Work on Pandemic Flu Vaccines Must Start Now, WHO Report Says

[Guest guest]

http://www.bloomberg.com/apps/news?pid=20601080 & sid=ahKTpB5eQCM4 & refer=asia

Work on Pandemic Flu Vaccines Must Start Now, WHO Report Says

July 15 (Bloomberg) -- Work on vaccines used to protect against a flu

pandemic must start immediately, even though the effectiveness of the

treatments might not be known until after a global outbreak ended, the World

Health Organization said.

Randomized trials of candidate pandemic vaccines will be important in

gauging their safety and gaining regulatory approval, the Geneva-based WHO

said in a report published yesterday in the Weekly Epidemiological Record.

``Internationally coordinated preparatory work for these trials should start

immediately, as little time would be available for putting the needed

infrastructure in place after the start of the pandemic,'' the report said.

Pharmaceutical companies, including Sanofi-Aventis SA, GlaxoKline Plc,

MedImmune Inc. and CSL Ltd. are racing to produce treatments for use in a

pandemic amid concern over the H5N1 strain of avian influenza, which has

infected at least 230 people in 10 countries in Asia and the Middle East,

killing 132.

Yesterday, Indonesia confirmed its 41st fatality after tests confirmed the

H5N1 virus killed a 3-year-old girl earlier this month.

Governments and international health authorities are trying to stem the

spread of H5N1 to reduce opportunities for the virus to mutate into a

pandemic form.

The Food and Agriculture Organization of the United Nations will open a

crisis management center in Rome later this month to help improve control of

H5N1, which spread in domestic fowl and wild birds to at least 55 countries

since late 2003.

Crisis Center

The center, to be run by the UN agency in collaboration with the Paris-based

World Organization for Animal Health, will provide animal disease analysis

and deploy international resources to prevent and contain dangerous animal

diseases, the FAO said in an e-mailed statement yesterday.

A pandemic can start when a novel influenza A-type virus, to which almost no

one has natural immunity, emerges and begins spreading worldwide. Experts

believe that a pandemic in 1918, which may have killed as many as 50 million

people, began when a lethal avian flu virus jumped to people from birds.

Shots produced each year for seasonal flu won't be effective in a pandemic

because the vaccine needs to closely match the pandemic virus, the WHO said

in a statement on its Web site.

At least four strains of bird flu are capable of spawning the next pandemic,

including the H5N1 virus, according to virologist Webster, the

Rosemary professor at St. Jude Children's Research Hospital in

Memphis, Tennessee.

Vaccine Delays

Although a vaccine against the H5N1 virus is under development in several

countries, none is ready for commercial production and no vaccines are

expected to be widely available until several months after the start of a

pandemic, the WHO said.

``Effectiveness of pandemic vaccines will not be known before the pandemic

and possibly only after it is over,'' the report in the Weekly

Epidemiological Record said. ``In addition, unexpected adverse events,

whether coincidental or vaccine- related, will occur that may lead to

anxiety and may affect vaccine uptake.''

The UN health agency said it could play a critical role in assisting

countries collect and review safety data on pandemic vaccines.

``WHO's role in gathering information on the safety profile of candidate

pandemic vaccines from clinical trials should be enhanced,'' it said. The

report follows a meeting in Geneva last month of the Global Advisory

Committee on Vaccine Safety, an expert clinical and scientific advisory

body.

The committee reviewed possible measures to overcome obstacles relating to

the use of newly formulated vaccines for emergency use, some of which will

contain new adjuvants, or compounds that allow immunization doses to be

diluted, giving more people access to the shots.

Pregnancy

Pregnant women are at special risk for influenza infection based on

morbidity and mortality from previous pandemics and from intense flu

seasons, the report said.

The committee reviewed the use of inactivated seasonal flu vaccine in 2003

and concluded that the risk-benefit of immunization during all stages of

pregnancy should be reconsidered, given the high risk to the mother and

fetus of the disease itself, and the likely small risk to mother and fetus

of the inactivated flu vaccine, the report said.

It said there are no data on the safety profile of candidate pandemic flu

vaccines when administered during pregnancy and reproductive toxicity

studies using animal models should be conducted.

To contact the reporter on this story:

Gale in Singapore at j.gale@...

Randi Airola

517-819-5926

When Good People do Nothing....

" Today Americans would be outraged if U. N. troops entered Los Angeles to

restore order; tomorrow they will be grateful! This is especially true if

they were told there was an outside threat from beyond, whether real or

promulgated, that threatened our very existence. It is then that all people

of the world will plead with world leaders to deliver them from this evil.

The one thing every man fears is the unknown. When presented with this

scenario, individual rights will be willingly relinquished for the guarantee

of their well being granted to them by their world government. "

~ Henry Kissinger

They that can give up essential liberty to obtain a little temporary safety

deserve neither liberty nor safety - lin