Although Bioport appears to be an issue, the interesting point is that FDA appears to be identifying "manufacturing" issues. FDA does not appear to be releasing publicly the nature of these observations at the various vaccine factories.
Perhaps we should suggest that FDA release their evaluations of the vaccine production lines. Why is it that there are these deficiencies? Is FDA over regulating? Or, is the vaccine company deficient?
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
The Weekly Standard
October 29, 2001
Vol. 7, No. 7; Pg. 29
All About Anthrax; Everything you didn't want to know
BY DAVID TELL
(snip)
And guarding public health against prospective anthrax releases isn't easy, either. It, too, has never really been tested on human subjects, but a vaccine against anthrax does exist. Trouble is, the sole source of that (understocked and controversial) vaccine in the United States is a company called BioPort in Lansing, Michigan, which is currently operating under a license suspended by the FDA as punishment for a history of laboratory contamination, inadequate documentation and staff training, and low manufacturing standards.BioPort's best known owner/investor is retired Admiral William Crowe. But day-to-day responsibility for the company, for what it's worth, falls to a German immigrant of Lebanese ancestry named Fuad El-Hibri. Fuad El-Hibri's father, an international businessman named Ibrahim El-Hibri, is prominently associated with an Islamic charity headquartered in Beirut.
(snip)
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
Townsend Letter for Doctors and Patients
January 1, 2002
Pg. 16Anthrax Vaccine; Shorts
Klotter, Jule
The Lansing, Michigan, laboratory that manufactures anthrax vaccine for the U.S. has been unable to pass FDA inspection since 1997. According to a Wall Street Journal article, an October 2000, FDA report cited multiple faults, resulting in the conclusion that "a section of the plant where vials are filled with the anthrax vaccine and other products 'does not assure sterility.'"The state of Michigan had put the laboratory up for sale in the mid-1990s. It was finally bought in September 1998, for $ 24.8 million by BioPort, a company formed by Fuad El-Hibri, a former German national of Lebanese extraction, now a US citizen. Mr. El-Hibri had directed a British company that made bio-defense vaccines for anthrax and botulinum.
Less than two weeks after the sale closed, the Pentagon signed a contract for $ 45 million that made BioPort its only source of anthrax vaccine. Shortly thereafter, BioPort closed its laboratory "for a major overhaul."
In August 1999, the US government gave BioPort an additional $ 24.1 million in 'extraordinary contractual relief,' and the Defense Department agreed to pay BioPort 2-5 times more per dose, for fewer doses than agreed upon in the original contract.
Although he denies trying to influence the Defense Department, retired Admiral and former US ambassador to Britain, William J. Crowe Jr., has supported Mr. El-Hibri from the beginning. The former chairman of the joint chiefs of staff was given 12-13% of the company in exchange for a "token amount" and BioPort's use of his name.
(snip)
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
The New York Times
November 12, 2001
Section B; Page 7
A NATION CHALLENGED: THE SUPPLIES;
The Only U.S. Laboratory for the Anthrax Vaccine Says Production Will Be Delayed
By KEITH BRADSHER
LANSING, Mich., Nov. 9
The only laboratory in the country that makes anthrax vaccine will not be ready for a crucial federal inspection until mid-December, later than federal officials had hoped.
The lab, owned by BioPort, a private 220-employee company here, was partly dismantled for a thorough cleaning just as the anthrax attacks began in early October. Company officials say they finished cleaning on Thursday and will need several more weeks to work up to production. The delay is the latest in a series of problems that have prevented the military from using the anthrax vaccine produced here since December 1997.American officials are anxious enough about vaccine supplies that they have asked foreign governments for samples of their vaccines to test for possible use in the United States. A bipartisan panel on terrorism, created by Congress in 1999, recommended on Nov. 1 that a government-owned vaccine laboratory be created to produce vaccines for anthrax, smallpox and other bioterrorism threats.
"We can't expect a private contractor to gear up and fill these contracts," said Gov. James S. Gilmore of Virginia, a Republican who is the panel's chairman.
But officials at BioPort say that they are close to resolving their production problems at last and making millions of doses available to the military.
