"Anthrax vaccine and public health policy" in AJPH

The latest issue of the American Journal of Public Health includes a very interesting paper by Martin Weiss and colleagues examining the spectrum of issues related to anthrax vaccine development and military vaccination efforts in recent years. The extensively-cited paper, "Anthrax vaccine and public health policy,"(subscription required for full text) also details the U.S. government's relationships with BioPort (now Emergent BioSolutions, the manufacturer of the currently licensed vaccine) and VaxGen, whose failures in anthrax vaccine development have been detailed at length here and elsewhere.

The paper raises far more questions than it answers, but it is worthwhile reading for those interested in the role of vaccines in biodefense efforts and, more generally, the role of government in vaccine development.

Bioterror: VaxGen stops work on anthrax vaccine; smallpox contract awarded

A few recent items about efforts to develop vaccines against possible agents of bioterrorism:

-- We've been following the saga of the VaxGen anthrax vaccine contract since beginning this site in March 2006 (complete coverage here). When we last checked in -- in January -- the news was that HHS had finally canceled the $877.5 million contract awarded to VaxGen as part of Project Bioshield. Just before Memorial Day weekend (likely deliberately timed to reduce media coverage), VaxGen announced that is was ceasing further development of the vaccine, an all-but-inevitable development without new funding.

Here's the VaxGen press release and a story from CIDRAP News. The press release notes that VaxGen will be laying off 20 employees as a result of this decision, which, amazingly, accounts for 25% of its workforce. There's little doubt that this point will be noted by those who had long criticized the decision to award such a significant contract to a very small, unproven player in vaccine development.

Even more bad news is highlighted in this CQ.com story, which notes the new hurdles VaxGen faces is selling its anthrax vaccine technology developed thus far.

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-- Speaking of CQ.com and bioterror vaccines, following up on this previous post, the anticipated agreement between HHS and Bavarian Nordic for a second-generation smallpox vaccine was completed last week. Here's the HHS press release and an AP story, courtesy of CBSNews.com.

$877m VaxGen anthrax vaccine contract cancelled

Since early last year, we've been covering the bad news related to VaxGen's anthrax vaccine development efforts (funded by Project Bioshield). In March 2006, we discussed a Washington Post story reporting a 'major setback'. Then in May, we noted the new government contract issued to Emergent Biosolutions, the manufacturer of the current vaccine. In October, the New York Times took a closer look at the story, as we wrote here, and a month later, we linked to the announcement that the FDA had halted further testing of the VaxGen project on account of insufficient data.

With that background, perhaps the news announced just before Christmas that HHS had cancelled its $877.5 million contract with VaxGen for 'default' should not come as a great surprise.

Here's the story from the New York Times and CIDRAP News. Also: the VaxGen press release and an interesting story from the San Jose Mercury News titled "What demise of anthrax vaccine contract means for VaxGen, U.S."

Here's an excerpt from the Times story:

"'This is a great disappointment and a very real setback,' said D. A. Henderson, the former director of the Department of Health and Human Services office that helped create the BioShield program.

By the end of this year, VaxGen was supposed to have delivered its first 25 million doses to the stockpile. But as it was testing the vaccine, the company noticed that it was breaking down too quickly, apparently because of an unexpected interaction with an additive intended to bolster the vaccine’s effectiveness, said Lance Ignon, a company spokesman."

With the development of a next-generation anthrax vaccine nearly back to step one, efforts now appeared directed at stockpiling the old vaccine as a stopgap measure while rerouting support to other manufacturers at much earlier stages of the development process, making a new vaccine years away.

Even more bad news for VaxGen anthrax vaccine development

Back in March, we wrote about the Washington Post's reporting on setback for VaxGen in their development of a next generation anthrax vaccine as part of a $1 billion contract through Project Bioshield. (The New York Times chimed in back in October, as we noted then as well.)

Today, this story, also from the Washington Post:

"The Food and Drug Administration has postponed advanced testing of a proposed anthrax vaccine that was supposed to be stockpiled this year because of concerns it could lose its potency too fast to be useful, the company developing the drug announced today.

The announcement by VaxGen Inc. was yet another setback to the U.S. government's $1 billion effort to develop a new anthrax vaccine. It followed predictions on Capitol Hill two-and-a-half years ago that a small company like VaxGen wouldn't be able to meet the government's aggressive schedule for stockpiling 25 million doses of the new vaccine by this month."

