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Until further data are available on safety and/or efficacy, LAIV is not recommended by the FDA for some groups.
Walter observed that the analyses were limited by several factors, including few studies directly comparing LAIV and IIV lack of standardized outcome definitions across studies, and difficulty judging the risk of serious rare adverse events.
When educating patients regarding potential adverse events, clinicians should emphasize that 1) TIV contains noninfectious killed viruses and cannot cause influenza, 2) LAIV contains weakened influenza viruses that cannot replicate outside the upper respiratory tract and are unlikely to infect others, and 3) concomitant symptoms or respiratory disease unrelated to vaccination with either TIV or LAIV can occur after vaccination.
It recommends using the live attenuated influenza vaccine (LAIV), which is a nasal spray, for children ages 2 through 8 years.
Four new, recently licensed vaccines are now available: FluMist Quadrivalent nasal LAIV (LAIV4) from Medlmmune for persons aged 2-49 years; Fluarix Quadrivalent inactivated influenza vaccine (IIV4) from GlaxoSmithKline for those 3 years and older; Flucelvax, a cell culture-based inactivated influenza vaccine (ccIIV3) from Novartis for patients aged 18 years and older; and Flublok, a recombinant hemagglutinin vaccine from Protein Sciences for adults aged 18-49 years.
Talbot of Vanderbilt University, Nashville, Tenn., nasal wash specimens revealed that only 10 of 20 adults aged 18-49 years were shedding any influenza virus at day 3 after receiving LAIV, only 1 of 18 tested was shedding by day 7, and none were shedding thereafter.
Because LAIV is an attenuated live virus vaccine, some children should not receive it, including those younger than 5 years of age with reactive airway disease (recurrent wheezing or recent wheezing); those with a medical condition that places them at high risk of influenza complications; and those younger than 2 years of age.
It is unknown whether administering influenza antiviral medications affects the safety or efficacy of LAIV, so the vaccine should not be administered until 48 hours following the cessation of antiviral therapy, nor should antivirals be given for 2 weeks following receipt of the vaccine.
Subsequently, randomized studies comparing LAIV with IIV in children younger than 8 years of age demonstrating the relative benefits of LAIV were reported (N.
** LAIV is approved only for healthy people who are 5 to 49 years of age, whereas TIV is approved for anyone over the age of 6 months
* ACIP reemphasizes the importance of administering 2 doses of vaccine to all children aged 6 months-8 years if they have not been vaccinated previously at any time with either LAIV (doses separated by [greater than or equal to] 6 weeks) or TIV (doses separated by [greater than or equal to] 4 weeks), on the basis of accumulating data indicating that 2 doses are required for protection in these children (see Vaccine Efficacy, Effectiveness, and Safety).
"There were no unexpected toxicities or adverse events associated with administration of LAIV [live attenuated influenza virus] or TIV in HIV-positive children in this study," she said, summarizing 6 months of follow-up on behalf of the Pediatric AIDS Clinical Trials Group.
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