Germany's countdown for swine flu vaccination

[Pathfinder]

Re: Germany's countdown for swine flu vaccination

10/19/2009

Second-Class Medicine

Germans Unhappy with Alternative Swine Flu Vaccine for Politicians

REUTERS​

Germany is in an uproar over the planned swine flu vaccination.



Damage control is the name of the game in Berlin on Monday as politicians rush to deny that they are receiving a better, safer swine flu vaccine than ordinary Germans. The first of 50 million doses arrived in Germany on Monday.

One might think that the arrival in Germany of the first of 50 million doses of swine flu vaccine on Monday might be cause for celebration. But with news breaking over the weekend that top government officials in Berlin will be injected with an alternative vaccine -- one widely seen as safer -- a debate about an alleged two-class medical system has erupted.
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SPIEGEL over the weekend reported that Chancellor Angela Merkel, a number of her ministers and other government officials would receive a vaccine manufactured by the pharmaceutical company Baxter -- the same vaccine that the German military opted for, as was reported last week.


The mass-circulation tabloid Bild on Monday plastered the story on its front page on Monday, assuring its readers that "experts are accusing the government" of serving up "second class medicine" to ordinary Germans.
Fevers and Headaches

The controversy centers on an additive included in the vaccine manufactured by pharmaceutical giant GlaxoSmithKline. The additive includes an inactive strain of the entire flu virus as opposed to virus fragments. Critics say the additive can increase the risk of side effects from the flu vaccine such as fevers and headaches.

Supporters counter that the additive is safe, and its use allows the drug manufacturer to quickly produce more doses of the vaccine. The SPIEGEL story mentioned that the GlaxoSmithKline vaccine, with the additive, has undergone more testing than the Baxter version.

An Interior Ministry spokesman told SPIEGEL that the Baxter vaccine had been ordered for all ministries and other agencies as well as for the employees of the Paul Ehrlich Institute, the authority responsible for approving vaccines.

Merkel's spokesman Ulrich Wilhelm on Monday denied that Merkel was taking a different vaccine than the one available to ordinary Germans. He said that the Baxter vaccine had been ordered four months ago as part of a deal hammered out one year ago and has nothing to do with recent concerns surrounding the GlaxoSmithKline vaccine.

'Second-Class Medicine'

Still, voices have become raised. The Green Party's health expert Biggi Bender said that the separate vaccines amount to "big risk for the people, little risk for the government. This type of second-class medicine cannot be allowed to exist in a democracy."

Leading physicians also complained about the planned vaccination. The head of the Institute for Hygiene and Public Health at the University of Bonn, Martin Exner, said: "The fact that politicians and top civil servants in ministries will be vaccinated with a vaccine other than the people is a terrible sign. Today politicians must take what they recommend."

Virologist Alexander Kekul? Hall of the University Hospital said the fact

"that the members of the Federal Government and the authorities have any other vaccine is a scandal."

The Interior Ministry has also rejected the sharp criticism. A spokeswoman for Interior Minister Wolfgang Sch?uble pointed out that at that time the Baxter vaccine was ordered the differences between the two vaccines was not yet an issue. The Paul Ehrlich Institute has repeatedly defended its decision to provide the population with the GlaxoSmithKline version, known as Pandemrix.

'Alleged Threat'

Germany is not the only government working to contain a potential outbreak of swine flu, the popular though inaccurate name given to the H1N1 flu virus. The UK has seen an increase in cases in recent weeks. As a result, the country has purchased 60 million doses of Pandemrix. Since swine flu emerged, a number of people in the US showing symptoms have died, leading the government to purchase 251 million doses of the swine flu vaccine from various manufacturers. The European Medicines Agency approved Pandemrix for use recently, amid concern for the upcoming winter flu season and the expected uptick in swine flu cases.

Some German politicians have joined Merkel in opting out of the alternative vaccine. Health Minister Ulla Schmidt said in Bild, "I will allow myself to be vaccinated with the same vaccine as the people. It is exactly like the other approved vaccine, safe and effective."

The weekend scandal has drowned out a second debate which has been raging in recent weeks in the US and which has also found resonance here in Germany: whether such a massive vaccination program is necessary in the first place.

