Another seasonal flu vaccine on way to US market

[Guest guest]

Note: This article, after my brief " two cents worth, " is off the CIDRAP Website.

This seasonal vaccine is " primarily for the 2010-11 season. " It " won't " have

protection against pandemic H1N1.

I'm still betting there will be problems with getting ample supply of H1N1

Vaccine in 2010-2011. (People are still trying to get seasonal vaccine for this

season.)

There's no reason to believe that everything will be " hunk dory " next year with.

Sure, they may get the seasonal vaccine out. Adding H1N1 may complicate matters

just a tad.

was an optimist,

Roos News Editor

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 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, 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), GlaxoKline (GSK) Biologicals (Fluarix),

ID Biomedical Corp. (a unit of GSK) (FluLaval), Sanofi Pasteur (Fluzone), and

MedImmune Inc. (FluMist).

http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/dec0209novartis.\

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