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aossa schreef:
Benieuwd wat er nu met Shan5 en WHO-prequalificatie gaat gebeuren...
"De in de markt gevonden flesjes Shan5 komen niet overeen met de stalen in ons bezit uit de WHO-goedkeuring" (aldus vrij vertaald een WHO-woordvoerder).
Imho is Shantha zichzelf en aan de WHO verplicht om Shan5 terug te brengen naar de onderzoeksfase om na succesvol doorlopen van het goedkeuringstraject uiteindelijk een nieuwe WHO-goedkeuring aan te vragen.
De WHO zal inmiddels haar conclusies hebben getrokken. FWIW, volgens recente (door mij ontvangen) info zal naar verwachting volgende week een statement betreffende Shan5 op de WHO website worden gepubliceerd. Er wordt momenteel echter al aan deze site gesleuteld. Als op pagina www.who.int/immunization_standards/va... wordt gefilterd op vaccine type = DTP+Hep+Hib, verschijnt Shantha nog steeds twee maal op de getoonde lijst. Maar na het activeren van de betreffende Shantha "View page" hyperlink wordt een melding "pagina niet beschikbaar..." gegeven waar voorheen de Shan5 detail pagina werd getoond. Misschien "gewoon" site onderhoud, maar gezien bovenstaande, en het feit dat vaccin detail pagina's van andere leveranciers gewoon beschikbaar zijn, wellicht toch het begin van het einde van Shan5 op de lijst van prequalified vaccins ....we zullen het hoe dan ook spoedig zien.
De wijziging vd WHO-site is van een week of vier geleden. Sinds zojuist slechts vermelding van HepB en tetanus echter geen vermelding meer van penta.www.who.int/immunization_standards/va... Een maandje te laat imo. ....If, however, the manufacturer is not able to identify the root cause of the quality issue and prepare a robust plan for corrective action within a period of two months, the product will be removed from the list of WHO prequalified products.www.iex.nl/forum/topic.asp?forum=228&... www.who.int/immunization_standards/va... Imo m.i.v. d.d. 26 april, 2010.
De oude bijsluiter(via de WHO-site).
flosz schreef:
....If, however, the
manufacturer is not able to identify the root cause of the quality issue and prepare a robust
plan for corrective action within a period of two months, the product will be removed from the
list of WHO prequalified products.
www.iex.nl/forum/topic.asp?forum=228&... www.who.int/immunization_standards/va... Imo m.i.v. d.d. 26 april, 2010.
Nu is de vraag wat Shanta moet doen om weer te prequalifyen. Is dat de gewone procedure, of is er een zevenmijlslaarzentraject. In beide gevallen lijkt het me dat we op korte termijn aanvullende orders kunnen verwachten. Nu nog wachten op de dag dat Ronald op een knop mag drukken in Korea. (-: Soon, very soon :-)
www.who.int/immunization_standards/va... als antwoord op mijn vorige post (ja eerst lezen dan posten, werd wat entiosiast) " Therefore, a new application for prequalification will be required. Accordingly, Shan5 will be removed from the list of WHO prequalified products. "
Prequalification status of other vaccines manufactured by Shanta Biotechnics (India) The review of the manufacturing process HAS RULED OUT AS THE ROOT CAUSE of the flocculation the manufacture of the diphtheria, HEPATITIS B and tetanus components. WHO will therefore maintain the tetanus toxoid Shan TT and hepatitis B Shanvac vaccines on the list of prequalified products. Also, the recently submitted application for evaluation of a cholera vaccine Shancol for prequalification will continue. As a potential root cause is linked with the manufacture of the pertussis component, WHO has decided to also remove the tetravalent (DTwP-hepatitis B) from the list of prequalified products, and to terminate the ongoing prequalification evaluation process for a DTwP vaccine Shantrip.
Ivm mogelijk extra orders QV volgende opmerkingen: India zal zelf bepalen welke vaccines ze zal toelaten en zal blijven de voorkeur geven aan Indiase producenten. Mogelijk wordt met de afzonderlijke componenten gevaccineerd en/of worden de prioriteiten in het vaccinatie programma herzien. Maw weinig extra omzet van QV verwacht voor afzet in India, mogelijk dat Panacea (en dus ook Novartis, toeleverancier van componenten voor EasyFive) profiteert van de situatie. Blijven de overige wereldmarkt(en) over waar voor Shan5 werd gekozen omwille van prijs en historische redenen. Hier is imo de rol van Unicef bepalend.