Wolf-Dieter Ludwig, chairman of the Drug Commission of the German Medical Association, has called the planned vaccination campaign a "scandal." "The health authorities have fallen for a campaign from the pharmaceutical companies, who simply want to earn money with an alleged threat," he told SPIEGEL.


http://www.spiegel.de/international/germany/0,1518,656028,00.html#ref=rss

 

[german-docter]

Re: Germany's countdown for swine flu vaccination

http://www.rki.de/cln_100/nn_200120...perty=publicationFile.pdf/VaccinationH1N1.pdf

1) Recommendations of the German Standing Committee on Vaccination (STIKO) at the Robert Koch-Institute: Vaccination against novel influenza A (H1N1)

The STIKO has reviewed and discussed appropriate vaccination strategies during its meetings on May 28, 2009 and on September 7, 2009, as well as during numerous teleconferences and a meeting of the Influenza Vaccination Working Group. The STIKO also reviewed data on immunogenicity and safety of the vaccines available from the licensing process.

During a meeting on September 22, 2009 and two supplemental teleconferences on September 28 and October 2, 2009 the STIKO made recommendations for use of vaccines against novel influenza A (H1N1). In the process of developing the recommendations, STIKO-members also considered statements made by the German Commission for the Pandemic, German Regional Health Authorities, and relevant professional medical associations.

In general, everybody can potentially benefit from a vaccination against novel influenza A (H1N1). Therefore, every citizen should have the opportunity to receive a vaccination against novel influenza A (H1N1) within its licensed indications.

Taking into consideration the availability of vaccines, vaccination against novel influenza A (H1N1) should be conducted in the following time-order and sequence; vaccination of the target groups 1 to 3 should take place immediately:
1. Health care workers and employees in public welfare with contact to patients or infectious material;
2. All persons older than 6 months with an increased health risk due to underlying chronic medical conditions, such as: chronic respiratory disease; chronic heart-, liver- or kidney diseases; malignant cancers; diabetes and other metabolic diseases; neurological and neuromuscular disorders; congenital or acquired immunodeficiency with partially remaining T- or B-cellular function; HIV infection;
3. Pregnant women, preferably from the second trimester onwards, and all women postpartum not vaccinated during their pregnancy;


4. Household contact persons who could serve as a possible source of infection for unvaccinated persons at risk (as listed under no. 2 and 3, and newborns under 6 months of age);
5. All remaining persons between 6 months and 24 years of age;
6. All remaining persons between 25 and 59 years of age;
7. All remaining persons from 60 years of age and older.

Based on the currently available data, a vaccination is recommended initially for target groups 1 to 3. Should new data on the epidemiological situation and on the vaccines become available at a national or international level, the STIKO will immediately review its position regarding target groups 4-7, but at the latest 4 weeks after the initiation of the vaccination campaign.

The STIKO recommends that if in doubt an individual risk-assessment should be performed before vaccination. This should be done especially before vaccinating chronically ill persons, children and pregnant women.

The STIKO is aware of the complex situation associated with vaccination during pregnancy, and pregnant women should therefore be vaccinated with nonadjuvanted split vaccines until further data are available.

The STIKO?s vaccination recommendations are based on medical and epidemiological considerations only. The commission does not assess the potential benefit of immunization strategies on the assurance of public safety and order.


2) Provisional recommendations of the Paul-Ehrlich Institute and the Robert Koch-Institute regarding the number of vaccine doses needed to immunize against novel influenza A (H1N1) when using the pandemic influenza vaccine Pandemrix? (GSK) and its administration during pregnancy

a) Number of vaccine doses needed to immunize against novel influenza A (H1N1)

The STIKO, providing its recommendations in the context of the national regulatory authorization according to the German Medicines Act, has not specified the number of vaccine doses required to immunize against novel influenza A (H1N1). As recommended by the European Medicines Agency (EMEA) the summary of product characteristics presents options for the immunization of different age groups and risk categories. These options are based on currently available clinical data.
For Pandemrix?, competent national authorities within the EU Member States may consider the option of recommending a single dose instead of a two-dose administration. For adults between the ages of 18 and 60 years, first data from small-scale clinical studies indicate, that an adequate immune response can be achieved with a single vaccine dose. This evidence is supported by results of clinical studies of other pandemic H1N1-vaccines.

