Higher Oz vax report rate
June 6, 2014
THE Advisory Committee on the
Safety of Vaccines (ACSOV) found
the reporting rate of adverse events
following immunisation (AEFI)
against influenza was much higher
in Australia than in the Northern
Hemisphere in 2013-14.
The Therapeutic Goods
Administration (TGA) Office of
Product Review’s found that the
overall reporting rate was about 81
cases per million doses distributed,
higher than other countries.
This compared with 12 to 23 cases
per million doses distributed for
the Northern Hemisphere during
2013 to 2014, with additional data
broken down by country showing
that across different Northern
Hemisphere countries reporting
rates varied between 10 and 19
cases per million doses distributed.
This difference was likely due to
more sensitive surveillance or lower
threshold for reporting influenza
vaccine AEFI rather than a higher
adverse vaccine reaction rate, the
TGA said.
The Committee looked at data
from routine surveillance of adverse
events in the Northern Hemisphere
in 2013-204 from five sponsors
providing six influenza vaccines
to Australian in 2014, including
Fluarix (GlaxoSmithKline), Agrippal
(Novartis) and Vaxigrip and Intanza
(Sanofi Pasteur) as part of the
influenza vaccine safety monitoring
program.
For all vaccines there were 2,364
spontaneous adverse event reports
from six months of age to 65 years.
The committee agreed there were
no new safety issues in the data
and the AEFI found were covered in
product information documents.
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