The U.S. Food and Drug Administration (FDA) approved adding a new indication for the use of Emergent BioSolution Inc's vaccine to prevent anthrax in an expanded population.
Initially approved to prevent anthrax in people who are at high risk for acquiring the disease, the FDA approved the use of the company's anthrax vaccine BioThrax for people ages 18 to 65 years old to prevent anthrax in conjunction with antibiotic therapy.
"With today's approval of BioThrax, we now have a vaccine that can be used, together with antibiotic treatment, to prevent disease after exposure to anthrax spores," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.
BioThrax is the first of its kind to receive FDA approval based on the Animal Rule, which allows data proving the drug's effectiveness on animal clinical trials to be used as the basis for human use approval when clinical trials on man are not feasible or ethical to facilitate.
Based on the conducted trials on rabbits and monkeys, at least a 70 percent probability of surviving after inhalation of the anthrax causative agent was noted, compared to the 23 to 44 percent survival rate of rabbits that were given only antibiotics. Further studies also showed that, depending on the dose given, chances of animal survival thanks to the vaccine can go as high as 100 percent.
Researchers concluded that the vaccine provided a reasonable enough amount of protection and likely to improve survivability of humans against the disease as well.
No drug however doesn't come with side effects, even vaccines. FDA noted that BioThrax's side effects include tenderness, swelling, redness and pain at the injection site, as well as limiting the movement of the injected arm temporarily. Systemic adverse effects that were noted included fatigue, headache and muscle pains.
Still, as a whole, BioThrax was confirmed by the FDA enough to be safe for use, with the benefits potentially outweighing possible side effects.
Anthrax is a fatal disease, especially when caught by inhalation. It can be treated with antibiotics but it must be caught early to maximize chances of survival. While it is not contagious, it can easily spread to many people at once if they are all in an environment teeming with anthrax spores, which was why it used as a bioterrorism weapon back in 2001, a week after the Sept. 11 World Trade Tower Attack, that killed five people when they opened mail containing white powder with anthrax bacteria.
"Anthrax, once in the environment, can be spread about the population when it comes into contact with clothes or shoes. The body of someone who had live Anthrax spores at the time can also spread them," wrote Alexander Ward for the Independent.
Image: CDC Global | Flickr
