GlaxoSmithKline announced Monday that federal regulators have delayed approval of its bird flu vaccine.

GSK said it has received a Complete Response Letter from the Food and Drug Administration, which is what the agency issues when its review process is complete and a drug application is not ready for approval.

GSK said the letter was triggered by an "administrative matter that has since been rectified." The company said it is working with the FDA to complete the review.

The vaccine is designed for use in a potential pandemic of bird flu, also known as H5N1.

In November, an FDA advisory committee voted unanimously to support the use of the vaccine in adults.

London-based GSK has its U.S. headquarters in Research Triangle Park and also operates a manufacturing facially in Zebulon.

Despite rumors to the contrary, the total investment that drug maker Novartis is making in its Holly Springs vaccine has not increased.

During an event this morning in Holly Springs, Jamie Iudica, senior director of technical operations for the Holly Springs plant, was introduced as an executive of a company that is investing $600 million in Holly Springs.

Iudica quickly clarified that the total investment in the plant is actually closer to one billion dollars.

Rob Ali, a Novartis spokesman who also attended this morning's event, said the figure is not new.

Ali said Novartis has publicized the size of its investment in the past.

Ali said Novartis still expects the vaccine plant to employ 350 people. It currently has 233 employees.

Novartis expects to begin commercial production of flu vaccines in Holly Springs by 2013, although the facility will be running before then to secure regulatory approval.
 

GlaxoSmithKline got good news today from federal health officials.

The Food and Drug Administration's vaccine panel said that the vaccine Cervarix successfully blocked the main virus that causes cervical cancer and appeared safe for females age 10 to 25.

Kerr Drug has started selling flu shots — joining other drug store chains who are attempting to get a jump on the season.

Drug store executives say they are expecting unprecedented demand and Kerr has trained an additional 115 pharmacists to immunize customers. The company has 18 stores in the Triangle.