As this VaxGen press release explains...

"The FDA's Center for Biologics Evaluation and Research (CBER) said the hold notice was issued because data submitted to date by the company are insufficient to determine that the product is stable enough to resume clinical testing. In the notification, the agency expressed concerns that the vaccine's potency could decline during the immunization phase of the trial, potentially resulting in an uninterpretable outcome."

NY Times on Project Bioshield and VaxGen anthrax vaccine

As we catch up on our inbox, a story on Project Bioshield in the New York Times in late September caught our eye. It's worth noting, albeit late, for those who haven't yet seen it. (Recall that Project Bioshield is the $5.6 billion series of programs which is largely the result of the 2001 anthrax attack, intended to develop drugs and vaccines to respond to probable agents of bioterrorism.)

The road to developing safe and effective products has been more than a bit bumpy, to put it mildly, and every few months a major publication offers a rather gloomy assessment of where the work stands, particularly with regard to VaxGen's next-generation anthrax vaccine, the keystone of the project. Back in March, the Washington Post weighed in, as we wrote about here.

The New York Times story linked above explores the struggle between Emergent Biosolutions (the maker of the old anthrax vaccine) and VaxGen (the small company awarded the major contract to develop the new product). For those few who didn't already recognize how entangled politics, science, and public health are (is there anyone?), the story makes that point, and others, quite clear.

BioPort contracted for 5 million more anthrax vaccine doses

Back in March, we wrote about VaxGen's apparent troubles developing a new anthrax vaccine and noted the continued availability of an older anthrax vaccine produced by BioPort. Over the weekend, news that HHS has contracted with BioPort to produce 5 million more doses of vaccine, having recently completed a previous 5 million dose order for the government. The $120 million contract comes from Project BioShield. This AP story has details and a follow-up on VaxGen's problems:

"The contract would run through September 2007 and delivery of the doses would begin almost immediately, said BioPort spokeswoman Kim Brennen Root.

Brisbane, Calif.-based VaxGen Inc. received the first contract worth $877.5 million to develop the company's experimental anthrax vaccine, but delivery has been delayed.

Lance Ignon, VaxGen's vice president corporate affairs, said the company expects it could begin delivery 'at the end of this year if all goes well with our development program and if HHS is willing to accept vaccines based on the data that's currently called for in the contract.'

VaxGen was warned in a March 24 letter from the Food and Drug Administration about sales material handed out at a government biodefense research meeting that contained 'false and misleading statements' about the experimental vaccine and how it compared to one produced by BioPort."

Major setback for VaxGen anthrax vaccine

From today's Washington Post:

"The government's $1 billion effort to develop a new anthrax vaccine has run into difficulty, with the company in charge of the project reporting failure in a major human test and falling at least a year behind schedule.

Officers at VaxGen Inc. of Brisbane, Calif., said in interviews that they believe they have isolated the problem with their vaccine and are well on their way to fixing it. But they acknowledged that they have no hope of meeting a deadline to deliver 25 million doses of the vaccine into a national stockpile by November and will default on their contract with the government unless it grants an extension they have requested."

As the story notes, this setback is only the latest for activities related to Project Bioshield. Most large vaccine manufacturers have stayed away from the program, citing concerns about profit limitations and potential damage to their reputations if problems are encountered fulfilling contract terms. Thus, the work has largely fallen to smaller outfits such as VaxGen that lack the track record of Merck, Sanofi, and GSK, for example. In fact, seeing an opportunity to fill this void, VaxGen touts its 'biodefense business model' on its website. (Oddly, there's no mention in the business model of high-profile failures such as this.)

According to the Post, government contracts to VaxGen for anthrax vaccine work approach $1 billion. Today's news means that 2008 or 2009 is the earliest that a vaccine could be delivered.

In the meantime, the only anthrax vaccine available is an older product made by Bioport, a subsidiary of Emergent Biosolutions. As its FAQ notes, all of Bioport's vaccine production is owned by the U.S. military. There was some controversy a few years back when members of the military expressed reluctance at receiving the vaccine due to safety concerns. In response, the Department of Defense has this impressively-designed site that outlines their positions on the importance of military vaccinations and the safety of the Bioport vaccine.

Update, 10:31 PM: Perhaps not surprisingly, VaxGen took issue with much of today's Washington Post story. Here's a press release from their CEO with responses.