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Shantha

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[verwijderd] 15 maart 2010 10:33

WHO RECOMMENDATION TO TEMPORARILY SUSPEND PROCUREMENT AND USE
OF ALL LOTS OF SHAN5 (DTwP-HEPATITIS B-HIB) VACCINE PRODUCED BY SHANTHA BIOTECHNICS, INDIA

triangle.bizjournals.com/triangle/sto...

Ben benieuwd wat dat Crucell gaat opleveren....er valt een gat id produktie op te vullen.

ivet

[verwijderd] 15 maart 2010 10:36

[verwijderd] 15 maart 2010 10:38

quote:
invoorentegenspoed schreef:
WHO RECOMMENDATION TO TEMPORARILY SUSPEND PROCUREMENT AND USE
OF ALL LOTS OF SHAN5 (DTwP-HEPATITIS B-HIB) VACCINE PRODUCED BY SHANTHA BIOTECHNICS, INDIA

triangle.bizjournals.com/triangle/sto...

Ben benieuwd wat dat Crucell gaat opleveren....er valt een gat id produktie op te vullen.

ivet

Bron?

Link slaat op Viehbacher.

Dirk

[verwijderd] 15 maart 2010 10:39

quote:
invoorentegenspoed schreef:
WHO RECOMMENDATION TO TEMPORARILY SUSPEND PROCUREMENT AND USE
OF ALL LOTS OF SHAN5 (DTwP-HEPATITIS B-HIB) VACCINE PRODUCED BY SHANTHA BIOTECHNICS, INDIA

triangle.bizjournals.com/triangle/sto...

Ben benieuwd wat dat Crucell gaat opleveren....er valt een gat id produktie op te vullen.

ivet

hahahahahhahahhahahhahhhahhahhahahahhhahah!!!!!!

yayayayayayayay!!!!

ROTFLMAO

[verwijderd] 15 maart 2010 10:45

quote:
Dirk R. Wijnen schreef:
[quote=invoorentegenspoed]
WHO RECOMMENDATION TO TEMPORARILY SUSPEND PROCUREMENT AND USE
OF ALL LOTS OF SHAN5 (DTwP-HEPATITIS B-HIB) VACCINE PRODUCED BY SHANTHA BIOTECHNICS, INDIA

triangle.bizjournals.com/triangle/sto...

Ben benieuwd wat dat Crucell gaat opleveren....er valt een gat id produktie op te vullen.

ivet
[/quote]

Sorry, moet zijn: www.who.int/immunization_standards/va...

Bron?

Link slaat op Viehbacher.

Dirk

www.who.int/immunization_standards/va...

[verwijderd] 15 maart 2010 10:46

Can't find this story on Google or on the link provided.

Can anyone confirm...this is big if it is true.

[verwijderd] 15 maart 2010 10:47

Thanks

Dirk

[verwijderd] 15 maart 2010 10:47

thank you.

[verwijderd] 15 maart 2010 10:48

waarschijnlijk verkeerde toets bij copy/paste, waardoor voorlaatste link per abuis werd vermeld, dus nog maar een keertje ter verduidelijking:

www.who.int/immunization_standards/va...

misschien is er een moderator in de zaal die de link in de eerste posting wil vervangen voor deze hierboven?

bvd ivet

[verwijderd] 15 maart 2010 10:48

Joint WHO-UNICEF Statement 2
12 March 2010
WHO RECOMMENDATION TO TEMPORARILY SUSPEND PROCUREMENT AND USE
OF ALL LOTS OF SHAN5 (DTwP-HEPATITIS B-HIB) VACCINE PRODUCED BY SHANTHA BIOTECHNICS, INDIA
As of 12 March 2010 the World Health Organization (WHO) recommends to stop procurement and to suspend use of all lots of the Shan5 vaccine supplied to countries pending ongoing investigations.
Countries are advised to put any remaining vaccine in quarantine until further notice.
If it is confirmed that the country has received shipments of any lot of Shan5 vaccine, the vaccine should not be used, but kept under recommended storage conditions, clearly marked ‘QUARANTINED; NOT TO BE USED OR DISTRIBUTED’ until further direction is provided by WHO.
WHO recommends that countries continue vaccination using pentavalent vaccine from an alternative manufacturer or an alternate DTP-containing vaccine until further notice. Countries may contact WHO and UNICEF country offices for assistance to fill shortfalls in vaccine supply as a result of the temporary suspension

aossa 15 maart 2010 10:55

Zoals al meermaals in de praktijk bewezen 'haast en spoed zijn zelden goed'...

harrysnel 15 maart 2010 11:04

Juiste keuze mbt positionering van Crucell als betrouwbare leverancier wordt hiermee mooi onderstreept. Ook op lange termijn een gunstige ontwikkeling. Bij Crucell viel al langer een EZDG mbt Shanta en produktlevering te beluisteren..

aossa 15 maart 2010 11:09

www.who.int/immunization_standards/va...

