FDA approves one more influenza vaccine ahead of flu season

The US Food and Drug Administration (FDA) has approved on Friday a new influenza vaccine for the adults, bringing the total number of licensed seasonal influenza vaccines for the U.S. market to six.

Manufactured by CSL Limited, a Biopharmaceutical products manufacturer of Parkville, Australia, the new influenza virus vaccine, called Afluria, is intended for people 18 and older.

FDA said in a statement that Afluria influenzation can now be used in the United States to protect adults against the highly contagious influenza disease caused by influenza virus types A and B.

"Today's action is important, because it brings to six the number of companies licensed to supply flu vaccine in the United States," said Dr. Jesse L. Goodman, director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research.

Influenza (commonly known as "the flu") is an acute respiratory illness caused by one of the family of influenza viruses. In infants, persons over the age of 65 years, and those with chronic medical conditions, flu can lead to pneumonia, hospitalization, and even death. Each winter, influenza engulfs 36,000 lives in America, most of them elderly and children, and more than 200,000 people are hospitalized with flu-related complications.

Overwhelmed with FDA’s approval to distribute its Afluria vaccine in the US, CSL said in a statement that "Today's approval marks the company's first entry into the US vaccine market."

Flu vaccine Afluria contains inactivated influenza viruses grown in chicken eggs, meaning people who are allergic to eggs or any other component of the vaccine should not receive the drug, FDA said.

The vaccine is administered as a single injection in the upper arm, and headache, fatigue, muscle aches, tenderness, pain, redness and swelling at the injection site are the most common side effects of the vaccine. The treatment will be available in both a single-dose, thiomersal-free, pre-filled syringes and in multi-dose vial with thimerosal, a mercury derivative, as a preservative, officials said.

CSL anticipates providing about 2 million doses of its flu vaccine Afluria for this year's U.S. flu season, which according to US Centers for Disease Control and Prevention can begin as early as October and can last as late as May.

This supply is among the massive quantity of 132 million flu-vaccine doses expected to be arranged for the impending influenza season in the United States this year.

CSL, better known for its blood products and cervical cancer vaccine, Gardasil, expects to gradually increase the supply to an average of 20 million doses within five years. According to Paul Perreault, executive vice president at the company's CSL Biotherapies unit, the company expects stronger supply network through a new plant in Melbourne that will expand the company's capacity.

Sanofi Pasteur, the vaccine unit of Paris-based Sanofi-Aventis SA, plans to provide 50 million doses of its Fluzone shots, while Basel, Switzerland-based Novartis AG said it would have 40 million doses of Fluvirin shots.

GlaxoSmithKline Plc of London said it would make available some 30 million to 35 million doses and MedImmune, a unit of London-based AstraZeneca Plc, said it would have 7 million doses of its nasal-spray vaccine called FluMist.

Officials at the U.S. Centers for Disease Control and Prevention have been urging for extended vaccinations and believe that each year; over 200 million Americans should get vaccinated to avoid perilous consequences of the seasonal influenza. So the companies are being encouraged to push their capacity to make influenza vaccines for the U.S. market.

The process of making flu-vaccines is complicated and risky as it involves chicken eggs and months of incubation and not many companies are interested. Also the viruses mutate each year, so the batch must be mixed up fresh.

Unlike in 2004, when the flu-vaccine supply went short, 120.9 million doses were produced for the 2006-07 season, of which around 17 million went waste, the CDC said. Hundreds of thousands of doses of vaccine may go waste, the consumption may be less but they must be equipped.