H1N1 Vaccines Could Have Increased, Says Drug Company

WASHINGTON, DC (WUSA) --- Dr. Vas Narasimhan, President of Novartis Vaccines USA, says the company makes an adjuvant, a chemical agent, that reduces the dosage of the H1N1 vaccine while still maintaining its effectiveness.

According to Narasimhan's statement, reducing the dosage allows for more vaccines to be created, therefore increasing the volume of the H1N1 vaccine supply.

Narasimhan testified before a hearing on H1N1 Preparedness with the Subcommittee on Health and the Subcommittee on Oversight and Investigations, Nov. 18, 2009.

"Although the government ordered bulk doses of [Novartis'] proprietary adjuvant MF59, which based on recently-available data could have quadrupled the number of doses supplied, it ultimately determined that use of the adjuvant was not warranted," states Narasimhan's testimony.

Novartis' Pamela McKinlay says the drug company has not applied for FDA approval of the adjuvant now. FDA has not responded at the time of this article.

Rep. Henry Waxman (D-CA) opened the hearing with the detail that the Center for Disease Control and Prevention (CDC) estimates about 4,000 people have died from the H1N1 virus in the U.S.

"Novartis Vaccines is currently providing only adjuvanted vaccine to all other regions of the world and believes that adjuvantation could have provided significant benefits to the U.S. in terms of supply volume for this year's pandemic," says Narasimhan.

The hearing also highlighted the ability to decrease significant production time of the vaccine by using cell-based vaccine cultures. Currently, the H1N1 vaccine has been created with cultures using chicken eggs which takes more time to process.

Novartis says it will open up its first, large-scale cell culture based manufacturing facility Nov. 24, 2009, in Holly Springs, North Carolina.

"The site will have the capacity to provide 150 million doses of adjuvanted pandemic vaccine within 6 months of declaration of an influenza pandemic," says McKinlay.

The U.S. Dept. of Health and Human Services provided the drug company a contract in May 2006, to develop "an influenza cell culture vaccine and to develop and design a manufacturing facility for such a vaccine in the U.S."

Marburg, Germany currently has the drug company's other cell culture facility.