Emergent Tries Add-On For Its Anthrax Vaccine
Monday, March 26, 2007
Emergent BioSolutions is in a predicament.
The Gaithersburg company makes the only federally licensed anthrax vaccine. It sells the vaccine to the Defense Department to inoculate soldiers, and in the past two years the government has purchased 10 million doses for the strategic national stockpile in case of another attack.
The problem is that federal health officials want 75 million doses for the stockpile, but they want those doses to be made using a newer generation of vaccine technology that requires just a few shots to produce immunity. That has left Emergent's vaccine, which currently requires up to six doses, mostly on the sidelines.
And it has left the government without a major supplier for the stockpile.
Emergent is trying to solve this problem by taking its vaccine, which has been around since 1970, and strapping on newer technology. The company recently cut a licensing deal with Coley Pharmaceutical Group to use its VaxImmune -- an adjuvant, or additive, that can enhance and speed up a vaccine's ability to boost immune response in the body. In some ways this is like putting new wheels on an older car in hopes that it will go faster.
"We think we can position this as a true next-generation product," said Fuad El-Hibri, Emergent's chief executive.
The company said it had some evidence that the combined technology could provide immunity with fewer shots. A study carried out by Emergent and Coley and funded by the Defense Advanced Research Projects Agency showed that people who received the combination vaccine developed peak concentrations of key antibodies 6.3 times higher than those who received the vaccine alone, and the peak was reached 21 days sooner.
Gene Mack, an analyst with HSBC Securities, which has done banking business with Emergent, said using the adjuvant technology, rather than developing a whole new vaccine, "is a way to meet the government in the middle" and give federal health officials what they want.
The question is: Will it be enough? Emergent faces some major hurdles in dealing with the Department of Health and Human Services, which sought the new generation of anthrax vaccines under the $5.6 billion Project BioShield program. In November 2004, HHS awarded an $877.5 million contract to VaxGen, a California company that had never produced a product. The company stumbled several times, and late last year the government canceled the contract. VaxGen is appealing the decision.
Emergent wants to fill the gap in the stockpile, but it's not clear how it would get to that point. The company's vaccine technology was not eligible for an award under the original Bioshield contract. The government would have to issue new requests under another Bioshield contract, which it hasn't done, or it could add to a contract with Emergent that it has outside Bioshield. The government has added to that contract once, when it increased its 2005 order from 5 million to 10 million doses.
An HHS spokesman could not be reached for comment.
The company also has to overcome lingering questions about the safety of its vaccine, which has caused controversy in the military, with soldiers complaining about significant side effects and with some refusing to be injected. A court battle temporarily stopped mandatory vaccinations, but the military resumed vaccinations after the Food and Drug Administration said the product was safe and effective.
Michael Greenberger, the director of the Center for Health and Homeland Security at the University of Maryland, said the FDA's ruling has not persuaded everyone in the skeptical vaccine community. "The vaccine," he said, "does not have a good reputation in the medical science community."
Emergent executives bristle at such claims, pointing to numerous studies that they say show the vaccine to have no more side effects than other vaccines. Several of the company's senior executives said they had taken the vaccine without any issues.
Tom Waytes, who heads up medical affairs for Emergent's division in Michigan, said any negative attention around the vaccine was being generated by anti-vaccine activists. "That buzz isn't coming from people who know vaccinology," he said.
Emergent is doing its best to get that message out and persuade lawmakers and federal health officials to more strongly consider its vaccine. The company has several lobbying groups working on its behalf, according to recent disclosure forms filed with the government. Also, the company's board includes Louis W. Sullivan, who was health and human services secretary from 1989 to 1993, and Jerome M. Hauer, a former senior HHS official who oversaw public health emergency preparedness.
"We would hope the government would get as excited about this as we are," chief executive El-Hibri said.