Whether or not it is finally necessary to administer a second vaccine dose will be decided when additional data are available, which is anticipated for mid-November 2009. This would be still in time for the administration of a second dose, because, as indicated by the summary of product information, the minimum interval between two doses should be three weeks, and clinical data show also that a second dose still produces an adequate immune response when being administered after 6 months. This opinion was supported by the Secretaries of the Ministries and Senates of Health of the German States at their working meeting on October 2, 2009.

A single dose administration of a vaccine against novel influenza A (H1N1) also offers the following additional benefits:

More persons can be vaccinated within the same time-frame;

Persons to be vaccinated need to arrange only one appointment to receive a single shot of the vaccine.

However, there is the possibility that there will be a relevant number of severe cases of novel influenza A (H1N1) due to insufficiently induced immunity from a single dose administration. At an individual level a two-dose administration therefore offers more assurance regarding the protection against novel influenza A (H1N1).

Given the background of these benefits and drawbacks, and considering data from pre-licensure studies for pandemic mock-up vaccines (H5N1) and the final pandemic H1N1-vaccine Pandemrix?, the Paul-Ehrlich-Institute (PEI) and the Robert Koch-Institute (RKI) recommend to apply specific administration schemes and dosages according to age groups. As a result, in some age groups only a single dose is recommended. These recommendations will be adapted accordingly in the event that on-going studies provide data indicating the necessity of a second dose.
The following table summarises the preliminary recommendations of PEI and RKI for the pandemic H1N1 influenza vaccine Pandemrix? produced by GlaxoSmithKline (GSK):

Tab. 1: Recommendations by PEI and RKI on the administration of the pandemic H1N1 influenza vaccine Pandemrix? produced by GlaxoSmithKline (GSK) (Status: October 5, 2009)

Age group Number of doses

Children from 6 months to 9 years 2 half adult doses (0,25 ml), with 3 weeks minimum interval between single doses

Persons from 10 to 60 years 1 adult dose (0.5 ml)

Adults over 60 years 2 adult doses (0.5 ml), with 3 weeks minimum interval between single doses

In case additional clinical data indicate the necessity of a two-dose administration scheme for persons 10-60 years of age, the second dose can still be given. Clinical studies have indicated that a second dose with Pandemrix? administered after a period of up to 6 months after the first dose still induces an adequate immune response.

b) Administration during pregnancy
The STIKO recommends that, until further data are available, pregnant women should exclusively be vaccinated with non-adjuvanted split vaccines against novel influenza (H1N1).

Until a non-adjuvanted H1N1-vaccine is available in Germany or other EU-Member States, PEI and RKI recommend that, after an adequate individual risk-benefit assessment, the administration of one adult dose of the H1N1 influenza vaccine Pandemrix? can also be appropriate for pregnant women.

An adequate risk-benefit assessment should include the epidemiological development of novel influenza A (H1N1) during the next weeks and the individual risk of the pregnant woman, especially the increased risk for the development of a severe course of novel influenza A (H1N1) resulting from underlying chronic medical conditions. Furthermore, a potentially increased risk for infection with novel influenza A (H1N1) should be considered, for example, through other child/children in the household, exposure due to profession, or others.

If vaccination against novel influenza A (H1N1) seems necessary, the administration of Pandemrix? (H1N1) during pregnancy is covered according to its licensure taking into consideration official recommendations.

Pandemrix? can be administered to breastfeeding women.

Scientific evidence was considered sufficient by EMEA to support use of adjuvanted vaccines also during pregnancy




EMEA:
http://www.emea.europa.eu/pdfs/human/press/pr/67119009en.pdf

European Medicines Agency Press office 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.europa.eu http://www.emea.europa.eu

London, 23 October 2009
Doc. Ref. EMEA/CHMP/671190/2009 corr.*

PRESS RELEASE
Meeting highlights from the Committee for Medicinal Products for Human Use,
19-22 October 2009

Update on H1N1 pandemic vaccines
The European Medicines Agency?s Committee for Medicinal Products for Human Use (CHMP) reviewed early data from clinical studies for the three authorised pandemic vaccines, Celvapan, Focetria and Pandemrix. The Committee concluded to maintain the recommendation it adopted in September, namely that the three vaccines be preferably given as two doses, at least three weeks apart.

