Memories of 2009's scary emergence of H1N1 "swine flu" have faded along with new cases of the virus, but the episode is worth remembering for the weakness it exposed in our domestic security.
The Obama administration has included $300 million for pandemic flu preparedness in its current budget, but that won't be enough to build even a single new vaccine manufacturing plant in the U.S. Yet the widespread shortage of swine flu shots last fall should have taught us the importance of a domestic capacity to produce pandemic vaccines as a matter of national strategic planning.
The depth of our vulnerability was laid bare when two close allies--Australia and Canada--effectively nationalized their domestic flu vaccine plants, seizing H1N1 swine flu shots destined for the U.S. This is one of the reasons why America didn't have enough vaccine when we needed it.
In Australia, the government pressured vaccine maker CSL Limited to turn over 36 million doses of H1N1 vaccine contracted for by the U.S. and produced in an Australian-based manufacturing plant. Meanwhile, in Canada, where British drug maker GlaxoSmithKline maintains its U.S.-focused flu vaccine facility, the company had to assure the local government that Canadians would be served from that manufacturing plant before Americans could receive any of their vaccine orders.
Pandemic preparedness should be viewed as a matter of our national security, not solely a public health challenge, with an intensive effort to build domestic vaccine capacity to serve our population.
Surprisingly, there is only one full-scale facility on U.S. soil for producing flu vaccine (owned and operated by Sanofi Aventis). The other four companies licensed by the Food and Drug Administration to produce flu vaccine all manufacture, fill and finish their shots in facilities located mostly in Europe. This leaves America at the mercy of foreign governments.
Even more worrisome, the single facility that the U.S. has on its soil won't help against the full range of potential pandemics. Our sole domestic facility relies on older-generation technology that uses chicken eggs as incubators to grow the vaccine components. While this is adequate for producing vaccine against a swine flu, if we're hit by avian "bird" flu, the egg process could be unfeasible. Bird flu can destroy the chickens and the eggs before vaccine components can be harvested. What's needed are manufacturing facilities that use cells as incubators for growing vaccines rather than chicken eggs.
H1N1 is arguably a milder flu, and a worse pandemic is inevitable. Imagine how other nations might behave when it strikes. Manufacturing sites would be seized--every country for itself.
The Department of Health and Human Services gave contracts to five companies to build cell-based facilities several years ago. Two of the companies gave up and returned the money. Another two are building plants overseas. Only a single firm, Novartis ( NVS - news - people ), is building a full scale, cell-based plant in the U.S. It's been under construction for more than two years and won't be fully operational for about another four. It shows the long lead-time needed to create production capacity.
To protect Americans, the government should also guarantee the annual purchase of a certain amount of seasonal flu vaccine. This would enable the industry to reliably forecast demand, spurring investment in new facilities that could also be used to produce vaccine in a pandemic. The annual procurement should favor vaccines produced in U.S. plants and with newer, cell-based methods.
Purchased vaccine could be distributed domestically, or better still, donated to Asian nations such as Vietnam. Flu strains often originate in Asia and we rely on local Asian government's to undertake vigorous surveillance and share emerging virus strains. Giving them free shots would encourage vaccination to reduce spread and give nations more skin in global efforts to stem outbreaks.
A stumbling block to more domestic vaccine capacity owes to how vaccines are regulated. The FDA often requires vaccine from each plant to be tested in completely separate clinical trials. There are good reasons why biologics such as vaccines can vary from one production run to the next. But these constraints make it far more economical for drug firms to expand existing vaccine facilities rather than build new ones. With better regulatory tools, there may be ways for FDA to allow a single clinical trial to suffice, even when similar vaccines are produced at two different sites.
Finally, despite its benefits, cell culture is just a new way of making an old vaccine. What's really needed is technology that allows us to produce vaccine without culturing the flu virus itself.
New processes such as recombinant technologies allow the manufacture of small fragments of virus (called virus like particles) rather than relying on whole copies of the bug. This and similar innovations can yield more vaccine in shorter time--about 10-12 weeks to scale up a big production run, compared with 26 weeks using an egg-based vaccine or 16 for a cell culture. The newer methods give us a better chance to intervene with vaccine during the first wave of a pandemic.
Given the long lead times to new medical products, if we're struck by another pandemic in 5 or 10 years, we'll be fighting it with whatever technology we invest in today. Viewed as a problem of public health preparedness, our incremental pandemic preparations may seem adequate. Seen as a national security threat, it's clear that our current efforts are insufficient.
Scott Gottlieb, M.D., is a resident scholar at AEI.