Japan: proposed vaccine trial
Date: Tue 15 Apr 2008
Source: CIDRAP News [edited]
<http://www.cidrap.umn.edu/cidrap/content/influenza/avianflu/news/apr1508vaccine-jw.html>
Japan's health ministry today [15 Apr 2008] said it was on the verge
of approving a plan to administer pre-pandemic vaccine to healthcare
workers, which would make it the world's 1st country to tap its
national stockpile for this purpose. Kishiko Yamaguchi, an official
from Japan's health and welfare ministry, said the plan, which awaits
approval tomorrow [Wed 16 Apr 2008], would allow the vaccination of
about 6000 quarantine officials and healthcare workers by the end of
the year, the Associated Press (AP) reported today.
Japan has already approved and stockpiled pandemic vaccines for 10
million people that are based on H5N1 viruses from China, Indonesia,
and Viet Nam, according to a report today [15 Apr 2008] from Reuters.
The health ministry said the vaccines were made by the Research
Foundation for Microbial Diseases of Osaka University and the
Kitasato Institute, the report said.
In a November 2005 presentation for the World Health Organization
(WHO) that summarized clinical study results for Japan's pandemic
vaccine, Masato Tashiro, MD, PhD, with the National Institute of
Infectious Diseases in Tokyo, revealed that the project is supported
by the government, and the same formulation of the alum-adjuvanted
whole-virus vaccine is produced by all of the manufacturers.
Yamaguchi told the AP that if initial tests show that the
pre-pandemic vaccine is safe and effective, the ministry would
consider vaccinating 10 million more people, including such vital
workers as lawmakers, police, and other healthcare workers. Reuters
reported that the 2nd vaccination wave would also include those who
maintain infrastructure networks such as gas and electricity.
International health officials have been cautious about taking steps
toward vaccination in advance of a pandemic, because researchers are
uncertain whether vaccines that are currently in national stockpiles
will offer cross-protection against a future pandemic strain. Also,
it's not clear whether any adverse events would arise from the use of
the vaccine, which makes it difficult to weigh the usefulness of the
strategy.
In a May 2007 bulletin, the WHO acknowledged that as pre-pandemic
vaccines become available, they could be used in poultry workers,
healthcare workers, and whole populations. However, the WHO did not
recommend that countries undertake the strategy. Gregory Hartl, a
spokesman for the WHO, told the AP that pre-pandemic vaccination is
"a big roll of the dice" but said the WHO doesn't oppose countries
using the vaccines. The European Centre for Disease Prevention and
Control in 2007 praised the development of pre-pandemic vaccines but
said it did not support countries using them until the WHO elevates
its pandemic phase to 5 or 6 (from the current phase 3), which would
indicate that significant human-to-human transmission is occurring.
[Byline: Lisa Schnirring]
- --
Communicated by:
ProMED-mail <promed@promedmail.org>
[Despite the precautionary approach of the WHO, it is evident that
some countries will prefer to proceed with pre-pandemic vaccination
trials. For example, a vaccine trial has been initiated recently in
Viet Nam; see: Avian influenza, human - MBDS region (16): vaccine
trials 20080328.1166. The comment of Gregory Hartl that, at this
juncture, (pre-pandemic) vaccination is "a big roll of the dice"
seems particularly apt. - Mod.CP] |