When will the 5-in-1 vaccine see the light of day? tinyurl.com/36xbaum ANALYSIS: Pentavalent Vaccine 24 July, 2010 (Panacea…) tinyurl.com/3863vjc Voor de liefhebber: Single versus multi-dose vaccine vials: An economic computational model tinyurl.com/37fpw5r Quinvaxem (Vietnam)http://www.youtube.com/watch?v=H0U62myRL08
Bijna vergeten... Cuba Reformulates Pentavalent Vaccine (CIGB) www.havanatimes.org/?p=26751
When will the 5-in-1 vaccine see the light of day? tinyurl.com/36xbaum ANALYSIS: Pentavalent Vaccine 24 July, 2010 Geen QV op hun lijstje :-( Prijs pentavalent lijkt hen 'te duur'... Waar halen ze het? Imo kost QV rond $3,65 en zijn de andere beschikbare pentavalent vaccines rond $3 (140 INR) beschikbaar via Unicef. Koers 1 USD = 46.61 INR
aossa schreef:
When will the 5-in-1 vaccine see the light of day?
tinyurl.com/36xbaum Art. verdwenen idd.(Easyfive). **************** "We"zijn er nog niet.... Five-in-one vaccine led to child deaths: experts 2010-07-29 14:40:00 The pentavalent or the five-in-one vaccine that has been recommended in India by the National Technical Advisory Group on Immunization actually killed children in Sri Lanka and Bhutan, warns an article in the latest issue of the British Medical Journal (BMJ). The report by a group, including paediatricians, professors, health activists and a former Indian health secretary, cautions against the introduction of the five-in-one vaccine that combines antigens against five diseases - diphtheria, pertussis, tetanus (DPT), hepatitis B and Haemophilus Influenzae type B (HIB) - in a single shot. 'Our article describes how the World Health Organisation (WHO), in an elaborate cover-up, changed its own criteria for classifying adverse effects to say the vaccine was not responsible for the deaths in Sri Lanka,' Jacob Puliyel, head of paediatrics at St Stephen's Hospital in Delhi and key author, told IANS. Former union health secretary K.B. Saxena, professors of community health in Jawaharlal Nehru University in Delhi Debabar Banerji, Imrana Qadeer and Ritu Priya, co-conveners of All India Drug Action Network Mira Shiva and Gopal Dabade and former adviser in finance ministry N.J. Kurian are the other authors of the report. The authors point out that the pentavalent vaccine was withdrawn in Sri Lanka in April 2008 after 25 serious adverse reactions that included five deaths and Bhutan stopped its use within two months of introduction in July 2009 after eight deaths. Bhutan has so far resisted pressure from WHO to restart immunisation but Sri Lanka reintroduced the vaccine this year after a WHO expert panel, which investigated the events, declared that the vaccine was 'unlikely' to have caused the deaths. The panel, however, could not conclusively attribute the deaths to any other cause. However, Puliyel and co-authors who obtained the full report of the investigation say the WHO panel in Sri Lanka did not follow the standard protocol of the UN agency for classification of adverse events following immunisation but instead used its own method. The authors point out that the Sri Lankan deaths would have been classified as 'very likely' or 'probably' related to the vaccine, had the standard WHO classification been employed. Changing its own criteria for classifying adverse effects following vaccination is 'an elaborate cover up' by WHO to remove any connection between pentavalent vaccine and the deaths in Sri Lanka, alleges Puliyel. The authors also ask the wider question whether this new classification of adverse events adopted for Sri Lanka should be allowed to replace the standard WHO classification. If so, deaths occurring following any vaccination will almost always be blamed on something else and not the vaccine and 'lives may thus be put at risk,' they say. The article also questions the need for HIB vaccine in the country, saying WHO's own studies have shown that the incidence of the disease in India is lower than projected and studies elsewhere in Asia show that the vaccine does not significantly reduce the burden of disease compared with placebo. Another letter published in the same journal notes that there have also been three deaths in Pakistan -- one child who died within half an hour of receiving the pentavalent vaccine and two others who passed away within 14 hours of the administration. 'In no case was the vaccine blamed and no alternate cause of death was found for any of the deaths,' says its author S.K. Mittal, chairman of paediatrics department at Pushpanjali Crossway Hospital in Ghaziabad, near Delhi. Mittal says that although Pakistan reintroduced the vaccine on assurance from WHO that the deaths were not related to it, 'the large cluster of 'sudden deaths' in Asia, following immunisation with pentavalent vaccine needs to be investigated dispassionately before more lives are lost'. sify.com/news/five-in-one-vaccine-led...
