Germany: 39 year old woman fell ill with pandemic influenza H1N1 although vaccinated 20 days ago

[german-docter]

Lothar Markus, MD, a general practitioner from Leipzig (Saxony) reported the case of a 39 year old woman who had been vaccinated with a single shot of the adjuvanted vaccine Pandemrix? (GSK) on November 12, 2009 but returned to his surgery only 20 days later suffering from the typical symptoms of influenza (headache, muscle aches, fever of 103,1?F (39,5? C)).

The PCR-test of the nasal swab came back positive from the lab of the department of virology at the university of Leipzig by fax the same day. A spokesman of the Saxon ministry of health said, he assumed that the woman might have been infected before the complete immunity could be acquired. Dr. Markus did not settle for that statement and wrote a note to the Robert Koch-Institute asking for further investigation of the case.

http://www.bild.de/BILD/regional/leipzig/aktuell/2009/12/09/schweinegrippe/patientin-nach-impfung-mit-virus-infiziert.html

SCHWEINEGRIPPE

Patientin nach Impfung infiziert

?ICH WAR SELBST ERSCHROCKEN?, SAGT IHR LEIPZIGER ARZT ZU BILD

09.12.2009 - 15:47 UHR

VON MARTINA KURTZ

Diagnose Schweinegrippe ? trotz Impfung!

Der Leipziger Allgemeinarzt Dr. Lothar Markus (60) berichtet jetzt erstmals von einem solchen Fall. Am 12. November habe er einer Patientin (39) eine Dosis des Schweinegrippe-Impfstoffs ?Pandemrix? geimpft. 20 Tage sp?ter sei sie wieder in seine Praxis gekommen. Der Arzt: ?Sie klagte ?ber starke Kopf- und Gliederschmerzen, hatte 39,5 Grad Fieber. Typische Grippe-Symptome!?

Der Mediziner machte sofort einen Nasenabstrich und veranlasste einen H1N1-Test in der Virologie der Universit?t Leipzig. Das Ergebnis bekam er noch am gleichen Tag per Fax ? es war positiv! Dr. Markus: ?Ich war selbst erschrocken. Denn das bedeutet, dass eine mit Pandemrix geimpfte Person nicht vor dem Virus H1N1 gefeit ist.?

Ralph Schreiber, Sprecher des S?chsischen Gesundheitsministeriums, vermutet eine ungl?ckliche Zeit?berschneidung: ?Die Immunit?t ist erst drei Wochen nach einer Impfung richtig aufgebaut, vermutlich hat sich die Patientin vorher angesteckt.?

Damit will sich Dr. Markus nicht zufrieden geben. ?Viele Schweinegrippe-Erkrankungen werden nicht erkannt, weil ?rzte nach einer Impfung keine Infektion vermuten?, bef?rchtet er und fordert jetzt in einem Schreiben an das Robert-Koch-Institut (RKI), die Wirksamkeit von Pandemrix zu pr?fen: ?M?glich, dass eine einmalige Impfung nicht reicht.?RKI-

Sprecherin Susanne Glasmacher: ?Solche F?lle sind durchaus denkbar. Kein Medikament ist einhundertprozentig wirksam.?

[Celvin11]

Re: Germany: 39 year old woman fell ill with pandemic influenza H1N1 although vaccinated 20 days ago

Pandemrix: Forsøkene så langt antyder at 80-90 prosent av de vaksinerte vil være beskyttet

Pandemrix: Tests so far suggests that 80-90 per cent of those vaccinated will be protected, [i.e. not all]

Quote from Statens legemiddelverk (Norwegian Medicines Agency)

Stated in this article http://www.rb.no/lokale_nyheter/article4665229.ece

[gsgs]

Re: Germany: 39 year old woman fell ill with pandemic influenza H1N1 although vaccinated 20 days ago

die Frage ist, warum es noch keine öffentlichen Berichte gibt,
wieviel % der Infizierten geimpft waren. Das muss doch längst vorliegen.
Auch aus anderen Ländern.

z.B. einfach die offiziell gemeldeten 192348 Fälle (mehr hat kein Land,
nichtmal USA !) nehmen und fragen, wer von denen geimpft war.
(mindestens 2 Wochen vorher)

[german-docter]

Re: Germany: 39 year old woman fell ill with pandemic influenza H1N1 although vaccinated 20 days ago

Pandemrix: Fors?kene s? langt antyder at 80-90 prosent av de vaksinerte vil v?re beskyttet

Pandemrix: Tests so far suggests that 80-90 per cent of those vaccinated will be protected, [i.e. not all]

Quote from Statens legemiddelverk (Norwegian Medicines Agency)

Stated in this article http://www.rb.no/lokale_nyheter/article4665229.ece

Yes, Celvin11

In a GSK study, recently published by EMEA, 58 out of 59 subjects (98.3 %) in a subgroup aged 18 to 40 years, gained a state of seroprotection on day 21 after a single shot of Pandemrix vaccine.

Although protection rate never could be expected to be 100 percent in any age group, this seems to be the first "real world" report of the problem.

Physicians usually would not expect their patients falling ill with pandemic influenza nearly three weeks after vaccination (as the doctor in the newspaper report pointed out).

http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/Pandemrix-H-832-II-23-AR.pdf

EMEA:
CHMP VARIATION ASSESSMENT REPORT
Invented name/Name: Pandemrix
International non-proprietary name/Common name: pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179a) TYPE II VARIATION: EMEA/H/C/000832/II/0023

1.1. Introduction
Pandemrix was granted Marketing Authorisation in the EU in May 2008, with use being restricted to subjects aged 18-60 years in section 4.2 of the summary of product characteristics (SPC) due to lack of data outside of this age range. The granting of the initial Marketing Authorisation was based on a mock-up vaccine derived from A/VietNam/1194/2004 (H5N1) like strain (NIBRG-14).

Following the declaration of the pandemic phase 6 by the World Health Organisation (WHO), the MAH applied for a strain change to include the pandemic H1N1v strain.
The currently approved vaccine contains split influenza virus with a haemagglutinin content equivalent to 3.75 micrograms derived from A/California/7/2009 (H1N1)v-like strain (X-179A).
The virus is propagated in eggs and the approved vaccine is manufactured in Dresden.
The vaccine also contains the marketing authorisation holder?s (MAH?s) proprietary adjuvant AS03, which is composed of squalene, DL-alpha-tocopherol and polysorbate 80.
The MAH applied to update sections 4.2 and 5.1 of the Summary of Product Characteristics (SPC) for Pandemrix H1N1 to reflect newly available results from a clinical study in adults 18-60 years of age and above (D-PAN-H1N1-008, called ?H1N1-008? in this report ).In support of this variation the MAH has submitted a synoptic report of day 21 (D21) safety and immunogenicity data (HI only) from study H1N1-008
(?)

1.2 Clinical aspects
H1N1-008
This is a phase II, randomised, open-label, single centre study to evaluate the safety and immunogenicity of Pandemrix H1N1 following administration of one or two doses to healthy adults aged from the age of 18 years onwards.

Study Design and objectives
The original design of this study was amended when the first results of study H1N1-021 became available (for further details of this study, please refer to the Scientific Discussion of the pandemic strain variation PU-17). Thus, instead of administering two doses to all subjects in each age stratum one cohort will receive two doses as planned and the other will receive only a single dose. Both cohorts will then be followed up serologically at M6 and at M12 to determine whether there is any advantage for two doses over a single dose in the longer term.
The study was initiated in September 2009 and is ongoing. Currently only the data obtained up to D21 after a single dose of Pandemrix H1N1 are available. The MAH provides an abridged study report that covers the post-dose I immunogenicity results (i.e. at D21) after a single dose of 3.75 μg/AS03A together with data on reactogenicity, adverse events (AEs) and serious adverse events (SAEs).
The complete list of objectives for study D-Pan-H1N1-008 is detailed below. However, only the post Dose 1 (Day 21) results are available at this point.
(?)

The primary objective is:
- To demonstrate that vaccination with one dose of the H1N1 vaccine (A/California/7/2009 (H1N1)v-like strain) containing 3.75 ?g of HA adjuvanted with AS03A results in an HI immune response to the vaccine-homologous virus that meets or exceeds the EMEA (CHMP) guidance targets for pandemic vaccine seroconversion rate (SCR), seroprotection rate (SPR), and geometric mean fold rise (GMFR) at 21 days after the vaccination in adults within the 18 to 60 years and above 60 years age strata.
(?)

Results
As was planned, the study enrolled 240 subjects, including 120 aged 18-60 years and 120 aged > 60 years. Since all subjects received the first dose the total on which post-vaccination safety and immunogenicity data are reported at D21 is 240.

In the four age strata there were 59 aged 18-40 years, 61 aged 41-60, 75 aged 61-70 and 45 aged >70. The results have been shown according to these age groups and not according to the pre-defined strata at the time of randomisation. The age range per stratum was from 19-40 years, 42-60, 61 to 70 and 71 to 85 years. Within each cohort the percentage of each gender was variable but all values fell within 43-57%. All subjects were Caucasian.
(?)