(vervolg)
History of temporary suspension
• On 19 February 2010, WHO recommended the temporary suspension of the distribution and use of specific lots of Shan5 vaccine due to the presence of a white sediment which sticks to the glass of the vaccine vial that is difficult or impossible to re-suspend with vigorous shaking (flocculation).This action was taken as a precautionary measure pending investigation of vaccine quality complaints from Colombia, Comoros and Nepal.
• Countries where the affected lots were distributed were contacted by WHO and requested to check all the available lots of the Shan5 vaccine. Some countries reported that additional lots that were not included in the temporary suspension also showed a similar problem.
• For instance, the Democratic Republic of the Congo reported that 15 out of 24 lots checked showed the presence of the above-mentioned white sediment that could not be re-suspended. In addition, Médecins sans Frontières reported to WHO a similar complaint concerning a lot number that was not included in the lots initially suspended on 19 February; this issue was reported directly to the manufacturer in 2009.
• Distribution information indicates that the Shan5 vaccine had been supplied through UN agencies or by direct procurement to Central African Republic, Chad, Colombia,
1
Comoros, Democratic Republic of the Congo, Lao People's Democratic Republic, Mauritania, Mozambique, Nepal, Nicaragua, Pakistan, Republic of Congo and Tanzania.
Supply of alternative vaccine
• UNICEF Supply Division is working with the country offices to ensure prompt supply of alternative product to enable resumption of vaccination. Countries are encouraged to ensure that UNICEF Country Offices are included on all aspects of dealing with this issue and kept closely informed.
UNICEF country offices will provide details of quantities and cold storage requirements of the first possible shipment of new vaccines. Countries need to review and confirm they have sufficient cold storage capacity and to inform whether there are any other impediments in accepting the delivery, such as registration requirements, etc..
• As the suspension is a precautionary measure pending the outcome of an investigation, and as long as the supplier had not recalled the vaccine, any claims processing is pending the outcome and conclusion of the investigation. WHO will keep UNICEF and the countries informed of the timeline for this.
• In this initial phase, the focus is on ensuring new vaccine deliveries to countries so vaccination can be resumed. Beyond the immediate supply, UNICEF will work with countries and partners to assess the funding and vaccine requirement for the rest of 2010 with a view to identifying solutions.
Shan5 vaccine quality and safety
• None of the information available to date suggests a vaccine safety problem with the Shan5 vaccine.
• No adverse events following immunization with Shan5 have been reported to WHO.
• No other vaccine quality complaints besides the flocculation described above have been reported to WHO.
• A vaccine quality investigation by the manufacturer and WHO is ongoing. The available information to date is insufficient to make conclusions about the potential causes of the flocculation as reported.
• The manufacturer's Quality Assurance Department has performed investigations that include: review of the batch records for deviations; changes in the manufacturing process including raw materials; review of the cold chain during transportation of the vaccines (temperature monitoring devices); and retesting of the retention samples. Additional Research and Development Department experiments are being performed by the manufacturer.
• WHO is conducting a vaccine quality review, including independent testing by WHO- contracted laboratories. This will include scanning electron microscopy (SEM) and X-ray elemental analysis of particles in SEM — procedures that are not routinely used in the quality control of the vaccines.
Further advice will be issued by WHO/UNICEF pending the outcome of the investigation performed by the manufacturer and WHO.
Shan5 vaccine composition and WHO prequalification:
Shan5 is a combined, pentavalent vaccine containing diphtheria, tetanus, whole cell pertussis recombinant DNA, hepatitis B, and Hib components. The vaccine is absorbed onto aluminium salts as an adjuvant and preserved with thiomersal.
2
Shan5 is a WHO prequalified vaccine supplied through UN agencies. Between January 2008 and February 2010 approximately 23 945 082 doses of this vaccine have been supplied through UNICEF and the Revolving Fund of the Pan-American Health Organization. The vaccine is also procured directly for use by public immunization services in a number of countries.
Shan5 vaccine currently remains on the WHO list of prequalified vaccines supplied through UN agencies. The WHO web page on prequalification indicates that the vaccine is temporarily suspended pending the outcome of the investigation.
__________________
This WHO-UNICEF joint statement supplements a previous communication by WHO to UNICEF, WHO Regional Advisers for Immunization and Vaccine Quality, and the Global Alliance for Vaccines and Immunisation advising of the temporary suspension of specific lots of Shan5 vaccine produced by Shantha Biotechnics India, and actions to be taken.
3

aossa 15 maart 2010 11:12

Maw EXTRA druk op Shantha vanuit WHO... (mogelijk omwille van een prul)

(Wat zegt de project-controller daarover ? Aja, het gaat ze waarschijnlijk VEEL EXTRA geld kosten)

[verwijderd] 15 maart 2010 11:17

Merkwaardig dat de koers hier nog pas "matig" op heeft gereageerd. Dit bericht lijkt mij zeer gunstig voor zowel de volumes als de prijzen van de aanstaande QV-contracten.

