As I write this the story is still hazy [see Addendum] but it sounds like the kind of colossal screw-up we had four years ago when the American College of Pathology sent a pandemic flu strain (H2N2) to thousands of clinical and hospital laboratories as part of routine competency testing (see here, here, here). That was inattention by CDC, whose Director was mesmerized by the bioterrorism phantom and couldn’t see beyond them. This time it’s a vaccine maker and the cock-up sounds pretty horrendous, although it is hard to figure out exactly what has happened given the incomplete descriptions and lack of information from the parties involved:
Baxter International Inc. in Austria unintentionally contaminated samples with the bird flu virus that were used in laboratories in three neighboring countries, raising concern about the potential spread of the deadly disease.
The contamination was discovered when ferrets at a laboratory in the Czech Republic died after being inoculated with vaccine made from the samples early this month. The material came from Deerfield, Illinois-based Baxter, which reported the incident to the Austrian Ministry of Health, Sigrid Rosenberger, a ministry spokeswoman, said today in a telephone interview.
“This was infected with a bird flu virus,” Rosenberger said. “There were some people from the company who handled it.”
The material was intended for use in laboratories, and none of the lab workers have fallen ill. The incident is drawing scrutiny over the safety of research using the H5N1 bird flu strain that’s killed more than three-fifths of the people known to have caught the bug worldwide. Some scientists say the 1977 Russian flu, the most recent global outbreak, began when a virus escaped from a laboratory.
The virus material was supposed to contain a seasonal flu virus and was contaminated after “human error,” said Christopher Bona, a spokesman for Baxter, in a telephone interview. (Michelle Fay Cortez and Jason Gale, Bloomberg)
On first reading this took my breath away because it sounded like a seasonal flu vaccine had become contaminated with H5N1. On second (and third) reading I am not sure what actually did happen and to whom. Here’s what I am unsure about:
- What was contaminated? The Bloomberg story refers to “samples,” but samples of what?
- Ferrets succumbed after failing ill after being “inoculated” with vaccine made from the samples. Does this mean it was a live virus vaccine? (inoculation usually means something living; if it were a vaccine without live materials you would ordinarily say “vaccinated” but people don’t always use words precisely).
- The contaminated material was “for use in laboratories.” What does this mean? It was raw material in a lab that was then made into something else for use outside the lab (like a vaccine)?
- The contaminated material was supposed to have seasonal flu virus in it, not bird flu virus. It sounds like it had both. (“The company was “supposed to get non-infected testing vaccine, which was by mistake of the supplier contaminated with the H5N1 virus”). That’s a recipe for reassortment between a human and a bird virus. Not the dish I’d like to see served up.
- Did this happen with a vaccine in clinical trials?
- We are told that no lab worker has fallen ill. How were they exposed?
- Labs have been “sanitized.” What exactly does this mean? How was the lab contaminated?
Maybe this isn’t the mess it sounds like. It would be nice to have more information from European health authorities. US CDC is apparently not playing any role, which suggests no US seasonal vaccines are involved. But the source of the contaminated sample was a US company, so inquiry from some US authorities seems appropriate.
That’s not happening as far as we are told. Why not? Lots of questions. Few answers.
Addendum: After drafting this post which was based on published reports, I saw Helen Branswell’s story (via crof’s blog). It doesn’t answer all the questions, but it is characteristically excellent reporting. Rather than summarize the wealth of additional details, go read Branswell’s story. Still, many details are still unclear and Baxter is claiming confidential business information. This seems like something CDC might well want to investigate. Just my opinion.