Emergent BioSolutions, Inc., continues to refine BioThrax

Dr. Thomas Waytes, vice president of the medical affairs group at Emergent BioSolutions, recently gave a presentation on the role of BioThrax in the effort to keep the public, first-responders and the military safe from the threat of anthrax as a biological weapon.

Waytes made his comments during a poster session at the 5th Annual Public Health Emergency Medical Countermeasures Workshop held in Washington, D.C. last week.

BioThrax is the only Food and Drug Administration licensed vaccine to protect against anthrax. It is produced by Rockville, Maryland-based Emergent BioSolutions.

BioThrax, Waytes said, has had, and continues to have, a huge impact on the medical countermeasures industry.

"Most terrorism experts would agree that the major bio-terrorism threat to the United States and world wide is anthrax," Waytes said. "It is found in nature. It is relatively easy to grow and be weaponized. It is extremely lethal. This would be the weapon of choice for terrorists."

To combat the threat of anthrax, Waytes said, Emergent BioSolutions has developed a working relationship with the various government entities that are tasked with keeping America safe from biological weapons.

"They have found in Emergent a passionate, skilled and dependable partner," Waytes said. "Over the years we have more than met our commitments."

The anthrax attacks in 2001 stimulated the perception that the United States needed a better means of protecting itself from such dangerous weapons. Waytes recalled several of the lessons learned from that period, including that only about half of the number of people offered antibiotics actually took them as directed. When offered, however, a number of people took the available anthrax vaccine.

"What we learned from that was to offer the vaccine right off the bat with the antibiotics," Waytes said. "Once protective immunity is reached, people will be protected even if they go off of the antibiotics."

It is also believed that if a terrorist was able to create anthrax weapons, terrorists could probably make anthrax that is resistant to one or more kinds of antibiotics.

"The Institute of Medicine concluded that BioThrax should be effective against every known strain of anthrax and probably any bioengineered strain," Waytes said, adding that BioThrax targeted the toxins produced by anthrax bacteria in the body and not the bacteria itself.

Since Emergent BioSolutions began making BioThrax, over 10 million doses have been given to over 2.5 million people, and the vaccine has shown to be safe for its intended use.

"Ten years ago people were speculating that because it's an anthrax vaccine it's probably dangerous, so it has become one of the more thoroughly studied vaccines in recent history and the record has been very supportive that it is safe," Waytes said.

The Department of Health and Human Services has recently begun incorporating BioThrax into the strategic national stockpile, aiming to have 75 million doses available for 25 million people. Emergent BioSolutions has already provided some 43 million doses.

To meet demand, Emergent BioSolutions has recently completed an $80 million state of the art manufacturing facility that will allow them to make 25 million doses every year, Waytes said.

Through a seven year study conducted by the Centers for Disease Control and Prevention, it has been found that even fewer doses of BioThrax than originally thought are needed to achieve optimal effectiveness. The FDA approved a reduced schedule in 2008.

Dr. Thomas Waytes said Emergent BioSolutions is continuing to improve the utility of BioThrax. It is currently seeking FDA licensure for post-exposure prophylaxis and continues to conduct a variety of clinical studies. Emergent BioSolutions has also increased the drug's shelf life from three to four years, making it more cost-effective.