The data currently available for Pandemrix and for Focetria indicate that one dose may be sufficient in adults, but are too limited to allow the Committee to recommend the general use of a single-dose vaccination schedule.

More information is available in a question and answer document.
The updated product information showing the changes is also available for Focetria and Pandemrix. The EPAR Summaries for Focetria and Pandemrix have also been updated and can be found on the Agency?s pandemic influenza H1N1 website http://www.emea.europa.eu/influenza/vaccines/home.htm

(?)

 

[tropical]

Re: Germany's countdown for swine flu vaccination

Thank you German-Docter.


#22, quite articulate infos.


If possible, it will be important to see a similar info about if they suggest an seasonal flu vaccination prior the pandemic one,
or it will be definitively dumped as option (because of the diatribe linked to Que./Canada study of lowered immunity result).
___

#22:
"However, there is the possibility that there will be a relevant number of severe cases of novel influenza A (H1N1) due to insufficiently induced immunity from a single dose administration."


#21:
"The controversy centers on an additive included in the vaccine manufactured by pharmaceutical giant GlaxoSmithKline.

The additive includes an inactive strain of the entire flu virus as opposed to virus fragments.

...
An Interior Ministry spokesman told SPIEGEL that the Baxter vaccine had been ordered for all ministries and other agencies as well as for the employees of the Paul Ehrlich Institute, the authority responsible for approving vaccines."
...
"the separate vaccines amount to "big risk for the people, little risk for the government. This type of second-class medicine cannot be allowed to exist in a democracy.

Leading physicians also complained about the planned vaccination. The head of the Institute for Hygiene and Public Health at the University of Bonn, Martin Exner, said: "The fact that politicians and top civil servants in ministries will be vaccinated with a vaccine other than the people is a terrible sign.Today politicians must take what they recommend."

Virologist Alexander Kekulé Hall of the University Hospital said
the fact "that the members of the Federal Government and the authorities have any other vaccine is a scandal.""

 

[FrenchieGirl]

Re: Germany's countdown for swine flu vaccination

Influenza A. Schweiz Zweifel an Impfstoff
31. Oktober 2009 - 1 Kommentar (s)

Die Schweiz hat die Beschr?nkung des Einsatzes von Pandemrix Impfstoff gegen Influenza H1N1 von GlaxoSmithKline (GSK) f?r schwangere Frauen, Kinder unter 18 Jahren durchgef?hrt und Erwachsene ?ber 60 Jahre. Die Beh?rde der Verordnung ?ber Arzneimittel Schweizer Swissmedic, hat in der Tat Zweifel am Adjuvans AS03 in der Impfstoff verwendet werden. "Wir sind zur Verfolgung von klinischen Studien zu Aufsichtsbeh?rden, Regierungen und die ?ffentlichkeit mit detaillierten Informationen ?ber das Risiko bieten engagierten / Nutzen der Impfstoff gegen das H1N1-Virus", sagte ein Sprecher von GSK. Dar?ber hinaus hat Swissmedic-Impfstoff Focetria der Schweizer Novartis mit "das Adjuvans MF59, lange in Impfstoffen gegen die saisonale Influenza" f?r Erwachsene und Kinder ?ber sechs Jahre eingesetzt. Aber "in Bezug auf schwangere und stillende Frauen, h?lt die Beh?rde, die sie den Arzt" Die Vermessung der Vorteile und M?glichkeiten Harms ist. "

------------------------------------------------------

Grippe A. La Suisse ?met des doutes sur un vaccin
31 octobre 2009 - 1 r?action(s)

La Suisse a mis en place des restrictions ? l'utilisation du vaccin Pandemrix contre la grippe H1N1 du laboratoire GlaxoSmithKline (GSK), pour les femmes enceintes, les enfants de moins de 18ans et les adultes de plus de 60 ans. L'autorit? de r?gulation des m?dicaments suisse, Swissmedic, a en effet ?mis des doutes quant ? l'adjuvant AS03 utilis? dans ce vaccin. ?Nous sommes d?termin?s ? poursuivre des essais cliniques pour fournir aux organes de r?gulation, aux gouvernements et au public des informations d?taill?es sur le rapport risques-b?n?fices du vaccin contre le virus H1N1?, a r?pondu un porte-parole de GSK. Par ailleurs, Swissmedic a autoris? le vaccin Focetria du suisse Novartis contenant ?l'adjuvant MF59, utilis? de longue date dans les vaccins contre la grippe saisonni?re? pour les adultes et les enfants ? partir de six ans. Mais ?pour ce qui est des femmes enceintes et de celles qui allaitent?, l'autorit? estime que c'est au m?decin traitant ?de mesure les avantages et les inconv?nients possibles?.

