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.

Smallpox: Vaccinia exposures linked to vaccinees; new vaccine updates

Somewhat unexpectedly, May has been a very busy month for news about smallpox and the vaccinia vaccine used against it. Here are the headlines:

• MMWR reported a vaccinia infection in the genital region of a woman reporting sexual contact with a U.S. military member who had received been vaccinated against smallpox. Here's the MMWR report, a related story from CIDRAP News, and the Reuters item. The woman's case was minor and resolved with minimal treatment.

• A similar story, albeit a much more severe event, was reported last week, also via MMWR and picked up by CIDRAP News and Reuters. A two-year old child developed a severe case of eczema vaccinatum from his father, a soldier vaccinated against smallpox prior to service in Iraq. After a 48-day hospitalization, the child is expected to suffer no long-term effects from his illness. It is the first case of the rare, potentially fatal condition in the U.S. since 1998.

• A new smallpox vaccine developed by Acambis received a positive vote from a key FDA advisory committee, all but assuring licensure in the near future. Here's the story from Forbes and the Chicago Tribune. The Tribune story acknowledges the very serious side-effects associated with this new vaccine, likely limiting its use to emergency scenarios only.

• The website of Congressional Quarterly reports that HHS is nearing a contract a Danish company called Bavarian Nordic for 20 million doses of a new smallpox vaccine. The vaccine is hoped to have a more favorable side-effect profile than the current vaccine or the Acambis product noted above.
  

• Finally, this MSNBC story notes that the WHO delayed a decision on the fate of the (known) stockpiles of smallpox -- the actual virus, not the vaccine -- held by the U.S. and Russia. The story reports that both countries are reluctant to destroy their stockpiles, citing their potential value if the virus is found elsewhere. Unclear from the story is the WHO or U.N. authority to enforce their decisions, whenever they may be made.
  

Smallpox vaccine 'possible' cause of soldier's death; vaccinations to continue

This Department of Defense press release and AP story report that the death of a 26-year old soldier from myocarditis may be linked to smallpox and flu vaccines administered 16 days before his sudden death. The press release explains:

"Following evaluation of multiple specialized test results, the panel considered a cause-and-effect relationship to be 'possible.' The smallpox vaccine received by [Pfc. Christopher] Abston is known to cause an inflammation of the heart muscle or myocarditis, a condition found at his autopsy.

Evidence of the vaccinia virus, the main ingredient of smallpox vaccine, was not found in his heart muscle, but evidence of a different virus, parvovirus B19, was found.Natural infection with parvovirus B19 is another known cause of heart inflammation and death. The expert panel cautioned that the findings pointing to vaccinations were neither probable nor unlikely, but they do suggest the possibility that the vaccines may have caused Abston’s death."

Today, the lead story of the Defense Department's website is an item titled "DoD to continue smallpox vaccinations despite soldier's death." The story notes that over 1 million service members have been vaccinated since DoD's smallpox vaccination program began in December 2002. Cardiac side effects have occurred in 120 people, but none died prior to Pfc. Abston.

This is the latest development in what has been a controversial program since its inception 3.5 years ago. To address worries and criticisms, the government has an impressive website at www.smallpox.mil that explains their rationale for the program and offers extensive resources regarding safety concerns, among other topics.

Mismanagement straight out of Central Casting, literally

The Los Angeles County Board of Supervisors will investigate how federal bioterror funds were spent after a report in yesterday's L.A. Times. Here is today's follow-up (registration required)...

"These expenses included $57,045 to hire extras from Central Casting to participate in a 2004 smallpox vaccination drill, along with gift bags to thank the paid actors and volunteers. The county also spent $128,000 on promotional items such as flashlights and letter openers, and $170,000 to train health department staff on how to put together videos to be viewed online. Two videos have been produced, neither of which focuses on bioterrorism."

Extras from Central Casting? Promotional letter openers? Hardly a ringing endorsement of the judgment of the disaster-preparedness folks in L.A.