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A ProMED-mail post
ProMED-mail is a program of the
International Society for Infectious Diseases
Date: Wed 11 Feb 2009
Source: Xinhua News Agency [edited]
China recalls more than 320 000 doses of flawed rabies vaccine
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More than 320 000 doses of rabies vaccine found to contain a banned
ingredient have been recovered in China after regulators ordered a
recall, an official said Wednesday [11 Feb 2009]. Among 360 200 doses
of the flawed vaccines for human use, 323 200 had been recovered by
Monday afternoon [9 Feb 2009] by the manufacturer, Dalian
Jingang-Andi Bio-products Co. Ltd. in northeast China's Liaoning
Province, said Yan Jiangying, spokeswoman for the State Food and Drug
Administration (SFDA). She said she believed the rest of the
vaccines, where not used, had been held for recall. There has been no
report of vaccine-related illness so far.
The SFDA asked the province's drug administration department to make
sure all products were recovered, Yan said at a press conference. The
agency ordered the company to recall all rabies vaccine it produced
in 2008, totaling 3.389 million does, soon after the department
received a report from the National Institute for the Control of
Pharmaceutical and Biological Products (NICPBP) in early January [2009].
The institute found in a test that 360 200 doses of the company's
vaccines contained nucleic acid, which was not supposed to be added
until its safety had been proven. Nucleic acid acts as an adjuvant,
or a substance used to enhance the effectiveness of anti-viral drugs.
However, China hasn't yet approved it for use in rabies vaccine, said
Dong Guanmu, a researcher at the NICPBP. Dong said although animal
tests showed the acid did enhance the effectiveness of the vaccine,
it had to undergo clinical trials before it could be used on humans.
The company said on its website that it now supplies 20 percent of
the rabies vaccine in China's market. The company could not be
reached immediately for further information on the recall because the
telephone number it published online was no longer in use.
Communicated by:
ProMED-mail
[The expanded use of rabies vaccine for both pre- and post-exposure
immunisation has created a requirement for vaccines of higher
potency. The production of vaccines in cell culture is complicated by
the need to exclude animal serum from the final product and addition
of adjuvants is one approach to enhancement of vaccine potency. The
report above does not identify the nature of the nucleic acid present
in the rejected vaccine, but if it is not merely indicative of a
contaminant it may be an adjuvant which has not yet received approval
from a regulatory organisation.
For example, in China Wang et al have described a CpG
oligodeoxynucleotide, which acts as a potent adjuvant for inactivated
rabies virus vaccine (Vaccine. 2008 Mar 28; 26(15): 1893-901;
abstract available at
Their data indicated that the CpG oligodeoxynucleotide could be used
as a promising adjuvant to replace or combine with aluminum for
developing more effective rabies vaccines. Their data show that the
CpG oligodeoxynucleotide could be used as an effective adjuvant in
experimental animals (mice) to replace of or combine with aluminum
for development of more effective rabies vaccine.
Further information on the reason for the withdrawal of the rabies
vaccine batches described in the preceding report would be welcomed. - Mod.CP]
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