- The Washington Times - Wednesday, September 16, 2009

As global pharmaceutical giants strain to meet government orders for the new swine flu vaccine, behind the scenes their suppliers struggle to produce hundreds of millions of the eggs needed to grow it and the syringes, needles and nasal sprayers needed to administer it.

The unprecedented effort to prevent a pandemic of the H1N1 influenza - discovered just five months ago - is looking successful so far, despite slower-than-expected progress growing the vaccine.

Four of the five companies licensed to produce vaccines in the United States had their swine flu vaccines approved by the Food and Drug Administration on Tuesday.

That clears “a really big hurdle” and means millions of doses will be available in the next few days, said Robin Robinson, director of the Biomedical Advanced Research Development Authority.

The agency, part of the Department of Health and Human Services, was created in 2007 to make sure the nation was prepared for crises including flu outbreaks, as well as nuclear, biological and chemical attacks. Mr. Robinson, previously in charge of U.S. influenza preparedness, became its first director early last year.

“We will have the vaccine over the course of the next two to three months and move it out to the public, beginning a little in early October and then moving very briskly,” he said.

It does not address the limited supplies of the vaccine, though researchers delivered the much-needed good news last week that a single dose of the vaccine was sufficient for an adult - half the amount authorities had expected.

Still, the government will have only a third as much vaccine next month as it had sought because the vaccine is growing slowly in the host eggs. The government awarded nearly $2 billion to the five companies this year to make enough vaccine to protect most Americans.

Gaithersburg-based biotechnology company MedImmune LLC has achieved better-than-expected growth because its FluMist vaccine is made with live rather than dead viruses.

“We originally thought we could probably make 30 [million] to 40 million doses,” spokeswoman Karen Lancaster said.

“We now estimate we can produce 200 million doses in bulk. We’re limited in the number of sprayers we have to put them in. We’ll have 50 million sprayers, but that leaves us excess capacity of 150 million doses,” she said.

Becton, Dickinson and Co., a 112-year-old maker of medical devices, tripled production at its AccuSpray plant in Nebraska earlier this year, according to a spokesman.

But it’s still not enough. MedImmune is now working with the Food and Drug Administration for potential approval of a dropper device to administer the vaccine. Since FluMist’s approval in 2003, sales have been lackluster, generating limited demand for the sprayers.

“It makes sense; we live in a just-in-time economy,” said Dr. Howard Markel, a pediatrician and professor of medical history at the University of Michigan.

He was referring to the trend among companies in recent decades to limit excess inventory in order to improve financial performance.

Becton says it will have no problem fulfilling the $52 million contract the government awarded it early this year for more syringes, needles, alcohol swabs and needle-disposal containers.

Mr. Robinson said the government has ordered 200 million syringes and needles from several manufacturers, including Becton and Covidien PLC.

Overall, Dr. Markel called the swine flu effort to date “truly remarkable.” He noted that in a typical flu season about 40 million people are vaccinated - and indeed, authorities say people should get both the normal and the swine flu vaccine this year.

The vaccine-makers - MedImmune, Novartis AG, Sanofi-Aventis SA, GlaxoSmithKline PLC and CSL Ltd. - have had to turn directly from seasonal vaccine production to making even greater quantities of swine flu vaccine. The latter was being made even as the former was being packaged and shipped. All but Glaxo had their swine flu vaccines approved by the FDA on Tuesday.

“To me as a historian of medicine and public health, it’s the grandest undertaking in mass vaccinations that we have seen in human history” in such a short period of time, he said.

For Mr. Robinson, it has been a long road, working with suppliers from “end to end” - using federal contracts and funds to ensure the supply of everything from the chicken to the needle.

The government started preparing for this sort of emergency years before April’s swine flu outbreak in Mexico. The effort began when quality problems at a Chiron vaccine plant in Britain caused a severe vaccine shortage in 2004.

The government awarded a $45 million contract that year to establish new poultry farms to produce the specialized eggs needed to make vaccine. The farms have established procedures to avoid avian-flu contamination, Mr. Robinson said. If too many chickens get the flu, then too few people will get a vaccine.

The government contracted with Novartis of Switzerland and Sanofi-Aventis of France to build vaccine-production facilities here at home. The $150 million Sanofi plant in southeastern Pennsylvania is already making vaccines. The U.S. gave the company a $77.4 million contract to retrofit an existing facility there in 2007.

The Novartis plant in North Carolina, funded in part with a $487 million federal contract announced in January, will use a new cell-based technology that makes vaccines faster than they grow in eggs. That plant, however, is not yet online.

The vaccine-makers also have plants overseas and big orders from countries such as Japan and Brazil. Mr. Robinson said there will be no conflict as the companies fill competing orders.

However, existing law does allow the government to lay first claim on any vaccines made in this country. The law is typically applied to military hardware but could apply in other situations, Mr. Robinson said.

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