Initial testing showed the first U.S. vaccine against H5N1 bird flu virus is
safe, but only partly protective, researchers reported Wednesday in The New
England Medicine Journal.
The vaccine sparked a protective immune response in 54 percent of the 451
volunteers who got two shots of the highest dose, which is 90 micrograms of
antigen, 12 times the use in the regular winter flu shot.
The experimental bird flu vaccine sparked a slightly lower immune response in
70 percent of the recipients, but scientists could not determine whether such a
response is protective.
Humans have never been exposed to the H5N1 bird flu virus, and it takes time
for the immune system to ramp up to fight unique types of influenza, said lead
researcher Dr. John Treanor of the University of Rochester in New York.
The good news is that the vaccine seems to be safe, even at very high doses.
Researchers are giving the receivers a third dose to see if the vaccine would
work better, while other studies are seeking to strengthen the effect of the
vaccine at regular dose through adding immune-enhancing chemicals, alum or MF59.
The vaccine is made by a unit of Sanofi-Aventis and based on a version of
H5N1 virus culled in Vietnam in 2004. It is unknown if the vaccine could partly
protect from a slightly different version that emerged in Indonesia last year.
"We have a long way to go," Dr. Anthony Fauci, chief of the National
Institute of Allergy and Infectious Diseases, told a telephone briefing
Wednesday.
The test findings mean that the United States has only stockpiled enough H5N1
vaccine to protect 4 million people in a pandemic, he said. That falls far short
of the government goal of protecting 20 million Americans.
The latest World Health Organization figures show that H5N1 bird flu has
since 2003 caused more than 180 human infections and 105 deaths. Experts fear
the virus could mutate quickly to transmit easily from human to human,
triggering a global pandemic that could kill tens of millions.
At the current high doses of H5N1 vaccine, vaccine factories worldwide could
only produce enough vaccine to fully immunize 75 million people, or 1.25 percent
of the global population, Mayo Clinic flu specialist Dr. Gregory Poland said in
an accompanying editorial in the Journal.