May 22, 2009 -- The Centers for Disease Control and Prevention said today that it has at least one, and possibly two versions of the new swine flu virus that may help drug makers develop a vaccine against the novel strain.
The first of these so-called "seed viruses" is a bit like a microscopic Frankenstein, consisting of pieces from the new strain combined with other viral fragments that will allow the virus to grow well in chicken eggs -- a preliminary step in the vaccine-making process.
The other was created through reverse genetics, a newer technique.
Once the CDC sends these template viruses to drug manufacturers -- probably by the end of next week -- the companies can use them to begin cranking out pilot lots of vaccine by mid to late June.
And that's where a $1 billion-dollar program -- also announced today -- comes in.
The first wave of government money will go to five flu vaccine manufacturers. So far, drug maker Novartis will receive the largest chunk of the allotment -- $288.8 million -- while GlaxoSmithKline will get $181.1 million and Sanofi Pasteur will receive $190.6 million.
An additional $150 million will go to these three companies as well as two others -- MedImmune and Australia's CSL -- for the purpose of developing test lots, which are needed for clinical trials and to test for potency.
The remaining money is still in contract negotiations.
The money comes not a moment too soon, said Dr. Bruce Gellin, director of the National Vaccine Program Office.
"It's critically important that we ask the manufacturers to get started, to begin to make the materials for a vaccine," he told ABC's World News.
Initially, the government's goal is to create enough vaccine to inoculate 20 million people -- what Gellin calls the "critical workforce." Gellin said this group mainly consists of first responders and whomever else may be in harm's way from the virus.
Swine Flu Vaccine Process Will Take Time
Timing is at the center of the discussions over the production of the new vaccine. Gellin said that the most crucial consideration is determining how to get a swine flu vaccine produced and distributed without disrupting the production of the seasonal flu vaccine.
"We know that the steps in manufacturing a vaccine take a long time, and just ordering something today doesn't mean you'll have it tomorrow," Gellin said. "So it's critically important that we ask the manufacturers to get started, to begin to make the materials for a vaccine. At the same time, we're very sensitive to talk to the manufacturers to be sure that what they're doing today doesn't interfere with their completion of their work on the seasonal flu vaccine that they're finishing now."
SanofiPasteur, which will handle the virus in its new Pennsylvania plant, said it will take a few weeks to determine how best to grow the virus in eggs before moving on to mass production.
Meanwhile, clinical trials, which will likely involve testing the vaccine on thousands of people, could begin by August. It is during these trials that scientists will have to determine if the medication works and at what dose.
But even though the development of the vaccine is still in its early stages, it is already clear that this new vaccine would not be part of the regular flu shot; rather, it would be given separately, probably in two immunizations, meaning three flu shots in all, Gellin noted.
Swine Flu Vaccine May Not Be Needed
But even though the wheels have been set in motion to prepare a swine flu vaccine, the administration is stressing that it has not yet decided whether to move forward on widespread immunizations. That will depend partly on how the virus acts in the next few months, when the Southern Hemisphere has its flu season.
Dr. Ed Janoff, professor of infectious disease at the University of Colorado Denver, said that the steps that the government intends to take are "prudent."
"The government is taking appropriate steps to do the background and organize the logistics to produce vaccine against the new H1N1 if it is ultimately deemed necessary to provide to the public," Janoff said. "They have not committed to making large-scale vaccine, only to doing their homework and identify the concrete steps necessary."
Preparation Is 'Prudent' for Swine Flu
He added that the fact that the government is staying one step ahead of the virus could be viewed by the public as a comforting sign -- particularly in light of the fact that researchers are still trying to determine whether the virus is likely to mutate into a deadlier form.
"This is a very fluid situation," said Dr. Gregory Poland, professor of Medicine and Infectious Diseases at the Mayo Clinic in Rochester, Minn. "This virus changes very quickly, and I think the big thing that we're watching for is, is this virus going to further mutate or trade genetic material with other circulating influenza viruses?
"If that happened, that could produce a virus that's more virulent and causes more disease."
It will take until this fall to figure out how much protection the vaccine offers. By then, the government will have to decide whether every American should roll up their sleeve.