Tue Apr 15, 2:07 PM ET Apr 15, 2008 (CIDRAP News) - Japan's health ministry
today said it was on the verge of approving a plan to
administer prepandemic vaccine to healthcare workers, which
would make it the world's first 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, would allow the vaccination of about 6,000
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 Vietnam, according to a
report today 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
prepandemic 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 second
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 if vaccines that are
currently in national stockpiles will offer cross-protection
against a future pandemic strain. Also, it's not clear if
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
prepandemic 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
prepandemic 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 prepandemic 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 significant human-to-human
transmission is occurring. Lisa Schnirring Staff Writer Wed Apr 16, 7:31 AM ET A health official disinfecting a poultry farm in western
Japan last year after 22 chickens died in a suspected
outbreak of bird flu. Japan is to vaccinate thousands of
medical workers and officials against bird flu to prepare
for a possible pandemic, a health ministry official has
said. (AFP/File/Okayama Prefecture Government) (BIRD FLU Pre
Pandemic) TOKYO (AFP) - Japan is to vaccinate thousands of medical
workers and officials against bird flu to prepare for a
possible pandemic, a health ministry official said
Wednesday. The ministry will vaccinate about 6,400 people by next
March 2009 and plans eventually to expand the programme to
about 10 million people including police and military
officers, the official said on condition of anonymity. "I believe it would be the world's first plan to
vaccinate thousands of people" for a possible outbreak of a
new type of flu, he said. Japan has stockpiles of so-called pre-pandemic vaccines
for 20 million people. The official said the government will study the
effectiveness and side effects of the vaccines, which are
expected to be given to volunteers. "Once the effectiveness and safety of the vaccines are
known, the government will consider expanding it to a scale
of some 10 million people," he said. The H5N1 strain has killed more than 230 people worldwide
since late 2003. Experts fear the virus, which is usually spread directly
from birds to humans, could mutate into a form easily
transmissible between people, sparking a deadly global
pandemic. Health minister Yoichi Masuzoe on Tuesday proposed using
part of the government's stockpiled vaccines on workers at
hospitals or quarantine, customs and immigration
offices. The plan was backed Wednesday by a government-appointed
panel of experts. "If we obtain good results over its effectiveness and
safety, we want to consider vaccinating (an additional) 10
million people who are in medical occupations" or other key
jobs such as at utilities, Masuzoe said. The ministry panel also approved plans to increase the
vaccine stockpile and to try to shorten to six months the
period needed to produce an effective vaccine if a pandemic
occurs. It currently takes 18 months. Japan saw several outbreaks of the deadly H5N1 strain in
early 2007, leading authorities to kill tens of thousands of
chickens as a precaution, but it has reported no human
deaths. Mon May 19, 1:34 AM ET A health worker culls a chicken at a poultry farm in
Bijoy village, about 28 miles west of the northeastern
Indian city of Agartala April 24, 2008. European authorities
have approved the first pre-pandemic bird flu vaccine,
Prepandrix, from GlaxoSmithKline Plc, its maker said on
Monday. Europe's biggest drugmaker hopes the move will spur
fresh stockpile orders from governments around the world.
(Stringer/Reuters) (VACCINES) (BIRD FLU Pre Pandemic) Mon May 19, 1:34 AM ET LONDON (Reuters) - European authorities have approved the
first pre-pandemic bird flu vaccine, Prepandrix, from
GlaxoSmithKline Plc, its maker said on Monday. Europe's biggest drugmaker hopes the move will spur fresh
stockpile orders from governments around the world. Prepandrix is intended for use before or in the early
stages of a flu pandemic. It triggers an immune response to
the H5N1 strain of bird flu, which experts fear may trigger
a widespread human flu outbreak threatening millions of
people. The official license from the European Commission puts
Glaxo ahead of rivals in the vaccine race. The green light
had been expected, following a positive recommendation from
experts at the European Medicines Agency in February. So far, Glaxo has received orders for Prepandrix from a
handful of governments, including the United States,
Switzerland and Finland. In 2007, it sold 146 million pounds
($284 million) of its pre-pandemic vaccine and bulk
antigen. Now Glaxo's flu vaccine head Emmanuel Hanon expects more
buyers to follow, justifying the $2 billion his company has
invested in increasing flu capacity. "It's clear that some governments are more proactive than
others ... the policy is evolving and I'm looking for some
kind of alignment in terms of what governments are going to
do," he told reporters. "Governments are concerned by the real medical and
economic threat of a pandemic." MASS IMMUNISATION Glaxo sees governments, rather than the private sector,
as the prime market for its new vaccine because of the need
to coordinate mass immunization programs. It has previously announced plans to donate 50
million doses of the pre-pandemic vaccine to the World
Health Organisation. Other drugmakers including Sanofi-Aventis and Novartis AG
are also working on bird flu vaccines and industry analysts
