by Maggie Fox, Health and Science Editor

Last Updated: 2009-11-23 13:00:35 -0400 (Reuters Health)

* New factory first in U.S. to use cells to make flu shots

* Novartis hopes U.S. market will accept boosted vaccines

* First dose won’t come before 2011

WASHINGTON (Reuters) – Novartis will officially open the first next-generation flu vaccine plant in the United States on Tuesday, but it will be years before it makes its first vaccine.

The factory in Holly Springs, North Carolina, will use batches of dog cells to grow influenza vaccine, instead of the chicken eggs widely used now. While the cell method is only slightly faster, it can be scaled up more quickly.

Federal advisers to the U.S. Food and Drug Administration last week asked for more safety data on another cell-based vaccine, one made by privately held Protein Sciences Corp. But U.S. officials said the new Novartis shot is not as experimental.

"I see them as totally different. The whole point of pushing on cell culture was increasing capacity and surge capacity," Dr. Bruce Gellin, head of the U.S. Health and Human Services Department’s National Vaccine Program Office, said in an interview.

HHS spent $487 million helping Novartis build the plant, which was planned before the current pandemic of H1N1 swine flu.

The U.S. government is struggling to vaccinate enough Americans against H1N1. The Centers for Disease Control and Prevention estimates 22 million Americans have been infected, and it wants to vaccinate at least 160 million people.

But just over 50 million H1N1 vaccines have been distributed.

When it gets up and going in 2011, Novartis says the Holly Springs facility will be able to make 50 million doses of seasonal flu vaccine a year and up to 150 million doses of pandemic vaccine within six months of a pandemic being declared.

That assumes that the pandemic vaccine contains an adjuvant — an additive that boosts the body’s response to a vaccine and lowers the dose needed.

Adjuvants are not licensed for U.S. use now, mostly because of widespread public suspicion of new vaccine ingredients.


Eric Althoff, a spokesman for Novartis, said the company will start making adjuvants at the new factory, anyway. The company’s cell-based influenza vaccine made with an adjuvant was approved in Germany this month, so vaccine could be made in the United States for export to the European market, he said.

Novartis is among the flu vaccine makers frustrated by the U.S. government’s refusal to use vaccines with adjuvants.

The Novartis cell-based vaccine needs only 3.75 micrograms of antigen, the active ingredient in a vaccine, compared to 15 micrograms for a vaccine made without antigen. So using an adjuvant could effectively quadruple vaccine supply.

European clinical trials have shown the adjuvants are safe and boost supply, but the FDA would require separate data to license a new vaccine.

"We need clarity on why (the results of) European trials are not accepted in the United States," Althoff said in a telephone interview.

Dr. Scott Gottleib of the American Enterprise Institute says the new technology is faster and more predictable than using eggs. And the new factory is on U.S. soil.

"We also lack domestic vaccine manufacturing facilities. In at least two cases we know of, this put the U.S. behind other countries in getting vaccine orders filled," Gottleib told Congress in written testimony earlier this week.

Gottleib said Canadian authorities had asked GlaxoSmithKline to ensure it would fill Canadian orders from its factory in Quebec before filling the U.S. order for 7.6 million doses. Likewise, Australian vaccine maker CSL was asked to ensure the Australian supply before filling U.S. orders.

Sanofi Aventis has a flu vaccine plant in Pennsylvania, but other flu vaccines for the U.S. market are made in other countries.

Many experts have cautioned that in the event of a very serious pandemic, countries would be likely to seize any vaccines made within their own territories.

(Editing by Julie Steenhuysen; editing by John Wallace)