Dec 2, 2009 (CIDRAP News) – A second seasonal influenza vaccine made by Novartis was approved recently by the US Food and Drug Administration (FDA), and the company said some doses may reach the market this flu season.
The FDA on Nov 27 announced its approval of the injectable vaccine, called AgriFlu, for use in patients age 18 and older. It is made in Siena, Italy, and comes in single-dose, pre-filled syringes with no preservative, the agency said. The vaccine is not intended to provide protection against the pandemic H1N1 virus.
Novartis spokesman Paul Newman told CIDRAP News that some doses of the vaccine will be supplied to the United States this winter, but it will be available primarily for the 2010-11 season. He said he couldn't estimate how many doses would be distributed this season, as quantities will depend on yields and quality testing.
The egg-based vaccine will be supplied only in a formulation free of thimerosal, a mercury-containing preservative, Newman said.
The FDA said it used its accelerated approval pathway in evaluating the vaccine. In the FDA announcement, Karen Midthun, MD, acting director of the Center for Biologics Evaluation and Research, called the approval of AgriFlu "an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons."
The Centers for Disease Control and Prevention (CDC) has estimated that this year's seasonal flu vaccine supply will reach about 115 million doses, but distribution has been slowed by the pandemic H1N1 vaccine campaign. CDC spokesman Tom Skinner said today that the estimate does not include any doses of AgriFlu.
Novartis already markets the seasonal flu vaccine Fluvirin, which is approved by the FDA for people age 4 and older. Commenting on the reasons for seeking US approval of AgriFlu, Newman said by e-mail, "To ensure adequate seasonal flu vaccine supply, Novartis is diversifying our manufacturing platform for, and in, the US. AgriFlu is made in Siena, Italy, and Fluvirin in Liverpool, UK, so Novartis is now able to supply the US market with vaccines produced at two different facilities."
More than 97 million doses of the vaccine have been distributed in other countries over the past 20 years, including some in Europe, where the vaccine goes by the name Agrippal, Newman reported.
He said the vaccine was tested only in adults in connection with the application for US licensing, but a development program for children and adolescents is under way. The European version of the vaccine is used in children from the age of 6 months, he reported.
The FDA said common side effects in clinical studies of the vaccine included pain, swelling and redness at the injection site, headache, muscle aches, and malaise. People with severe allergies to chicken eggs should not receive the vaccine, the agency noted.
Newman said the name AgriFlu is partly derived from "grippe," an older name for influenza.
Besides Novartis, manufacturers supplying seasonal flu vaccines in the United States are CSL Limited (Afluria), GlaxoSmithKline (GSK) Biologicals (Fluarix), ID Biomedical Corp. (a unit of GSK) (FluLaval), Sanofi Pasteur (Fluzone), and MedImmune Inc. (FluMist).
Nov 27 FDA press release