Robert G. Kramer Sr., BioPort's president, [No more mention of el-Hibri. Gee, I wonder why?] said that the comprehensive cleaning of the laboratory was carefully planned so that equipment could be reassembled at any time and put back into production within 10 days. But the military never asked the company to do so, he said.
"We are taking all the prudent and precautionary steps to be ready for a very rigorous inspection by the F.D.A. while being sure that we can be back in production quickly if need be," Mr. Kramer said. "It's a balancing act." He added that the country should have a second anthrax vaccine factory, possibly run by another company, as a precaution.
The company and the Food and Drug Administration have argued for years over quality-control problems at the Lansing laboratory. The F.D.A. has in particular criticized the sterility of the lab's process for decanting the vaccine into 10-dose vials. The company has given up trying to use its own equipment for this task, and now plans to ship the vaccine in bulk to another company, Hollister-Stier Laboratories, in Spokane, Wash., which will decant it into the vials and ship it back to Lansing.
Decanting vaccine into vials was a problem for the Lansing laboratory even before its sale to BioPort, said George Burgoyne, a BioPort critic who was the laboratory's chief of vaccine production until the state of Michigan sold it to BioPort in September 1998.
Mr. Burgoyne said the laboratory had two people sterilize vials and carry them into the room that contained the filling machine. "No matter how you dress people, organisms come off them all the time," Mr. Burgoyne said.
Many drug companies, including Hollister-Stier, automated this task entirely in the 1980's and early 1990's, and the F.D.A. responded by setting more stringent standards for sterility in the vial-filling process. The state of Michigan began renovating the lab in February 1998, and BioPort completed the task in April of the following year. But the renovation did not include automating the filling process, and the laboratory failed an F.D.A. inspection in October 2000.
The inspection report describes numerous problems, especially in the filling area. Inspectors noted that insufficiently clean air was entering the area, and that employees were touching nonsterile surfaces on their way in.
BioPort has also had problems with its labeling. At the F.D.A.'s urging, the company replaced the labels on an unspecified number of anthrax vials in September 2000, after it printed inaccurate expiration dates on them. Hollister-Stier is talking with BioPort to take over the labeling, too.
The lab will work up to full production over the next several weeks in preparation for another inspection, Mr. Kramer said. If it passes the inspection this time, BioPort will ask the F.D.A. to approve the use of 600,000 vaccines already decanted by Hollister-Stier in late summer, he said. Earlier vaccines, decanted here, would be administered only under the F.D.A.'s program for new drugs, which requires close medical supervision.
BioPort and the F.D.A. have been leery of moving too quickly to resume anthrax vaccine production because the vaccine itself has long been controversial. Several hundred military personnel have refused to take it after reports that it might be linked to a wide range of illnesses, including "Gulf War sickness," a combination of symptoms sometimes seen in veterans of that conflict.
Dr. Meryl Nass, a physician who advises soldiers who oppose the vaccines, said that fixing manufacturing problems was a good idea, but that the way the vaccine is produced -- by filtering toxins from anthrax bacteria -- inherently produces excessive variations in the vaccine's potency and purity.
The Defense Department, the F.D.A. and BioPort all say the vaccine, which was developed in the early 1960's, is safe. The Army is working with the drug industry to develop a new vaccine, but still has years of work ahead, a person involved in the work said.
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
American Health Line
January 15, 2002, Tuesday
SECTION: BIOTERRORISM
BIOPORT: FDA APPROVES RENOVATED ANTHRAX VACCINE FACTORY
Lansing, Mich.-based BioPort Corp., the country's only maker of the anthrax vaccine, has received FDA approval for its newly renovated factory, but the company still has many "hurdles" to clear before it can resume distribution of the vaccine, the Wall Street Journal reports. According to the Journal, the FDA on Dec. 27 sent a letter to the company saying that before distribution could begin, BioPort must finish work on two quality control tests (Wall Street Journal, 1/15).The company was forced to close its plant in 1998 after FDA inspectors found quality control and sterility problems (American Health Line, 10/29/01). In addition, the sterility of the laboratory's process for decanting the anthrax vaccine into 10-dose vials is still an issue.
