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[e-med] L'OMS interdit un vaccin utilisé dans des campagnes de l'Unicef

[voir aussi ci-dessous: 
http://www.who.int/immunization_standards/vaccine_quality/shan5_suspension_12_march_10.pdf
et la liste des vaccins préqualifiés : 
http://www.who.int/immunization_standards/vaccine_quality/pq_suppliers/en/
CB]

L'OMS interdit un vaccin utilisé dans des campagnes de l'Unicef
LEMONDE.FR avec AFP | 18.03.10 | 14h42
http://www.lemonde.fr/planete/article/2010/03/18/l-oms-interdit-un-vaccin-utilise-dans-des-campagnes-de-l-unicef_1321148_3244.html
L'Organisation mondiale de la santé (OMS) a annoncé, jeudi 18 mars, la 
suspension "par précaution" d'un vaccin produit par la société indienne de 
biotechnologies Shantha Biotechnics (contrôlée depuis juillet par Sanofi 
Pasteur, la division vaccins de Sanofi-Aventis) et utilisé par l'Unicef pour 
la vaccination contre cinq maladies.

"Le fabricant a reçu des plaintes rapportant la présence de sédiment blanc 
dans certaines ampoules", a indiqué à l'AFP une porte-parole de l'OMS, 
Alison Brunier. En conséquence, l'OMS a décidé de suspendre l'utilisation de 
ce vaccin contre la diphtérie, la coqueluche, le tétanos, l'hépatite B et 
les infections à Haemophilus influenzae de type B, a-t-elle ajouté.
Le vaccin pentavalent Shan5 fait notamment l'objet de contrats sur trois ans 
pour un montant de 350 millions de dollars (près de 256 millions d'euros) 
avec le Fonds des Nations unies pour l'enfance (Unicef) depuis avril 2009 
selon l'Economic Times, et est utilisé au Tchad, en Colombie et au Pakistan. 
"Aucune information ne donne à penser qu'il y a un problème de sécurité. Il 
s'agit plutôt d'une mesure de précaution", a expliqué Mme Brunier, précisant 
que les vaccins incriminés avaient été mis sous quarantaine dans les pays 
concernés. Ils n'ont pas fait l'objet d'un rappel par la société indienne, 
a-t-elle encore souligné.
La société de biotechnologies devait fournir ce vaccin pour une période 
allant de 2010 à 2012. Selon l'OMS, quelque 23,9 millions de doses ont été 
livrées par Shantha à ses clients entre janvier 2009 et février 2010.

************************

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
http://www.who.int/immunization_standards/vaccine_quality/shan5_suspension_12_march_10.pdf

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.

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.
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 and tetanus 
toxoids, whole cell pertussis, recombinant DNA derived hepatitis B surface 
antigen, and Hib components. The vaccine is absorbed onto aluminium salts as 
an adjuvant and preserved with thiomersal.

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.




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