In Nov issue of INFECTIOUS DISEASES IN CHILDREN:
ACIP TO DELAY CONSIDERING UNIVERSAL PEDIATRIC FLU VACCINE RECOMMENDATION
ATLANTA - The influenza vaccine is now strongly recommended for all
children 6 to 23 months old, but the Advisory Committee on Immunization
Practices (ACIP) appears ready to stall consideration of a universal
recommendation due to a lack of safety and efficacy data.
Pediatric flu vaccine recommendation looks
unlikely, according to ACIP
The panel requested additional safety and efficacy data, which could
take two to three years
to collect.
by Bryan Bechtel
Staff Writer
November 2002
ATLANTA -- The recommendation to vaccinate all healthy children 6 months
to 23 months old against
influenza may still be years away, according to the Advisory Committee
on Immunization Practices
(ACIP).
The influenza vaccine is now strongly recommended by the ACIP for all
children 6 to 23 months old, but
the ACIP appears ready to stall consideration of a universal
recommendation due to missing data.
Several members of the panel requested additional safety and efficacy
data before considering a stronger
recommendation.
But the optimal data would come from studies conducted over multiple
winters, according to researchers.
Because vaccination efforts have already begun for the 2002 to 2003
season, studies probably could not
be started until next year, which means that consideration of
recommendations would be pushed to at
least 2004 for the 2004 to 2005 influenza season, explained Keiji
Fukada, MD, a medical epidemiologist
with the CDC.
Although the vaccine has been recommended for use in high-risk children
since the late 1970s, efficacy
data have come from a few clinical trials with relatively small patient
populations. There have also been
limited safety studies on the trivalent inactivated influenza vaccine in
young children.
A study by the Kaiser Permanente Vaccine Study group, using information
from the Vaccine Safety
Datalink, a linked databases of five separate managed care organizations
covering 3.5 million children
younger than 18, found no signals of any serious adverse events except
for a possible rise in visits for
impetigo after vaccination. Furthermore, said Jason Glanz, MS, of Kaiser
Permanente of Colorado, who
presented the data to the panel, the study confirmed that no signal had
been missed by the Vaccine
Adverse Events Reporting System.
The study reported on the odds of a medical event one to 14 days after
vaccination, considered the most
likely time for an adverse event, compared with medical events 15 to 28
days after vaccination, in 8,476
children 6 to 23 months of age.
The study found 33 diagnosis codes for visits in the 14 days post
vaccination, with rises in visits for
uncomplicated diabetes, atopic dermatitis, renal and ureteral disorders
and impetigo during days one to
three. However, only impetigo was considered possibly associated. Other
reasons for a second visit
included upper respiratory tract infection or cold, asthma, rhinitis,
dyspnea and pharyngitis.
However, the ACIP was critical of the study, saying it was unclear
whether the visits were after the first
or second dose of vaccination and that further analysis was needed for
the possible link to renal and
ureteral disorders.
Jon Abramson, MD, head of the AAP's panel on infectious diseases and an
ex officio member to the
ACIP, said that while more safety and efficacy data would be nice to
have, feasibility issues are more
problematic. He pointed out that the ACIP previously recommended
influenza vaccine for pregnant
women based on no efficacy data.
As well, the Vaccine Injury Compensation Program (VICP) will not
immediately cover the influenza
vaccine, so physicians and providers who vaccinate children will not be
protected against litigation.
Congressional support is needed before the vaccine is added to the
injury compensation table, a move
that is likely in the next couple of years, according to Geoffrey Evans,
MD, director of the VICP.
"Given the direction of the governing bodies, it is likely that
influenza will be covered some time down the
line," he said, adding that once influenza is added, it will have eight
years of retroactive coverage by
VICP.
In other ACIP news, discussion of combination vaccines and their
potential impact on the structure of the
childhood immunization schedule has been pushed to a future meeting,
possibly in June. The original
agenda included discussion of combination vaccines, but the ACIP was
asked in late September to
strengthen its recommendations on smallpox vaccine use, precluding all
other topics.
As a result, it is unlikely that new combination vaccines will be added
to the 2003 childhood immunization
schedule due out in January, even if they are approved by the FDA in the
interim.