Vaccine challenge conjures VaxGen specter

George Miller

Unlike President John F. Kennedy's 1961 mandate to put a man on the moon by the end of that decade, HHS secretary Kathleen Sebelius' mandate for weeks-long vaccine production technology (see related story) is missing the critical deadline component. But you can bet that timelines are already being calculated.

"Viruses are mutating," says Sebelius, in a speech this week. "Terrorists may be planning. The threats we face are always evolving, so our defenses must evolve, too."

Vaccine and manufacturing technologists need to respond to Sebelius, quickly and enthusiastically. Tell her what you need to get the job done, and supply her with the missing deadline.

It's likely that no one in either industry or government wants a repeat of the great vaccine-development debacle of the middle of the last decade. Remember VaxGen, the California biotech flush with Project BioShield funding to supply an anthrax vaccine? The company brought the genetically engineered candidate to the latter stages of development in 2006, when it stalled because of stability issues. VaxGen was unable to meet a contracted milestone date.  The government canceled a 75-million dose order. The company withered and was blown away at the feet of the FDA, which correctly refused to advance a drug that hadn't been proven from a company that appeared unable to finish the job.

The finger-pointing that followed is matched in ugliness only by the amount of taxpayer money wasted. And the incident calls into question two matters, as then reported in the New York Times, that remain today: The ability of small biotechs to deliver on big government contracts, and the ability of the government to manage such projects, given the vagaries of drug development.

So vaccine makers, let's take charge of the process to meet the mandate before someone else does.

George Miller

Suggested Articles

In a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S. 

After months of delay for ultra-pricey gene therapy Zynteglo, Bluebird Bio is hoping to dose its first German patients in the first half of the year.

North Carolina is providing some financial assistance for the construction of Audentes gene therapy facility in Sanford, North Carolina. (Astellas)