Technology

Preparing for a New Pandemic

U.S. capacity for producing flu vaccines could increase at least 25% if innovative production methods of a new North Carolina vaccine-production facility live up to expectations.

The Novartis Vaccines and Diagnostics–owned facility, to be located in Holly Springs, North Carolina, will be unlike any other vaccine facility in the United States in one respect: It will not use chicken eggs to produce its vaccines.

For more than 50 years, “egg-based” production has been the pharmaceutical industry’s standard method of producing flu vaccines. It involves inserting flu viruses into chicken eggs, leaving them to develop for a few days, and then retrieving the infected egg yolk to create a vaccine.

Technicians can generate an average of one to two vaccines per egg. The first vaccines typically appear about six months after a flu outbreak has been identified; a mass supply of vaccines is available in nine months.

But the new North Carolina facility could produce new vaccines “in a matter of weeks,” according to the U.S. Department of Health and Human Services (HHS), which awarded Novartis a $487 million contract in January to construct it. This facility can operate on a faster timetable because it will rely on “cell-based” production, which substitutes lab-grown cells for eggs.

Cells can be grown more rapidly than eggs and stored in far larger quantities, according to HHS. So the Department plans to produce many more vaccines more quickly. Speed is critically important to prevent a flu outbreak from becoming a pandemic.

“In a [highly lethal] pandemic, we would need a vaccine ready within six months. That goal could not be accomplished using the traditional egg-based method of producing flu vaccines,” says Robin Robinson, director of the HHS Biomedical Advanced Research and Development Authority.

Novartis says that the facility, scheduled to be completed by 2012, will produce 150 million doses of a flu vaccine within six months.

The 2009 H1N1 flu virus has required a whole new vaccine because current seasonal vaccines are ineffective against it. Its genetic code is a variant of human, swine, and avian flu strains, all mixed together into a mutant strain that current treatments cannot recognize.

“Pigs serve as mixing vessels. A pig can be jointly infected by multiple species’ strains of influenza,” explains Daniel Barnett of the Johns Hopkins Bloomberg School of Public Health. “Those strains can then recombine in a pig to generate a novel strain for which there is no preexisting immunity in human populations.”

H1N1 has been relatively mild in its impact compared with flu outbreaks of the past. As of May 29, 2009, according to the World Health Organization, the virus had killed only 99 human victims, but Barnett warns that it could get much worse.

Microbiologist and futurist Tyler Kokjohn of Midwestern University agrees, and thinks that it is all the more reason to have as many flu vaccines in stock as possible.— Rick Docksai

Sources: Daniel Barnett, Johns Hopkins Bloomberg School of Public Health, www.jhsph.edu.

World Health Organization, www.who.int.

Tyler Kokjohn, Midwestern University, www.midwestern.edu.