Ter aanvulling. Antivaccine lobby resists introduction of Hib vaccine in Indiatinyurl.com/3y4wg6k Letter(o.a. Jacob Puliyel) "Antivaccine Lobby" replies to the BMJwww.bmj.com/cgi/content/extract/341/j...
flosz schreef:
De wijziging vd WHO-site is van een week of vier geleden.
Het nieuwe filter met Vaccine Type is inderdaad al een aantal weken aanwezig, maar wat ik zonder al teveel succes poogde aan te geven is dat m.b.v. dit nieuwe filter Shantha wel in de "pentavalent" lijst voorkwam, maar details in de "View page" hyperlink gisteravond plotseling niet meer werden getoond en voorheen wel. Achteraf gezien blijkbaar "werk in uitvoering" om Shan5 van de site te verwijderen. Het is dan wel komkommertijd, maar het lijkt alsof de waarde van dit nieuws niet helemaal doordringt, of ik overschat de vermoedelijke impact ervan op Crucell als leverancier van een werkend product, voor huidige opdrachtgevers en nieuwe "target" landen, alswel mogelijke aanvullende orders n.a.v. het wegvallen van een concurrent die voor 340 M$, 100+ miljoen vaccins had moeten leveren. Aangezien die order betrekking had op 2010-2012 neem ik aan dat de circa 24 miljoen reeds geleverde Shan5 vaccins hier grotendeels buiten vallen; die waren hoofdzakelijk geleverd vóór 2010. Het zal nog wel even duren voordat Shan5 weer op de prequalified lijst voorkomt, en tot die tijd heeft iig de WHO/Unicef geen andere alternatieven dan levering door de overblijvende spelers. Kortom: een tijdje geen royalties voor Crucell voor Shan5, misschien een eenmalige negatieve impact op ontvangen royalties voor uiteindelijk geretourneerde Shan5, maar tenzij ik iets mis staan daar de komende maanden/jaren waarschijnlijk aanzienlijke extra orders voor Quinvaxem tegenover waar niet op was gerekend. In dat geval is het te hopen dat aan de vraag kan blijven worden voldaan cq er zich geen capaciteits problemen voordoen bijvoorbeeld door introductie van uniject.
Alpen schreef:
[quote=flosz]
De wijziging vd WHO-site is van een week of vier geleden.
[/quote]
Het nieuwe filter met Vaccine Type is inderdaad al een aantal weken aanwezig, maar wat ik zonder al teveel succes poogde aan te geven is dat m.b.v. dit nieuwe filter Shantha wel in de "pentavalent" lijst voorkwam, maar details in de "View page" hyperlink gisteravond plotseling niet meer werden getoond en voorheen wel.
Was hartstikke duidelijk hoor, vandaar ook de opmerking "Sinds zojuist slechts vermelding van HepB en tetanus echter geen vermelding meer van penta".
Alpen schreef:
[...]
Kortom: een tijdje geen royalties voor Crucell voor Shan5, misschien een eenmalige negatieve impact op ontvangen royalties voor uiteindelijk geretourneerde Shan5, maar tenzij ik iets mis staan daar de komende maanden/jaren waarschijnlijk aanzienlijke extra orders voor Quinvaxem tegenover waar niet op was gerekend. In dat geval is het te hopen dat aan de vraag kan blijven worden voldaan cq er zich geen capaciteits problemen voordoen bijvoorbeeld door introductie van uniject.
Toevoegende aan bovenstaande: - Het tijdelijk wegvallen van Shanta brengt WHO en Crucell dichter bij elkaar om de nieuwe fabriek in Incheon zo snel mogelijk "up en running" te krijgen. - Prijserosie op Quinvaxem zal minder snel optreden hetgeen de bruto winstmarges ten goede komt.
