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Flu Vaccine Recommendations


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.