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INFLUENZA PANDEMIC (H1N1) (13): VACCINE RECALL
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A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
Date: Wed 3 Feb 2010
Source: CIDRAP News [edited]
<http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/feb0310sanofi.html>
The US Centers for Disease Control and Prevention (CDC) yesterday [3
Feb 2010] notified healthcare providers that 50 lots of Sanofi
Pasteur's pandemic (H1N1) 2009 virus vaccine in pre-filled syringes
have a shorter shelf life than shown on the label. The CDC said in its
Health Alert Network message that Sanofi's routine stability testing
of vaccine that had already been shipped to providers showed that
although the lots remained potent, they are losing potency more
rapidly than expected. The company said the pre-filled syringe doses
in the affected lots should be used by 15 Feb 2010, regardless of the
expiration date shown on the package. The new expiration date does not
apply to multidose vials.
The 50 lots subject to yesterday's [3 Feb 2010] expiration change
comprise 12 million doses. 14 of the lots are single-dose pediatric
flu vaccine, and the remaining 36 are single-dose vaccine for older
children and adults. The lots were shipped to providers between
November 2009 and January 2010. The CDC said there are no safety
concerns with the affected lots and that people who were immunized
with doses from the lots do not need to be revaccinated. The CDC said
its notice yesterday applies specifically to the 50 lots of vaccine
but that the expiration date change and 2 earlier non-safety-related
recalls apply to all of Sanofi's pandemic pre-filled syringe vaccine
doses. The CDC emphasized that though most of the doses have already
been administered, it was almost certain that some haven't yet been
used.
In an earlier Health Alert Network notification detailing a 29 Jan
2010 non-safety-related recall of 5 lots of Sanofi pandemic vaccine
totaling 1.3 million doses, the CDC said Sanofi planned to submit a
field correction request to the Food and Drug Administration (FDA) to
change the expiration date of its remaining pediatric and adult
pre-filled syringes.
In addition to the 29 Jan 2010 Sanofi vaccine recall, there have been
2 others, both in December [2009], related to a drop in potency after
shipping. One involved Sanofi pediatric pre-filled syringe doses and
the other was from MedImmune, the company that makes the nasal spray
H1N1 vaccine.
[Byline: Lisa Schnirring]
--
Communicated by:
ProMED-mail <promed@promedmail.org>
[This alert concerns vaccine supplied in pre-filled syringes, and it
does not imply any inadequacy in the vaccine already administered.
However, the loss of potency of vaccine in pre-filled syringes is
something that governments intending to purchase surplus stocks of
vaccine from donors should take into consideration. - Mod.CP]
[Photo of pre-filled syringe:
<http://assets.nydailynews.com/img/2009/12/16/alg_vaccine_swine-flu.jpg>
- Mod.JW]
[see also:
Influenza pandemic (H1N1) (12): vaccine distribution, WHO update 20100202.0359
2009
----
Influenza pandemic (H1N1) 2009 (123): vaccine safety 20091205.4152
Influenza pandemic (H1N1) 2009 (112): Canada (MB), vaccine reaction
20091121.4009
Influenza pandemic (H1N1) 2009 (67): vaccine delivery 20091011.3515
Influenza pandemic (H1N1) 2009 (63): USA military vaccine 20091002.3437
Influenza pandemic (H1N1) 2009 (55): vaccine formulation 20090925.3359
Influenza pandemic (H1N1) 2009 (54): vaccine availability 20090921.3325
Influenza pandemic (H1N1) 2009 (53): vaccine donation 20090919.3290
Influenza pandemic (H1N1) 2009 (49): FDA vaccine update 20090917.3254
Influenza pandemic (H1N1) 2009 (21): vaccine prioriities 20090730.2669
Influenza pandemic (H1N1) 2009 (11): vaccine issues 20090722.2595
Influenza pandemic (H1N1) 2009 (10): vaccine 20090720.2577
Influenza pandemic (H1N1) 2009 (05): vaccine 20090716.2540
Influenza pandemic (H1N1) 2009 (03): vaccine 20090713.2505]
.........................................................cp/msp/jw
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