ANALYSIS JOURNAL
A postlicensure evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in
children 24–59 months of age
Nama Kelompok
1. NINDHITA WAHYU NUGROHO (170103059)
2. RIZKI HANDAYANI (170103076)
3. TRI HERLINA SARI RAHAYU (170103092)
SARJANA KEPERAWATAN
UNIVERSITAS HARAPAN BANGSA PURWOKERTO
TAHUN 2021
Analisis journal
Student 1
A postlicensure evaluation of the safety of Ann Arbor strain live attenuated (variable
independen ) influenza vaccine in children 24–59 months of age ( variable dependen )
there are eight writers (Seth L. Toback, Christopher S. Ambrose, Abigail Eaton, John
Hansen, Laurie Aukes , Ned Lewis , Xionghua Wu, Roger Baxter)
they are a health worker who is analyzing ann arbor strain of influenza vaccine
in a hospital in one area of the united states
yes, they are health worker practitioners
problems
whether the ann arbor strain of influenza vaccine is safe to administer to children 24–59
months of age ?
purpose
- describe the safety of the ann arbor strain of influenza vaccine
- describe safety for children 24-59 months of age
Student 2
Influenza was increased after LAIV in 2 comparisons each versus unvaccinated and TIV
controls within 42 days postvaccination, and decreased after vaccination with LAIV in
the within-cohort analysis in 2 comparisons . Of 193 influenza events among LAIV
recipients during the study period, 191 (99%) occurred during the 2009 2010 H1N1
influenza pandemic season. During this season, 2009 pandemic H1N1 vaccine was
received by 34%, 62%, and 6% of LAIV recipients, TIV-vaccinated, and unvaccinated
controls, respectively.
After the post hoc adjustment for multiple comparisons, 81 of 304 incidence rate
comparisons remained statistically signifi-cant; 2 and 79 comparisons occurred at higher
and lower rates, respectively, after vaccination with LAIV (Table3). Wheezing / SOB
occurred at increased rates after vaccination with LAIV in 2 com-parisons versus
unvaccinated controls in those 36 – 59 months and 24 –59 months of age with in 180
days postvaccination; AW events occurred at lower rates after LAIV compared with TIV-
vaccinated and unvaccinatedc ontrols in 42 comparisons. Events occurring at decreased
rates after LAIV included any respiratory tractevent, AW event, any event, asthma /
RAD, cough, otitis media, upper respiratory tract infection, viral syndrome, andw heez-
ing / SOB.
Stundent 3
Do vaccines affect children's health, according to this study?
1. 42 days
- A 4-year-old boy developed fever 3 days postvaccination; a chest radiograph
revealed right middle lobe infiltrate concomitant with positive test.
- A 31-month-old boy developed abdominal pain the same day after vaccination and
was evaluated in the ED the following day.
2. Sleep apnea and tonsillitis occurred in 5 children
Did you find any weaknesses in this study?
due to the exploratory nature of this study and the lack of formal hypothesis testing, no
corrections were made for multiple comparisons in the primary analysis. Among a large
numbercomparison, one would expect many statistically significant results just a
coincidence. Differences in the non-randomized comparison groups were fixed though
matches most likely contributed to events that occurred at a higher level after vaccination
with LAIV compared with unvaccinated controls, as well as events which occurred to a
lesser extent after LAIV compared to controls vaccinated against TIV.
3. Will you give your child this vaccine based on this safety study? Why or why not?
Yes, because the results of reports to the Vaccine Adverse Events Reporting System in
the years after the initial approval of LAIV, demonstrated no significant adverse
outcomes after receipt of LAIV by eligible children 2–17 years of age.
4. What about the population (children) in this study, is it big enough?
Yes, total population LAIV doses 33,443 and unvaccinated controls 28,766