Pandemic Produces New Stimulus To Develop Universal Vaccine, Create Better Defenses Against Flu Mutations Of The Future

BEIJING - The first pandemic to threaten the planet in decades, by focusing a global spotlight on influenza mutations and on biotech-based defenses, is creating a new stimulus to develop a universal vaccine and to expand the sectors of the worldwide populace - especially in lower-income regions - that are immunized.

The current march of the H1N1 pandemic across the continents could spearhead a relatively high incidence of child mortality rates in developing countries, according to Rino Rappuoli, who heads Novartis Vaccines and Diagnostics in Siena, Italy.

Rappuoli outlined that danger in an interview following the publication of an article that he co-authored in the U.S. journal Science entitled, "Rethinking Influenza." In that paper, co-written with scholars at the Vaccine Research Center under the U.S. National Institutes of Health and at the World Health Organization in Geneva, Switzerland, Rappuoli stated: "Because most of our knowledge of influenza virus is based on data accumulated in developed countries, we have an incomplete, and sometimes inaccurate, view of virus spread and its global impacts."

"In the few developing countries where studies have been performed," he added, "influenza has been associated with an unexpectedly high mortality rate among infants and children."

The same trend could follow the paths of the pandemic, Rappuoli said.

Whether seasonal or pandemic, he explained, "Flu is a major contributor to pneumonia; that is the main cause of childhood mortality in developing countries."

In some low-income tropical countries studied, influenza "persists year-round and often manifests itself as pneumonia," he added.

Meanwhile, the WHO's Strategic Advisory Group of Experts on Immunization has recommended that high-priority groups to be inoculated against H1N1 around the world should include children and young people to reduce the pandemic's rate of expansion, he noted.

Scientists at Novartis point out: "The Spanish influenza pandemic of 1918 traversed the globe within four months and took more lives - well over 50 million - than did the First World War."

"Although the present manufacturing capacity is unlikely to have all the vaccines needed before the peak of the next wave of cases," Rappuoli said, "the potential output of vaccine manufacturing has increased from 400 to 900 million."

In Europe, Novartis has sped up the production of vaccines, including the H1N1 defense, by switching from traditional eggs to modern cell culture technology.

A cell culture-based vaccine facility is now being built by Novartis in Holly Springs, North Carolina. "When licensed by the Food and Drug Administration and fully operational, it will be capable of churning out, within just six months, up to 150 million doses of vaccine against a potential pandemic influenza strain," Rappuoli explained.

"The plant should be able to produce at full capacity in 2013," he added.

Even as Novartis races to ramp up production of vaccines for H1N1 and potential pandemics of the future, Rappuoli said, the biotech outfit is also conducting extensive research on the use of adjuvants to bolster each shot's effectiveness (Also see "Chinese Tank Commanders, Megacity Teens First In Line For A/H1N1 Vaccine" - Scrip, 9 Sep, 2009.). Adjuvants combined with antigens in a vaccine have been shown to increase the body's immune response.

New studies should test whether adjuvants promote multi-year protection, Rappuoli said.

"Research toward development of a universal vaccine should be accelerated by testing adjuvants to increase cross-protection," stated Rappuoli and co-authors of the Science article.

To that end, Rappuoli said, he is heading the Novartis drive to develop a universal vaccine through the use of the proprietary adjuvant MF59.

"We believe we have already made progress in getting vaccines that cover drifted strains by using M59," he said. "The long-term goal is to have vaccines that will cover all or most strains, but these vaccines are still far away."

- Kevin Holden ([email protected])