Firms vie for anthrax pacts

Annapolis, Rockville companies seeking share of millions of vaccine doses

August 11, 2008|By Frank D. Roylance | Frank D. Roylance,Sun reporter

Drug companies based in Annapolis and Rockville are battling for potentially lucrative federal contracts to supply at least 25 million doses of new, improved anthrax vaccine to protect Americans against another bioterror attack like the one in 2001.

PharmAthene Inc. of Annapolis, which is also developing drugs to protect against chemical nerve agents and the plague bacterium, says it could begin delivering its SparVax vaccine to the Strategic National Stockpile as early as 2012.

In Rockville, Emergent BioSolutions Inc. announced that it, too, had a recombinant anthrax vaccine in development.

Both companies filed proposals July 31 in response to a request from the U.S. Department of Health and Human Services for a more modern, bioengineered vaccine to replace the current vaccine, BioThrax, made by Emergent.

Officials at the Department of Health and Human Services said contract awards could come as early as this fall.

"This will not be a cakewalk for us. We have very strong competitors," said David P. Wright, PharmAthene's president and CEO. "But I believe, with the caliber of the staff we have ... that we will be successful at the end of the day in producing for this country the vaccine we need."

Emergent's chairman and CEO, Fuad El-Hibri, said in announcing its participation, "We are confident that our ... vaccine is a leading candidate to be selected as an advanced ... anthrax vaccine. Our company is proud of our proven track record of delivering critical biodefense countermeasures to the U.S. government."

The government is still beefing up its biodefenses in the wake of the 2001 letter attacks that prosecutors say were launched by Bruce E. Ivins, a federal microbiologist who killed himself last month as officials prepared to indict him.

The push is now on to replace BioThrax, which requires six doses over 18 months to achieve immunity and has a history of side effects and shelf-life problems. Emergent said almost 2 million U.S. military personnel have received the vaccine.

In its request for proposals, the Department of Health and Human Services called for a purer vaccine made with modern recombinant DNA technology that would eliminate side effects, require fewer injections over a shorter period, and have a longer shelf life. Ultimately, the government wants to build the stockpile from 18.2 million doses to a supply big enough to protect 300 million Americans.

It is not clear whether drug companies other than the two that announced their bids had entered the chase.

"We're not able to say who actually provided a proposal, other than that we did have multiple offers and they look pretty good," said Robin Robinson, director of the HHS Biomedical Advanced Research and Development Authority.

"They will be evaluated for technical merit over the next several weeks. Then we will enter into negotiations, and we're looking toward contracts by the fall," he said. The agency expects to award multiple contracts, "so if one doesn't make it, others will still be going forward."

Robinson said the department eventually expects to spend $1.5 billion acquiring anthrax vaccines for its stockpile.

The inventory is stored in undisclosed locations around the country. Robinson said it includes two types of antibiotics to prevent illness in up to 60 million people potentially exposed to an anthrax release. Those drugs are "ready to go," he said.

In addition, the stockpile has acquired anti-toxins to treat or prevent illness after anthrax exposure. There's enough now to treat about 20,000 people, Robinson said. Several companies are under contract to produce more.

To be ready to immunize people months or years before a potential exposure, HHS policy requires that the stockpile acquire enough anthrax vaccine for 25 million people, Robinson said, "and ultimately we would like to have enough for 300 million people."

So far, he said, there are just 18.2 million doses of BioThrax in the stockpile, enough for 3 million to 6 million people. It is the only anthrax vaccine currently licensed by the Food and Drug Administration.

"We're buying all that they can make until we have more vaccines available," Robinson said.

First licensed in 1970, BioThrax is produced using traditional methods, from the killed remains of the whole anthrax bacteria. But the vaccine has several drawbacks that the National Institute of Medicine and HHS believe more modern vaccines can eliminate.

Side effects, thought to be caused by fragments of the killed bacteria that do not help to produce immunity, include headaches, fever, swelling and pain at the injection site, nausea and dizziness, Wright said. Six percent of the reactions are considered serious.

In addition, the need for six injections over 18 months "makes it a very difficult vaccine to administer," Robinson said. "You have to keep track of everyone and make sure they're receiving all the doses they're supposed to. It's not what you'd call the optimum vaccine strategy."

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