Ik heb mijn handelsvoorraad in ieder geval even stevig aangevuld.

maxen 15 maart 2010 11:19

quote:
invoorentegenspoed schreef:
www.who.int/immunization_standards/va...

History of temporary suspension
• On 19 February 2010, WHO recommended the temporary suspension of the distribution and use of specific lots of Shan5 vaccine due to the presence of a white sediment which sticks to the glass of the vaccine vial that is difficult or impossible to re-suspend with vigorous shaking (flocculation).This action was taken as a precautionary measure pending investigation of vaccine quality complaints from Colombia, Comoros and Nepal.
• Countries where the affected lots were distributed were contacted by WHO and requested to check all the available lots of the Shan5 vaccine. Some countries reported that additional lots that were not included in the temporary suspension also showed a similar problem.
• For instance, the Democratic Republic of the Congo reported that 15 out of 24 lots checked showed the presence of the above-mentioned white sediment that could not be re-suspended. In addition, Médecins sans Frontières reported to WHO a similar complaint concerning a lot number that was not included in the lots initially suspended on 19 February; this issue was reported directly to the manufacturer in 2009.
• Distribution information indicates that the Shan5 vaccine had been supplied through UN agencies or by direct procurement to Central African Republic, Chad, Colombia, Comoros, Democratic Republic of the Congo, Lao People's Democratic Republic, Mauritania, Mozambique, Nepal, Nicaragua, Pakistan, Republic of Congo and Tanzania.

Kortom:
Er is een wittige neerslag onstaan in de buisjes Shan5, die niet/moeilijk meer op te lossen is door te schudden.

Waarschijnlijk is/zijn 1 of meer van de componenten van het vaccin neergeslagen. Uiteraard kan een vaccin met neerslag niet meer worden ingespoten. De know-how die het in Quivaxem voor het eerst mogelijk maakte om de vijf pentavalent componenten allemaal op te lossen en opgelost te HOUDEN, blijkt behoorlijk ingewikkeld. Het gekke is daarbij dat Shanta die know-how van Berna heeft ,wat royalties voor Crucell betekent: zie bv. pagina 30 van:

hugin.info/132631/R/1359009/331102.pdf
•
Tender period 2010-2012: new Indian competition from Shantha (royalties for Crucell), Panacea
•
Crucell has stake in Shantha/Sanofi Pasteur pentavalent vaccine.

Dus het zit hem bij Shanta dan wellicht niet in de know-how, maar in de juiste uitvoering daarvan?

In ieder geval hele slechte zaak voor Shanta.
Goed voor Crucell als vervangende leverancier, maar slecht voor 't imago voor pentavalent vaccins als geheel, dus ook 'n beetje voor Crucell.

[verwijderd] 15 maart 2010 11:22

quote:
xynix schreef:
Merkwaardig dat de koers hier nog pas "matig" op heeft gereageerd. Dit bericht lijkt mij zeer gunstig voor zowel de volumes als de prijzen van de aanstaande QV-contracten.

Ik heb mijn handelsvoorraad in ieder geval even stevig aangevuld.

hou er rekening mee dat koers en fundamenten niet één op één bewegen...

CRXL is m.i. een prima belegging, maar wat het bedrijf presteert en wat de koers 'presteert', loopt nog wel eens uiteen.

mvg ivet

z0n0p 15 maart 2010 11:24

Het is in geval van Crucell al 145 miljoen keer goed gegaan. Dus vooral shame on Shanta.

maxen 15 maart 2010 11:24

quote:
ronbanged2 schreef:
Can anyone confirm...this is big if it is true.

...the stealing of market share outside of India by Panacea and Shantha...

Kom er maar in met de schattingen wat dit voor 't marktaandeel van Crucell betekent.

josti5 15 maart 2010 11:37

quote:
maxen schreef:
[quote=ronbanged2]
Can anyone confirm...this is big if it is true.

...the stealing of market share outside of India by Panacea and Shantha...
[/quote]
Kom er maar in met de schattingen wat dit voor 't marktaandeel van Crucell betekent.

Nou, geef mij maar liever een PB van Crucell over extra verkopen...

Kom op, Oya: doe je best en ga er intern voor!

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