U.S. LOOKS FOR MORE VACCINE SOURCES
27 Dec 2002
Source: New York Times, November 5, 2001.
U.S. Looks for More Vaccine Sources
By KEITH BRADSHER with MICHAEL WINES
WASHINGTON, Nov. 4 -- The United States has begun looking for scarce anthrax vaccine overseas as a precaution in case lingering production problems cannot be resolved at an American vaccine factory.
Britain has already provided samples of its vaccines for testing, and more samples are being sought from other countries, federal health officials said. The Food and Drug Administration does not accept medicines produced overseas until they have been extensively tested in the United States, which sometimes takes years.
"We have not done the tests, and that's one of the problems," Tommy G. Thompson, the secretary of health and human services, told reporters on Friday. A federal drug official said the agency was trying to work quickly on many bioterrorism issues, including anthrax vaccines, but without sacrificing safety.
The F.D.A. required the only American factory making anthrax vaccine to shut down in December 1999 after an inspection found 30 violations involving safety, consistency, record-keeping and sterility. Mr. Thompson predicted two weeks ago that the factory, in Lansing, Mich., owned by the BioPort Corporation, would pass inspection and resume shipments by Thanksgiving.
But a federal official said this weekend that the factory might not be ready until the end of November or early December. BioPort declined to provide a timetable.
In addition to the United States, three countries are known to produce anthrax vaccine for humans: Britain, China and Russia. At least a dozen countries, including the United States, manufacture vaccines for livestock; medical experts say the veterinary vaccines are very similar to the Russian vaccines for people.
Many doctors say veterinary vaccines could be used to treat people in the United States in an emergency -- if millions of Americans were exposed to anthrax and all other supplies of antibiotics and vaccine ran out. But veterinary vaccines may carry more serious side effects than the American vaccine for people, they warn.
In Britain, a government laboratory known as the Center for Applied Microbiology and Research makes a vaccine that is administered each year to about 1,000 people, most of them veterinarians, farmers, tanners and others who may encounter anthrax at work.
Dr. Philip Luton, a spokesman for the British laboratory, declined to discuss the center's production capacity or stockpiles. But vaccine samples have been sent to American health officials for testing, he said.
The British vaccine is similar to the American vaccine. Neither uses live anthrax spores or bacteria. Instead, toxins excreted by anthrax bacteria are filtered from a bacterial culture. Tiny quantities of these toxins are mixed with a fluid and injected so the inoculated person will develop antibodies to the toxins. British and American vaccines use slightly different strains of bacteria and are mixed with different fluids.
China has also developed a vaccine that uses filtered toxins, but less is known about it.
Russia uses an older vaccine technology, inoculating people with live spores of a weakened strain of anthrax. The vaccine was developed for livestock in the late 1930's and came to be used for people, said Dr. Veniamin L. Cherkassky, one of Russia's leading experts on anthrax.
Russia produces large quantities of the vaccine, inoculating 60,000 livestock industry workers for the first time each year and administering an additional 100,000 booster shots annually, Dr. Cherkassky said. The Russian vaccine is very strong, requiring a single dose, compared with four doses for the British vaccine and six doses over two years for the American vaccine.
Dr. Cherkassky asserted that the Russian vaccine was safe because the spores came from the weakened strain. "This vaccine does not give any reactions -- it cannot give any reactions," he said. "There's nothing in it that can give reactions."
Six American experts on anthrax vaccines said the Russian vaccine was probably even more effective than the American vaccine in preventing the recipient from falling ill with anthrax. But all six said the Russian vaccine had more serious side effects.
Dr. Martin E. Hugh-Jones, an anthrax expert at Louisiana State University, has studied Soviet-era medical records for 60,000 people in Sverdlovsk who were inoculated in 1979 immediately after a leak from a nearby anthrax weapons factory. The records showed a dozen cases of permanent neurological damage from the vaccines, he said. The American and British vaccines carry no such risk, he said, because they do not use live spores.
The Russian vaccine was probably painful, too, because many of the people inoculated skipped subsequent prescribed doses, Dr. Hugh- Jones added.
Dr. Cherkassky said no one in Sverdlovsk had experienced a bad reaction to the vaccine.
In the United States, no public officials have suggested mass immunizations for the general public because they think that the risk of a mass anthrax infection is low. The government is making plans to vaccinate 800 laboratory workers, and there have also been proposals to vaccinate police officers, firefighters and workers who decontaminate areas with anthrax.
Mr. Thompson has sought to reassure the public about anthrax vaccine, saying on Friday that there was a stockpile of 5.4 million doses. But many of those doses were recently produced by BioPort at the factory that the federal drug agency closed. Representative Christopher Shays, a Connecticut Republican who has led hearings on the vaccine's safety, said that fewer than 20,000 of the doses in the stockpile were clearly safe.
The side effects of the American vaccine have been controversial, even though they are not as serious as those from the Russian vaccine. The American vaccine can cause redness and itching at the site of the injection and sometimes flulike illnesses. Hospitalization is necessary for about one out of each 200,000 people who get the vaccine, according to the Defense Department, which inoculates soldiers going to high-risk regions like the Persian Gulf and South Korea.
Several hundred people have quit the military in the last four years to avoid receiving the injections. The F.D.A. has responded by saying the vaccine is safe.