[voir aussi ci-dessous:
et la liste des vaccins préqualifiés :
L'OMS interdit un vaccin utilisé dans des campagnes de l'Unicef
LEMONDE.FR avec AFP | 18.03.10 | 14h42
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
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
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
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
. 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
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
. 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
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
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.