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IPFS News Link • Vaccines and Vaccinations

FDA uses 'animal' rule to approve anthrax vaccine for humans ...


(NaturalNews) The FDA has dramatically expanded the permitted uses of the anthrax vaccine using a post-9/11 law known as the Bioterrorism Act of 2002. A clause of that act, known as the Animal Rule, allows the FDA to bypass human studies of drugs in cases where exposing humans to a disease or toxin would be unfeasible or unethical.

The rule is intended for highly lethal diseases such as anthrax or Ebola. It does not necessarily have to be limited to diseases that might be used as biological weapons.

The Animal Rule has only been invoked nine times before, and never for a vaccine.

Dead rabbits plus human antibodies = evidence?

The FDA actually first approved the anthrax vaccine – manufactured by Emergent BioSolutions – in 1970, but only to protect people at high risk of exposure. The new approval allows the vaccine to be given to people aged 18 to 65 known or suspected to have already come into contact with the anthrax bacteria. The vaccine should be given in addition to, rather than instead of, the currently recommended course of antibiotics, the FDA said.

There have been no suspected cases of anthrax exposure in the United States since 2001, in which anthrax-laced letters were sent to politicians and media outlets, leading 17 people to become sick. In that case, doctors used the anthrax vaccine off-label in the fashion now approved by the FDA. Five people still died.

To justify the new approval without human studies, researchers decided that a 70 percent survival rate in rabbits would constitute a "reasonable level of protection." So researchers exposed rabbits to anthrax, then treated them either with only antibiotics or with antibiotics plus the vaccine. Between 70 and 100 percent of the rabbits in the vaccine group survived, compared with 23 to 44 percent in the antibiotic only group.