Ik zou willen weten of QV op de Indiase markt gaat verschijnen. Crucell heeft immers voor 2010-2012 niet getenderd voor deze markt. * Zal het wegvallen van Shan5 daar iets aan doen? * Hoe sterk worden de overige Indiase spelers: Serum Institute en Panacea (oa. prijszetting en beinvloeding van de plaatselijke autoriteiten) ? * Wat is de policy van Novartis (leverancier van componenten voor QV en EasyFive en patenteigenaar van Quinvaxem) ?
aossa schreef:
Ik zou willen weten of QV op de Indiase markt gaat verschijnen. Crucell heeft immers voor 2010-2012 niet getenderd voor deze markt.
Begin juli 2010 is een "for decision" vanuit WHO/UNICEF uitgegaan waarbij naar voor is gekomen dat in India vertraging is ontstaan. Het aantal deelgebieden voor pentavalent introduktie zou voor de aankomende tijd worden beperkt en in het "for decision" schrijven zijn 3 mogelijkheden benoemd. (Uit mijn hoofd, heb het document niet scherp) - Het gereserveerde bedrag voor India blijft staan en wordt in de tijd verschoven. - Een deel van het beschikbare bedrag wordt overgeheveld naar andere landen. - ???? (vergeten, meen dat de introduktie in India zou worden beperkt).
WHO delists Shantha bestseller NEW DELHI/HYDERABAD: Shantha Biotech’s bread-winner vaccine has fallen out of favour with the World Health Organisation, or WHO, dealing the company a crippling blow and opening up opportunities for rivals such as Panacea Biotech, Serum Institute and Novartis The WHO said on July 28 that Shantha’s Shan5 vaccine is no longer on its list of pre-qualified medicines, in effect terminating what was a contract worth $340 million over three years. The WHO order last week sealed the fate of Shan5, whose future has been in doubt for months now, after a white sediment was found sticking to glass vials containing the vaccine. Hyderabad-based Shantha is 80% owned by France’s Sanofi Aventis, which bought the company in July 2009. “This is a vaccine version of Ranbaxy’s regulatory problems in the US. Since Shantha’s main revenue stream will be cut off, it may run into losses until it resumes sales of Shan5,” a pharmaceutical industry expert said. Shan5 is estimated to account for more than three-fourths of the revenues of Shantha. The vaccine maker reported revenues of e17 million for the four months to December 2009, a Sanofi Aventis spokeswoman said. She did not say how much Shan5 earned. Shan5 is a ‘five-in-one’ vaccine to protect infants against diphtheria, whooping cough, tetanus, hepatitis-B as well as a bacterium that causes diseases such as pneumonia and meningitis. The WHO said it disqualified the vaccines after coming to the conclusion that the corrective action plan suggested by Shantha for dissolving the sediments detected in Shan5 vials would require a revised manufacturing procedure and hence new approvals. In April, the organisation had suspended the supply of Shan5 vaccines to Unicef following discovery of the sediments. The Indian company had recalled $72 million worth of vaccines and discontinued sale in the domestic retail market. The WHO has also delisted Shantha’s tetravalent (DTwP-hepatitis B) vaccine and terminated ongoing prequalification evaluation process for a DTwP vaccine Shantrip as the two vaccines also use the pertussis component, the root cause that is linked with flaws in Shan5. “The financial impact will depend on the ramp-up (of its) production. We are confident that Shantha will be able to resume production and supply of Shan5 and Shantetra in compliance with WHO requirements," the Shantha spokeswoman said. She added the decision to withdraw the prequalification for Shan5 is a precautionary measure and none of the information available so far suggests a safety problem. The WHO has asked Shantha to reapply for prequalification, so that it can become eligible to resume supply of Shan5 and other vaccines to Unicef and other global health organisations. But the process of obtaining these approvals may take 2-3 years, industry executives said. Shantha had started executing the supply order last year and it may have to reimburse Unicef and other buyers for transportation and storage charges for the vaccines. “We are working with Unicef to define the best way to compensate for the recall of Shan5 in the interest of public health," the company spokeswoman said. The WHO had in October last year probed a similar vaccine manufactured by Delhi-based Panacea Biotech after four infants who had reportedly taken this vaccine died in Bhutan. The Indian company was given a clean chit. The development with Shantha opens up an opportunity for other makers of five-in-one vaccines that have already been qualified by the WHO. Panacea Biotech, Serum Institute and Novartis are seen as potential gainers. Several Indian drugmakers such as Ranbaxy and Sun Pharma have been pulled up by the American drug regulator for lapses in manufacturing standards in the past 2-3 years. But Shantha’s problems are a “company issue” and have nothing to do with the Indian vaccine industry, industry experts and executives with rival firms said.tinyurl.com/35aq83j