say such products may represent a $1 billion-plus sales
opportunity for such companies. Glaxo's vaccine should give a degree of protection until
a more precisely tailored pandemic vaccine can be produced
-- a process likely to take four to six months from the time
any pandemic strain is identified. Tests have shown that Prepandrix protects against H5N1
variants currently circulating in Asia, Europe and
Africa. The new vaccine contains a special additive, or adjuvant,
which allows a very low dose of active ingredient to be used
in each shot. A key challenge in producing a vaccine for millions of
people around the world is how to make the maximum number of
shots from the minimum amount of antigen, or active
ingredient. While H5N1 remains mainly a virus affecting birds,
scientists say it is the most likely source of the next
global flu pandemic in humans, since it may soon mutate into
a form that is easily transmitted from person to person. So far, most human cases can be traced to direct or
indirect contact with infected birds. The H5N1 virus has
killed around 240 people since 2003. By Ben Hirschler (Editing by Jason Neely) Mon May 19, 8:09 AM ET LONDON - The media pandemic may have died down, but
GlaxoSmithKline is betting that the threat of an actual bird
flu pandemic is still real enough for governments across
Europe. (VACCINES) (BIRD FLU Pre Pandemic) (BIRD FLU
PANDEMIC) Mon May 19, 8:09 AM ET LONDON - The media pandemic may have died down, but
GlaxoSmithKline is betting that the threat of an actual bird
flu pandemic is still real enough for governments across
Europe. The pharmaceutical company said on Monday it had secured
European approval for the first pre-pandemic vaccine against
the dreaded H5N1 virus, more commonly known as bird flu,
which began to gain notoriety five years ago. Although there is no sign yet of the much-heralded
worldwide bird flu pandemic, largely because H5N1 has still
failed to transmit itself effectively from human to human,
Glaxo's product offers governments the chance to stockpile
the vaccine just in case. Shares in GlaxoSmithKline rose 20 pence (39 cents), or
1.8%, to £11.59 ($22.63), on Monday afternoon in
London. The approval is the latest in a string of small
positives for the British company, which also got European
approval for lung cancer drug Hycamtin earlier this
month. "I don't think there will be a big sales boost," said
Thomas Brenning, analyst with BayernLB. He said the bird flu
media frenzy had died down somewhat, and that stockpiling
the vaccine might not be seen as being in the public's
interest anymore. Furthermore, there are doubts as to how effective
stockpiling pre-pandemic treatments can be. If a pandemic
breaks out that involves a strain different from H5N1, say
H6, or H7, the vaccine is likely to be useless. "If governments, in taking a public health decision based
on sound risk assessments, believe they should stock H5N1
vaccine, we would not disagree with that," said a spokesman
for the World Health Organization on Monday. But he added that there was "no guarantee" that the next
pandemic would be an H5N1 pandemic, a fact which could cast
serious doubt on the effectiveness of stockpiling the
vaccine. A spokesperson for GlaxoSmithKline said that the company
believed an eventual pandemic would involve a strain in the
H5N1 family, and that a pre-pandemic treatment would save
the four-to-six-month delay of having to react to an
official pandemic announcement. "The U.K. government could
buy it tomorrow and vaccinate us tomorrow," she said. Finland, Switzerland and the United States all placed
orders for Glaxo's H5N1 vaccine totaling £146 million
($285.1 million), in 2007. Forbes by Lionel Laurent, Mon May 19, 7:45 PM ET An Indian health worker carries out a chicken cull after
an outbreak of bird flu in the village of Sukna on the
outskirts of Siliguri on May 11. British pharmaceutical firm
GlaxoSmithKline has said that the European Commission has
granted the first licence to market a vaccine in preparation
for a pandemic of H5N1 bird flu in Europe.(AFP/File/Diptendu
Dutta) (VACCINES) (BIRD FLU Pre Pandemic) LONDON (AFP) - The European Commission has granted the
first licence to market a vaccine in preparation for a
pandemic of H5N1 bird flu in Europe, British pharmaceutical
firm GlaxoSmithKline said on Monday. The ruling from the European Medicines Agency (EMEA)
allows GSK to sell Prepandrix, which targets the most
virulent strain of the virus that can be fatal to humans, in
all 27 European Union member states. "This vaccine marks a significant step in the world's
ability to cope with an influenza pandemic," GSK chief
executive Jean-Pierre Garnier said. The company said the vaccine is based on the strain of
H5N1 currently circulating, which the World Health
Organisation said on April 30 has killed 241 people, mainly
in southeast Asia, since 2003. Prepandrix is based on the Vietnam strain and been found
to be effective in preventing death in 96 percent of cases,
it added. GSK said it had already signed contracts for the
pre-pandemic vaccine with the United States and Switzerland
plus a number of EU countries such as Finland. A number of other drug firms, such as Switzerland's
Novartis and France's Sanofi Aventis, have been working on
bird flu vaccines, amid fears that a mutation of the virus
could cause widespread outbreaks in humans. Pre-pandemic vaccines are produced before a pandemic
using currently circulating strains and provide immunisation
against disease until a pandemic vaccine using the specific
strain is created. The EMEA's decision was expected after it said on
February 22 that it had granted a "positive opinion" on
Prepandrix and the pandemic vaccine Pandemrix. Tue May 20, 11:15 PM ET Brussels, May 20: The European Union has granted licence
to a British company to market a human pre-pandemic bird flu
vaccine, called Prepandrix, in all 27-member European Union
countries, the EurActiv news portal reported Tuesday. (BIRD
FLU Pre Pandemic) (VACCINES) Brussels, May 20: The European Union has granted licence
to a British company to market a human pre-pandemic bird flu
vaccine in all 27-member European Union countries, the
EurActiv news portal reported Tuesday. Although no cases of human-to-human transmission of the
deadly H5N1 strain of bird flu have been reported,
scientists fear the virus could mutate into a strain that
could pass easily between people, causing a global
pandemic. The vaccine, developed by GlaxoSmithKline PLC and called
Prepandrix, is a mix of antigens from currently circulating
virus strains, and is aimed at offering protection against
bird flu ahead of a major outbreak. Tests of the vaccine have been conducted in 400 adults
aged between 18 and 60 since the fall of 2006, and showed at
least a four-fold increase in serum neutralizing antibodies
in 77 percent to 85 percent of subjects against three
distinct H5N1 strain variants. The European Medicines Agency believes that Prepandrix
"will provide a clinically useful degree of cross-protection
against the strain that causes the next pandemic," EurActiv
reported. However, scientists maintain that the large-scale
commercial production of a true pandemic vaccine is unlikely
to start before the virus mutates into its pandemic
strain. According to the World Health Organization, avian
influenza has so far killed 241 people out of 382 confirmed
cases worldwide. GlaxoSmithKline intends to donate 50 million doses of
Prepandrix to the World Health Organization for distribution
to the world's poorest countries. Thu May 22, 10:45 AM ET SCOTTSDALE, Ariz. eFoodSafety.com, Inc. applauds the
European Commission's marketing authorization in the
European Union of GlaxoSmithKline's H5N1 pre-pandemic bird
flu vaccine Prepandrix™. eFoodSafety, which is also
dedicated to developing solutions aimed at combating the
virulent H5N1 strain of bird flu, commends the European
Commission for raising global awareness of the influenza
pandemic and allowing for the advancement of technologies
designed to address potential human threats relating to this
deadly virus. (BIRD FLU Pre Pandemic) SCOTTSDALE, Ariz. eFoodSafety.com, Inc. applauds the
European Commission's marketing authorization in the
European Union of GlaxoSmithKline's H5N1 pre-pandemic bird
flu vaccine Prepandrix™. eFoodSafety, which is also dedicated to developing
solutions aimed at combating the virulent H5N1 strain of
bird flu, commends the European Commission for raising
global awareness of the influenza pandemic and allowing for
the advancement of technologies designed to address
potential human threats relating to this deadly virus. The company's proprietary product, Citroxin™, an
environmentally safe sporicidal product formulated entirely
of food-grade components, has shown 68% efficacy in
eradicating the H5N1 strain of bird flu in chick
embryos. "The European Commission's marketing approval of
GlaxoSmithKline's Prepandrix signifies tremendous progress
in global efforts to fight bird flu in humans," says
Patricia Gruden, CEO of eFoodSafety. "eFoodSafety has been committed to eradicating the avian
flu through its development of Citroxin and we have long
believed that H5N1 should be addressed in order to prevent a
potential pandemic. This week's news further supports our contention that
bird flu is a global social health concern, and that, given
the proper solutions, we can mitigate potential risks to
humans." A World Health Organization (WHO) action plan notes that
over the past decade H5N1 has successfully "crossed the
species barrier" from animals to humans, a shift that it
considers "[poses] an imminent pandemic threat. " The several hundred human cases of H5N1 since 2003 have
often resulted in fatality; as the number of cases continues
to increase, countries around the world are spending more
money to help avoid a global pandemic. As reported by the Wall Street Journal, Switzerland and
Finland have already placed orders for GSK's vaccine, and
other countries are considering the same, in order to amass
a cautionary supply in the event of an outbreak or
pandemic. The World Bank projects that costs associated with
fighting avian flu will range between $1.2 and $1.5 billion
by 2009. In addition to the human implications of the virus, bird
and farm animals are also at risk of infection. As an early entrant in the market, eFoodSafety recognizes
potential to use its Citroxin formula in the mass market as
a solution against the virulent influenza. After positive initial results for Citroxin's ability to
eradicate H5N1 in chick embryos, eFoodSafety has planned to
conduct additional rounds of testing in live animals
affected with forms of flu that closely resemble human
strains of the disease. The company's initial tests were conducted at
Chulalongkorn University in Thailand, one of only two labs
in Asia that is used by the U.S. Centers of Disease Control
to conduct research on treatments of H5N1. Subsequent rounds of testing are planned by the company
to be conducted at a university in the United States that
has been nationally recognized for its field studies in bird
flu.
Japan set to begin pre-pandemic vaccination
Japan to vaccinate medical workers against bird flu
EU licenses first pre-pandemic bird flu vaccine
Bird Flu Not Forgotten By GlaxoSmithKline
First EU licence granted for pre-pandemic bird flu
vaccine: GSK
EU approves human pre-pandemic bird flu vaccine called
Prepandrix
eFoodSafety Endorses the European Commission's Marketing
Authorization of GlaxoSmithKline's Pre-Pandemic Bird Flu
Vaccine