MSM: GSK:n oman lehdistötiedotteen (7/2009) testejä ei tehty

http://www.gsk-clinicalstudyregister.com/result_comp_list.jsp?compound=H5n1+Pandemic+Influenza+Vaccine&studyType=All&phase=All&population=All&marketing=All

http://www.gsk-clinicalstudyregister.com/result_comp_list.jsp?compound=H1n1+Pandemic+Influenza+Vaccine&studyType=All&phase=All&population=All&marketing=All

The attack rate for the A(H1N1)v virus strain is expected to be higher than for recently circulating
seasonal strains of influenza because of the lower levels of pre-existing immunity in the population.
Current estimates for the attack rate associated with the influenza A(H1N1)v virus over the first major
wave of infection in 2009–10 vary from approximately 10-30 % in different geographical areas. As a
result, the actual numbers of clinically apparent infections, cases that require hospitalisation and
deaths in the pandemic period is expected to be higher than in recent years for seasonal influenza.
These estimates may change (upwards or downwards) during the course of the pandemic.
SIIS PANDEMIAN LAAJUUS JA VAKAVUUS OLI MYYNTILUVAN MYÖNTÄMISEN AIKOIHIN ?

Current estimates for the attack rate associated with the influenza A(H1N1)v virus over the first wave
of infection vary from approximately 10-30 % in different geographical areas. There are no
established criteria for classifying pandemics in terms of severity. The perceived severity can vary
with geographical area, with sequential pandemic waves and in accordance with several other factors.
Descriptions of severity based on factors such as rates of hospitalisation may be misleading due to
different thresholds for this between countries and age groups.
SIIS TAUDINKUVAN ARVIOINTI SAIRAALAAN JOUTUNEIDEN PERUSTEELLA ON HUONO MITTARI TAUDIN VAKAVUUDESTA MONESTA ERI SYYSTÄ JOHTUEN MM. SIITÄ, ETTÄ KRITEERIT SAIRAALAAN OTTAMISELLE VAIHTELEVAT ERI MAISSA!

The mock-up H5N1 vaccine was commonly or very commonly associated with a range of local and
systemic adverse reactions but these were not often of severe intensity. The current safety database
with H5N1 vaccine is considered to be sufficient to describe adverse reactions that occur uncommonly
and to give an indication of any rare events in the population it has been tested. There are some
adverse reactions known to be very rarely associated with influenza vaccines and it is currently not
possible to predict if higher rates might be observed with Pandemrix A(H1N1)v compared with, for
example, seasonal influenza vaccines.

On the basis of a reasonable assumption that the safety of the A(H1N1)v vaccine should be
comparable to that of the mock-up vaccine the anticipated safety profile would not preclude the use of
the vaccine as currently described in the SPC. However, it remains possible that the data generated
with mock-up H5N1 vaccine cannot entirely predict the safety profile of Pandemrix A(H1N1)v since
there remains a possibility of adverse reactions associated with the pandemic influenza strain. The
specific commitments include collection of safety, immunogenicity and effectiveness data from the
ongoing and planned clinical studies.
SIIS PANDEMRIX -ROKOTTEEN MAHDOLLISET RISKIT ON ARVIOITU MYYNTILUPAA MYÖNNETTÄESSÄ HYVÄKSYTTÄVIKSI PERUSTUEN VASTAAVAN TYYPPISELLÄ ROKOTTEELLA AIKAISEMMIN TODETTUIHIN HAITOIHIN.

The development of Pandemrix was based on the guideline on dossier structure and content for
pandemic influenza vaccine marketing authorisation applications (CPMP/VEG/4717/03) and the
guideline on submission of marketing authorisation applications for pandemic influenza vaccines
through the centralised procedure (CPMP/VEG/4986/03). The core dossier procedure allows the
insertion of the pandemic strain A(H1N1)v into the authorised mock-up vaccine as a strain change
variation procedure.

This principle is based on the extrapolation of the extensive clinical safety and immunogenicity data
obtained with the mock-up vaccine (containing H5N1 strains) to the same vaccine construct using the
current influenza A(H1N1)v pandemic strain. That is, on an expectation that insertion of the influenza
A(H1N1)v strain into the mock-up vaccine construct would result in a vaccine similarly or even more
immunogenic than the H5N1 mock-up version and with a similar safety profile when used in a
comparable population (i.e. in terms of immunological naivety, health status and age group).

The specific commitments that accompany the strain change variation include collection of data from
ongoing and planned clinical studies, which will provide safety and immunogenicity data. These data
will be submitted and reviewed on a rolling basis and updates to the Clinical Particulars in the SPC
will be made as necessary.
SIIS ARVIO ROKOTTEEN TEHOSTA PERUSTUI MYYNTILUPAA MYÖNNETTÄESSÄ MUILLA VASTAAVAN TYYPPISILLÄ ROKOTTEILLA TODETUUN IMMUNOGEENISYYTEEN (= ROKOTETUILTA MITATTUJEN VASTA-AINETASOJEN NOUSUUN SEERUMISSA). LISÄKSI FIRMAA ON VAADITTU TEKEMÄÄN NÄITÄ VASTA-AINETASOJEN MITTAAMISEEN PERUSTUVIA TUTKIMUKSIA TÄLLÄ UUDELLA ROKOTTEELLA MYYNTILUVAN MYÖNTÄMISEN JÄLKEEN.

There are no data on co-administration of Pandemrix with other vaccines.

SIIS TIETOA MAHDOLLISISTA ROKOTTEIDEN VÄLISISTÄ INTERAKTIOISTA EI OLE.

YHTEENVETO: Tämän tiettävästi kaikista puolueettomimman saatavissa olevan tiedon perusteella rokotteen hyöty/riski -suhde on myyntilupaa myönnettäessä perustunut olettamukseen siitä, että Pandemrix -rokotteen hyödyt ja haitat ovat samaa luokkaa kuin mitä muilla vastaavan tyyppisillä, rokotteilla on aikaisemmin kliinisissä tutkimuksissa todettu olevan.

Kokonaisuudessaan EPAR löytyy ao linkeistä:

http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/Pandemrix-H-832-PU-17-AR.pdf
tai “täppää” klikkaamalla ao sivulta:
http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm