L'OMS et l'Unicef ont annoncé lundi dans un communiqué commun le rappel du
vaccin Shan5 sur avis d'un comité d'experts
Le vaccin Shan5 est utilisé contre la diphtérie, la coqueluche, le tétanos,
l'Haemophilus influenzae de type b, et l'hépatite B.
La société Shantha Biotechnics Ltd., contrôlée par Sanofi-Aventis SA , a
commencé à rappeler plusieurs lots de vaccins Shan5 au niveau mondial
Joint WHO-UNICEF Statement 2
26 April 2010
RECALL AND DESTRUCTION OF ALL LOTS OF SHAN5 VACCINE
AS A PRECAUTIONARY MEASURE
The World Health Organization (WHO) recommends as a precautionary measure
and destruction of all lots of the Shantha Biotechnics (India) produced
(DTwP-hepatitis B-Hib) vaccine remaining in stock in countries.
The Shan5 vaccine currently held in stock in countries should not be used.
already identified the concerned stock and are now requested to organize
transport of all
unused vaccine to central level, in coordination with WHO and UNICEF country
the in-country entity facilitating the procurement of the vaccines if
vaccines were not
supplied through UNICEF or the Pan American Health Organization). Once
vaccine will handed over to the named Shantha representative in the country
appropriate handling of return and/or destruction.
This recommendation is based on the advice of an ad hoc committee of experts
on 8 April, following incidents of white sediment sticking to Shan 5 vaccine
vials that was
difficult or impossible to resuspend. There have been no reports of any side
the use of Shan5.
WHO recommends that countries continue vaccination using pentavalent vaccine
alternative manufacturer or an alternative DTP-containing vaccine. Countries
contact WHO or UNICEF country offices (or the in-country entity facilitating
or procurement of these vaccines) for assistance with ensuring sufficient
supply of vaccine
for continuation of immunization programmes.
Further advice and support on the necessary process for collection, return
of the vaccine will be provided to the concerned UNICEF/WHO country offices.
supplied through other channels should coordinate directly with a Shantha
. During recent months, WHO received vaccine quality complaints from
Comoros, and Nepal regarding the presence of a white sediment sticking to
vials containing Shan5 vaccine which would not re-suspend even after
. On 19 February, WHO recommended the temporary suspension of the
and use of specific lots of Shan5 vaccine as a precautionary measure pending
. On 12 March, WHO recommended that the procurement and use of all lots of
Shan5 vaccine be temporarily suspended, after WHO received reports that
lots, not included in the temporary suspension, showed a similar problem.
were advised to put any remaining vaccine into quarantine until further
. The manufacturer was asked to provide additional data and WHO undertook
independent testing in WHO-contracted laboratories.
. WHO called on an ad hoc committee of experts (from regulatory, vaccine
manufacturing and immunization programme management fields) to review
the investigation from the manufacturer, results of WHO-commissioned tests,
physical appearance of the Shan5 vaccine received from the countries.
lots of the Shan5 vaccine received during the prequalification process and
combination vaccines were also reviewed.
. The committee concluded that the batches of the product being held in
unsuitable for use and should be destroyed. This recommendation was based on
several factors: the product has a different physical appearance to that
prequalified; there are uncertainties about the safety and immununogenicity
the vaccine in this situation (although no reports of adverse events
immunization have been received); and the root cause of the change in
appearance has not been established.
Shan5 vaccine quality, safety and efficacy
Although no reports of adverse events following immunization have been
received, in view of
the changed physical appearance of the affected lots, there remain
uncertainties about the
safety and immununogenicity profile of the vaccine. While the difficulty in
vaccine suggests that the full dose would not be given when using affected
vials, a change in
efficacy has not yet been proven..
Given this, WHO does not recommend revaccination of individuals who have
received the full
DTP-hepatitis B-Hib vaccination schedule using Shan5 at present. For
individuals who have
begun, but not completed, the schedule using Shan5, an alternative vaccine
should be used to complete the schedule.
Samples from affected vaccine lots are being tested in WHO-contracted
check for a change in immunogenicity. Based on the results of these tests
WHO will review
its current advice not to revaccinate children who have received the full
primary series with
Shan 5. No other vaccine quality complaints besides the flocculation
described above have
been reported to WHO.
Shan5 vaccine composition and WHO prequalification
Shan5 is a combined, pentavalent vaccine containing diphtheria and tetanus
cell pertussis, recombinant DNA derived hepatitis B surface antigen, and
Haemophilus influenza type b (Hib). The vaccine is absorbed onto aluminium
salts as an
adjuvant and preserved with thiomersal.
Shan5 remains on the list of WHO prequalified vaccines for the time being.
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. The list of prequalified vaccines on the
WHO web site
currently indicates that WHO recommends recall and destruction of remaining
stocks as a
Shan5 and alternative vaccine supply
According to updated estimates, between November 2008 and February 2010,
million doses of this vaccine were supplied to countries through UNICEF and
American Health Organization (PAHO) Revolving Fund. The vaccine is also
by a number of countries.
UNICEF and PAHO have been working with alternative suppliers of pentavalent
and with the concerned countries to ensure that there is an adequate
alternative supply of
vaccines for continuation of immunization programmes.