In mid 1970s, the World Health Organization declared smallpox as a completely stamped out disease. Since then no vaccines have been made, although the possibility of reappearance of the deadly virus is still there.
The suspicions that some “pro-terrorism,” countries or terrorist groups possess biological weapons has made it necessary for reproducing the vaccine primarily for military reasons.
According to a report by Washington Post Thursday, an American company has already started on the project.
Following is full text of the report:
A Rockville company has signed on to manufacture a smallpox vaccine for the military, marking the first time in decades that a weapon against the disease will have been produced.
BioReliance Corp., a biological testing and manufacturing company that has specialized mostly in gene therapies, said it will initially make about 300,000 doses of the smallpox vaccine at its facilities on Broschart Road in Rockville. Company officials expect to begin the initial production process for the vaccine by the end of the year.
Making the vaccine has become a priority in recent years amid growing fears of a bioterrorist attack using the deadly virus. A vaccine for smallpox hasn't been produced since the disease was eradicated in the mid-1970s, leaving whole populations open to infection in the event the virus is released.
Only two tightly controlled samples of the virus are supposed to have survived the eradication of the disease, one in Russia and one at the federal Centers for Disease Control and Prevention in Atlanta. But health officials and biological warfare experts say that virus samples may have been obtained by other countries, including North Korea, Iran, Syria and Libya.
"The potential for an outbreak is very real," said Michael Osterholm, chief executive of the Infection Control Advisory Network in Minnesota. "It's been so long since anyone has had the vaccine. If smallpox came back, it would be one of the most horrible nightmares we could imagine among humans."
BioReliance was chosen to make the smallpox vaccination as only one part of a 10-year, $322 million contract, which Frederick-based DynPort is overseeing, to make new, more efficient and safer vaccines for the military. The CDC says it has enough vaccine for 15 million people, but scientists estimate that as much as a quarter of the vaccines are no longer effective. The CDC expects to choose a manufacturer by the end of September to make another 40 million doses of the vaccine.
Smallpox, caused by the variola virus, was a major plague through most of human history, killing an estimated half-billion people - more than all the wars and epidemics put together. The last reported case occurred in 1978 in England. Like chickenpox, smallpox is highly contagious and produces a striking, pustular rash. Unlike that disease, however, smallpox kills about 30 percent of people who contract it, researchers said. In the fatal form of the disease, victims typically die of massive hemorrhaging.
There is no drug treatment for smallpox, and the only way to halt an outbreak is to quarantine infected patients and to conduct a mass vaccination campaign, said Donald A. Henderson, the physician who ran the World Health Organization's smallpox eradication campaign and who is now director of the Center for Civilian Biodefense Studies at Johns Hopkins University.
A worldwide vaccination campaign began in 1966, a campaign that was largely responsible for the disease's eradication. The United States stopped widespread vaccinations in 1972, and Wyeth Laboratories, the last company to make a vaccine, stopped doing so in 1975. The American military stopped routinely vaccinating troops against smallpox in the mid-1980s.
World health experts declared humans free of smallpox in 1980, and nearly all laboratory stocks of the disease were destroyed. Outside of the lab, variola can exist only in the human body.
Attention came back to the disease when in 1992 a Soviet official named Kanatjan Kalibekov, who is now known as Ken Alibek, defected to the United States. In secret debriefings, Alibek, formerly a top player in Soviet germ warfare, told Washington that Moscow had made large quantities of smallpox for war, and he suggested that the virus might have been sold or secreted away as the Soviet state collapsed and Russian scientists were looking for jobs in other countries. The danger, many researchers and scientists said, could come if the virus gets into the hands of terrorists.
"We know the Russians produced smallpox in large quantities and intended to use it as a biological weapon," Henderson said. "Many of those people have left those labs and they may have carried the virus with them. We don't know."
Last year, the Clinton administration announced that it opposed destroying the last remaining samples of the deadly virus, for research purposes.
"A biological event is expected to be rare, but if it were to occur a smallpox outbreak would be catastrophic," Henderson said. "We need a lot more vaccine than we have on hand."
The smallpox vaccine is made not from smallpox virus but from a related virus known as cowpox virus. It was originally produced by making a laceration on a calf's belly and inserting the virus, whereupon the wound produces defenses against the virus that can be given to humans. "It was made from what was in essence purified cow pus," Osterholm said.
That way of making the vaccine will not be used because health regulations are now much stricter. BioReliance said it will grow the vaccine in cell cultures in its new laboratory, which was specially designed handle developing a vaccine. The facility can hold between 10 million and 20 million doses, said John Gilly, vice president of the manufacturing division at BioReliance.
The company was founded in 1947 and went public in 1997. It now has 470 employees - most of whom are in Rockville. The deal, company officials said, is worth at least $10 million to BioReliance. It also gives the company more exposure.
"It's going to give us visibility," said Capers W. McDonald, chief executive at BioReliance – Albawaba.com
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