April 30, 2009 -- The CDC says a swine flu vaccine will take at least six months to make in large quantities.
And that's if all goes well.
"If things go well, and we develop a full-scale production, it would be several months until the vaccine were available," the CDC today announced in a news release. "By traditional methods, it takes about six months to produce large quantities of influenza vaccine."
There are two important phrases in the CDC announcement.
The first is "if things go well." To make any vaccine, scientists first have to develop a "seed" strain of the virus that grows well in hens' eggs -- currently the only FDA-approved way to make flu vaccine. This means taking DNA from the swine flu virus and putting it into an egg-loving flu strain capable of rapid, massive growth.
That process takes about three weeks, the CDC estimates. Around-the-clock work is under way, but the virus grows only so fast.
Once the seed virus is created and sent to manufacturers, it will take them eight to 11 weeks to create small batches of flu vaccine for safety testing. If the vaccine proves safe, mass production begins.
That normally takes several months. "But influenza vaccine production is pretty unpredictable," the CDC warns.
Flu vaccine makers already are making flu vaccine for the next Northern Hemisphere flu season. Normally, vaccination begins in September.
The question is whether the CDC will ask manufacturers to switch to making swine flu vaccine -- and risk not having enough seasonal flu vaccine -- or to try to add the swine flu to the seasonal vaccine, thereby risking delay of seasonal flu vaccine.
In either case, there won't be enough flu vaccine to give to every single American -- let alone everyone in the world. So even before there's a swine flu vaccine, we'll have to face difficult decisions, CDC Acting Director Richard Besser, MD, today said at a news conference.
"We would be looking to see ... who the groups are at greatest risk for having bad outcome," Besser said. "It's less of a science decision than it is a societal decision because, clearly, we would not be able to have vaccine for 300 million people."
Faster Swine Flu Vaccine?
The second interesting phrase in the CDC announcement is "by traditional methods."
Hens can lay only so many eggs in the sterile production facilities used to make vaccine. It's a tricky process, and a lot can go wrong -- but in most years, flu production goes smoothly along its six-month time track.
If growing viruses in eggs seems old-fashioned, that's because it is. There is a faster way to grow vaccine viruses -- in cultures of human cells -- and it's already approved in Europe. Baxter International Inc. has already asked the CDC for seed virus to get production under way.
And according to media reports, Baxter already is in talks with the World Health Organization about making a swine flu version of its Celvapan vaccine. Baxter told Dow Jones Newswire it could make vaccine available 12 to 16 weeks after getting a seed strain of the virus.
And there are other technologies, too. For example, Novavax Inc., in Rockville, Md., says its virus-like particle technology could produce a swine flu vaccine in 10 to 12 weeks.
One reason officials may hesitate to order a flu vaccine made by methods that haven't yet met the FDA's safety standard is the U.S. experience during the 1976 swine flu scare.
That year, a deadly swine flu outbreak among military recruits in New Jersey led to crash development of a swine flu vaccine. Just as the vaccine was about to be deployed, vaccine makers asked the government to indemnify them against any possible harm the vaccine might cause.
That led people to suspect -- wrongly, as it turned out -- that the manufacturers suspected the vaccine was unsafe. And when serious side effects occurred in a small number of early vaccine recipients, the entire vaccine program came to a halt. Later analysis -- too late to save the CDC and the Ford administration major embarrassment -- showed these side effects weren't actually unusually frequent.
WebMD senior writer Miranda Hitti contributed to this report.