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(Agri-Flu) New vaccine approved to fight seasonal flu

AlaskaDenise

AlaskaDenise

In Memoriam
UNDATED (WKOW) -- The Food and Drug Administration approved a new vaccine to battle the seasonal flu

It's called Agri-Flu, and its administered as a single injection in the upper arm.

Its not intended to protect against the H1N1 virus.

Early studies show the vaccine induces levels of antibodies in the flood that are effective in preventing the seasonal flu.

But it still needs to go through further tests.

According to the FDA, no vaccine is 100 percent effective in preventing the flu.

http://www.wkowtv.com/Global/story.asp?S=11585583
 
Re: New vaccine approved to fight seasonal flu

Re: New vaccine approved to fight seasonal flu

Novartis New Drug for Seasonal Flu, Agriflu, Approved by FDA

A new drug for seasonal flu from the house of giant drug-manufacturer Novartis, Agriflu has been approved by the US Food and Drug Administration. The drug is a preventative medicine for seasonal influenza and should not be confused as a protective medicine against H1N1 or Swine Flu.

As confirmed by the FDA, the medicine was approved using the agency's accelerated approval process, and the manufacturing firm has demonstrated that Agriflu is capable of inducing the levels of antibodies in the blood, which in turn help fight against seasonal flu better, but because the drug has been approved under the special accelerated program, more studies need to be conducted.

Intended for ages 18 and above, the medicine is administered as a single shot in the upper arm and is, according to the FDA, "available in single-dose, pre-filled syringes".

Agriflu is made in Siena, Italy, with eggs and is already available throughout Europe where it is marketed as Aggripal, as has been confirmed by Novartis spokesman Eric Althoff, who believes that the approval will add to "future seasonal vaccine supplies".

http://topnews.us/content/28617-novartis-new-drug-seasonal-flu-agriflu-approved-fda
 
Re: New vaccine approved to fight seasonal flu

Re: New vaccine approved to fight seasonal flu

So does this include an adjuvant? What exactly is in this vaccine, is it a trivalent vaccine?
 
Re: (Agri-Flu) New vaccine approved to fight seasonal flu

Package insert:

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM192127.pdf

(snipped)

11. DESCRIPTION

AGRIFLU, Influenza Virus Vaccine, for intramuscular injection is a trivalent inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens? eggs inoculated with an influenza virus suspension containing kanamycin and neomycin sulphate. Each of the influenza virus strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with formaldehyde. The inactivated virus is concentrated and purified by zonal centrifugation.

The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the
presence of cetyltrimethylammonium bromide (CTAB), a process which removes most of the internal proteins. The CTAB is removed from the vaccine preparation by subsequent purification steps.

AGRIFLU is a sterile clear aqueous suspension and is formulated to contain a total of 45 mcg hemagglutinin (HA) per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following three influenza virus strains recommended for the 2009/2010 influenza season: A/Brisbane/59/2007, IVR-148 (H1N1); A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus); and B/Brisbane/60/2008.

AGRIFLU is manufactured and formulated without thimerosal or any other preservative.

Each 0.5 mL dose may contain residual amounts of egg proteins (<0.4 mcg), formaldehyde (≤10 mcg), polysorbate 80 (≤50 mcg), and CTAB (≤12 mcg). Each dose may also contain residual amounts of neomycin (≤0.02 mcg by calculation) and kanamycin (≤0.03 mcg by calculation), which are used during the initial stages of manufacture. The syringe plunger does not contain latex.
Click to expand...

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Re: (Agri-Flu) New vaccine approved to fight seasonal flu

Thanks. So when will this be available. And why isn't there a novel H1N1 component rather than A/Brisbane/59/2007, IVR-148?
 
Re: (Agri-Flu) New vaccine approved to fight seasonal flu

Laidback Al said:
.............. And why isn't there a novel H1N1 component rather than A/Brisbane/59/2007, IVR-148?
Click to expand...

Agree - why are they even talking about old seasonal H1???

Perhaps there was a contract that was in effect, even though reality has changed.

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