November 04, 2009
Policy Decisions Slow H1N1 Vaccine Production

Why is H1N1 influenza vaccine coming out so slowly in the United States? Dr. Scott Gottlieb, a former FDA deputy commissioner, says a few policy decisions slow the production of vaccine.

Why do adjuvants matter? An adjuvanted H1N1 vaccine being used in Europe contains 3.75 micrograms of vaccine stock. The same vaccine in the U.S., without the adjuvant, requires 15 micrograms of vaccine for equal potency. If we used adjuvants, we could have had four times the number of shots with the same raw material.

Our regulators are more risk-averse. If a much more lethal pandemic flu strain popped up would the regulators continue to be so conservative?

We need to move beyond the use of chicken eggs to produce virus proteins for vaccine. The much more rapid and scalable approach using mammalian cells is already in use in Europe, not so in the US. Again, regulatory conservatism makes a difference.

The third policy decision was to stick for too long with a proven, but slow process for making flu shots that uses chicken eggs to grow the raw vaccine material. Shots can be made much faster using mammalian cells to grow vaccine, and this process is already being used in Europe. The cell-based vaccines are unlikely to be approved in the U.S. Our precaution when it comes to vaccines means we don't easily embrace novel technologies, even if the Europeans would part with some of their limited supply.

Luckily H1N1 isn't lethal to all that many people. Tens of thousands might die. But a repeat of 1918 levels of lethality would require a far far less conservative approach to vaccine approvals. Would the US government make the needed changes in regulatory policy when tens of millions of lives are at stake?

Forget global free trade when lives are at stake. Where the vaccine manufacturing plants are located also matters.

In 2004, only two companies were licensed to sell flu vaccine in the United States; now there are five, but only one, Sanofi-Pasteur, has a domestic plant. The others ó GlaxoSmithKline, Novartis, CSL Ltd. and Medimmune ó use plants in England, Germany and Australia.

The drawback of relying on foreign plants was made clear recently when the Australian government pressured CSL to keep its vaccine at home instead of fulfilling its contract for 36 million doses of swine flu vaccine for the United States.

H1N1 vaccine production is late.

Frieden said the CDC had a cumulative 26.6 million doses of vaccine available -- far short of the 40 to 80 million that had been forecast for the end of October.

My advice: take vitamin D and clean your hands more often.

Share |      Randall Parker, 2009 November 04 11:07 PM  Pandemic Vaccines

Brett Bellmore said at November 5, 2009 3:13 AM:

"Would the US government make the needed changes in regulatory policy when tens of millions of lives are at stake?"

How likely is it they'd know *in time* to make those changes? I'm suspecting that the regulatory changes would have to be made, in some cases, several years in advance. Sure, you can dilute your vaccine stock with saline spiked with adjuvants quick enough, but you can't switch from eggs to cell cultures in a hurry.

Would we make the regulatory changes *after* millions of Americans have died? Maybe...

Anonymous said at November 6, 2009 3:27 PM:

We can thank the Clinton administration for demonizing big Pharm, demanding vaccines at half price "for the children", and encouraging them to leave the industry.

jaymaster said at November 6, 2009 5:04 PM:

European governments may well be far ahead of the US in accepting new technologies in immunizations. But they are well behind the US in accepting similar advances in food production.

I canít help but wonder how much of this is due to actual science, as opposed to political turf protection.

Thomas said at November 6, 2009 6:21 PM:

How about tort protction too? Isn't this a declared national emergercy

Paddy said at November 6, 2009 9:19 PM:

Risk of tort claims is one of he primary causes that led American companies to stop making vaccines. They were denied legal immunity. Now we are dependent upon foreign manufacturers for most of our supplies. We can thank the Democrats and trial lawyers for this intolerable situation.

Paul said at November 11, 2009 5:30 AM:

Adjuvants are not necessarily without risk. They might increase the risk of auto-immune disorders. As an example, consider what happens when you inject a rodent with Freund adjuvant and myelin: the animal develops EAE, a very serious auto-immune disorder that either kills the animal or leaves it with permanent CNS damage.

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