WHO cancels Shan5 pre-qualification Posted on: Tue, 03 Aug 2010 03:27:29 EDT Aug 03, 2010 (Mint - McClatchy-Tribune Information Services via COMTEX) -- French drug maker Sanofi Aventis SA on Monday said the World Health Organization (WHO) has cancelled the pre-qualification to its Indian subsidiary Shantha Biotechnics Ltd's combination vaccine Shan5 due to manufacturing defects found in samples produced at a Hyderabad plant. The UN agency procures medicines only after they meet quality tests, known as pre-qualification. Shantha Biotechnics will not be able to supply Shan5 to WHO anymore, despite large orders. Other markets will also be unwilling to buy it until the company rectifies the defects and is granted pre-qualification again. Shan5 is a five-vaccine combination that prevents diphtheria, pertussis, tetanus (DPT), haemophilus influenza B and hepatitis B. "The potential root cause (of the defect) is linked with the manufacture of pertussis vaccine Shantera," Sanofi said in a statement. In February, WHO had suspended the use of specific batches of the vaccine supplied to it due to quality concerns, giving the company time to investigate the defects internally and submit a report. A month later, WHO had also extended its suspension to all batches of the vaccine made by Shantha Biotechnics in India. Mint had reported in June that Sanofi-Aventis, currently the majority owner of Shantha Biotechnics, was in the final stages of preparing a detailed response to WHO about its position on the agency's decision to suspend purchase and distribution of Shan5. A team from the parent company as well as local biotechnology experts had been studying the problem. Though some individual vaccines in the combination continue to retain their pre-qualification, Sanofi will now have to re-apply for qualifying the entire combination after rectifying the defects. "Given the pre-qualification requirements, it could happen by 2013," a Sanofi spokesperson said. Shantha Biotechnics had in September 2009 secured a $340 million (around Rs1,570 crore) contract from United Nations Children's Fund to supply the vaccine between 2010 and 2012. That contract was also suspended after WHO's action. The Indian company is a stand-alone entity within Sanofi's global operations , and has already supplied some 24 million doses of Shan5 globally through WHO and its own network. tinyurl.com/38s2sbq Panacea Biotech (Rs.186.20, up 0.89%) - A decision by the World Health Organization to remove Shantha Biotech's Shan5 vaccine from its list of pre-qualified medicines may open up opportunities for its rivals such as Panacea Biotech, Serum Institute and Novartis , the Economic Times says.www.rttnews.com/Content/IndianNews.as...
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Scandinavische (Noorse, Zweedse, Deense, Finse) aandelen
Schuitema
Seagull
Sequana Medical
Shurgard
Siemens Gamesa
Sif Holding
Signify
Simac
Sioen Industries
Sipef
Sligro Food Group
SMA Solar technology
Smartphoto Group
Smit Internationale
Snowworld
SNS Fundcoach Beleggingsfondsen Competitie
SNS Reaal
SNS Small & Midcap Competitie
Sofina
Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
Sparen voor later
Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
Sucraf A en B
Sunrun
Super de Boer
SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
Tele Atlas
Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
USG People
Vallourec
Value8
Value8 Cum Pref
Van de Velde
Van Lanschot
Vastned
Vastned Retail Belgium
Vedior
VendexKBB
VEON
Vermogensbeheer
Versatel
VESTAS WIND SYSTEMS
VGP
Via Net.Works
Viohalco
Vivendi
Vivoryon Therapeutics
VNU
VolkerWessels
Volkswagen
Volta Finance
Vonovia
Vopak
Warehouses
Wave Life Sciences Ltd
Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
Wessanen
What's Cooking
Wolters Kluwer
X-FAB
Xebec
Xeikon
Xior
Yatra Capital Limited
Zalando
Zenitel
Zénobe Gramme
Ziggo
Zilver - Silver World Spot (USD)
Indices
AEX
915,80
+0,58%
EUR/USD
1,0828
+0,04%
FTSE 100
8.355,21
-0,18%
Germany40^
18.740,20
+0,32%
Gold spot
2.356,87
-0,91%
NY-Nasdaq Composite
16.801,54
-0,18%
Stijgers
Dalers