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ACIP: One-Dose HepB Vax OK for Some Infants Needing Revaccination

— Two more doses needed if infant still non-responsive after testing, committee advises

MedpageToday

ATLANTA -- Infants born to mothers with hepatitis B and who do not respond to the initial three-dose hepatitis B vaccination series should first receive one additional dose, instead of a full second three-dose series of the vaccine, the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP) recommended at a meeting here.

The committee voted for a more tiered approach -- that is, if the infant is non-responsive to the first full three-dose vaccination series following post-vaccination serologic testing (defined as anti-HBs <10 mIU/mL), the infant should receive one additional dose of hepatitis B vaccine, followed by post-vaccination serologic testing 1 to months later.

Infants whose anti-hepatitis B antigen levels remain less than 10 mIU/mL following this single-dose revaccination should receive two additional doses of the hepatitis B vaccine, followed by post-vaccination serologic testing 1 to 2 months after the final dose, the committee advised.

Not included in the formal recommendation language is that if post-vaccination serologic testing indicates that the infant has become responsive to the vaccine (anti-HBs ≥10 mIU/mL) after the first additional dose, no further vaccination is needed.

Data were presented indicating that most infants who do not respond after an initial round of revaccination do respond after a single additional dose, and that fewer doses are needed for most infants. One-dose revaccination was also found to be cost effective compared with three-dose revaccination, provided it happens during well child visits.

"I can hear perinatal hepatitis coordinators around the states cheering for this," said ACIP member , director of the Center for Community Health and co-director of the Clinical and Translational Science Institute at the University of Rochester School of Medicine and Dentistry in New York, who said the tiered approach would allow workers to close out children's cases faster if testing indicated that one additional dose was effective, rather than three additional doses.

Also agreeing was another ACIP member, , director of the Clinical Vaccine Unit of Duke University in Durham, N.C., who added: "I want to applaud the group for looking at ways to simplify revaccination."

The committee did not remove language about revaccination with a three-dose series entirely, saying that infants may receive the complete three-dose series based on "clinical circumstances or family preference." ACIP members said they thought there may be some families who did not want to subject their children to additional blood draws, or might find it difficult to come back to the office for testing.

Also included in the recommendation was that available data do not suggest a benefit to administering additional hepatitis B vaccine doses to infants who have not attained anti-HBs ≥10 mIU/mL following receipt of two complete HepB vaccine series.

The committee voted 13-0 (with one abstention) to include the revised language for inclusion in the updated hepatitis B vaccine statement, and 13-0 (with one abstention) to include these revised recommendations in the CDC's program.

New guidance adopted by ACIP becomes final once it is accepted by the CDC director and is published in Morbidity and Mortality Weekly Report.

No FluMist, No Difference in Influenza Vaccination Rates

In June 2016, the ACIP voted to remove the live activated influenza vaccine (LAIV), FluMist, from their recommendations for the 2016-2017 season, mainly due to the vaccine's ineffectiveness against H1N1 strains of the virus.

That has not led to a reduction in overall flu vaccination coverage, according to preliminary estimates from ACIP's Influenza Work Group.

There was no statistically significant difference in influenza vaccination coverage through December compared with a year ago (50% versus 51%, respectively), suggesting that nearly everyone who would have used the intranasal product accepted the conventional injections.

A representative from the National Association of Pediatric Nurse Practitioners added that, anecdotally, they did not see a lot of rejection in schools, healthcare organizations, and community health centers: "Those who want to be vaccinated are taking the injectable," she said.

The Influenza Work Group said that in order for FluMist to be considered for recommendation in future years, they would need vaccine effectiveness data against the H1N1 strains. But they will not be able to assess effectiveness against H1N1 strains from the data from this current year, and would need an H1N1-predominant season to gather that data -- which the Work Group members acknowledged could be years away.

The Work Group said they might be willing to accept human shedding and antibody, or immunogenicity data as "the most constructive data" that could be collected in a time frame of 1 to 2 years.

But several ACIP members remained skeptical of FluMist, and pushed for vaccine effectiveness data before it could be considered again: "If you're not decreasing the number of kids being vaccinated, we want to make sure we give them something that works," said , director of Obstetrics and Gynecology Infectious Disease at Massachusetts General Hospital in Boston.

ACIP member , director of the Division of Infectious Diseases at Emory University in Atlanta, was even more skeptical: "I think we have a long way to go," he said.

The Influenza Work Group currently does not plan on changing any policy language in the recommendations for the 2017-2018 influenza season, and will reiterate that influenza vaccination is recommended for all persons ages 6 months and older, the committee noted.

Disclosures

Advisory Committee on Immunization Practices (ACIP) member José Romero disclosed support from Merck, and abstained during the voting.

Another ACIP member disclosed support from Taneka Pharmaceuticals.