LANSING (AP) The nation”s sole producer of the anthrax vaccine has won federal approval for its laboratory.
But a few hurdles still remain before it can ship the vaccine, possibly by later this month.
BioPort Corp. of Lansing received a Dec. 27 letter from the U.S. Food and Drug Administration clearing it to begin shipping the vaccine, provided a Washington state laboratory that puts the vaccine into vials also receives FDA approval.
The vaccine already manufactured by BioPort also must be tested by the company for purity, potency and sterility and be released by the FDA before each lot can be shipped.
BioPort already has conducted tests on three lots of the vaccine manufactured in 2000 as part of the FDA approval process, BioPort spokeswoman Kim Brennen Root said yesterday.
The anthrax vaccine has been licensed by the FDA since the 1970s. But BioPort has been unable to sell the vaccine since buying its labs from the state in 1998 because it failed two FDA inspections after a renovation.
The Pentagon owns all of the vaccine BioPort has been producing and pays the company around $36 million each year, Root said.
In its letter, the FDA said BioPort has made or is in the process of making the seven production-related changes requested by FDA inspectors during their visit last month. The company still must improve monitoring and complete studies showing it can successfully pool batches of the vaccine.