Featured Research

from universities, journals, and other organizations

FDA Approves New Influenza Vaccine Production Facility

Date:
May 7, 2009
Source:
U.S. Food and Drug Administration
Summary:
The U.S. Food and Drug Administration (FDA) has announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

The U.S. Food and Drug Administration (FDA) has announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

As part of its overall pandemic influenza preparedness efforts, the FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency promptly reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine.

The facility, located in the United States, is owned and operated by sanofi pasteur, which manufactures Fluzone Influenza Virus Vaccine. This new facility will greatly increase sanofi pasteur’s production capability.

“This approval represents an important step towards increasing the availability of influenza vaccines,” said Karen Midthun, M.D., the FDA’s acting director of the Center for Biologics Evaluation and Research.

“Increased manufacturing capacity for influenza vaccine is critical to our preparedness for an influenza pandemic,” said Jesse Goodman, M.D., M.P.H., the FDA’s acting chief scientist and deputy commissioner for scientific and medical programs. “This action also enhances the ability to produce and provide vaccines to protect the public from seasonal influenza, still estimated to cause more than 30,000 deaths per year. Thanks to strategic investments by the federal government and proactive efforts and engagement by the FDA and the vaccine industry, our nation’s preparedness has come a long way over the last five years.”

The FDA has interacted with the company throughout the regulatory process to help ensure compliance with applicable requirements.

The bulk manufacturing facility will be used for the production of Fluzone, sanofi pasteur’s egg-based influenza vaccine.

Sanofi Pasteur is located in Swiftwater, Pa.

Information on the FDA’s response to the new 2009 H1N1 influenza virus may be found on the FDA’s Web site at http://www.fda.gov/h1n1flu/default.htm.

Information on seasonal influenza vaccine may be found on the FDA’s Web site at http://www.fda.gov/cber/flu/flu.htm.

The FDA’s Pandemic Influenza Preparedness Strategic Plan may be found on the FDA’s Web site at http://www.fda.gov/oc/op/pandemic/strategicplanupdate03_08.html.


Story Source:

The above story is based on materials provided by U.S. Food and Drug Administration. Note: Materials may be edited for content and length.


Cite This Page:

U.S. Food and Drug Administration. "FDA Approves New Influenza Vaccine Production Facility." ScienceDaily. ScienceDaily, 7 May 2009. <www.sciencedaily.com/releases/2009/05/090507175916.htm>.
U.S. Food and Drug Administration. (2009, May 7). FDA Approves New Influenza Vaccine Production Facility. ScienceDaily. Retrieved September 30, 2014 from www.sciencedaily.com/releases/2009/05/090507175916.htm
U.S. Food and Drug Administration. "FDA Approves New Influenza Vaccine Production Facility." ScienceDaily. www.sciencedaily.com/releases/2009/05/090507175916.htm (accessed September 30, 2014).

Share This



More Health & Medicine News

Tuesday, September 30, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

How 'Yes Means Yes' Defines Sexual Assault

How 'Yes Means Yes' Defines Sexual Assault

Newsy (Sep. 29, 2014) Aimed at reducing sexual assaults on college campuses, California has adopted a new law changing the standard of consent for sexual activity. Video provided by Newsy
Powered by NewsLook.com
Scientists May Have Found An Early Sign Of Pancreatic Cancer

Scientists May Have Found An Early Sign Of Pancreatic Cancer

Newsy (Sep. 29, 2014) Researchers looked at 1,500 blood samples and determined people who developed pancreatic cancer had more branched chain amino acids. Video provided by Newsy
Powered by NewsLook.com
Colo. Doctors See Cluster of Enterovirus Cases

Colo. Doctors See Cluster of Enterovirus Cases

AP (Sep. 29, 2014) Doctors at the Children's Hospital of Colorado say they have treated over 4,000 children with serious respiratory illnesses since August. Nine of the patients have shown distinct neurological symptoms, including limb weakness. (Sept. 29) Video provided by AP
Powered by NewsLook.com
Dr.'s Unsure of Cause of Fast-Spreading Virus

Dr.'s Unsure of Cause of Fast-Spreading Virus

AP (Sep. 29, 2014) Doctors at the Children's Hospital of Colorado say they have treated over 4,000 children with serious respiratory illnesses since August. Nine of the patients have shown distinct neurological symptoms, including limb weakness. (Sept. 29) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins