Had the H1N1 influenza pandemic instead been the feared H5N1 pandemic, the on-going shortages of H1N1 vaccine would mean the world would, well, be screwed. Current shortages have left untold thousands without access to the vaccination. Many hospitals and clinics have run out, forcing them to turn people away - some who'd been waiting in long lines to get vaccinated. Though news organizations, pundits, and critics have implied that blame for the shortage rests with federal and state public health authorities, the critics have largely misplaced their venting.

Governments and the handful of vaccine manufacturers for the entire world have been doing the best they can using 1950s vaccine production technology at break-neck production speed. Compounding this problem was the unpredictable slow growth of the H1N1 virus in eggs, in which viruses are grown for producing vaccines in current manufacturing processes. This could not have been foreseen.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), has explained that the principle problem has been the slow growth of H1N1 in eggs in combination with the extremely short time there was available to produce a vaccine between the time the pandemic was declared and the onset of flu season.

Indeed. Manufacturers have had a hard time getting the H1N1 virus to grow in eggs quickly enough. Switzerland-based Novartis, for example, initially was able to grow only 23 percent of the virus it normally is able to grow for a typical seasonal flu vaccine.

Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), told the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies a few weeks ago that "it's likely that the current wave of infection will peak, crest, and begin to decline before there are ample supplies," of H1N1 vaccine, adding: "Whether there'll be another wave of H1N1 between now and May and whether we'll get a different strain [requiring yet another new vaccine], only time will tell."

As Homeland Security Today reported earlier on in the debate over H5N1, at best, the world’s vaccine makers are hard pressed to produce just a billion doses of pandemic vaccine for the whole world, a grim reality US and world emergency public health planners have had to accept. It also on average takes a minimum of six months to develop a workable vaccine and perform safety testing once the specific pandemic strain is isolated. So, given that H1N1 first emerged last April and wasn’t declared by the World Health Organization (WHO) to be a pandemic until June 11, vaccine developers and governments have done a herculean job of producing and distributing as much vaccine around the world as they have.

According to WHO, global vaccine production capacity is roughly 565 million doses, a total that incorporates actual capacity increases achieved by manufacturers and theoretical capacity that would be created if manufacturing lines operated around the clock all year. But this would still only be a production capacity of perhaps as many as 1.5 billion doses.

And a vaccine is the closest thing to salvation from a pandemic that there is.

It was only after the realization about five years ago that the highly virulent H5N1 avian flu might become transmissible between humans and erupt into a devastating planetary pandemic that investments slowly began to be made in state-of-the-art vaccine production technologies.

In its pandemic preparedness-funding package three years ago, the government earmarked less than $2 billion for exploring new vaccine manufacturing methods, assisting manufacturers in retrofitting their half-a-century-old vaccine production processes with 21st-century technology and expanding existing production lines.

The Department of Health and Human Services (HHS) awarded two contracts totaling $132.5 million to Sanofi Pasteur, Lyon, France, and MedImmune Inc., Gaithersburg, Md., over five years to retrofit their existing egg-based domestic vaccine manufacturing facilities on a cost-sharing basis to expand influenza vaccine manufacturing capacity that could be used in the event of a pandemic.

Upon completion, these facilities will expand domestic pandemic vaccine manufacturing capacity by 16 percent.

In June, 2007 Novartis Vaccines & Diagnostics began construction of the first cell culture-derived flu vaccine plant in the United States. HHS awarded a $220.51 million grant to the company a year earlier to aid in the construction. The facility is expected to produce up to 150 million doses of monovalent vaccine supplemented with the company’s adjuvant technology in the event of a pandemic outbreak. The plant is expected to be ready to start making vaccine in 2011.

But even then, it’s unclear just how soon a cell-based flu vaccine would win Food and Drug Administration approval.
WHO estimates that building and licensing a new vaccine production line can take up to five years.

In May 2006, DynPort Vaccine Company LLC, Frederick, Md., and Baxter International Inc., Deerfield, Ill., received a potential $242.5 million contract from HHS to develop Baxter’s cell-cultured seasonal and pandemic influenza vaccines.

GlaxoSmithKline, Brentford, UK, received a $274.75 million assistance grant; MedImmune, $169.6 million; DynPort Vaccine, $40.97 million; and Solvay Pharmaceuticals Inc., Marietta, Ga., $298.59 million.

Dr. Robin Robinson, acting associate director for HHS’ Pandemic Influenza Program, said HHS wants to be able to produce 475 million doses of pandemic vaccine by 2011 within six months of a pandemic outbreak.

But according to sources familiar with the progress, adequate production capacity isn’t expected until well after 2012.

“We must be prepared to face the first wave of the next pandemic without vaccine and potentially without sufficient quantities of influenza antiviral medications,” a CDC statement warned.

Meanwhile, other vaccine manufacturing companies have abandoned plans for such plants in the US and instead are rennovating their egg-based production plants.

Not just a few xperts have warned that the only way to expand global vaccine manufacturing capacity is if governments step up to the plat to help pay for expanding their production lines.

"If we really want to have surge capacity for pandemic vaccine, we have to invest in it like we do our oil reserves, or military reserve capacity," Dr. Michael Osterholm has pointed out. Osterholm is director of the Center for Infectious Disease Research & Policy and director of the National Institutes of Health-supported Center of Excellence for Influenza Research and Surveillance within CIDRAP. "The facilities may sit for years before they are utilized. But the analogy is having an airport fire department in case of a plane crash: You hope never to use it, but you invest as though it were a possibility.”

Other companies are developing so-called recombinant vaccines using proteins or DNA, but those are still in various stages of development and production. But these facilities are still years away from coming on line.

Authorities agree that the United States – nay, the world – must continue to invest in large-scale capacity for manufacturing vaccines using the latest technologies.

Fauci has said that cell-based vaccine production technology will be an improvement, but still isn’t the ultimate answer to flu vaccine production problems. "We want to take vaccinology into the 21st century by not requiring the virus to grow … The end game is to get away from requiring the virus to grow."

"What we're going to see over the next years is a gradual transition from egg-based to egg-based with cell-based to advanced molecular technology," Fauci said.

The ultimate goal is to make a universal flu vaccine that targets a component of flu viruses that doesn't change each season. A vaccine like this could then be made in large quantities and stored – and, Fauci stressed, people wouldn't have to be vaccinated every year.

"That's the plan,” he said. But that plan is “going to take years.”