-----------------------------------------------

Influenza A. Switzerland doubts on vaccine
31 October 2009 - 1 comment (s)

Switzerland has implemented restrictions on the use of Pandemrix vaccine against influenza H1N1 from GlaxoSmithKline (GSK) for pregnant women, children under 18 years old and adults over 60 years. The authority of drug regulation Swiss Swissmedic, has indeed raised doubts about the AS03 adjuvant used in the vaccine. "We are committed to pursuing clinical trials to provide regulatory bodies, governments and the public with detailed information on the risk / benefits of the vaccine against the H1N1 virus," said a spokesman for GSK. In addition, Swissmedic approved vaccine Focetria the Swiss Novartis containing "the adjuvant MF59, long used in vaccines against seasonal influenza" for adults and children over six years. But "in terms of pregnant and lactating women, the authority considers that it is the doctor" Measuring the benefits and potential harms. "

 

[german-docter]

Re: Germany's countdown for swine flu vaccination

Thank you German-Docter.


#22, quite articulate infos.


If possible, it will be important to see a similar info about if they suggest an seasonal flu vaccination prior the pandemic one,
or it will be definitively dumped as option (because of the diatribe linked to Que./Canada study of lowered immunity result).
___

#22:
"However, there is the possibility that there will be a relevant number of severe cases of novel influenza A (H1N1) due to insufficiently induced immunity from a single dose administration."


#21:
"The controversy centers on an additive included in the vaccine manufactured by pharmaceutical giant GlaxoSmithKline.

The additive includes an inactive strain of the entire flu virus as opposed to virus fragments.

...
An Interior Ministry spokesman told SPIEGEL that the Baxter vaccine had been ordered for all ministries and other agencies as well as for the employees of the Paul Ehrlich Institute, the authority responsible for approving vaccines."
...
"the separate vaccines amount to "big risk for the people, little risk for the government. This type of second-class medicine cannot be allowed to exist in a democracy.

Leading physicians also complained about the planned vaccination. The head of the Institute for Hygiene and Public Health at the University of Bonn, Martin Exner, said: "The fact that politicians and top civil servants in ministries will be vaccinated with a vaccine other than the people is a terrible sign.Today politicians must take what they recommend."

Virologist Alexander Kekul? Hall of the University Hospital said
the fact "that the members of the Federal Government and the authorities have any other vaccine is a scandal.""

tropical,
Paul-Ehrlich-Institute (PEI) already has published a denial on that issue:

In reply to an article in the magazine ?Spiegel?, PEI stated on October 18 that one week before PEI has made the decision to vaccinate its employees with the same vaccine that will be used for the public and that solely will be Pandemrix?.

But there are still questions. Baxter?s Celvapan? presumably is not yet available in October, and that may be one of the reasons for the PEI to choose Pandemrix? instead. One also may ask why the decision for the vaccine had come that late (just ?one week before? ?). The ?decision? also could be a mere reaction to the public?s outrage. PEI is more or less a part of the German Ministry of Health and the employees of the latter certainly will be vaccinated with Celvapan?. Thus it seems to be quite feasible that the PEI-staff will have Celvapan?, too. But PEI ?s office in not in Germany?s capital Berlin (as the Ministry of Health) but in Langen (nearby Frankfurt) and there also could be some logistic reasons for the latest preference of Pandemrix?.

http://www.pei.de/cln_116/nn_150973...weineinfluenza/zusatzinfo-spiegelartikel.html
PEI: Was ?Der Spiegel? in seinem Artikel "Immun gegen die Impfung" nicht geschrieben hat

