FDA approves novel Novartis seasonal flu vaccine

Wed Nov 21, 2012 4:46am IST

A man walks past the logo of Swiss drugmaker Novartis AG in front of a plant in Basel October 25, 2011. REUTERS/Arnd Wiegmann

A man walks past the logo of Swiss drugmaker Novartis AG in front of a plant in Basel October 25, 2011.

Credit: Reuters/Arnd Wiegmann

Related Topics

Stocks

   

(Reuters) - The U.S. Food and Drug Administration said on Tuesday it approved a seasonal flu vaccine produced by Novartis using animal cell culture rather than the traditional manufacturing using chicken eggs - a speedier process that could help build stockpiles in the event of a pandemic.

The vaccine, to be sold by the Swiss drugmaker under the brand name Flucelvax, is approved to prevent season influenza in people aged 18 and over, the agency said.

To produce Flucelvax, virus strains for the vaccine are grown in animal cell cultures derived from mammals instead of in chicken eggs. Similar cell culture technology has long been used to produce other types of vaccines, FDA said.

"Today's approval represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process," Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

Using cell cultures rather than chicken eggs allows for a faster start-up of the vaccine manufacturing process in the event of a health crisis, such as a flu pandemic. Traditional flu vaccine production requires a tremendous number of fertilized chicken eggs to grow virus strains and often takes several months before it is ready to be delivered to physicians or pharmacies.

The cell-based process also enables manufacturers to maintain a supply of readily available, previously tested cells for use in vaccine production.

"Modern cell-culture technology will likely become the new standard for influenza vaccine production," predicted Andrin Oswald, head of Novartis' vaccines and diagnostics division.

Flucelvax will eventually be manufactured at a new U.S. plant in Holly Springs, North Carolina, once that facility is ready for full-scale commercial production, Novartis said.

The production takes place in a sterile, controlled environment, which significantly reduces the risk of potential impurities, the company said.

In clinical trials, Flucelvax was 83.8 percent effective in preventing flu when compared with a placebo.

A limited supply of the new vaccine will be available for this year's flu season, Novartis spokeswoman Liz Power said.

Novartis supplies the United States with about 30 million doses of flu vaccine annually, she said.

(Reporting by Bill Berkrot; Editing by Leslie Gevirtz and David Gregorio)

FILED UNDER:

Ebola Watch

Feature: Africa's medicine men key to halting Ebola spread in Guinea

Feature: Africa's medicine men key to halting Ebola spread in Guinea

In a land where witchcraft is sought after more than science for curing illness, medicine men in Guinea say the Ebola epidemic would be over by now if they had been properly included in the outbreak response.  Full Article 

Reuters Showcase

India Cricket Chief

India Cricket Chief

Former ICC boss Dalmiya returns as BCCI chief.  Full Article 

S&P on Budget

S&P on Budget

Budget shows commitment to keep fiscal deficit low - S&P.  Full Article 

New Phone

New Phone

Samsung unveils sleek new Galaxy phones to battle Apple.  Full Article 

MH370 Search

MH370 Search

Interview: Australia says hunt for missing MH370 jet may be called off soon.  Full Article 

Blogger's Murder

Blogger's Murder

Bangladesh says arrests main suspect in U.S. blogger Avijit Roy's killing.  Full Article 

England under Fire

England under Fire

Changes demanded after England's latest World Cup flop.  Full Article 

Anti-Putin Rally

Anti-Putin Rally

Anti-Putin protesters rally in New York after Nemtsov's murder.  Full Article 

Brit Awards

Brit Awards

Brit awards shake up British album chart, boost Sam Smith.  Full Article 

Lathmar Holi

In Pics: Lathmar Holi

Images of "Lathmar Holi" at Nandgaon in Uttar Pradesh.  Full Coverage 

Reuters India Mobile

Reuters India Mobile

Get the latest news on the go. Visit Reuters India on your mobile device.  Full Coverage