BioPort has "given up" trying to use its own equipment for the process and now plans to send the vaccine "in bulk" to Hollister-Stier Laboratories in Spokane, Wash., which will decant and then ship the vials back to Michigan (American Health Line, 11/12/01). FDA inspectors have cited six "production-related changes" that must be made at the Spokane facility before it can receive approval (AP/CBS News.com, 1/14).
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
American Health Line
February 1, 2002, Friday
SECTION: BIOTERRORISM
ANTHRAX: FDA ALLOWS BIOPORT TO DISTRIBUTE VACCINE
In an "important step in the government's efforts to prepare for anthrax attacks," the FDA yesterday cleared BioPort Corp., the nation's sole maker of the anthrax vaccine, to resume shipping and production of the shots, ending a four-year delay caused by safety violations at the company's factory, the Los Angeles Times reports (Ornstein, Los Angeles Times, 2/1).The agency said that BioPort, based in Lansing, Mich., had met "all federal [safety] requirements" and can now make the vaccine for the Department of Defense, which will allow the agency to resume its mass inoculations of American military personnel (AP/New York Times, 2/1). The FDA clearance will allow BioPort to ship 209,000 doses of the vaccine immediately and make more as necessary (Gillis, Washington Post, 2/1).
HHS Secretary Tommy Thompson said that BioPort will produce two million doses this year and three million to eight million next year. The Defense Department vaccine program has been on hold since 1998, as the FDA has found repeated safety violations at the factory BioPort purchased from the state of Michigan that year, including contamination of doses, inadequate record-keeping, sterility problems and unapproved procedures (AP/New York Times, 2/1).
Getting the company back on line took on more urgency within the FDA following last fall's anthrax incidents, which caused five deaths. Mark Elengold, deputy director of the FDA's Center for Biologics Evaluation and Research, said the agency did not compromise safety standards in its assessment of BioPort, but said, "Did we have people working on it longer and harder? Yes" (Los Angeles Times, 2/1).
THE DEFENSE DECISION
While yesterday's action allows the Defense Department to resume its vaccination program, it is not clear if, or to what extent, it will do so, given the controversial nature of the program. So far about 500,000 armed forces members have been inoculated, a process that requires six shots over 18 months and an annual booster shot (AP/New York Times. But citing possible health risks, many military personnel have refused to receive the vaccine. "Hundreds" have been dismissed from the military after refusing the vaccine, and at least 100 have been court-martialed after refusing (Washington Post, 2/1).The Pentagon said yesterday that it will continue to vaccinate only special mission units while it reviews the approval, with a decision about the larger vaccination program to be made in the near future. The Los Angeles Times reports that the consensus among most scientists is that the vaccine is safe and produces only minor side effects. In its approval, the FDA did require BioPort to place some additional warnings on the vaccine, including one about possible risks of birth defects for pregnant women (Los Angeles Times, 2/1).
According to an attorney who has represented soldiers court-martialed for refusing to take the vaccine, the recent anthrax incidents may sway more soldiers toward wanting to obtain the vaccine. "It's hard to say whether you'll see the same type of opposition in the ranks, because of the change in circumstances," the attorney said.
CIVILIAN USE?
All of the anthrax vaccine BioPort has made so far is owned by the Defense Department, and the company currently has no plans to supply the vaccine for "broad civilian use" (Washington Post, 2/1). And while the federal government does not recommend vaccination for the general public, Thompson said that the resumption in production is important if a bioterrorist attack on the civilian population makes the vaccine necessary for members of the public."This product is a critical component in our arsenal," he said (AP/New York Times, 2/1). In December, the CDC offered the vaccine to 10,000 people deemed at high risk of anthrax exposure resulting from tainted letters mailed last fall along the East Coast, but only 190 have chosen to take it so far (Los Angeles Times, 2/1). BioPort also plans to discuss with federal health officials whether the vaccine should be given to emergency responders who would be first on the scene at a bioterrorist attack (Washington Post, 2/1).