Fearful of pandemic, the FDA is doing all it can to ramp up production of vaccine against the H1N1 virus.
(Our friends at CBS covered the 1976 swine flu outbreak, from which this image is taken.)
But there won't be enough, and so Douglas Powell is telling anyone who will listen that he has an alternative.
The director of immunology for Antigen Express, Worcester, Mass., is banging the drum for his company's chemical vaccine process, saying it's the only way to supply the market in time.
Antigen Express creates vaccines by stringing amino acids into peptides chemically, resulting in a powder that can be mixed with fluid to guard the body against specific threats.
It won a grant in 2003 to try this with an HIV vaccine. It has also tested an H5N1 "bird flu" vaccine in Lebanon and Powell is hoping to test an H1N1 vaccine in Latvia within months.
"People have been making synthetic vaccines for at least 10-20 years. Most are used in the field of oncology, therapeutic vaccines. We have one for breast cancer," said Powell.
" We have already had peptides in clinical trials. We can outsource the peptide production. Companies can make hundreds of kilograms of peptides."
The problem is the FDA, which has been reluctant. Small trials won't guarantee the safety and effectiveness of a vaccine that must be administered to millions, Powell admits.
"Even with fast track approval, even with an emergency use authorization from the FDA, you're still talking about a minimum of six months to get it done in this country, maybe nine."
So Powell is looking to other markets.
In Latvia, the President has told their board of health they need to roll out a flu vaccine as soon as possible." With approval from the European Medicines Agency, a trial there could start in months and cover the country.
"We're also talking to people in India and elsewhere – they're not going to get Tamiflu or egg-based vaccines. They're willing to try experimental vaccines," he said. "We're just getting in contact with them, putting protocols in their hands, and trying to find out how to start clinical trials."
There is irony here. If H1N1 turns into a true pandemic, one capable of killing millions, and if foreign regulators act quickly, they could get more protection from an American vaccine maker than Americans do.
But again, all this is theoretical. The egg-based method for vaccine production has been around for 50 years. Powell's plan remains experimental, with a limited number of trials. If it doesn't work it might be no help, or people elsewhere could die from complications.
While discussing all this I was reminded of an old song lyric, John Fogerty's "Centerfield." Put me in coach, I'm ready to play, today.
So let's pretend you're Margaret Hamburg. You're the new head of the FDA. You have vaccine coming in this fall, but not enough for everyone. And you don't really know how virulent this H1N1 strain will be.
Do you put Powell and Antigen Express in the game? Or do you keep them on the bench, let them play some minor league ball in Latvia, and hope for the best?
Either call could be right. And either call could be disaster.
This post was originally published on Smartplanet.com