Unterschiedliche Impfstoffe f?r Bundesbedienstete und Bev?lkerung
Spiegel: Nicht nur f?r die Kanzlerin ist also ein anderes Mittel vorgesehen als f?r das gemeine Volk, sondern auch f?r die Mitarbeiter des Paul-Ehrlich-Instituts (PEI), die f?r die Zulassung von Impfstoffen zust?ndig sind.
Was fehlt: H?tte der Spiegel im Paul-Ehrlich-Institut nachgefragt, warum es einen Impfstoff mit Verst?rker f?r die Bev?lkerung verteidigt, seine eigenen Mitarbeiter aber (angeblich) mit Celvapan impft, dann h?tte er mit einer korrekten Information aufwarten k?nnen: Schon vor ?ber einer Woche wurde entschieden, dass diejenigen Mitarbeiter des Paul-Ehrlich-Instituts, die im Rahmen des PEI-Pandemieplans zu den vorrangig zu impfenden Personengruppen z?hlen, den Impfstoff Pandemrix erhalten werden. Dazu geh?ren neben der Leitung des Instituts u.a. Mitarbeiter aus der Impfstoffpr?fung, der Arzneimittelsicherheit, der Pressestelle und verschiedenen anderen Bereichen des Instituts, die f?r ein reibungsloses Funktionieren auch in einer Pandemie ben?tigt werden.​

Influenza A. Schweiz Zweifel an Impfstoff
31. Oktober 2009 - 1 Kommentar (s)
(...)
Influenza A. Switzerland doubts on vaccine
31 October 2009 - 1 comment (s)

Switzerland has implemented restrictions on the use of Pandemrix vaccine against influenza H1N1 from GlaxoSmithKline (GSK) for pregnant women, children under 18 years old and adults over 60 years. The authority of drug regulation Swiss Swissmedic, has indeed raised doubts about the AS03 adjuvant used in the vaccine. "We are committed to pursuing clinical trials to provide regulatory bodies, governments and the public with detailed information on the risk / benefits of the vaccine against the H1N1 virus," said a spokesman for GSK. In addition, Swissmedic approved vaccine Focetria the Swiss Novartis containing "the adjuvant MF59, long used in vaccines against seasonal influenza" for adults and children over six years. But "in terms of pregnant and lactating women, the authority considers that it is the doctor" Measuring the benefits and potential harms. "

Merci, FrenchieGirl

 

[tropical]

Re: Germany's countdown for swine flu vaccination

German-Docter, #25: "one week before"


So the news was fake ...
Do we have a picture of the purchase original doc?

Any way, will we see our vip's stayed in line with the ordinary guys,
and the wide public vaccine dose will be extracted and given to the person? Hardly. Obviously we must believe the statements.

What if no newspaper news filtered about the 200.000 doses there,
do the wide public know anything about?
Maybe special lots exists elsewhere, but are not mentioned?
Why the release delays?

EU are in an full blown chimerized pandemic, with Ukrainian additional bad news,
and mostly, there is insecurity which kind of vaccine will be administered,
as you see from the Swiss Pandemrix case.

I know that when things starts to heat up, the folks will take anything ...,
but is it correct?

 

[german-docter]

Re: Germany's countdown for swine flu vaccination

German-Docter, #25: "one week before"


So the news was fake ...

(snip)

... mostly, there is insecurity which kind of vaccine will be administered,
as you see from the Swiss Pandemrix case.

I know that when things starts to heat up, the folks will take anything ...,
but is it correct?

tropical,

no, IMO the "Spiegel" news was not a fake.

The German Government definitely has bought separately 200,000 doses of the non-adjuvanted vaccine Celvapan? (Baxter). The special order of the Federal Ministry of the Interior is provided only for the vaccination of politicians (cabinet members) and officials in ministries as well as for the employees in subordinate authorities.The officials would get the same non-adjuvanted vaccine which the Federal Armed Forces had ordered for the German soldiers. But for now, such a non-adjuvanted vaccine will not be available for the public. The Federal Ministry of the Interior said there had been obliging preliminary contracts for a vaccine supply by the manufacturer Baxter.

The argument that Baxter's Celvapan(R) originally might have been scheduled even for PEI empoyees has not been rejected clearly . The PEI only stated that recently the decision has been made to use GSK's Pandemrix(R) for the PEI empoyees for reasons whatsoever.