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2007-08 INFLUENZA PREVENTION & CONTROL RECOMMENDATIONS
Adverse Events After Receipt of Live, Attenuated Influenza Vaccine (LAIV)
NOTE: The text below is taken directly from Prevention & Control of Influenza - Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2007 Jul 13;56(RR06):1-54. Also available as PDF (720K).
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Children
In a subset of healthy children aged 60–71 months from one clinical trial, certain signs and symptoms were reported more often after the first dose among LAIV recipients (n = 214) than among placebo recipients (n = 95), including runny nose (48% and 44%, respectively); headache (18% and 12%, respectively); vomiting (5% and 3%, respectively); and myalgias (6% and 4%, respectively). However, these differences were not statistically significant. In other trials, signs and symptoms reported after LAIV administration have included runny nose or nasal congestion (20%–75%), headache (2%–46%), fever (0%–26%), vomiting (3%–13%), abdominal pain (2%), and myalgias (0%–21%). These symptoms were associated more often with the first dose and were self-limited. Data from a study including subjects aged 1–17 years indicated an increase in asthma or reactive airways disease among children aged 18–35 months. In another study, medically significant wheezing was more common within 42 days after the first dose of LAIV (3.2%) compared with TIV (2.0%) among previously unvaccinated children aged 6–23 months, and hospitalization for any cause within 180 days of vaccination was significantly more common among LAIV (6.1%) recipients aged 6 months–11 months compared with TIV recipients (2.6%). Another study was conducted among >11,000 children aged 18 months–18 years in which 18,780 doses of vaccine were administered for 4 years. For children aged 18 months–4 years, no increase was reported in asthma visits 0–15 days after vaccination compared with the prevaccination period. A significant increase in asthma events was reported 15–42 days after vaccination, but only in vaccine year 1.
Adults
Among adults, runny nose or nasal congestion (28%–78%), headache (16%–44%), and sore throat (15%–27%) have been reported more often among vaccine recipients than placebo recipients. In one clinical trial among a subset of healthy adults aged 18–49 years, signs and symptoms reported more frequently among LAIV recipients (n = 2,548) than placebo recipients (n = 1,290) within 7 days after each dose included cough (14% and 11%, respectively); runny nose (45% and 27%, respectively); sore throat (28% and 17%, respectively); chills (9% and 6%, respectively); and tiredness/ weakness (26% and 22%, respectively).
Persons at Higher Risk from Influenza-related Complications
LAIV is currently licensed for use only among healthy nonpregnant persons aged 5–49 years. However, data assessing the safety of LAIV use for certain groups at risk for influenzarelated complications are available. Studies conducted among children aged 6–71 months with a history of recurrent respiratory infections and among children aged 6–17 years with asthma have not demonstrated differences in postvaccination wheezing or asthma exacerbations, respectively. In one study of 54 HIV-infected persons aged 18–58 years and with CD4 counts greater than or equal to 200 cells/mm3 who received LAIV, no serious adverse events were reported during a 1-month followup period. Similarly, one study demonstrated no significant difference in the frequency of adverse events or viral shedding among HIV-infected children aged 1–8 years on effective antiretroviral therapy who were administered LAIV, compared with HIV-uninfected children receiving LAIV. LAIV was well-tolerated among adults aged 65 years and older with chronic medical conditions. These findings suggest that persons at risk for influenza complications who have inadvertent exposure to LAIV would not have significant adverse events or prolonged viral shedding and that persons who have contact with persons at higher risk for influenzarelated complications may receive LAIV.
Serious Adverse Events
Serious adverse events requiring medical attention among healthy children aged 5–17 years or healthy adults aged 18–49 years occurred at a rate of <1% (218). Surveillance will continue for adverse events, including those that might not have been detected in previous studies. Reviews of reports to VAERS after vaccination of approximately 2.5 million persons during the 2003–04 and 2004–05 influenza seasons did not indicate any new safety concerns. Health-care professionals should report all clinically significant adverse events promptly to VAERS after LAIV administration.
- Page last updated October 23, 2007
- Content Source: Coordinating Center for Infectious Diseases (CCID)
- National Center for Immunization and Respiratory Diseases (NCIRD)
