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Hepatitis
B Vaccination for Newborns
To the Editor: In their article on the impact of
recommendations regarding the birth dose of hepatitis B virus (HBV) vaccine,
Dr Daum and colleagues1
concluded that "special efforts may be required to make at-birth
administration of HBV vaccination universal." However, since HBV
vaccination of newborns has never been shown to be better than vaccination
after the maturation of the immune system, this worry about missing the birth
dose seems misplaced.
There is no scientific
evidence to justify HBV vaccination before the age when those risk factors
associated with the HBV transmission (sex, needles, etc) become relevant.
Recent risk-benefit analyses show HBV vaccination among children carries one
of the largest unjustified risks and substantial financial costs, second only
to the new controversial conjugate pneumococcal vaccine.2, 3
Specifically, HBV immunization has been associated with 53 deaths and 828
serious injuries, but for 38 million children younger than age 10 years, the
total yearly incidence of HBV infection is 191. For children younger than age
14 years, the estimated total mortality secondary to HBV disease is only 11.2 With
such statistics, it is difficult to rationalize HBV vaccination for newborns.
Erdem I. Cantekin, PhD
Department of Otolaryngology
University of Pittsburgh School of Medicine
Children's Hospital of Pittsburgh
Pittsburgh, Pa
Michael Belkin
Bainbridge Island, Wash
1. Oram
RJ, Daum RS, Seal JB, Lauderdale DS. Impact of recommendations to suspend the
birth dose of hepatitis B virus vaccine. JAMA. 2001;285:1874-1879. ABSTRACT
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TEXT | PDF
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2. Horwin
M. Ensuring safe, effective and necessary vaccines for children. Calif
West Law Rev. 2001;37:101-148.
3. Orient
J. Statement by the AAPS in "Vaccines: Public Safety and Personal
Choices" before the Government Reform Committee of the House of
Representatives." Presented to: 106th Cong, August 3, 1999; Washington,
DC.
In Reply: Dr Cantekin and Mr Belkin
question the importance of initiating routine HBV vaccination at birth, a
practice whose benefits we described recently.1 They
are correct that some behaviors rendering people at high risk for HBV do not
begin until adolescence or adulthood. However, a lower but nevertheless
substantial incidence of HBV infection affects individuals, including adults
and children, who do not engage in these high-risk behaviors.2
Furthermore, there are at least 4 benefits to newborns of HBV-infected
mothers. First, it eliminates confusion in birthing units regarding the need
for immediate immunization of newborns of mothers whose hepatitis surface
antigen status is positive or unknown, thereby avoiding irretrievable missed
opportunities to interrupt vertical transmission, which can have tragic
consequences.3, 4
Second, rendering children immune to HBV in early infancy provides protection
against the small but measurable incidence of HBV infection that is acquired
horizontally during childhood. Third, initiation of the 3-dose series at
birth has been associated with a higher likelihood of on-time receipt of the
entire series of HBV vaccinations,5, 6 and
of unrelated immunizations, such as diphtheria, tetanus, pertussis vaccine;
inactivated poliovirus vaccine; and measles, mumps, rubella vaccine.5
Fourth, immunization during infancy with integration into a schedule with
other vaccinations has the best chance for high coverage and protection for
most US children when the burden of disease increases sharply beginning in
adolescence. Such a strategy has paid great dividend in the case of rubella
immunization.
Risks of this simple
neonatal intervention are few. Cantekin and Belkin cite data abstracted from
the US Food and Drug Administration/Centers for Disease Control and
Prevention, the Vaccine Adverse Events Reporting System (VAERS) reports,7 which
passively report data regarding putative adverse events temporally associated
with vaccine administration, to indicate that the HBV vaccine has been
temporally associated with 53 deaths/y. However, analysis of VAERS data
obtained only from newborns immunized with HBV vaccine tells a different
story. From 1991 to 1998, 18 reports were submitted to VAERS regarding death
in infants who recently had received the HBV vaccine.7
Seventeen of these infants had another plausible diagnosis and had no
recognizable syndrome that might have resulted from the HBV vaccine.
We do share the implied
view of Cantekin and Belkin that vaccine safety is a great concern and must
be an area of constant vigilance. However, we also believe that protection
against HBV infection is of great benefit to all members of our society.
Initiating the vaccination series with an initial dose of HBV vaccine during
the newborn period is the best strategy to ensure the highest level of
protection.
Ronda J. Oram, MD
Diane S. Lauderdale, PhD
John B. Seal, MA
Robert S. Daum, MD
Departments of Pediatrics and Health Studies
Pediatric Immunization Program
University of Chicago
Chicago, Ill
1. Oram
RJ, Daum RS, Seal JB, Lauderdale DS. Impact of recommendations to suspend the
birth dose of hepatitis B virus vaccine. JAMA. 2001;285:1874-1879. ABSTRACT
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TEXT | PDF
| MEDLINE
2. Alter
MJ, Hadler SC, Margolis HS, et al. The changing epidemiology of hepatitis B
in the United States. JAMA. 1990;263:1218-1222. MEDLINE
3.
Centers for Disease Control and Prevention. Impact of the 1999 AAP/PHS joint
statement on thimerosal in vaccines on infant hepatitis B vaccination
practices. MMWR Morb Mortal Wkly Rep. 2001;50:94-97. MEDLINE
4. Watson
B. Comment. In: Transcript of the National Vaccine Advisory Committee
Workshop on Thimerosal in Vaccines. Washington, DC: Government Printing
Office; August 12, 1999.
5.
Lauderdale DS, Oram RJ, Goldstein KP, Daum RS. Hepatitis B vaccination among
children in inner-city housing, 1991-1997. JAMA. 1999;282:1725-1730. ABSTRACT
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TEXT | PDF
| MEDLINE
6. Yusef
HR, Daniels D, Smith P, Coronado V, Rodewald L. Association between
administration of the hepatitis B vaccine at birth and completion of the
hepatitis B and 4:3:1:3 vaccine series. JAMA. 2000;284:978-983. ABSTRACT
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TEXT | PDF
| MEDLINE
7. Niu
MT, Salive ME, Ellenberg SS. Neonatal deaths after hepatitis B vaccine. Arch
Pediatr Adolesc Med. 1999;153:1279-1282. ABSTRACT
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TEXT | PDF
| MEDLINE
Letters Information
Guidelines for Letters
Letters Section Editors: Stephen J. Lurie, MD, PhD, Senior
Editor; Jody W. Zylke, MD, Contributing Editor.
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