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So far the swine flu infections in the U.S. have been mostly mild. But if the
virus should continue to spread, or the infections worsen, rapid development of
a vaccine could be our best protection.
The ability to make a vaccine quickly isn’t easy, but we’re better able to do
it today than just five years ago. This is because we’ve taken steps to improve
our ability to thwart biological threats: both the naturally occurring kind,
like swine flu, and even the ones that could be used deliberately as
It’s especially true in the vaccine industry, which has undergone a
renaissance in recent years partly as a result of government incentives and
improvements in how vaccines are regulated. These policy steps have improved our
medical footing and are worth bearing in mind as we deal with swine flu.
But we still face a lot of vulnerabilities. These come not only from nature,
but also from Washington, where some of these steps to build our vaccine
capacity remain deeply unfashionable.
Vaccines were long seen as commodity products, marked by little new
investment. The sector made vaccines that reflected little innovation and sold
them cheaply, mostly to government agencies that valued low price–enabling
wider use–over advances in how vaccines worked or were manufactured.
The end result was a skeleton industry with few reliable suppliers. Flu
vaccines, in particular, were made by the same process used for 50 years–by
being grown inside chicken eggs–despite advances in science that enable
ordinary animal cells to be turned into more reliable incubators.
The chicken egg process is dirty, slow and expensive; it costs more than $300
million to build a new plant and requires about five years to bring it on line.
Using eggs, simply creating a novel production run to target a new strain like
swine flu can take four to six months. (First the “wild” virus needs to be
converted into a weaker “seed” strain, which can grow inside the eggs without
This is a rate-limiting step we are still mastering when it comes to swine
flu. By comparison, using the cell-based technology, a vaccine could
theoretically be produced in a matter of weeks.
Over the last five years, the vaccine market has re-emerged as a key industry
and a growing business for the large drug firms, which have invested heavily in
better ways to make these products.
These investments are a result of both rising profit margins for these
products and the success of several consumer vaccines. But it’s also a
consequence of legislation that created new incentives to develop these products
and practical regulatory changes at the Food and Drug Administration (FDA) that
lowered development risks by applying better scientific tools to how vaccines
This includes a series of key “guidance” documents the FDA’s biologics center
issued, mapping out a streamlined development process for the approval of flu
vaccines. It relied on more rapid measures of benefit from tests against
biological markers that gauge immune response to the vaccine. These measures
reduced the cost of developing the vaccine and created more predictability for
new vaccine developers.
Among other steps, the FDA put in place an express inspection process for
certifying new vaccine manufacturing facilities. The agency also worked with
manufacturers to help them develop the new cell-based vaccine technology. This
process could be especially important for making vaccines against a potentially
virulent form of pandemic flu that might not be efficient or even possible to
manufacture using older, egg-based production methods.
Taken together, these regulatory steps gave rise to new vaccine products that
give today’s policymakers many more options for responding to the swine flu
The Department of Health and Human Services also established a process for
making and contracting government grants for vaccines (under its BioShield
program) for medical products that could protect against biological weapons and
other threats. One contract, for $487 million, was awarded three months ago for
construction of the first U.S. facility to manufacture cell-based flu
If we had to widely distribute a vaccine against a pandemic flu, the
cell-based process could be used in a pinch. But so few of these worldwide
facilities are operational–and, thus far, none are approved by the FDA. So
right now, we’ll need to rely on the egg-based process that takes four to six
But today there are three times as many manufacturers licensed to make flu
vaccines as there were just four years ago. This means we could make swine flu
vaccines with the egg process without using up too much of the egg stock
reserved for making next year’s seasonal flu vaccines.
Another option to boost supply is to use an adjuvant, which is basically a
vaccine additive that makes a smaller amount of vaccine more effective. It lets
you stretch your vaccine supply.
Right now, there are adjuvants approved in Europe that could be used in a
swine flu vaccine, but none are approved in the U.S. There’s reason to believe
this adjuvant–already used in Europe for a vaccine against avian flu as well as
human papilloma virus (HPV)–could boost supply of a swine flu vaccine as much
as five-fold. The FDA needs to rapidly assess this vaccine additive and make a
decision if it will use it in this case. There is ample experience in Europe to
Our improved preparedness is not a sure thing, nor are continued advances in
vaccines that can reduce risks. One reason is diminishing incentives for
investment in the industrial capacity to make these things.
As a result of legislative endeavors favoring generics and lower drug costs,
the average patent life on big new drugs has been reduced to as little as 10
years from more than 12 just nine years ago. These measures improve access to
the drugs but reduce incentives to invest in new plants and technology. There’s
legislation right now on Capitol Hill, sponsored by Congressman Henry Waxman,
D-Calif., that would reduce the effective patent life on “biologics” like
vaccines to as little as five years.
In addition, there’s political pressure on the FDA to increase regulatory
hurdles to “promote drug safety.” Some of these efforts undermine steps the FDA
has taken to modernize regulation of vaccines. There’s still work to be done to
improve regulation further and enhance our preparedness for pandemic. The
cell-based manufacturing processes, for example, as well as the approval of
adjuvants, should become regulatory priorities for the FDA.
Preparing for future threats requires a broad armamentarium and the residual
capacity to create new things quickly. We are better prepared to respond to
swine flu as a consequence of these lessons. But this strategic capacity doesn’t
come cheap, and we need to strike a careful balance between policies that enable
better access to today’s medicines and incentives that invest in tomorrow’s. As
the biology of threats like swine flu grow more complex, it’s not a sure thing
our medical industry will be robust enough to keep pace with it.
Scott Gottlieb, M.D., is a resident fellow at AEI.
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