET A FREE ELECTRONIC SUBSCRIPTION TO THE MMWR (delivered weekly), go to the MMWR
website and sign up. When you sign up, you will also receive all new ACIP statements which
are published as MMWR's "Recommendations and Reports." To get to the MMWR
website, click here: http://www.cdc.gov/epo/mmwr/mmwr.html |
